News

Phase III study of Tomtovok (Boehringer) meets endpoint for NSCLC

The LUX-Lung 6 randomized, open-label Phase III trial comparing Tomtovok (afatinib), from Boehringer, to standard chemotherapy in 364 Asian patients with Non Small Cell Lung Cancer has met its primary endpoint. Within the study population, patients treated with afatinib (n=242) lived for a median of 11.0 months before their tumor started to grow again versus 5.6 months for patients treated ...

IDMC halts Phase III study of Vargatef (Boehringer) in NSCLC

The LUME-LUNG 2 double-blinded Phase III study evaluating Vargatef (nintedanib), from Boehringer, plus pemetrexed compared to pemetrexed plus placebo in patients with advanced non-squamous NSCLC has been halted at the recommendation of the Independent Data Monitoring Committee after 713 patients had been enrolled. This decision was based on the results of an interim review of efficacy (PFS) for a pre-defined ...

FDA approves Tarceva (Genentech/Astellas) for NSCLC as detected by cobas EGFR Mutation Test

Genentech, and Astellas Pharma US, Inc. have announced that the FDA has approved Tarceva (erlotinib) tablets for the initial (first-line) treatment of people with metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors have certain epidermal growth factor receptor (EGFR) activating mutations as detected by an FDA-approved test.

The FDA also approved the cobas EGFR Mutation Test, which was ...

Merck Inc files MK 3641 at FDA for treatment of Ragweed Pollen Allergies

Merck & Co. has announced that the FDA has accepted its biologics license application for MK 3641, a dissolvable tablet to treat Ragweed Pollen Allergies and expects the agency to complete its review in the first half of 2014.

Merck has partnered with ALK-Abello A/S to develop the sublingual allergy immunotherapy tablets for ragweed.

Ruconest (Santarus/Pharming) is re-filed with FDA for treatment of Hereditary Angioedema

Santarus, Inc. and Pharming Group NV have announced the submission of a Biologics License Application (BLA) to the FDA to obtain marketing approval for Ruconest (recombinant human C1 esterase inhibitor) 50 U/kg, an investigational drug for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE). The safety and efficacy of Ruconest for the treatment of HAE attacks ...

Phase II study of Favorite (Activaero) shows superiority over conventional Asthma treatment

Results from a Phase II trial in children with mild to moderate Asthma, conducted with the Favorite Inhalation system (budesonide suspension), from Activaero, shows it is effective and holds the promise to become the preferred treatment option when compared to conventional, general purpose therapy. Activaero's Favorite (Flow and Volume Controlled Inhalation Technology) is a drug-device combination consisting of budesonide in ...

FDA approves Karbinal ER (Tris Pharma) for Allergic Rhinitis

The FDA has on 3 April 2013 approved a New Drug Application (NDA) for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, from Tris Pharma, being the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial Allergic Rhinitis in children ages 2 and up.

Prior to 2006, carbinoxamine was widely used, with dozens of carbinoxamine-containing ...

Merck Inc. files Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet at FDA

Merck Inc., announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the FDA. In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT.

The BLA for Merck’s grass pollen AIT is supported by ...

NICE rejects Xalkori (Pfizer) for treatment of Non Small Cell Lung Cancer

The National Institute for Health and Clinical Excellence (NICE) has issued new draft guidance in which it does not recommend Xalkori (crizotinib),the tyrosine kinase inhibitor from Pfizer. for use in previously treated anaplastic-lymphoma-kinase-(ALK) positive advanced Non-Small-Cell Lung Cancer (NSCLC), but has opened a public consultation on this preliminary decision. NICE did not view the drug as being cost effective. ...

CRLX 101 (Cerulean Pharma) fails in Phase II trial for NSCLC

A randomized Phase IIb study of CRLX 101, from Cerulean Pharma, in patients with advanced Non-Small Cell Lung Cancer (NSCLC) did not meet its primary efficacy endpoint, overall survival benefit. Patients in the trial had measureable disease, previously progressed through one or two different regimens of chemotherapy, and had evidence of disease progression prior to enrollment.

The study enrolled 157 ...

FDA approves TOBI Podhaler (Novartis) for treatment of Cystic Fibrosis infections

The FDA has approved TOBI Podhaler (tobramycin inhalation powder) from Novartis on 22 March 2013 for the management of Cystic Fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.

TOBI Podhaler was approved in the EU for treatment of pseudomonas lung infection in Cystic Fibrosis patients in July 2011.

NICE now recommends Esbriet (InterMune) for idiopathic Pulmonary Fibrosis

InterMune submitted additional evidence of benefit after NICE (The National Institute of Health and Clinical Excellence) rejected Esbriet (pirfenidone) as a treatment for patients with idiopathic Pulmonary Fibrosis.InterMune agreed to revise its patient access scheme.

NICE now recommends Esbriet for use in patients who have a Forced Vital (Lung) Capacity of between 50% and 80% predicted.The cost was ...

Dymista(Meda AB) is EU approved via decentralised procedure for Allergic Rhinitis

Dymista (azelastine hydrochloride and fluticasone propionate)from Meda AB has received medical approval in Europe via the decentralized registration procedure. Dymista is approved for the treatment of seasonal and perennial Allergic Rhinitis and is now approved by the MHRA in the UK .

National registration processes, including negotiations regarding pricing and reimbursement, will now follow in each country prior ...

Phase II study of CYT003 (Cytos Biotechnology) for Allergic Asthma meets all end points

Results from a Phase IIa clinical trial with CYT003 (vaccine), from Cytos Biotechnology, show the Allergic Asthma treatment has met all its end points. The study is a randomized, double-blind, placebo-controlled trial in patients requiring long-term treatment with inhaled corticosteroids (ICS). The study recruited 63 patients who received 7 weekly to bi-weekly subcutaneous injections, with efficacy assessment during 12 weeks. ...

NICE now recommends Xolair (Novartis) for Allergic Asthma

NICE,the National Institute for Health and Clinical Excellence said it now recommends Xolair (omalizumab) from Novartis as an option for treating severe, persistent Allergic Asthma in adults, adolescents and children, in a complete change from its earlier intention to exclude it from the NHS.

Phase II trial of ToleroMune (Circassia) shows benefits for Cat Allergy two years after treatment

Results of a Phase II clinical study show that a course of just four doses of ToleroMune Cat Allergy therapy (T cell vaccine), from Circassia Ltd, maintained improvements in patients' symptoms two years after the start of treatment. The study originally measured improvements in nasal and ocular allergy symptoms (Total Rhinoconjunctivitis Symptom Score; TRSS) in 202 patients, following treatment with ...

Analysis of two Phase III studies shows Spiriva (Boehringer) provides benefits for Asthma patients

New data from two UniTinA-asthma studies of Spiriva (tiotropium bromide), from Boehringer, shows that the drug improved lung function and Asthma control in patients with poorly controlled Asthma, irrespective of their allergic status. The two studies were replicate double-blind parallel-group trials involving a total of 912 patients, who were randomized to receive tiotropium 5 mcg or placebo in addition to ...

NICE rejects extended use of Alimta (Eli Lilly) in NSCLC

NICE (The National Institute of Health and Clinical Excellence) has not recommended Alimta (pemetrexed) from Eli Lilly for use as a maintenance treatment for Non-Small-Cell Lung Cancer (NSCLC) following induction therapy with pemetrexed and cisplatin in its preliminary guidance.

NICE had given its recommendation to the drug as a first line treatment option for NSCLC and as a maintenance ...

Treprostinil diolamine extended release tablets (United Therapeutics) re-filed at FDA for treatment of PAH

United Therapeutics Corporation has announced that the FDA has acknowledged the re-submission of the new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of Pulmonary Arterial Hypertension. The FDA classified the re-submission as a complete, class 1 response to the FDA Complete Response Letter and set a user fee goal date of March 31, ...

Bayer files riociguat for CTEPH and Pulmonary Arterial Hypertension at FDA and EU

Bayer HealthCare has submitted the oral investigational drug riociguat to treat patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH) for regulatory approval in the United States and in the European Union. Riociguat was discovered by Bayer and represents the first member of a novel class of compounds, the stimulators of soluble guanylate cyclase. Riociguat ...

Bronchitol (Pharmaxis) is rejected by FDA Advisory Committee as a treatment for Cystic Fibrosis

Pharmaxis has received a negative recommendation from the Pulmonary-Allergy Drugs Advisory Committee (PADAC) advising the FDA on the use of Bronchitol (inhaled dry powder mannitol) for Cystic Fibrosis patients in the United States.

The PADAC voted on three questions relating to Bronchitol’s safety and efficacy in Cystic Fibrosis patients aged 6 years and over, with a negative result on ...

FDA recommends approval of BI 1744-CL (Boehringer) for COPD

The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended supporting the approval of BI 1744-CL (olodaterol), from Boehringer, as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic Bronchitis and/or emphysema. If approved by the FDA, it is anticipated that olodaterol will be marketed under the brand name Striverdi Respimat in the ...

