News

SAR 302503 (Sanofi) successs in JAKARTA study of Myelofibrosis

Sanofi has announced that the pivotal study, JAKARTA, examining the selective JAK2 inhibitor SAR 302503 for Myelofibrosis versus placebo in 289 patients, met its primary endpoint in both dose groups. The primary endpoint assessed the proportion of patients achieving >35% reduction of spleen volume. Consistent with data reported in previous trials, the most common adverse events were anemia, diarrhea, ...

Enzastaurin (Eli Lilly) fails Phase III trial for B Cell Lymphoma

Eli Lilly and Company has announced Phase III clinical trial results from enzastaurin's PRELUDE study, which explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL). The study failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based ...

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.

NICE confirms rejection of Jakavi(Novartis) for Myelofibrosis

NICE has confirmed that it will not recommend Jakavi(ruxolitinib) from Novartis after it found problems with its data and the costing model. NICE has published final draft guidance not recommending Jakavi for the treatment of disease-related splenomegaly (enlarged spleen) or its symptoms in adults with primary Myelofibrosis, or post polycythaemia vera Myelofibrosis or post essential thrombocythaemia Myelofibrosis.

Novartis ...

European Commission approves Hexyon/Hexcima (Sanofi Pasteur) Six in One vaccine

Sanofi Pasteur, the vaccines division of Sanofi has announced that the European Commission, on 22 April 2013, approved Sanofi Pasteur’s 6-in-1 pediatric vaccine Hexyon/Hexacima (DTaP-IPV-Hib-HepB vaccine) for primary and booster vaccination of infants from six weeks of age. Hexyon/Hexacima is the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), Hepatitis B, poliomyelitis ...

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 ...

EU extends Berinert (CSL Behring) indication for pre-procedure prevention of acute HAE episodes

The EU has approved an extended use of Berinert (C1 inhibitor concentrate), from CSL Behring, for pre-procedure prevention (short-term prophylaxis) of acute episodes of Hereditary Angio-Oedema (HAE) in adult and pediatric patients undergoing medical, dental or surgical procedures. Berinert is already indicated in Europe for the treatment of acute attacks of HAE at all body sites in adults and children. ...

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 ...

European Commission grants conditional marketing approval to Bosulif (Pfizer) for PH+CML

The European Commission (EC) has granted conditional marketing authorization for Bosulif (bosutinib) from Pfizer, in the European Union for the treatment of adult patients with chronic phase (CP), accelerated phase (AP) and blast phase (BP) Philadelphia chromosome positive Chronic Myelogenous Leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib ...

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 ...

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.

Study shows RoActemra/Actemra (Genetech/Roche) superior to Humira in achieving remission in Rheumatoid Arthritis patients

New data confirms RoActemra/Actemra (tocilizumab), from Genetech/Roche, is superior to Humira (adalimumab) in achieving disease remission in Rheumatoid Arthritis patients when either is used without methotrexate (MTX). Data shows that over 50% of RA patients can achieve low disease activity or remission with RoActemra/Actemra, compared to under 20% of those treated with the most widely prescribed anti-TNF Humira when neither ...

HyQvia (Baxter/Halozyme) is CHMP recommended for treatment of Immunodeficiencies

Baxter International and Halozyme Therapeutics, Inc. have announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (EMA CHMP) has granted a Positive Opinion to Baxter for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary Immunodeficiencies.

The product is a combination of human normal immunoglobulin (IGSC, ...

RTS,S Malaria Vaccine (GSK) disappoints

The effectiveness of a Malaria Vaccine, RTS,S, developed by GlaxoSmithKline wanes over time, with the shot protecting only 16.8 percent of children over four years, according to trial data. The disappointing results for RTS,S - the world's first potential malaria vaccine - raise further questions about whether it can make a difference in the fight against the disease, a major ...

Positive topline results from Phase III trial of Enterovirus 71 vaccine (Sinovac Biotech) against Hand, Foot and Mouth Disease

Preliminary top-line data from a Phase III clinical trial assessing the efficacy, immunogenicity and safety of Enterovirus 71 vaccine, from Sinovac Biotech, against Hand, Foot and Mouth Disease, showed that the vaccine was 95.4% efficacious against HFMD. The Phase III trial involving 10,000 healthy infants of 6 to 35 months old showed good immunogenicity and safety.

The overall incidence of ...

Takeda files vedolizumab at EMA for Crohns and Ulcerative Colitis

Takeda Pharmaceutical Company Limited has announced that a Marketing Authorisation Application (MAA) has been submitted to The European Medicines Agency (EMA) for vedolizumab, an investigational, gut-selective humanized monoclonal antibody for the treatment of adults with moderately to severely active Ulcerative Colitis (UC) and Crohn’s disease (CD), the two most common types of inflammatory bowel disease (IBD). If approved, vedolizumab would ...

Study suggests omega-3 fish oil can help protect against Skin Cancer

Researchers have carried out the first clinical trial to examine the impact of the fish oils on the skin immunity. Results of the study found that taking a regular dose of fish oils boosted skin immunity to sunlight. Specifically, it also reduced sunlight-induced suppression of the immune system, which affects the body’s ability to fight Skin Cancer and infection. Volunteers ...

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 ...

CHMP recommends Hexyon/Hexacima vaccine (Sanofi Pasteur)

The CHMP has recommended market approval for the 6-in-1 pediatric vaccine Hexyon/Hexacima (DTaP-IPV-Hib-HepB vaccine), from Sanofi Pasteur. The new vaccine will be commercialized under the brand name Hexyon in Western European countries by Sanofi Pasteur MSD, the joint venture between MSD and Sanofi Pasteur, and under the brand name Hexacima in Eastern European countries by Sanofi Pasteur. The new vaccine ...

UCB files Cimzia at FDA and EMA for treatment of axial Spondyloarthritis

UCB announced two new regulatory filings with the FDA and with the European Medicines Agency (EMA) to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active axial Spondyloarthritis (axSpA)

FDA approves Zortress (Novartis)for prophylaxis of organ rejection in Liver Transplant patients

Novartis announced that the FDA has, on 15 February 2013 ,approved Zortress (everolimus) for the prophylaxis of organ rejection in adult patients receiving a Liver Transplant.

Zortress is the first mammalian target of rapamycin (mTOR) inhibitor approved for use following Liver Transplantation. It is also the first immunosuppressant approved by the FDA in over a decade for use following ...

Positive data from Phase III study of Humira (AbbVie) in pediatric patients with Crohn's Disease

New data from the Phase III IMAgINE-1 trial of Humira (adalimumab), from AbbVie, shows that pediatric Crohn's Disease patients taking the drug experienced a significant improvement in select measures of health-related quality of life. The analyses assessed improvements in health-related quality of life (HRQOL) measures for pediatric patients aged 6 to 17 years with severe active Crohn's disease, taking Humira, ...

NICE does not recommend Jakavi (Novartis) for Myelofibrosis

NICE (National Institute for Health and Clinical Excellence) in its draft guidance stated that it is not recommending Jakavi (ruxolitinib) from Novartis, for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adults with primary Myelofibrosis, or Myelofibrosis secondary to polycythaemia vera or essential Thrombocythaemia.

NICE stated that although the drug might offer a survival benefit, ...

NICE does not recommend Krystexxa (Savient Pharma) for treatment of severe Gout

The National Institute for Health and Clinical Excellence (NICE) has opened a consultation on the use of Krystexxa (peglioticase) from Savient Pharma, in treating severe debilitating chronic tophaceous Gout in adults. Draft guidance does not recommend the drug for this use. NICE's independent appraisal committee has decided that the drug effectively lowers the level of uric acid in the ...

Phase III study of Neulasta (Amgen) for Neutropenia in Colorectal Cancer meets primary endpoint

PAVES, a Phase III trial evaluating Neulasta (pegfilgrastim), from Amgen, in 845 patients receiving FOLFOX or FOLFIRI and bevacizumab for first-line treatment of metastatic Colorectal Cancer, has met its primary endpoint, with Neulasta significantly reducing the incidence of febrile Neutropenia. All patients received treatment with either FOLFOX or FOLFIRI plus bevacizumab and were randomized to receive either placebo or 6 ...

FDA approves extension of Prevnar 13 vaccine indication

Pfizer Inc. has announced that the FDA has granted approval on 25 January 2013 for the expansion of the company’s pneumococcal conjugate vaccine, Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for use in older children and adolescents aged 6 years through 17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus ...

FDA approves Gleevec (Novartis) to treat Ph+ALL

The FDA on 25 January 2013 approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated. Children with Ph+ ALL have a genetic abnormality that causes proteins called tyrosine kinases ...

CHMP recommends bosutinib (Pfizer) for PH+CML

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding the conditional marketing authorization of bosutinib from Pfizer, in the European Union (EU), for the treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive Chronic Myelogenous Leukemia (Ph+ CML) ...

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 ...

FDA approves Uceris (Santarus) for mild to moderate Ulcerative Colitis

The FDA has approved Uceris (budesonide) extended release tablets, from Santarus, for the induction of remission in patients with active, mild to moderate Ulcerative Colitis. Approval is based on two trials, namely study CB 01-02/02 in Europe and CB 01-02/01 in USA and India, which showed the drug superior to placebo in achieving clinical remission as measured by the Ulcerative ...

Luveniq (Isotechnika) fails Phase III trial for treatment of Uveitis

Isotechnika Pharma Inc. announced that the Phase III clinical study using Luveniq (voclosporin) for the treatment of non-infectious Uveitis, conducted by Lux Biosciences, under a license agreement with Isotechnika, did not meet its primary endpoint of change from baseline in vitreous haze at 12 weeks or at the time of treatment failure, if earlier. As a result, Lux does ...

FDA approves VariZIG (Cangene Corpn) for Chicken Pox treatment

The FDA on 21 December 2012 approved VariZIG,a varicella zoster immune globulin preparation from Cangene Corporation, for reducing the severity of Chicken Pox (varicella zoster virus) infections in high risk individuals when given within four days after exposure. Varicella zoster immune globulin (VZIG) has been shown to lower the risk of severe infections if given soon enough after exposure. An ...

FDA approves Bivigam (Biotest Pharmaceuticals Corporation) for Primary Humoral Immunodeficiency

The FDA has given Biotest Pharmaceuticals Corporation approval for Bivigam for the treatment of patients with Primary Humoral Immunodeficiency. Approval is based on a pivotal clinical study which successfully achieved its primary endpoints for safety, efficacy and tolerability. The results were recently published in the Journal of Clinical Immunology (Wassermann RL, Church JA, Stein M, et al. "Safety, efficacy and ...