Novartis withdraws application at EMA for Ruvise treatment for PAH

The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Ruvise (imatinib mesilate), 100- and 400-mg film-coated tablets. It was intended to be used for adults as add-on therapy for the treatment of Pulmonary Arterial Hypertension.

The company stated that it is ...

NICE now recommends Colobreathe (Forest Labs)for Cystic Fibrosis infections.

NICE now recommends Colobreathe(colistimethate dry powder for inhalation) from Forest Labs as an option for treating chronic pulmonary infection caused by Pseudomonas aeruginosa in people with Cystic Fibrosis.

Colobreathe is recommended for those patients who would clinically benefit from continued Colobreathe treatment, but do not tolerate it in its nebulised form and the positive recommendation is subject to ...

Cinryze(ViroPharma) success in paediatric Hereditary Angio-Oedema

New data demonstrates that use of Cinryze (C1 esterase inhibitor [human]), from Viro Pharma, in pediatric patients provided relief from symptoms of Hereditary Angio-Oedema (HAO) attacks and reduced the rate of attacks. In the study, children had a nearly twofold reduction in number of HAE attacks while receiving Cinryze for prophylaxis compared with the time period during which they received ...

Aranesp (Amgen) fails Heart Failure trial

Amgen announced top-line results of the Phase III Aranesp (darbepoetin alfa) RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial. The trial was initiated in 2006, and a total of 2,278 patients with symptomatic systolic heart failure and anemia (hemoglobin levels ranging from 9.0-12.0 g/dL) were randomized to receive either treatment with Aranesp to achieve a target ...

GSK/Theravance file GSK 573719 plus vilanterol at the EMA for COPD

GlaxoSmithKline and Theravance have announced the submission of a regulatory application to the EMA for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with Chronic Obstructive Pulmonary Disease (COPD).

UMEC/VI is a combination of two investigational bronchodilator molecules -- GSK 573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist and vilanterol (VI), a long-acting beta2 agonist ,administered using ...

IQWiG finds no additional benefit in Eklira Genuair (Almiral) in COPD treatment

IQWiG reports in a preliminary review of data of Eklira Genuair/Bretaris Genuair (aclidinium bromide) from Almiral compared to Spiriva (tiotropium) offers no additional benefit to COPD patients.

IQWiG is the German review organisation that carries out assessments under AMNOG for the G-BA which has the final decision in Germany.Some studies were too short and others had shortcomings. According ...

FDA approves Sirturo (Janssen Therapeutics) for multi-drug resistant Tuberculosis

The FDA has granted accelerated approval to Sirturo (bedaquiline), from Janssen Therapeutics, for the treatment of pulmonary multi-drug resistant Tuberculosis (MDR-TB) as part of combination therapy in adults. The FDA accelerated approval is based on Phase II data from TMC207-C208 Study 1 and Study 2.

The primary endpoint was time to sputum culture conversion: the interval in days between the ...

GSK/Theravance file GSK 573719 plus vilanterol at the FDA for COPD

GlaxoSmithKline plc (GSK) and Theravance, Inc. have announced the submission of a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with Chronic Obstructive Pulmonary Disease (COPD).

UMEC/VI is a combination of two investigational bronchodilator molecules -- GSK 573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a ...

Phase III trial of Stimuvax (Merck Serono) fails to meet primary endpoint in patients with NSCLC

The Phase III START study, a trial of L-BLP25 (formerly called Stimuvax), from Merck Serono, in patients with unresectable, locally advanced stage IIIA or IIIB Non-Small Cell Lung Cancer (NSCLC) failed to meet its primary endpoint of demonstrating a statistically significant improvement in overall survival. No new or unexpected safety concerns were noted for the study. In prior clinical studies, ...

EU awards CE mark to Revivent Myocardial Anchoring System (BioVentrix) for Heart Failure patients

BioVentrix has received the CE mark for its Revivent Myocardial Anchoring System, a surgical device that offers Heart Failure patients an alternative therapy to surgical ventricular restoration. The Revivent system is comprised of a series of titanium anchor pairs, each consisting of an internal anchor and an external anchor, which are introduced by transmural catheters. Once the desired number of ...

FDA Advisory Committee recommends bedaquiline (Janssen)for treatment of Tuberculosis

Janssen Research & Development, LLC (Janssen) has announced that the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA), in a unanimous vote (18-0), agreed that the efficacy findings for investigational bedaquiline support the proposed indication for the treatment of pulmonary multi-drug resistant Tuberculosis (MDR-TB) as part of combination therapy in adults. The committee agreed in a ...

New Phase II trial shows combination treatment with selumetinib (AstraZeneca) has promise for patients with NSCLC

A new Phase II study finds that the combination of selumetinib, from AstraZeneca, and docetaxel, was more effective than docetaxel chemotherapy alone for patients with a form of Non-Small Cell Lung Cancer (NSCLC) that carries a mutation in the gene KRAS - representing about 20 percent of all NSCLC cases. Previously, no targeted agent had proven beneficial in a trial ...

FDA Advisory Committee gives restricted recommendation for Vibativ (Theravance) for Nosocomial Pneumonia

The Advisory Committee (AIDAC) of the FDA has voted 9-6 that data, from Theravance relative to Vibativ (telavancin), failed to provide substantial evidence of the safety and effectiveness of Vibativ in treating Nosocomial Pneumonia (NP) including ventilator-associated pneumonia, caused by the susceptible Gram-positive microorganisms Staphylococcus aureus, including methicillin-resistant isolates (MRSA), and Streptococcus pneumoniae.

However in a 13-2 vote, the ...

Nice rejectes Esbriet (InterMune) as a treatment for Pulmonary Fibrosis

The National Institute for Health and Clinical Excellence (NICE) has rejected the use of Esbriet(pirfenidone), from InterMune, on the National Health Service to treat patients with idiopathic Pulmonary Fibrosis as it finds the drug is not cost effective....

Actelion submits Opsumit to EMA for treatment of PAH

Actelion has announced that the submission of the Marketing Authorisation Application for macitentan (Opsumit) for the treatment of patients with Pulmonary Arterial Hypertension to the EMA has been accepted. The FDA had already received the registration dossier on October 22nd 2012.

Macitentan, a novel oral dual endothelin receptor antagonist, was studied in the pivotal, long-term, event-driven Phase III outcome ...

NICE will not recommend Xolair (novartis) on re-appraisal for Allergic Asthma

NICE, the National Institute for Health and Clinical Excellence, has reviewed evidence on Xolair (omalizumab) from Novartis and decided not to recommend the drug as a treatment for severe persistent Allergic Asthma in adults and children. NICE noted that clinical trials submitted included data on people whose asthma was less severe than those currently treated with Xolair and that the ...

Study of Pycnogenol (Horphag Research Ltd) shows positive results in treatment of Asthma

A new study suggests that Pycnogenol (pine bark extract), from Horphag Research Ltd, can help improve control of allergic Asthma, reducing night awakenings caused by asthma symptoms by nearly 50 percent. Asthma patients who used Pycnogenol experienced reduced dependence on inhalation corticosteroid (ICS), which is commonly administered through an inhaler, and required less visits to a doctor due to asthma ...

RELAX-AF trial positive for serelaxin (Novartis) for Acute Heart Failure

RELAX-AF was a randomized, double-blind study involving 1,161 patients and was designed to compare the efficacy and safety profile of RLX030, from Novartis, to placebo in addition to standard therapy for the treatment of Acute Heart Failure (AHF). RLX 030 was given upon hospitalization in the form of an intravenous infusion (30 mcg per kg per day) for 48 ...

Positive results from Phase III trial of Ruconest (Santarus) in patients with Hereditary Angioedema

A pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug Ruconest (recombinant human C1 esterase inhibitor), from Santarus, for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met the primary endpoint of time to beginning of symptom relief. A statistically significant difference in the time to beginning of symptom ...

NICE recommends Bronchitol (Pharmaxis) for treatment of Cystic Fibrosis

The National Institute for Health and Clinical Excellence (NICE)has issued a positive recommendation in its Final Appraisal Determination for Bronchitol (mannitol dry powder) from Pharmaxis, clearing the way for reimbursement by the National Health Service. Bronchitol is recommended for adults whose lung function is rapidly declining and who do not use inhaled mucolytics for certain reasons. Bronchitol was filed at ...

NICE does not recommend Colobreathe (Forest Labs) for treatment of Cystic Fibrosis infection

NICE does not recommend Colobreathe (colistimethate dry powder for inhalation)from Forest Labs as a cost effective option for treating chronic pulmonary infection caused by P. aeruginosa in people with Cystic Fibrosis. The Committee noted that there was no economic analysis pitting the product against the nebulised form of colistimethate, while results of its preferred economic analysis showed that Colobreathe was ...

NICE recommends Tobi Podhaler (Novartis) for treatment of Cystic Fibrosis

NICE has recommended the use of Tobi Podhaler (tobramycin inhalation powder) from Novartis for the treatment of pseudomonas lung infection in Cystic Fibrosis patients aged six years and above. Tobi Podhaler may only be used in cases where treatment with the nebulised form of the drug is considered appropriate, i.e. when patients cannot have or do not respond to treatment ...

PT 003 (Pearl Therapeutics) success in Phase IIB study for COPD

Pearl Therapeutics Inc. has announced the completion of a randomized, double-blind, dose-ranging Phase IIb trial of PT003, Pearl's lead investigational inhaled combination bronchodilator product for the treatment of patients with moderate-to-severe COPD. This study assessed five BID doses of PT003, in which formoterol fumarate (FF) was co-formulated with five descending doses of glycopyrrolate (GP) and administered via metered-dose inhaler (MDI). ...

Novartis files QVA 149 in EU for COPD

QVA 149 (indacaterol plus glycopyrronium bromide), an investigational drug from Novartis, for Chronic Obstructive Pulmonary Disease (COPD) has been filed for marketing authorisation with the EMA. The first five studies in the Phase III IGNITE clinical trial program for QVA 149 formed the basis of the filing. ILLUMINATE, SHINE, SPARK and BRIGHT met their respective superiority primary endpoints of FEV1 ...

Positive results for Phase III trial of BAY 63-2521 (Bayer HealthCare) in patients with CTEPH

Data from the Phase III CHEST-1 trial evaluating BAY 63-2521 (riociguat), from Bayer HealthCare, in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or with persistent or recurrent pulmonary hypertension (PH) after surgery showed the study met its primary endpoint by demonstrating a statistically significant improvement in the six-minute walk distance. In the CHEST-1 study, 261 patients with inoperable CTEPH ...

Xalkori (Pfizer) is EU approved conditionally for Non Small Cell Lung Cancer

Pfizer Inc. announced that the European Commission on 23 October 2012 has given conditional marketing authorization for Xalkori (crizotinib) in the European Union (EU) for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Similar to accelerated approvals in the United States, conditional marketing authorizations in the EU are ...

Oral Treprostinal (United Therapeutics) attracts Complete Response Letter from FDA

A Complete Response Letter was received by United Therapeutics from the FDA declining to approve its new drug application (NDA) for treprostinil diethanolamine extended release tablets (oral treprostinil) for the treatment of Pulmonary Arterial Hypertension (PAH).

The FDA letter questioned the clinical importance of the 6 Minute Walk Distance (6MWD) effect size shown in the FREEDOM-M study, the ...

Actelion files Opsumit at FDA for treatment of PAH

Actelion has announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval for macitentan Opsumit (macitentan)for the treatment of patients with Pulmonary Arterial Hypertension.

Macitentan, a novel oral dual endothelin receptor antagonist, was studied in the pivotal, long-term, event-driven Phase III outcome study, SERAPHIN, in which 742 patients suffering from pulmonary arterial hypertension ...

NICE positive for Procoralan (Servier) for Heart Failure

The National Institute for Health and Clinical Excellence (NICE) has now published final draft guidance recommending Procoralan (ivabradine) from Servier Labs, as an option for treating Chronic Heart Failure, specified as NYHA class II to IVi. It has, however, stipulated that the drug should only be used in patients with systolic dysfunction, those who are in sinus rhythm, when ...

Phase III trial of BAY 63-2521 (Bayer HealthCare) for PAH meets primary endpoint

The Phase III PATENT-1 Pulmonary Arterial Hypertension (PAH) trial evaluating BAY 63-2521 (riociguat), from Bayer HealthCare, in both treatment-naive patients and those pre-treated with an endothelin receptor antagonist or an oral, inhaled or subcutaneous prostanoid has met its primary endpoint. PATENT is an international program with active centers in 32 countries. It includes a randomized, double-blind, placebo-controlled trial phase (PATENT-1) ...

FDA extend approval of Alimta (Eli Lilly) for maintenance treatment in NSCLC

The FDA has announced that patients may receive Alimta (pemetrexed for injection), from Eli Lilly, as a maintenance therapy following first-line Alimta plus cisplatin for locally advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NS NSCLC). The FDA approved the label inclusion of Phase III data that demonstrated progression-free and overall survival advantages in the continuation maintenance setting for these ...

FDA approves Abraxane (Celgene Oncology) for NSCLC

The FDA has on 11 October 2012 approved Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) from Celgene Oncology, for the first-line treatment of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

The Abraxane sNDA approval is based upon the results ...

ARQ 197 Phase III trial MARQUEE for NSCLC is stopped

ArQule, Inc. and Daiichi Sankyo, Co., Ltd. have announced that the independent Data Monitoring Committee (DMC) of the Phase III MARQUEE (Met inhibitor ARQ 197 plus Erlotinib vs Erlotinib plus placebo in NSCLC) trial recommended the study be stopped early following a planned interim analysis, when they concluded that the study would not meet its primary endpoint of improved overall ...

EU approval for Seebri Breezhaler (Novartis) for COPD

Novartis announced that the European Commission has approved Seebri Breezhaler (glycopyrronium bromide) 44 mcg delivered dose (equivalent to 50 mcg glycopyrronium measured dose per capsule), as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD). This follows the September 28 approval of once-daily Seebri (glycopyrronium bromide) Inhalation Capsules 50 mcg in ...

Positive results for Xalkori (Pfizer) in treatment of patients with ALK-positive Lung Cancer

The results of a new phase III trial show that Xalkori (crizotinib), from Pfizer, is a more effective treatment than standard chemotherapy for patients with advanced, ALK-positive Lung Cancer. The current global randomized phase III study compared the efficacy and safety of crizotinib with standard chemotherapy with pemetrexed or docetaxel, in 347 patients with ALK-positive lung cancer who had already ...

FDA approves Aerospan (Acton Pharma) for Asthma

Acton Pharmaceuticals, Inc. has announced that the FDA has approved the sNDA (Supplemental New Drug Application) for Aerospan (flunisolide HFA, 80 mcg) Inhalation Aerosol, a hydrofluoroalkane (HFA) orally inhaled corticosteroid indicated for the maintenance treatment of Asthma as a prophylactic therapy in adult and pediatric patients 6 years of age and older. With this approval, Acton is now planning ...

New quality-of-life data presented for Tomtovok (Boehringer) treated patients with NSCLC

Boehringer has released new results on the secondary endpoints of LUX-Lung 3, a Phase III trial of Tomtovok (afatinib) compared to chemotherapy (pemetrexed/cisplatin) in patients with epidermal growth factor receptor (EGFR) mutation-positive advanced Non-Small Cell Lung Cancer (NSCLC). Three lung cancer symptoms – cough, dyspnea (shortness of breath), and pain – were analyzed and results showed that a higher proportion ...

Positive results from study of delamanid (Otsuka) for patients with MDR-TB

Results from an observational study evaluating delamanid, from Otsuka, have found that the treatment can improve outcomes and reduce mortality among patients with both multi-drug resistant Tuberculosis MDR-TB and extensively drug-resistant Tuberculosis (XDR-TB). A previous trial had evaluated the effectiveness of 2 months treatment but the new study followed the same patients for a further 24 months of treatment.

The ...

Breo(GSK/Theravance)combination filed at FDA for COPD

GSK and Theravance, Inc. announced that the New Drug Application (NDA) for the once-daily investigational medicine, Breo (US)/Relvar (EU) (fluticasone furoate “FF”/vilanterol “VI” (FF/VI)) for patients with Chronic Obstructive Pulmonary Disease (COPD), has been accepted by the FDA indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date has ...

Thalomid (Celgene) successful treatment of cough associated with IPF

On September 18, 2012, a new study published in the Annals of Internal Medicine found thalidomide (Thalomid) from Celgene was effective in treating coughing associated with Idiopathic Pulmonary Fibrosis (IPF), a debilitating disease characterized by the scarring or thickening of tissues deep in the lung. A 24 patient trial showed that Thalomid decreased cough by 65% and improved cough specific ...

Phase III study results for serelaxin (Novartis) for Acute Heart Failure

Phase III study results show that investigational RLX030 (serelaxin) reduced all-cause mortality in patients with Acute Heart Failure (AHF). The six-month RELAX-AHF study shows that RLX030 reduces the number of deaths in patients with this disease, which has a higher mortality rate than most other cardiovascular diseases. The study had two primary endpoints using different scales to measure reduction in ...

Boehringer files Tomtovok at EMA for NSCLC

Boehringer Ingelheim has announced the submission of a Marketing Authorisation Application to the European Medicines Agency for approval of Tomtovok (afatinib) the first irreversible ErbB Family Blocker, as a treatment for patients with EGFR (ErbB1) mutation positive Non-Small Cell Lung Cancer. Afatinib has demonstrated unprecedented efficacy versus chemotherapy in the Phase III LUX-Lung 3 registration trial, which provides pivotal support ...