NICE recommends Revolade (GSK) for ITP

The National Institute for Health and Clinical Excellence(NICE) now recommends the use of Revolade (eltrombopag olamine)for patients with the bleeding disorder Chronic Immune Thrombocytopenic Purpura (ITP). The recommendation is for use of the drug for treating ITP in patients who have had their spleens removed or those refractory to other treatments, or as a second line treatment in those who ...

Phase II study of PCI 32765 (Pharmacyclics Inc) shows some benefits in patients with Mantle Cell Lymphoma

Findings from an ongoing, open-label, Phase II, single-agent study shows that in patients with relapsed or refractory Mantle Cell Lymphoma (MCL), PCI 32765 (ibrutinib), from Pharmacyclics Inc., resulted in an overall response rate of 68 percent, including a complete response of 22 percent and a partial response of 46 percent. The study included both bortezomib-naive and bortezomib-exposed patients; 111 received ...

European Commission approves Constella(Almirall/Ironwood) for Irritable Bowel Syndrome with Constipation

Almirall, S.A. and Ironwood Pharmaceuticals, Inc. announced that the European Commission has granted marketing authorization to Constella (linaclotide 290mcg) for the symptomatic treatment of moderate to severe Irritable Bowel Syndrome with Constipation (IBS-C)in adults.

Constella is an oral, once-daily medication. Linaclotide, the active ingredient in Constella, is a guanylate cyclase-C agonist (GCCA) with visceral analgesic and secretory activities, ...

European Commission approves Humira (Abbott Labs) for paediatric Crohn's Disease

The European Commission has approved Humira (adalimumab) from Abbott Labs for the treatment of paediatric patients aged six to 17 years with severe active Crohn’s Disease who have failed conventional therapy, such as maintaining proper nutrition, a corticosteroid and an immunomodulator. With this approval, it becomes the first biologic treatment for these patients in more than five years....

Sobi files Kineret at EMA for CAPS treatment

Sobi (Swedish Orphan Biovitrium)) has filed an application for an EU Marketing Authorization with the European Medicines Agency (EMA) for Kineret (anakinra) for the indication of Cryopyrin Associated Periodic Syndromes (CAPS). The filing is based on positive safety and efficacy outcome data from a long-term treatment study in children and adults with neonatal-onset multisystem inflammatory disease (NOMID), the most severe ...

ACZ 885 (Novartis) continues positively in Phase II trial for TRAPS

An ongoing Phase II, open-label, multicenter study is investigating the efficacy and safety of ACZ 885 ,from Novartis, in patients with active Tumor Necrosis Factor (TNF) Receptor-associated Periodic Syndrome (TRAPS).

Patients received ACZ 885 150 mg (or increased to 300 mg for those without complete or almost complete response by Day 8) every four weeks for four months. ...

Two year results of Certican (Novartis ) in Liver Transplant rejection confirm superiority over tacrolimus

Novartis announced new two-year results from the largest Phase III study ever in Liver Transplantation that confirmed comparable efficacy to control and superior renal function results previously seen at 12 months. The trial evaluated the introduction of Certican (everolimus) with reduced exposure tacrolimus administered twice-daily starting one month after liver transplantation versus standard-exposure tacrolimus.

At 24 months, the incidence ...

RTS.S anti malaria vaccine further results in African study

Results from a pivotal, large-scale Phase III trial, published online in the New England Journal of Medicine, show that the RTS,S malaria vaccine candidate can help protect African infants against malaria. When compared to immunization with a control vaccine, infants (aged 6-12 weeks at first vaccination) vaccinated with RTS,S had one-third fewer episodes of both clinical and severe malaria and ...

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 ...

FDA approves Xeljanz (Pfizer) to treat Rheumatoid Arthritis

The FDA has approved Xeljanz (tofacitinib) , from Pfizer,on 6 November 2012, to treat adults with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate. The safety and effectiveness of Xeljanz were evaluated in seven clinical trials in adult patients with moderately to severely active RA. In all of ...

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 ...

Sanofi Pasteur has submitted Hexaxim vaccine to EMA for approval in Europe

The Hexaxim vaccine (DTaP-IPV-Hib-HepB) has been submitted by Sanofi Pasteur MSD to the EMA for approval to licence within the European Union. Upon approval the company says it will commercialise it in its European territories under its own brand name. The new hexavalent vaccine, developed by Sanofi Pasteur, is the only fully liquid, ready to use 6-in-1 vaccine to protect ...

CHMP recommends Humira (Abbott) for paediatric patients with Crohn's Disease

The CHMP has adopted a positive opinion for Humira (adalimumab), from Abbott Labs, for the treatment of paediatric patients aged six to 17 years with severely active Crohn's Disease (CD) who failed, are intolerant to or have contraindications to conventional therapy. Following the CHMP's positive opinion, a final decision from the European Commission is anticipated in the next few months. ...

CHMP recommends Krystexxa (Savient Pharma) for treatment of Gout

On 18 October 2012, the CHMP adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Krystexxa, 8 mg/ml, concentrate from Savient Pharma, for solution for infusion intended for the treatment of severe debilitating chronic tophaceous Gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric ...