Merck Serono withdraws EMA application for treatment of Non Small Cell Lung Cancer

Merck-Serono announced the strategic decision to voluntarily withdraw the marketing authorization application to the European Medicines Agency of a label extension for Erbitux (cetuximab) in combination with standard first-line platinum-based chemotherapy in patients with advanced or metastatic Non-Small Cell Lung Cancer with high epidermal growth factor receptor expression. The decision to withdraw the application was based on feedback from European ...

Phase II success for bavituximab (Peregrine Pharma) in NSCLC

Interim results were presented from a 121 patient randomized, double-blind, placebo-controlled Phase IIb trial of bavituximab from Peregrine Pharma, in patients with refractory Non-Small Cell Lung Cancer (NSCLC). The blinded study evaluated two dose levels of bavituximab (bavituximab-containing arms) given with docetaxel versus docetaxel plus placebo (control arm). The interim data showed a statistically significant improvement in overall survival (Hazard ...

CPL 1001 (Sorbent Therapeutics) success in Phase II Heart Failure trial

There has been positive data from a randomized, double-blind Phase IIa clinical study of CLP 1001 from Sorbent Therapeutics. In the study of 111 Heart Failure patients with chronic kidney disease, CLP 1001 demonstrated improvement in Heart Failure symptoms as compared to placebo. CLP1001-treated patients achieved significantly greater weight loss – an accepted measurement of fluid retention – as compared ...

Phase II success for GSK 961081(GSK/Theravance) for COPD

GSK and Theravance announced positive data from a Phase II study of the dual acting muscarinic antagonist and beta 2 agonist (MABA) GSK 961081 as a treatment for moderate to severe COPD. The trial of 436 subjects showed clinically significant improvements to placebo for FEV1 trough on day 29, the primary endpoint....

FDA votes to support inhaled powder form of tobramycin (Novartis) for patients with Cystic Fibrosis

An FDA drug advisory committee has voted 13 to 1 that there was adequate evidence of efficacy and safety to support the use of tobramycin inhalation powder (TIP), from Novartis, for the management of Cystic Fibrosis (CF) patients whose lungs contain bacteria called Pseudomonas aeruginosa (Pa). It based its recommendation on three Phase III clinical studies involving more than 650 ...

Phase III data on Kalydeco (Vertex) shows benefits for Cystic Fibrosis patients

A Phase III study of Kalydeco (ivacaftor), from Vertex, for patients with Cystic Fibrosis shows the drug significantly improves lung function and reduces pulmonary exacerbations. The STRIVE study randomised 161 patients aged 12 and over with at least one copy of the G551D mutation in the CFTR gene to ivacaftor (150mg every 12 hours) or placebo. Results showed a mean ...

Success for SNG 001 (Synairgen) in early Asthma trial

In a mid-stage study of 134 adults who caught a cold, SNG001 from Synairgen, was effective in the most difficult-to-treat patients, preventing asthma symptoms from getting worse during the first week of infection and treatment. There was also a 65 percent reduction in the number of patients who experienced asthma attacks during the treatment period compared with a group on ...

Positive data on Esbriet (InterMune) in patients with Pulmonary Fibrosis

New analyses of data from the RECAP extension study of Esbriet (pirfenidone), from InterMune, show that patients with mild-to-moderate Pulmonary Fibrosis (PF) newly-treated with Esbriet in RECAP for 60 weeks had similar FVC and survival outcomes when compared to those treated with Esbriet for the same duration as in previous studies (the CAPACITY trial).

The new analyses showed that the ...

Positive data on QVA 149 (Novartis) from three Phase III studies of COPD

Three new studies of QVA 149 (indacaterol plus glycopyrronium bromide), from Novartis, in the IGNITE Phase III trial program demonstrate the drug significantly improves lung function compared to other COPD therapies. SHINE met its primary endpoint by demonstrating that once-daily QVA 149 improved lung function as measured by trough FEV1 compared to once-daily indacaterol maleate and once-daily glycopyrronium. It was ...

Positive results from studies of Seebri Breezhaler (Novartis) for patients with COPD

Results of the first pooled analysis of GLOW1 and GLOW2 data demonstrated that patients with COPD using the Seebri Breezhaler (glycopyrronium bromide), from Novartis, experienced rapid, sustained and clinically meaningful bronchodilation over 52 weeks. The improvement in FEV1 was seen within five minutes after the first dose on Day 1 and was sustained throughout the 52-week period (p<0.001 vs. placebo). ...

Studies show Onbrez Breezhaler/Arcapta Neohaler (Novartis) effective for patients with COPD

New results from a pooled post-hoc sub-group analysis from three studies (INVOLVE, INHANCE and INLIGHT2) showed that Onbrez Breezhaler/Arcapta Neohaler (indacaterol maleate), from Novartis, was statistically significantly more effective than OL tiotropium at improving breathlessness in COPD. These three randomized studies included 3,176 patients with moderate-to-severe COPD and assessed patients randomized to receive once-daily indacaterol maleate 150 mcg, once-daily indacaterol ...

Positive data from Phase III trial of Spiriva (Boehringer) in Asthma patients

Initial data from the Phase III UniTinA-asthma program reveals that Spiriva (tiotropium bromide), from Boehringer, delivered daily via the Respimat inhaler significantly improved lung function and reduced Asthma exacerbations in patients who remained symptomatic on current treatment with at least high dose inhaled corticosteroids (ICS) and long-acting beta agonists (LABA). The two studies were replicate double-blind parallel-group trials including Asthma ...

Janssen submit MAA to the EMA for TMC 207 as treatment for multi-drug resistant Tuberculosis

Janssen Pharmaceuticals has submitted a Marketing Authorisation Application to the EMA seeking conditional approval for the use of the investigational drug TMC 207 (bedaquiline) as an oral treatment as part of combination therapy for pulmonary, multi-drug resistant Tuberculosis (MDR-TB) in adults. The submission is supported by 24-week data from the Phase II clinical development program, which includes an open-label study ...

EU approves Zinforo (AstraZeneca) for cSSTI and CAP infections

AstraZeneca announced that the European Commission has granted Marketing Authorisation to Zinforo(ceftaroline fosamil), a new intravenous cephalosporin antibiotic, for the treatment of adult patients with complicated Skin and Soft Tissue Infections (cSSTI) or Community Acquired Pneumonia (CAP). This makes Zinforo the only approved cephalosporin monotherapy in Europe with demonstrated clinical efficacy against methicillin-resistant Staphylococcus aureus (MRSA), a common cause ...

Phase III programme of GSK 573719 plus vilanterol (Glaxo Smith Kline/Theravance) for COPD completed

The Phase III programme of GSK 573719 plus vilanterol, from Glaxo Smith Kline and Theravance, involving approximately 6,000 patients with Chronic Obstructive Pulmonary Disease (COPD) has been completed. On 2 July 2012, GSK and Theravance announced the completion of four pivotal studies for GSK 573719 plus vilanterol. The pivotal programme for the drug combo also includes a 52-week safety study, ...

Medtonic receives CE mark for Viva and Brava CRT-D devices for Heart Failure patients

Medtronic Inc has received CE Mark in Europe for its Viva and Brava Cardiac Resynchronization Therapy with Defibrillation (CRT-D) devices for treating patients with Heart Failure. The family of CRT-Ds features a new algorithm, called AdaptivCRT(R), which significantly improves heart failure patients' response rate to CRT-D therapy, as compared to historical CRT trials, by preserving the patients' normal heart rhythms ...

Bosatria (GSK) study in severe Eosinophilic Asthma

A year-long study involving 621 patients treated with Bosatria (mepolizumab) from Glaxo Smith Kline found that the rate in patients on mepolizumab of clinically significant exacerbations - defined as episodes requiring oral corticosteroids or a hospital visit - was around half that of those on placebo. But while monthly intravenous injections of the drug cut attacks they failed to produce ...

Delay in review of QT 1571(Novartis) for PAH

The FDA postponed a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review QT 1571 which is imatinib (Gleevec/Glivec in its cancer indication) from Novartis for Pulmonary Arterial Hypertension. Novartis has decided to withdraw the NDA to allow time to produce more information for the FDA...

FDA approves GeNOsyl MV-1000 (GeNo LLC) for neonates

GeNo LLC has received clearance from the FDA to market its inhaled nitric oxide (NO) delivery system GeNOsyl MV-1000. The target patient population is controlled by the drug labeling for FDA-approved NO which is currently neonates. The GeNOsyl MV-1000 is intended to be used in hospital settings including the NICU and intra-hospital transport settings. The GeNOsyl MV-1000 injects a constant ...