Study shows safety and efficacy of Hizentra (CSL Behring) for treating Immunodeficiency

A new study conducted in Japan supports the previously demonstrated safety and efficacy of Hizentra (Immune Globulin Subcutaneous [Human]), from CSL Behring, for the treatment of primary Immunodeficiency (PID). The Phase III study, conducted in patients who converted from intravenous immunoglobulin (IVIG) treatment, found that a dose-equivalent switch to Hizentra therapy maintained serum IgG (immunoglobulin) at a similar level of ...

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 ...

FDA approves new sNDA for Sorilux (Stiefel/GSK) to treat Plaque Psoriasis of the scalp

The FDA has approved a supplemental New Drug Application for Sorilux (calcipotriene) Foam, from Stiefel/GSK. The sNDA expands the indication for Sorilux Foam to include the topical treatment of Plaque Psoriasis of the scalp in patients aged 18 years and older. It is not known if the product is safe and effective in people under 18 years old. The treatment ...

FDA approve Humira (Abbott) for patients with moderately to severely active Ulcerative Colitis

The FDA has approved Humira (adalimumab), from Abbott, for inducing and sustaining clinical remission in adult patients with moderately to severely active Ulcerative Colitis (UC) when certain other medicines have not worked well enough. Abbott's submission was supported by results from two Phase III studies, ULTRA 1, an 8-week study, and ULTRA 2, a 52-week study, both of which enrolled ...

FDA approves Humira (Abbott) for patients with moderately to severely active Ulcerative Colitis

The FDA has approved Humira (adalimumab), from Abbott, for inducing and sustaining clinical remission in adult patients with moderately to severely active Ulcerative Colitis (UC) when certain other medicines have not worked well enough. Abbott's submission was supported by results from two Phase III studies, ULTRA 1, an 8-week study, and ULTRA 2, a 52-week study, both of which enrolled ...

EU approval for Dacogen (Janssen Cilag) for treatment of Acute Myeloid Leukemia

Astex Pharmaceuticals has announced that Janssen-Cilag International NV was notified that the European Commission has approved the marketing authorization for Dacogen (decitabine) for the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary Acute Myeloid Leukemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction ...

Belinostat (TopoTarget/Spectrum) success in BELIEF study for PTCL

The pivotal BELIEF trial (PXD101-CLN-19) evaluating the efficacy and safety of belinostat from Topo Target A/S for the treatment of patients with relapsed/refractory Peripheral T-Cell Lymphoma (PTCL) met its primary endpoint. A Special Protocol Assessment agreement with the FDA requires the BELIEF trial to reach an objective response rate (ORR) of at least 20% and this objective was met. Data ...

CHMP recommends Constella (Almirall) for for the symptomatic treatment of Irritable Bowel Syndrome.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of the first medicine specifically for the symptomatic treatment of Irritable Bowel Syndrome (IBS) in the European Union (EU). The Agency is recommending that Constella (linaclotide) from Almirall in Europe, be authorised for adults with moderate to severe IBS with constipation (IBS-C), a common ...

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 ...

FDA approves Elecsys HSV Assays (Roche) for detecting Herpes Simplex virus

The FDA has cleared the Elecsys HSV-1 IgG and HSV-2 IgG assays, from Roche, for detecting Herpes Simplex virus (HSV) types 1 and 2. The assays are for use on Roche's cobas modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection. The ...

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 ...

FDA approves Linzess (Forest/Ironwood) for Chronic Constipation and IBS

The FDA on 30 August 2012 approved Linzess (linaclotide) from Forest Labs and Ironwood Pharma, to treat Chronic Idiopathic Constipation and to treat Irritable Bowel Syndrome with Constipation (IBS-C) in adults. Almirall has the European rights and has filed a marketing application to EMA for Irritable Bowel Syndrome with Constipation....

Ariad Pharma files ponatinib at EMA for CML and Ph+ALL

Ariad Pharmaceuticals has submitted its marketing authorisation application to the European Medicines Agency for ponatinib for resistant or intolerant Chronic Myeloid Leukaemia and Philadelphia-chromosome positive Acute Lymphoblastic Leukaemia.The drug was filed in the US for these indications in July 2012....

FDA Advisory Panel recommends Humira (Abbott Labs) for treatment of Ulcerative Colitis

The FDA Gastrointestinal Drugs Advisory Panel voted 15-2 to recommend Humira (adalimumab) from Abbott Labs for reducing the signs and symptoms of moderate to severe Ulcerative Colitis in patients who have an inadequate response to conventional therapy.The members of the Panel considered that the benefits outweight the potential risks with the drug. The Panel called for post-approval studies in Ulcerative ...

EMA accepts filing for Heplisav (Dynavax Technologies), a vaccine for Hepatitis B.

The EMA has accepted the filing of the Marketing Authorization Application for Heplisav vaccine, from Dynavax Technologies, pursuing an indication for immunization against infection caused by all known subtypes of Hepatitis B virus in adults 18 through 70 years of age and in patients with chronic kidney disease. Acceptance of the MAA confirms that the submission is sufficiently complete to ...

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 ...

Tofacitinib (Pfizer) success in Phase II study for Ulcerative Colitis

A Phase II trial of tofacitinib from Pfizer shows it has potential as an effective treatment for Ulcerative Colitis. The trial studied the efficacy of tofacitinib in 194 adults with severely active forms of the disease. Patients were randomised for treatment with tofacitinib at a dose of 0.5 mg, 3 mg, 10 mg, or 15 mg or were given a ...