Talactoferrin fails FORTIS-M trial for NSCLC

The FORTIS-M trial of talactoferrin from Aggenix AG, investigated the effect of talactoferrin plus best supportive care (BSC) compared with placebo and BSC in patients with Stage IIIb/IV Non Small Cell Lung Cancer, whose disease had progressed following two or more prior treatment regimens. Results showed that median overall survival in the talactoferrin arm was just 7.5 months compared to ...

NICE recommends Procoralan (Servier) for treatment of Chronic Heart Failure

Procoralan (ivabradine) from Servier Labs has been recommended by NICE in draft guidance as a treatment option for people with Chronic Heart Failure. The treatment has been recommended in combination with standard therapy or when beta-blocker therapy is contraindicated or not tolerated, after impressing in clinical trials....

FDA approves generic Singulair for Asthma

The FDA has approved the first generic versions of Singulair (montelukast sodium)from AstraZeneca for use in adults and children to control Asthma symptoms and to help relieve symptoms of indoor and outdoor allergies. Apotex Inc., Aurobindo Pharma, Endo Pharmaceuticals, Glenmark Generics, Kudco Ireland Inc., Mylan Inc., Roxane Laboratories, Sandoz Inc., Teva Pharmaceuticals Inc., and Torrent Pharmaceuticals have gained FDA approval ...

Zetonna (Sunovion) launched in US for Allergic Rhinitis

Sunovion Pharmaceuticals Inc. announced the nationwide US availability of Zetonna (ciclesonide) Nasal Aerosol, 74 mcg once-daily, for the treatment of allergic rhinitis (AR), also known as hay fever or nasal allergies. Zetonna is a corticosteroid indicated for the treatment of symptoms associated with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and adolescents 12 years of age ...

EU approves Humira (Abbott) for treatment of Axial Spondyloarthritis

Abbott has announced that the European Commission (EC) has approved Humira(adalimumab) for the treatment of adults with severe Axial Spondyloarthritis (axSpA) who have no X-ray evidence of structural damage. Humira is the first and only approved medication available for non-radiographic axSpA patients (nr-axSpA). This approval marks the eighth indication for Humira in the European Union since the product's first approval ...

EC approves Eklira/Bretaris Genuair (Almirall/Menarini) for treatment of COPD

Almirall has announced that the European Commission has granted marketing approval to Eklira/Bretaris Genuair(aclidinium 322µg twice daily) in all EU member states, plus Iceland and Norway, as a maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD).

Clinical efficacy studies showed that aclidinium provides around the clock significant and sustained bronchodilation ...

Study shows Cinryze (Viro Pharma) effective for long-term treatment of Hereditary Angio-oedema

New results demonstrate that routine prophylactic use of Cinryze (C1 esterase inhibitor), from Viro Pharma, provided effectiveness and maintained a generally favorable safety profile in the majority of treated subjects with Hereditary Angio-oedema. Treated with Cinryze 1000 units every 3 to 7 days, subjects experienced a 93.7 percent reduction in attacks while taking prophylactic Cinryze (median of 0.19 attacks per ...

FDA approves Tudorza Pressair ( Forest Pharma) for COPD

The FDA on 23 July 2012 approved Tudorza Pressair (aclidinium bromide) from Forest Pharma for the long-term maintenance treatment of bronchospasm (narrowing of the airways in the lung) associated with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema. The safety and efficacy of Tudorza Pressair were demonstrated in three randomized, placebo-controlled confirmatory clinical trials that included 1,276 patients ...

CHMP recommends Xalkori (Pfizer) for treatment of NSCLC

On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Xalkori (crizotinib), 200 mg, 250 mg, hard capsule from Pfizer and intended for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced Non-Small Cell Lung Cancer (NSCLC) . ...

Fluticasone/vilanterol combination (GSK) is filed in US for COPD and in the EU for Asthma and COPD

GSK and Theravance announced the submission of regulatory applications in the US and European Union for the once-daily investigational medicine Relovair( fluticasone furoate /vilanterol).

In the European Union the application is for patients with Chronic Obstructive Pulmonary Disease (COPD) and an application for Asthma. The Marketing Authorisation Application for the European Union for the combination has a new proposed ...

GSK/Theravance announce results of four Phase III studies of GSK 573719 plus vilanterol in COPD

GSK and Theravance announced results of four pivotal Phase III studies of GSK 573719 (umeclidunium bromide) ("UMEC"),a long acting muscarinic antagonist (LAMA) and vilanterol, a long acting beta agonist (LABA) ("VI") administered by dry powder inhaler for treatment of COPD.The results of the four pivotal phase III studies of UMEC/VI involved over 4,000 patients with chronic obstructive pulmonary disease (COPD). ...

EMA approves Flutiform (Mundipharma) for Asthma treatment

The EMA has approved Flutiform (fluticasone plus formoterol), from Mundipharma, for the maintenance treatment of Asthma. This decision is binding on all 21 Concerned Member States involved in the decentralised procedure and the first national approvals of Flutiform are expected across a number of countries by the end of 2012. It is indicated for the regular treatment of Asthma in ...

CHMP recommends Seebri Breezhaler (Novartis) for COPD

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Seebri Breezhaler (glycopyrronium/NVA237) 44 mcg delivered dose (50 mcg glycopyrronium per capsule), as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD). Seebri Breezhaler is a long-acting muscarinic antagonist (LAMA), a type of ...

Xalkori(Pfizer)success in Phase III trial in ALK-positive advanced NSCLC

The PROFILE 1007 study met its primary endpoint, demonstrating that Xalkori (crizotinib) from Pfizer significantly improved progression-free survival when compared with pemetrexed or docetaxel, in previously treated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). PROFILE 1007 is the first randomized Phase III study in ALK-positive advanced NSCLC patients. Xalkori received an accelerated approval by the ...

Positive data from Phase III study of PTC 124 (PTC Therapeutics) for patients with nonsense mutation Cystic Fibrosis

Results from a Phase III study of PTC 124 (ataluren), from PTC Therapeutics, in patients with nonsense mutation Cystic Fibrosis (nmCF) demonstrated positive trends in lung function as measured by FEV1 (forced expiratory volume in one second). The secondary endpoint, the number of pulmonary exacerbations in 48 weeks, also showed a positive trend in favor of ataluren, with the rate ...

Abediterol (Almirall/Forest) superior to indacaterol in Phase IIa trial for COPD

In the Phase IIa, single-dose, study change from baseline in trough FEV1 following a single dose administration of a range of abediterol from Almirall/Forest Labs. doses below 10µg once daily, showed a statistically significant improvement versus placebo (p<0.001 for all abediterol doses) and, also, versus indacaterol 150µg (p<0.001 for abediterol doses of 2.5, 5 and 10µg. Abediterol once-daily in fixed ...

German IQWiG finds Esbriet (InterMune) of 'no proven added benefit' for Pulmonary Fibrosis patients

In an early benefit assessment of Esbriet (pirfenidone), from InterMune, for the treatment of adults with mild to moderate idiopathic Pulmonary Fibrosis, the German Institute for Quality and Efficiency in Health Care (IQWiG) found that there was an indication that pirfenidone gave minor added benefit with respect to patients' exercise tolerance. On the other hand, greater harm has been proven: ...

Humira (Abbott) benefits in ABILITY-1 study in patients with active non-radiographic Axial Spondyloarthritis

Initial 12-week data from the ABILITY-1 study of Humira (adalimumab)from Abbott showed that a significantly higher proportion of patients receiving Humira (40mg every other week) achieved a 40% or greater improvement from baseline using the ASAS (or Assessment of SpondyloArthritis international Society) response criteria compared with placebo (36% vs 15%, p<0.001). Also, significantly more patients achieved the secondary endpoint of ...

Positive results from LUX-Lung 3 trial of Tomtovok (Boehringer) in NSCLC patients

LUX-Lung 3, the pivotal Phase III clinical trial investigating Tomtovok (afatinib), from Boehringer, in patients with stage IIIB or IV non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor mutation (EGFR M+), met its primary endpoint of progression-free survival (PFS). LUX-Lung 3, which compares Tomtovok to pemetrexed/cisplatin, is the largest Phase III trial to date in first-line EGFR ...

Positive data from Phase III study of Abraxane (Celgene Oncology) for NSCLC patients

A retrospective analyses of CA-031, the Phase III study where Non-Small Cell Lung Cancer patients received either Abraxane (nab-paclitaxel), from Celgene Oncology, plus carboplatin or paclitaxel plus carboplatin demonstrated a higher overall response rate for patients in the Abraxane arm compared to those in the paclitaxel arm (33% vs. 25%). A second analysis evaluating patients with squamous-cell histology and non-squamous ...

CHMP recommends EU approval of Eklira (Almirall) for COPD

The EMA's CHMP has issued a positive opinion for the regulatory approval of Eklira (aclidinium), from Almirall, in all EU member states as a maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD). As part of its assessment, CHMP reviewed efficacy and safety data of aclidinium BID from more than 2,500 patients. The clinical ...

CHMP recommends EU approval of Kalydeco (Vertex) for Cystic Fibrosis

The EU's CHMP recommends the authorisation of Kalydeco (ivacaftor), from Vertex. Kalydeco is a first-in-class medicine for patients aged six and older who have the specific G551D mutation in the Cystic Fibrosis transmembrane regulator gene. The drug was reviewed under accelerated assessment (in 150 days) and is the first treatment that targets the underlying mechanism of the disease, by restoring ...

Positive data from ADVANCE trial of Ventricular Assist Device (HeartWare) for Heart Failure patients

Updated results from the ADVANCE trial evaluating the use of the Ventricular Assist Device, from HeartWare, as a bridge to heart transplantation demonstrate the potential utility of the pump to improve treatment outcomes for end-stage Heart Failure patients. Success for the primary endpoint was judged by establishing non-inferiority between the HeartWare device and data derived from contemporaneous patients from the ...

BI 1744-CL (Boehringer) shows positive results in Phase II COPD trial

A Phase II study shows that BI 1744-CL (olodaterol), from Boehringer, provides a significant increase in the lung function parameter FEV1 over a 24-hour period for patients with COPD. It found BI 1744-CL (5 microgram QD) provided significant improvement in lung function as measured by FEV1 AUC(0-12) versus twice-daily BI 1744-CL (2 microgram), while twice-daily dosing of BI 1744-CL (5 ...

Spiriva (Boehringer) in Phase III for Asthma

Boehringer announced that a comprehensive confirmatory Phase III trial program named UniTinA-asthma is ongoing to fully evaluate the potential of the long-acting bronchodilator, Spiriva(tiotropium bromide)in the treatment of Asthma in pediatric, adolescent and adult patients....

Bronchitol (Pharmaxis) is filed at the FDA for the treatment of Cystic Fibrosis

Pharmaxis has submitted a new drug application (NDA) to the FDA for Bronchitol, a formulation of mannitol administered as a dry powder in a hand?held inhaler, as a treatment for patients with Cystic Fibrosis. Bronchitol, which is used to clear mucus – a major source of lung infections – improve lung function and reduce exacerbations in patients with cystic fibrosis, ...

Nexavar (Bayer/Onyx) fails to improve overall survival in MISSION study for NSCLC

Bayer HealthCare and Onyx Pharmaceuticals, announced that the Phase III MISSION trial evaluating Nexavar (sorafenib) tablets in patients with advanced relapsed or refractory non-squamous Non-Small Cell Lung Cancer whose disease progressed after two or three previous treatments, did not meet its primary endpoint of improving overall survival. An improvement in the secondary endpoint of progression-free survival was observed....

Seebri Breezhaler(Novartis) success in GLOW 2 study for COPD

Novartis and Vectura reported one-year data from the pivotal, Phase III GLOW 2 study, confirming that the inhaled long acting muscarinic receptor antagonist, NVA237 (glycopyrronium bromide), is superior to placebo and has similar efficacy to open-label tiotropium in the treatment of patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)....

Seebri Breezhaler (Novartis) success in GLOW-3 trial for COPD

The GLOW 3 study investigated the effects of Seebri Breezhaler (NVA237), (glycopyrronium bromide) 50 mcg once-daily from Novartis on exercise endurance in moderate-to-severe COPD patients. The study met its primary endpoint by showing a significant 21% improvement in exercise endurance versus placebo at the end of the study (i.e. day 21), with a significant 10% increase from day one (both ...

NICE recommends Tarceva (Roche) for NSCLC

NICE has announced that Tarceva (erlotinib) from Roche will join Iressa (geftinib) from AstraZeneca in the UK and Wales as a first line option for patients with locally advanced or metastatic EFGR mutation positive Non Small Cell Lung Cancer....

Iressa (AstraZeneca) is withdrawn from US market for NSCLC

Iressa (gefitinib) from AstraZeneca, was granted accelerated approval by the FDA on 2 May 2003 as monotherapy after failure of both platinum-based and docetaxel chemotherapies for the continued treatment of patients with locally advanced or metastatic Non Small Cell Lung Cancer. Postmarketing studies were completed but failed to verify and confirm clinical benefit. The FDA has withdrawn the approval....

FDA approve Dymista (Meda AB) for Seasonal Allergic Rhinitis

The FDA has approved Dymista, from Meda AB, for treatment of Seasonal Allergic Rhinitis. The efficacy and safety of Dymista has been documented in several studies involving over 4,000 patients, including a long-term safety study with more than 600 patients. Dymista will be available in the US during the second half of 2012. The treatment was filed for marketing approval ...

Macitentan(Actelion) success in Phase III for PAH

Initial analysis indicates that the pivotal, long-term, event-driven study SERAPHIN with macitentan, a novel dual endothelin receptor antagonist from Actelion, in 742 patients suffering from Pulmonary Arterial Hypertension (PAH) and treated for up to three and a half years, has met its primary endpoint. SERAPHIN is the largest randomized, controlled study in PAH patients with a long-term treatment to include ...

EU gives marketing approval for Bronchitol (Pharmaxis ) to treat Cystic Fibrosis

The EU has given marketing authorisation for Bronchitol (inhaled dry powder mannitol), from Pharmaxis, for Cystic Fibrosis patients. The licence allows the new Cystic Fibrosis treatment to be made available for patients aged 18 and above as an add-on therapy to the best standard of care in 29 European countries. Patients in Germany and the UK, where there is less ...

Phase III Study of QVA 149 (Novartis) for COPD meets primary endpoint and clarifies timing of US filings

New data on ILLUMINATE, a head-to-head Phase III study of QVA 149 (indacaterol plus glycopyrronium bromide), from Novartis, compared to Seretide(fluticasone plus salmeterol), shows the drug has met its primary endpoint in patients with moderate to severe Chronic Obstructive Pulmonary Disease. The ILLUMINATE study of more than 500 patients demonstrated that superior lung function (measured by FEV1 AUC0-12h with a ...

CHMP recommends Flutiform (Skye Pharma/MundiPharma) for Asthma

The CHMP of the European Medicines Agency ("EMA") has issued a positive opinion recommending the granting of a marketing authorisation for Flutiform (fluticasone propionate/formoterol fumarate) from Skye Pharma. The decentralised procedure ("DCP")of the marketing authorisation application for Flutiform was referred to the CHMP for arbitration because a concerned member state did not agree with the positive benefit/risk assessment made by ...

Phase III study of Arikace (Insmed) in Cystic Fibrosis patients with Pseudomonas lung infections begins in Europe

A Phase III study of Arikace (liposomal amikacin for inhalation), from Insmed, for Cystic Fibrosis (CF) patients with Pseudomonas aeruginosa (Pa) lung infections has begun in Europe. CLEAR-108 is a randomized trial comparing Arikace 560 mg, delivered once daily via an optimized, investigational eFlow Nebulizer System (PARI Pharma GmbH) with TOBI (inhaled tobramycin solution), a commercially available inhaled antibiotic that ...

Benefits of Avastin (Roche) for older patients with NSCLC are not clear

Adding Avastin (Roche) to the standard chemotherapy regimen for Non-Small Cell Lung Cancer (NSCLC) – an approach approved by the FDA in 2006 – does not lead to significantly increased survival rates for patients over the age of 65, a new study shows. A previous trial found that adding Avastin to the standard two-drug treatment for NSCLC – the chemotherapy ...

Cimzia success in Phase III trial for Axial Spondyloarthritis

UCB has announced positive top-line results from the phase III study designed to evaluate the efficacy and safety of Cimzia (certolizumab pegol) in patients with adult-onset active axial spondyloarthritis (AxSpA), a family of inflammatory rheumatic diseases which includes ankylosing spondylitis (AS).In this 24-week, multicenter, double-blind, placebo-controlled phase III study, 325 patients with AxSpA were randomized to receive certolizumab pegol, 200 ...

Actelion discointinues setipiprant in Asthma and Allergic Rhinitis

Actelion is discontinuing development of its orally-active CRTH2 antagonist, setipiprant, in asthma (Phase IIb) and seasonal allergic rhinitis (Phase III profiling), after two recently concluded studies did not confirm efficacy findings made in earlier studies....

Alair Bronchial Thermoplasty System(Boston Scientific) has positive technology assessment

Boston Scientific Corporation announces the first published technology assessment in support of the safety, efficacy and long-term positive health outcomes of bronchial thermoplasty (BT) as delivered by the Alair Bronchial Thermoplasty System, a catheter-based device designed to treat patients 18 years or older with severe persistent asthma. The report was published by the California Technology Assessment Forum (CTAF) and states ...

First three Phase III studies positive for QVA 149 (Novartis)in COPD

The first three Novartis QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg) Phase III studies in the treatment of chronic obstructive pulmonary disease (COPD) all met their primary endpoints. The SHINE, BRIGHT and ENLIGHTEN studies, which are key components of the IGNITE program, demonstrate the potential of QVA149 in the treatment of COPD.The results of SHINE, with an enrollment of more ...