Dutch regulatory authority rejects Cortiment (Cosmo/Ferring) for Ulcerative Colitis

Cosmo Pharmaceuticals received a communication from the Dutch Regulatory Agency (MEB) declining the approval of Cortiment(budesonide with MMX technology), indi­ca­ted for the induction of remission in patients with active, mild to moderate Ulce­ra­tive Colitis. The reasons given for the decline were on the grounds of clinical relevance. Cosmo is awaiting the formal letter to get full disclosure of the reasons ...

Positive results for Humira (Abbott) for pediatric patients with Crohn's Disease

Humira (adalimumab), from Abbott, is effective in maintaining remission in pediatric patients with Crohn's disease, according to a new study in the journal Gastroenterology. This study is the largest double-blind study of an anti-TNF agent in children with Crohn's disease.

Researchers studied 192 patients, ages 6 to 17 years, across 45 sites in Canada, Europe and the US between ...

CytoFab (BTG/AstraZeneca) fails Sepsis trial

BTG disclosed top-line results from a Phase IIb study conducted by AstraZeneca which had compared two doses of CytoFab (polyclonal ovine anti-TNF antibody fragments) with a placebo in patients with severeSepsis and/or Septic Shock. Treatment with CytoFab failed to show any significant improvements versus placebo with regard to either the primary endpoint of ventilator-free days or secondary endpoints such as ...

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 ...

FDA issues Complete Response Letter for HyQ (Baxter) for treatment of Primary Immunodeficiencies

The FDA has issued a complete response letter for HyQ, an investigational combination immunoglobulin product from Baxter for the treatment of patients with Primary Immunodeficiencies that includes Immune Globulin (IG) Infusion 10% (Human) and Recombinant HumanHyaluronidase. The letter requested additional preclinical data to support the biologics license application. The primary issues raised in the letter focused on non-neutralizing antibodies generated ...

FDA requires more data for Arcalyst (Regeneron) for Gout Flares treatment

The FDA has again issued a Complete Response Letter for the supplemental Biologics License Application for Arcalyst (rilonacept) from Regeneron for subcutaneous use for the prevention of Gout Flares in patients initiating uric acid-lowering therapy. The agency has requested additional clinical data, as well as additional chemistry, manufacturing and controls information related to a proposed new dosage form....

ARRAY-797 (Array Biopharma) reports Phase II results in Osteoarthritis

ARRAY-797 from Array Biopharma met its primary endpoint in a randomized, placebo-controlled and active-controlled (oxycodone ER) Phase II clinical trial in 157 Osteoarthritis patients suffering from moderate to severe knee pain despite the use of non-steroidal anti-inflammatory drugs (NSAIDs). Patients in all treatment groups continued using NSAIDs throughout the trial.The investigational compound, ARRY-797, is a novel, oral, selective p38 ...

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 ...

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 ...

CHMP refuses recommendation of Istodax( Celgene) for T-cell Lymphoma

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) . ...

Simponi(Janssen Biotech) filed at FDA and EMA for Ulcerative Colitis treatment

Janssen Biotech and Janssen Biologics have requested the FDAand European Medicines Agency to approve Simponi(golimumab) a treatment for "adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy." Simponi ,a once-monthly subcutaneously administered drug , received approvals in the United States, Europe and Canada in 2009 for the treatment of moderately to ...

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 ...

Ferring licenses elobixibat from Albireo for Chronic Constipation and IBS.

Ferring has licensed from Albireo the world rights to elobixibat, excluding those territories held by Ajimoto. Elobixibat is a first-in-class investigational drug in development for Chronic Constipation and Irritable Bowel Syndrome with Constipation....

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 ...

Positive data in study of Krystexxa (Savient Pharma) in patients with Gout

New results show that adult patients with refractory chronic Gout (RCG) treated bi-weekly with Krystexxa (pegloticase), from Savient Pharma, experienced statistically significant and clinically meaningful improvements in health-related quality of life (HRQOL), pain and physical function. The analysis evaluated patient-reported outcomes from two replicate, randomized, double-blind, placebo-controlled Phase III studies. Results at week 25 demonstrated that mean improvements from baseline ...

Positive results in Phase III study of VPRIV (Shire) for Gaucher-related bone disease

New data shows VPRIV (velaglucerase alfa for injection), from Shire, significantly improved selected markers of Gaucher-related bone disease in patients. A head-to-head Phase III study (HGT-GCB-039) of VPRIV and Cerezyme, and follow-on extension trial (HGT-GCB-044) of VPRIV, demonstrate a statistically significant improvement in lumbar spine (LS) bone mineral density in Gaucher patients starting at nine months of treatment with VPRIV, ...

Positive results from Phase IV study of MuGard (Access Pharma) for oral Mucositis

Results from the ongoing Phase IV clinical trial of mouth rinse treatment Mu-Gard, from Access Pharma, for oral Mucositis show that patients undergoing chemoradiation therapy for head and neck cancer and using Mu-Gard experienced a statistically significant reduction in mouth and throat soreness, a statistically significant delay to onset of oral Mucositis as measured in days or cumulative radiation, and ...