CEM-101 (Cempra) success in Phase II trial for CABP

Cempra Inc. announced that data will be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in London, March 31 to April 3,demonstrating CEM-101's (solithromycin's) efficacy to be comparable to levofloxacin in a Phase II trial of patients with Community-Acquired Bacterial Infections (CABP). The study also demonstrates solithromycin's favorable safety and tolerability profile compared to levofloxacin.Clinical success ...

Relovair (GSK/Theravance)programme is now complete for COPD and Asthma

Glaxo Smith Kline and Theravance, Inc. have announced that the registration programme for Relovair (fluticasone furoate plus vilanterol) is now complete. In addition, results from two studies for the once-daily Relovair (fluticasone furoate "FF"/vilanterol "VI" (FF/VI)) in patients with chronic obstructive pulmonary disease (COPD) and results from a study to evaluate the efficacy and safety of FF and FP (fluticasone ...

TC 6987 (Targacept) success in Phase II Asthma study

A Phase II asthma study of TC 6987 from Targacept was a double blind, placebo controlled, parallel group trial conducted at 23 sites in the United States. The study enrolled 93 adult patients with persistent mild to moderate Asthma that were being treated with inhaled corticosteroids, and 90 patients completed the study. The study included a number of different efficacy ...

Positive results for Phase III study of Eklira/Bretairis (Almirall) for COPD

Full results of ATTAIN, a six month pivotal study of the efficacy and safety of Eklira/Bretairis (inhaled aclidinium), from Almirall, in patients with moderate to severe Chronic Obstructive Pulmonary Disease have been published in the European Respiratory Journal. Significant improvement from baseline was observed with aclidinium 200 microg and 400 microg versus placebo for trough FEV1 (99 and 128 mL; ...

Arcapta Neohaler (Novartis) is launched in USA for COPD

Novartis has launched its once-daily long-acting beta2 agonist Arcapta Neohaler (indacaterol inhalation powder) in the USA following its approval for chronic obstructive pulmonary disease by the FDA in July 2011. Indacaterol is already available in more than 30 countries following its first approval in the EU in November 2009 as Onbrez Breezhaler. The drug is approved in a total of ...

FDA refuses to approve lipid-lowering combination of atorvastatin and ezetimibe (Merck)

The FDA has issued a Complete Response Letter regarding Merck's new drug application ezetimibe and atorvastatin tablets, an investigational combination medicine for Dyslipidaemia. In the letter, the agency advised Merck that it has completed its review of the submission and stated that additional data are needed. Merck plans to discuss next steps with the agency in the near future, including ...

FDA Advisory Committee recommends aclidium bromide(Forest/Almirall) for COPD

Forest Laboratories, Inc. and Almirall, S.A. announced that the FDA Pulmonary-Allergy Drugs Advisory Committee voted 12 to 2 in favor of approving the New Drug Application (NDA) for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of COPD. The Committee was also asked to separately evaluate if the efficacy and safety of the 400 ug twice daily dose ...

EMA approves Colobreathe (Forest Labs) for Cystic Fibrosis

European Medicines Agency (EMA)has given approval to market Colobreathe dry powder colistimethate sodium for inhalation, from Forest Laboratories Europe, for the treatment of Cystic Fibrosis in patients aged 6 years and older with chronic lung infection caused by P.aeruginosa. The pivotal study which was submitted to EMA for authorization was an open-label active comparator study comparing the efficacy of Colobreathe ...

FDA accepts NDA for oral Remodulin (United Therapeutics) for PAH

The FDA has accepted for review the new drug application (NDA) for oral Remodulin (treprostinil diethanolamine sustained release), from United Therapeutics, for the treatment of Pulmonary Arterial Hypertension. The NDA will be subjected to a standard 10-month review period, with a targeted user fee deadline of October 27, 2012....

FDA approves Kalydeco (Vertex Pharma) for Cystic Fibrosis

The FDA has approved Kalydeco(ivacaftor)from Vertex Pharma, the first medicine to treat the underlying cause of Cystic Fibrosis (CF), a rare, genetic disease. Kalydeco is approved for people with CF ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Approximately 1,200 people in the United States ...

FDA extends Berinert (CSL Behring) indication to self administration in HAE attacks

The FDA has approved an extended indication to allow self administration of Berinert (C1 inhibitor concentrate), from CSL Behring, in cases of acute abdominal or facial attacks of Hereditary Angioedema (HAE). This means that there is no need with Berinert for a patient to visit a clinic or hospital to receive the drug intravenously and allows the possibility of quicker ...

Nexavar (Bayer HealthCare) effective in patients with Non-Small Cell Lung Cancer

Nexavar (sorafenib tosylate), from Bayer HealthCare, was effective in patients with Non-Small Cell Lung Cancer and a KRAS mutation, but survival rates were reportedly "unsatisfactory," according to data presented at the AACR-IASLC Joint Conference on Molecular Origins of Lung Cancer: Biology, Therapy and Personalized Medicine. In the Phase II study, researchers assigned 57 patients with NSCLC and a KRAS mutation ...

EU approval is given for intravenous formulation of Remodulin (United Therapeutics)

European approval has been given to United Therapeutics Corp for the intravenous formulation of its prostacyclin vasodilator, Remodulin (treprostinil), to treat Pulmonary Arterial Hypertension (PAH). Twenty two European Union member states have approved the formulation through the French regulatory agency AFSSAPS under the mutual recognition process. United Therapeutics has separately filed in the US for the oral version of Remodulin. ...

Flutiform (Skye/Mundipharma) European application referred to arbitration

SkyePharma PLC announced that the decentralised procedure ("DCP") for the regulatory review of Flutiform (fluticasone plus formoterol),which was submitted by its partner MundiPharma International, has been referred to the European Medicines Agency ("EMA") and its Committee for Medicinal Products for Human Use ("CHMP") for arbitration. The arbitration procedure is part of the DCP and is initiated when a unanimous decision ...

CHMP recommends Procoralan (Servier Labs) for Chronic Heart Failure

The CHMP has recommended Procoralan (ivabradine) from Servier Laboratories for Chronic Heart Failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is = 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated....

Kalydeco is filed at FDA and EMA for Cystic Fibrosis

The FDA has accepted the New Drug Application (NDA) for Kalydeco (ivacaftor) from Vertex Pharmaceuticals and granted the company's request for six-month Priority Review. Kalydeco targets the defective protein that causes Cystic Fibrosis (CF) in a subset of people with the disease. A target review date of April 18, 2012 is set. The EMA has validated the marketing authorization application ...

Cobas EGFR Mutation test (Roche) receives CE mark for NSCLC testing

The Cobas EGFR Mutation Test, from Roche, is now CE marked for commercial availability in Europe and other countries that recognise CE mark. The Cobas EGFR Mutation Test is a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who harbour mutations in the EGFR (epidermal growth factor receptor) gene and who may benefit from treatment with anti-EGFR ...

Kalbitor (Dyax/Defiante Farma) is withdrawn from EMA for acute Hereditary Angioedema

Kalbitor from Dyax Corporation and Defiante Farmaceutica S.A. is withdrawn from its application to the EMA for the treatment of acute attacks of Hereditary Angioedema in patients 16 years and older. The CHMP had required further data. The drug is approved for the indication in the USA....

Phase III trial of Humira (Abbott) shows significant benefits for Axial Spondyloarthritis treatment

The Phase III ABILITY-1 study of Humira (adalimumab), from Abbott, in patients with active non-radiographic Axial Spondyloarthritis (axSpA), has reported encouraging results. At week 12, more than twice as many Humira patients compared to those receiving placebo achieved the primary endpoint of 40 percent improvement in the Assessment of SpondyloArthritis international Society criteria (ASAS 40). AxSpA is a debilitating condition ...

Erbitux (Merck Serono/BMS) effective in NSCLC patients with EGFR mutation

Patients with the most common form of Non-Small Cell Lung Cancer whose tumours express high levels of epidermal growth factor receptor (EGFR) are more likely to benefit from treatment with Erbitux (cetuximab), from ImClone /BMS/ Merck-Serono, and live longer compared with those given chemotherapy alone. The findings suggest that testing for level of EGFR expression could be used in everyday ...

Kalydeco Phase III STRIVE study for Cystic Fibrosis is published in NEJM

Vertex Pharmaceuticals announced that the New England Journal of Medicine (NEJM) has published data from a Phase III study of Kalydeco (ivacaftor, VX-770), a medicine in development that targets the defective protein that causes cystic fibrosis (CF). In this study, called STRIVE, people with CF ages 12 and older with at least one copy of the G551D mutation who were ...