CHMP refuses to recommend approval to Uplyso(Pfizer)for Gaucher Disease

The Committee for Medicinal Products for Human Use (CHMP) will not recommend approval to Uplyso (taliglucerase alfa) from Protalix/Pfizer for long-term enzyme replacement therapy for adults with Type 1 Gaucher disease because the drug works in the same way as Vpriv (velaglucerase alfa) from Shire and as Vpriv is an orphan drug it has 10 years exclusivity...

Horizon Pharma licenses Latin American rights to Duexis to Grunenthal

Horizon Pharma has exclusively licensed Duexis (ibuprofen and famotidine) to Grunenthal for commercialisation in Latin America. Duexis is a single-tablet combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine. It is indicated in the US for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, in ...

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 ...

Ceptaris Therapeutics receives Complete Response Letter from FDA for mechlorethamine hydrochloride treatment for Mycosis Fungoides

Ceptaris Therapeutics (formerly Yaupon Therapeutics) has received a Complete Response Letter (CRL) from the FDA for mechlorethamine hydrochloride gel as a treatment for early-stage Mycosis Fungoides, the most common type of cutaneous T-Cell lymphoma a rare form of non-Hodgkin's lymphoma. Mechlorethamine hydrochloride is a water-soluble, greaseless topical gel, which could lead to better compliance for patients with Mycosis Fungoides....

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 Phase III data for Krystexxa (Savient Pharma) in Gout patients with chronic Kidney Disease

New results show that patients with refractory chronic Gout (RCG) who also suffer from chronic Kidney Disease (CKD) responded to treatment with Krystexxa (pegloticase), from Savient Pharma, regardless of baseline CKD stage. This post-hoc analysis evaluated more than 200 patients with CKD stages one through four who were randomized to receive treatment with Krystexxa 8 mg every other week, 8 ...

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 ...

Simponi (Janssen Biotech) shows positive results in Phase III trial for Ulcerative Colitis

A study of subcutaneous induction regimens of Simponi (golimumab), from Janssen Biotech/Merck Inc., induced clinical response in a majority of patients with moderately to severely active Ulcerative Colitis who had previously failed or were intolerant to conventional agents. The PURSUIT trial had an adaptive design with Phase II dose ranging followed by a confirmatory Phase III component. All enrolled patients ...

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, ...

Postive results from Phase III analysis of Amitiza (Sucampo) for IBS-C

A post-hoc analyses of two pivotal Phase III studies of Amitiza (lubiprostone), from Sucampo, for the treatment of Irritable Bowel Syndrome with constipation (IBS-C) demonstrates that the drug provides a statistically significantly higher proportion of patients with consistent relief from IBS-C symptoms compared to placebo treatment. Patients with documented IBS-C, as defined per Rome II criteria, were randomized in a ...

Omega 3 fatty acids cellular processes are mapped.

US based scientists have mapped the cellular processes that power the heath effects of Omega 3 fatty acids by studying living mouse cells and finding that the beneficial fatty acids block an enzyme known as cyclooxygenase (COX) which produces the prostaglandin hormones that spark inflammation. This is the first comprehensive study of what fish oils actually do inside a cell. ...

FDA Advisory Committee rejects Arcalyst(Regeneron) for treatment of Gout Flares

The FDA Arthritis Advisory Committee rejected Arcalyst (rilonacept) from Regeneron , voting 11-0 that the data submitted had failed to support the approval of a subcutaneous once weekly dosage of Arcalyst to prevent Gout Flares. The Advisory Committee noted the small numbers of patients in the studies and the absence of long term and safety data which did not exist ...

F 627 (Generon) commences Phase II study for Neutropenia

A Phase II clinical trial for F 627,recombinant G-CSF from Generon(Shanghai)Corporation, has been started after FDA regulatory clearance. The study is a randomized, multicenter, open-label, active-controlled trial of F 627 in women with Breast Cancer receiving myelotoxic chemotherapy. The clinical trial will enroll approximately 200 patients and will be conducted at approximately 35 clinical centers in North America and Europe. ...

FDA aproves Elelyso (Pfizer) for Type 1 Gaucher Disease

The FDA on 1st May 2012 approved Elelyso (taliglucerase alfa) from Pfizer for long-term enzyme replacement therapy to treat a form of Gaucher Disease. Gaucher Disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. The enzyme deficiency causes fatty materials (lipids) to collect in the spleen, liver, kidneys, and other organs. Elelyso is an injection ...

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 ...

NICE rejects Benlysta (GSK) for SLE in final guidance

The health technology appraisal body in England and Wales, NICE, has in its final guidance rejected Benlysta ((belimumab ) from GSK/Human Genoma Sciences for Systemic Lupus Erythematosus (SLE) treatment. The decision was criticised by GSK, which said the UK's failure to adopt innovative medicines is a continuing systemic problem....

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 ...

Positive results in Phase IIb study of CG100649 (CrystalGenomics) for Osteoarthritis

A Phase IIb study of the CG100649, from CrystalGenomics, shows the candidate drug for Osteoarthritis met its primary and secondary endpoints in an evaluation of the safety, analgesic efficacy and functional benefits of CG100649 (2 mg or 4 mg per day) versus Celebrex (celecoxib) (200 mg per day) over a 4 week treatment period. Anti-arthritic efficacy was evaluated using the ...

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 ...

FDA requires longer term trials for HyQvia (Halozyme/Baxter) for Primary Immonodeficiency

The FDA wants additional safety data before it will complete its review of the biologics license application (BLA) for HyQvia, a combination of immune globulin infusion and recombinant human hyaluronidase (rHuPH20) from Halozyme and Baxter under investigation to treat primary immunodeficiency disorder....

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 ...

European Commission approves Humira(Abbott Labs) for Ulcerative Colitis

The European Commission has approved Humira (adalimumab)from Abbott Labs, for the treatment of moderately to severely active Ulcerative Colitis (UC) in adult patients who have had an inadequate response to conventional therapy. With this approval, Humira becomes the first and only self-injectable biologic therapy for the treatment of moderately to severely active Ulcerative Colitis in adults. The approval also marks ...

Minophagen extends marketing rights to bexarotene for T-Cell Lymphoma

Minophagen Pharma has acquired further rights to market the synthetic retinoid bexarotene from Eisai. Minophagen has added to its rights to market in Japan the territories of Asia, Oceana, the Middle East and Eastern Europe.The drug is marketed in 20 countries for refractory/recurrent T-Cell Lymphoma and in the USA by Eisai as Targretin....

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....

Albireo licences Asian rights for Elobixibat to Ajimoto

Albireo Pharma licences Ajimoto rights to elobixibat in Japan, South Korea, Thailand, Indonesia, Vietnam and Taiwan.Elobixibat is a first-in-class investigational drug in development for chronic constipation and irritable bowel syndrome with constipation .Phase II trials have been promising....

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 ...

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 ...

PA 32540 (Pozen) effective against Gastric Ulcers in Phase III study

Top-line results from Study 303, a Phase III trial tracking the safety of PA 32540, from Pozen Inc.,, in patients at risk for aspirin-associated Gastric Ulcers, shows that adverse events were consistent with those expected in this population of patients requiring cardio-aspirin therapy and with the known safety profile of the drug's components. PA 32540 is a combination tablet of ...

ALLEGRO trial of laquinimod reported in NEJM

Teva/Active Biotech have announced the publication of results from the laquinimod Phase III ALLEGRO study in the March 15 issue of The New England Journal of Medicine. Data from the two-year study showed that oral once-daily laquinimod reduced inflammatory disease activity as measured by clinical relapses and Magnetic Resonance Imaging (MRI), slowed disability progression and decreased brain tissue loss, while ...

Wheat bran Brana Vita(Fugeia NV) positive in Gut trial

Brana Vita, a wheat bran, from Fugeia NV, is associated with an increase in gut levels of bifidobacteria according to a placebo controlled trial published in the British Journal of Nutrition.Results showed that 10 grams produced significant changes to levels of bifidobacteria in the faeces and an increase in short chain fatty acids.see British Journal of Nutrition published online ahead ...

NICE endorses Victrelis (Merck Inc.)for Hepatitis C genotype 1 infection

In its final draft guidance, NICE recommends Victrelis (boceprevir) from Merck Inc., in combination with Roche’s Pegasus (peginterferon alfa) and Copegus (ribavirin) injections,as an option for the treatment of genotype 1 Chronic Hepatitis C in adults with compensated liver disease.A final endorsement is expected next month. Hepatitis C has a poor diagnosis and low treatment compliance rate, with a high ...

APG101 (Apogenix) meets primary endpoint in Phase II trial for Glioblastoma Multiforme

The Phase II clinical efficacy trial with APG101, from Apogenix, has met its primary endpoint in the 2nd line treatment of a common form of Brain Cancer, Glioblastoma Multiforme (GBM), following a six month follow up of the last patient treated. The primary endpoint of the trial was the six-month-rate of progression-free survival (PFS6) and secondary endpoints include overall survival ...

Procoralan (Servier) approved by European Commission for Chronic Heart Failure

Procoralan (ivabradine) from Servier Laboratories, the first selective If channel inhibitor, has been approved by the European Commission for the treatment of patients with Chronic Heart Failure. The European Commission´s decision to authorise this new indication for Procoralan followed the review of data from the SHIfT trial, the largest-ever morbi-mortality study of treatments for Chronic Heart Failure involving more than ...

Repligen files Secreflo with EMA for detection of Pancreatic Duct Abnormalities

Repligen has submitted a marketing authorization application (MAA) for SecreFlo (synthetic human secretin) as an agent to improve the detection of pancreatic duct abnormalities in patients with Pancreatitis. SecreFlo stimulates secretion of watery fluid into the pancreatic ducts. When the ducts are filled with water they are more effectively visualised. FDA decision expected on 21 June 2012....

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 ...

HyQ (Baxter)brand name to be HyQvia for Immunodeficiency

Baxter International has announced the presentation of additional long-term data supporting the clinical profile of HyQ, its investigational combination product for use in patients with primary immunodeficiencies. The company also introduced HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], as the submitted brand name for the investigational product, previously referred to as HyQ....

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 ...

Vedolizumab (Takeda) meets endpoints in Phase III Ulcerative Colitis trial

The GEMINI I Phase III trial evaluating vedolizumab, from Takeda, for Ulcerative Colitis has met its endpoints. The study involved 895 patients with moderately to severely active Ulcerative Colitis who have failed at least one conventional therapy, including tumour necrosis factor-alpha antagonists, such as Abbott Laboratories Humira. Patients received a year of vedolizumab, also known as MLN0002, or placebo, starting ...