EU approves Alimta as continuation maintenance therapy in non squamous NSCLC

The European Commission has granted approval for the use of Alimta (pemetrexed for injection) from Eli Lilly as a single agent for continuation maintenance therapy in patients with a particular type of lung cancer, called advanced nonsquamous non-small cell lung cancer (NSCLC). The approval is based on clinical trial results showing an improvement in progression-free survival, as well as a ...

Brochitol has CHMP recommendation for treatment of Cystic Fibrosis

The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bronchitol ( inhaled mannitol) from Pharmaxis, an Australian pharmaceutical company, for the treatment of Cystic Fibrosis. The drug is an inhaled dry powder formulation of mannitol and is intended to reduce the amount of mucus in the lungs of patients suffering from chronic respiratory syndromes. Pharmaxis have ...

TG 4010 combination raises progression free survival in Non Small Cell Lung Cancer patients

Results published in The Lancet Oncology suggest that a combination of chemotherapy and an experimental vaccine called TG4010, from Transgene, results in significantly more progression free survival in patients with advanced Non Small Cell Lung Cancer compared to those on chemotherapy alone. In this the Phase II trial, led by Elisabeth Quoix from the Université de Strasbourg in Strasbourg, France, ...

Flutiform delays in EU for treatment approval for Asthma

Mundipharma/Napp filed Flutiform (fluticasone propionate plus formoterol fumarate) for asthma using the decentralised procedure in the EU with the UK as reference state and has now encountered delays in achieving consensus amongst the reference states. A launch in 2011 now looks unlikely although most reference states have found the drug approvable.Skye Pharma is the originator of the drug....

Kalydeco filed at FDA for Cystic Fibrosis treatment

Vertex Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for Kalydeco (VX-770, ivacaftor), a medicine in development that targets the defective protein that causes cystic fibrosis (CF). Kalydeco was studied among people with CF ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator gene. In ...

Arikase trials for use in Cystic Fibrosis are placed on hold by FDA

Phase III clinical trials of Arikace (liposomal amikacin for inhalation) from Insmed for cystic fibrosis have been placed on hold by the FDA due to cases of carcinogenicity....

FDA approves CFC-free Combivent Respimat Inhaler for COPD

The FDA has announced the approval of Combivent Respimat (ipratropium bromide and albuterol sulfate) Inhalation Spray for patients with Chronic Obstructive Pulmonary Disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator. Combivent Respimat contains two different types of medicines that open airways in the lungs to help patients with ...

Adventrx Pharma discontinues Exelbine for Non Small Cell Lung Cancer

Meetings between Adventrx Pharma and the FDA were not productive regarding the FDA Complete Response Letter and Adventrx has decided to focus its capital on its other compounds, ANX-188 and ANX-514, which reflect larger market opportunities. The company will discontinue its Exelbine programme until it finds a partner or outside investor....

Higher radiation dose plus Erbitux not beneficial for Lung Cancer patients

An interim analysis of a Phase III trial to find out if high doses of radiation plus Erbitux (cetuximab), from BMS, increases survival among stage III non-small cell lung cancer patients reveals that a higher dose of radiation (74 Gy) does not improve overall survival for non-small cell lung cancer that has spread to the lymph nodes, compared to the ...

Surfaxin is re-filed at FDA for Respiratory Distress Syndrome

The FDA has accepted the re-application for the humanised surfactant Surfaxin (lucinactant) from Discovery Laboratories as a preventive therapy for respiratory distress syndrome (RDS) in premature infants as complete and has classified it as a Class 2 submission, setting 6 March 2012 as the Prescription Drug User Fee Act action date. Respiratory Distress Syndrome is a condition in which premature ...

CHMP recommends Alimta for continuation maintenance therapy in NSCLC

The European Committee for Medicinal Products for Human Use (CHMP) delivered a positive opinion for the use of Alimta (pemetrexed) from Eli Lilly as continuation maintenance therapy in patients with advanced NSCLC who have already received an initial treatment with the agent. This opinion will now be reviewed by the European Commission. The opinion was based on the results from ...

RESPeRATE device study shows benefits for Heart Failure patients

Results of a 72-patient controlled study of RESPeRATE, from InterCure, demonstrate that device–guided respiratory modulation with RESPeRATE applied at home can significantly relieve symptoms of Heart Failure in elderly patients. RESPeRATE is an FDA-cleared, CE-marked device indicated for the adjunctive treatment of hypertension for use as a relaxation aid by leading the user through interactively guided and monitored breathing exercises. ...

INTENSITY study of Onbrez Breezhaler and Spiriva in COPD reported in European Respiratory Journal

Results of the INTENSITY study ,being a comparison of Onbrez Breezhaler (indacaterol) from Novartis with Spiriva(tiotropium)from Boehringer/Pfizer were announced in November 2010. These results showed once-daily Onbrez Breezhaler was as effective as Spiriva in improving lung function in COPD patients. It also demonstrated that the indacaterol treatment provides "significantly greater clinical benefit in terms of reduced shortness of breath, lower ...

Studies show Flutiform benefits for Asthma patients

According to three phase III studies presented at the 2011 European Respiratory Society Congress, the single aerosol inhaler Flutiform (fluticasone plus formoterol) from Napp Pharmaceuticals, offers a safe and efficient treatment for patients with Asthma. These studies support previous data that shows the efficacy and safety of Flutiform in adults and adolescents aged 12 years and above. As measured by ...

Study finds benefits of Xolair for Allergic Asthma treatment

New results from the APEX trial of Xolair (omalizumab), from Novartis, show that the drug considerably reduces patients need for steroid use, while at the same time helping disease control and lowering the amount of Asthma exacerbations. Usual treatment for Allergic Astham is oral steroids, but these are associated with weight gain, hypertension, osteoporosis and depression. The data, presented at ...

Daxas shows positive data on "Frequent exacerbations" in COPD

New findings from a post-hoc pooled analysis of two one-year studies of more than 1,500 roflumilast-treated patients with severe COPD, chronic bronchitis and a history of exacerbations show that Daxas (roflumilast) from Nycomed ,helps to prevent exacerbations in COPD patients of the 'frequent exacerbator' phenotype. The 'frequent exacerbator' group show worse health status and faster disease progression than those who ...

GLOW 1 and GLOW 3 studies to support SeebriBreezhaler application.

The GLOW 1 and GLOW 3 studies show that investigational NVA237 (glycopyrronium bromide)from Novartis significantly increased patients' lung function compared to placebo with a fast onset of action at first dose, as well as improving exercise endurance. NVA237 is a new drug in the long-acting anti-muscarinic (LAMA) class which has recently been submitted for approval in the European Union under ...

Alimta maintenance therapy positive in elderly NSCLC patients

A new subgroup analysis of data from the Phase III PARAMOUNT study showed that continuation maintenance therapy with Alimta from Eli Lilly (pemetrexed for injection) also reduces the risk of disease progression in patients aged 70 years or older with advanced nonsquamous non-small cell lung cancer (NSCLC), the most common type of lung cancer. Results from the new analysis were ...

Imatinib effective in Pulmonary Arterial Hypertension

The pivatol Phase III IMPRES clinical trial showed that the investigational therapy QTI571 (imatinib), known as Gleevec and Glivec in oncology indications from Novartis, significantly improved exercise capacity in patients with pulmonary arterial hypertension (PAH) after 24 weeks compared with placebo. Evidence indicates that QTI571 targets an underlying cause of PAH by counteracting uncontrolled growth of arterial smooth muscle cells. ...

Combination Oladaterol and Tiotropium enters Phase III for COPD

Boehringer Ingelheim has initiated its Phase III trial that will investigate Spiriva (tiotropium) in combination with a new compound, olodaterol, a novel once-daily long-acting beta-2 agonist ,for the treatment of chronic obstructive pulmonary disease. Spiriva (tiotropium), a long-acting muscarinic antagonist (LAMA) co-marketed with Pfizer, is the most prescribed COPD drug worldwide, while olodaterol is a novel once-daily long-acting beta-2 agonist ...

Tarceva approved in EU as first line treatment against NSCLC with EGFR-mutations

Tarceva (erlotinib), an oral lung cancer treatment from Roche, has been officially licensed in the EU as first-line monotherapy for the treatment of patients with advanced forms of non-small cell lung cancer with EGFR-activating mutations....

Bronchitol gets "negative trend" vote at CHMP for Cystic Fibrosis

Pharmaxis is unlikely to receive a positive EU opinion for its cystic fibrosis therapy Bronchitol (inhaled mannitol) following a "negative trend" vote from the CHMP. The drug is intended for the treatment of cystic fibrosis and has been approved in Australia and is not yet filed in the USA....

Bronchitol results in cystic fibrosis

Pharmaxis announced results of pooled data from its two large scale six month Phase III trials of Bronchitol (inhaled mannitol) in people with cystic fibrosis. The two studies were of similar design and encompass 643 patients from 11 countries. Over the 26 weeks of the two studies, patients treated with Bronchitol had an average 7.3% improvement in lung function (FEV1) ...