CHMP recommends Humira(Abbott) for Ulcerative Colitis

The CHMP gives a positive opinion to expand the label on Humira (adalimumab) from Abbott Labs to include the treatment of adults with moderate to severely active Ulcerative Colitis for whom conventional therapies are not suitable. If the European Commission acts on the advice, Humira will be the first self-injectable biologic therapy available for those Ulcerative Colitis patients....

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 ...

CHMP recommends Remicade (Janssen Biologic) for Paediatric Ulcerative Colitis

The CHMP has issued a positive opinion for Remicade (infliximab) from Janssen Biologic for the treatment of severely active Ulcerative Colitis in paediatric patients aged between six to 17 who have had an inadequate response to conventional therapy, or who or intolerant to, or have medical contraindications to these therapies. The recommendation is based on a Phase III randomised, open-label ...

CHMP rejects Folotyn (AllosTherapeutics and Mundipharma) for T-Cell Lymphoma

The CHMP adopted a negative opinion, recommending the refusal of marketing authorisation for the medicinal product Folotyn,(pralatrexate injection), from Allos Therapeutics, intended for the treatment of peripheral T-cell Lymphoma. The CHMP was concerned that the main study was designed in a way that did not allow the Committee to assess the benefit of the medicine, particularly since Folotyn was not ...

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 ...

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 ...

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 ...

FDA extends review date of Uplyso (Pfizer)for Gauchers Disease until 1 May 2012

The FDA has extended its review by three months of the new drug application for Uplyso (taliglucerase alfa) from Pfizer/Protalix Biotherapeutics for the treatment of Gaucher's Disease .The effect delays the Prescription Drug User Fee Act action date until 1 May 2012. No additional data was requested by the FDA....

Arcalyst (Regeneron) is filed at FDA for Gout Flares

The FDA has accepted the supplemental Biologics License Application for Arcalyst (rilonacept) injection from Renereron, for subcutaneous use for the prevention of Gout Flares in patients initiating uric acid-lowering therapy. The FDA plans to review the application on July 30 2012. Arcalyst is already available in the USA and EU for treatmentof rare genetic cryopyrin-associated periodic syndromes (CAPS). Arcalyst is ...

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....

EU approvbes Plenadren (DuoCort Pharma) for Adrenal Insufficiency

The European Commission has granted marketing authorisation for dual-release hydrocortisone replacement therapy Plenadren (hydrocortisone, modified-release) from DuoCort Pharma as a once-daily oral treatment for adults with adrenal insufficiency – the first new therapy for the condition in 50 years. DuoCort Pharma is being acquired by Viro Pharma....

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 ...

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 ...

Lipitor ineffective for Atherosclerosis in pediatric Lupus

A trial to determine the efficacy and safety of Lipitor (atorvastatin), from Pfizer, in preventing subclinical Atherosclerosis progression in pediatric-onset Systemic Lupus Erythematosus (SLE) found that the therapy was ineffective in reducing Atherosclerosis progression in children and adolescents. However results from the trial showed that the treatment could benefit patients with more severe SLE who were not included in the ...

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 ...

Luveniq is withdrawn from EMA for chronic non-infectious Uveitis

Lux Biosciences has withdrawn Luveniq (voclosporin oral) from the EMA as a treatment for chronic non-infectious Uveitis following a negative opinion from the CHMP which considered that the benefits of the drug did mnot outweight its risks....

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....

Mechlorethamine hydrochloride gel is filed at FDA for Mycosis Fungoides

Yaupon Therapeutics has filed at the FDA an application (NDA) for its gel formulation of mechlorethamine hydrochloride as a topical treatment for early-stage mycosis fungoides, the most common type of cutaneous T-Cell lymphoma (CTCL), a rare form of non-Hodgkin's lymphoma. Mycosis fungoides is the most common type of Cutaneous T-Cell Lymphoma, a rare form of non-Hodgkin's lymphoma. The cause of ...

NICE refuses to recommend Benlysta for SLE

In a draft guidance, NICE, the health technology appraisal institute for England and Wales, has provisionally rejected Benlysta (belimumab) from GlaxoSmithKline (GSK) and Human Genome Sciences (HGS), for the treatment of adult patients with active autoantibody-positive systemic lupus erythematosus, where patients have a high degree of disease activity despite the individual receiving standard therapy. GSK plans to contest the decision....

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 ...

Baxter files subcutaneous HyQ at EMA for Primary Immune Deficiency

The European Medicines Agency's Committee for Human Medicinal Products (CHMP)has accepted an application from Baxter International for a marketing authorization for HyQ. HyQ is Baxter's investigational immunoglobulin (IG) therapy administered subcutaneously and facilitated by recombinant human hyaluronidase, a dispersion and permeation enhancer, for use in patients with primary immunodeficiencies. The application is based on results from a phase III, prospective, ...

FDA approves Remicade for Pediatric Ulcerative Colitis

The FDA has approved Remicade (infliximab), from Janssen Biotech, for the treatment of moderately to severely active Ulcerative Colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy. The approval was supported by evidence from studies of Remicade in adults with Ulcerative Colitis plus additional data from a pivotal Phase III trial evaluating the efficacy and ...

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) ...