News

Phase III study of NEPA (Helsinn and Eisai) meets endpoint in patients with Nausea

Top-line results from a pivotal Phase III clinical study investigating NEPA (netupitant and palonosetron), from Helsinn and Eisai, for chemotherapy-induced Nausea and Vomiting (CINV), shows NEPA has superior complete response rates compared with palonosetron during the delayed phase after chemotherapy administration, which was the primary endpoint of the study. The global, randomized, double-blind, parallel group superiority study was designed to ...

ASPECCT study of Vectibix (Amgen) compared to Erbitux in treatment of Colorectal Cancer

Amgen announced that the Phase III head-to-head ASPECCT ('763) trial evaluating Vectibix (panitumumab) versus Erbitux (cetuximab) as a single agent for the treatment of chemorefractory metastatic Colorectal Cancer (mCRC) in patients with wild-type KRAS tumors (n=1,010) met its primary endpoint of non-inferiority for overall survival. The estimated overall survival hazard ratio (Vectibix/Erbitux) was 0.966 (95 percent CI: 0.839, 1.113) ...

FDA approves Amitiza(Sucampo/Takeda) for Opioid-induced Constipation

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A., Inc. have announced that the FDA has approved Sucampo’s supplemental new drug application for Amitiza(lubiprostone) (24 mcg twice daily) as the first and only oral medication for the treatment of Opioid-induced Constipation (OIC) in adult patients with chronic, non-cancer pain. The effectiveness of Amitiza in the treatment of Opioid-induced Constipation in patients ...

FDA approves Diclegis (Duchesnay USA) for treatment of Nausea in pregnancy

The FDA has approved Diclegis (doxylamine succinate/pyridoxine hydrochloride) delayed-release tablets, from Duchesnay USA, for the treatment of Nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management. The NDA submission was based on a 15-day double-blind, randomized, multi-center placebo-controlled trial studying pregnant women 18 years of age or older, 7 to 14 weeks gestation, with ...

FDA issues Complete Response Letter to AP Pharma relating to AP F 530 for CINV

AP PHarma as announced that it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for its lead product candidate, APF 530, for the prevention of Chemotherapy-induced Nausea and Vomiting (CINV). The FDA has requested the refinement of a product quality analytical test method, and that certain deficiencies identified during facility pre-approval inspections ...

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 ...

Phase III trial of Naloxegol (AstraZeneca) confirms earlier safety studies in patients with Opioid-induced Constipation

New results from KODIAC-08, an open-label, randomised, 52-week, long-term safety trial of Naloxegol (naxolol), from AstraZeneca, in patients with non-cancer related pain and Opioid-induced Constipation, are similar to safety results seen in earlier Phase III studies. A total of 534 patients received Naloxegol daily for up to 52 weeks, while 270 patients received usual care. The most commonly reported AEs ...

FDA approves Stivarga (Bayer HealthCare) in patients with GIST

The FDA has approved Stivarga (regorafenib), from Bayer HealthCare, to treat patients with locally advanced, unresectable or metastatic Gastrointestinal Stromal Tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. Approval is based on data from the pivotal Phase III GRID trial, which showed that Stivarga plus best supportive care (BSC) statistically significantly improved progression-free survival (PFS) ...

New data shows benefits of Linx Reflux System (Torax Medical Inc) for patients with GERD

A new study provides evidence of safety and effectiveness for the Linx Reflux Management System, from Torax Medical Inc, for the treatment of patients with GERD. This prospective, multicenter trial is part of the FDA pre-market approval process. The patients were evaluated before and after treatment to determine the effect of the Linx System on their GERD using pre-defined success ...

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, ...

Study shows prebiotic Bimuno (Clasado) shows some benefits to Gastrointestinal health

A randomized, placebo-controlled study of the prebiotic Bimuno, from Clasado, shows evidence of benefit in patients at risk of reduced Gastrointestinal health. A total of 45 overweight adults (body mass index > 25 kg/m2) with at least 3 risk factors for Metabolic Syndrome were followed for 28 weeks. During the first 12 weeks, volunteers were randomly assigned to consume either ...

Positive topline results from study of VXM01 (Vaximm) for Pancreatic Cancer

Topline data from a randomized, placebo-controlled, double-blind Phase I/II dose escalation study of vaccine VXM01, from Vaximm, shows the treatment met all key endpoints and demonstrated safety and tolerability in patients with Pancreatic Cancer. In this study (VXM01-01-DE), 45 patients with inoperable pancreatic cancer received several doses of VXM01 in addition to standard-of-care treatment, or placebo. Results indicate that the ...

Study of Qsymia (Vivus inc.) shows positive benefits for treatment of Obesity

A new study concludes that weight loss resulting from treatment with Qsymia (phentermine and topiramate extended-release), from Vivus inc., led to significant improvements in cholesterol, blood pressure and triglycerides in Obese and overweight patients. The improvements were significantly greater among patients who lost 10% or more of their starting weight. Participants in the study with body mass indexes of 27 ...

ThermoDox (Celsion) fails Phase III trial for Liver Cancer

Celsion Corporation has announced that ThermoDox in combination with radiofrequency ablation (RFA) did not meet the primary endpoint of the Phase III HEAT Study in patients with Hepatocellular Carcinoma (HCC), also known as Primary Liver Cancer. Specifically, Celsion has determined, after conferring with its independent Data Monitoring Committee (DMC) that the HEAT Study did not meet the goal of demonstrating ...

Positive results from Phase III trial of Avastin (Genentech/Roche) in elderly Colorectal Cancer patients

The results of the Phase III AVEX trial show that Avastin (bevacizumab), from Genentech/Roche, in combination with Xeloda (capecitabine) can significantly extend the time people aged over 70 live without their previously untreated advanced Bowel Cancer worsening - by 4 months - compared to Xeloda alone (median progression free survival of 9.1 months compared to 5.1 months respectively, HR =0 ...

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 ...

EU approves APPY1 test (Venaxis) for patients at low risk for acute Appendicitis

The EU has given CE Mark approval to the APPY1 blood-based Appendicitis test, from Venaxis. The unique test is designed to aid in the identification of patients at low risk for acute Appendicitis, allowing for more conservative patient management. APPY1 is being developed initially for pediatric, adolescent and young adult patients with abdominal pain, as this population is at the ...

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 ...

FDA approves acetylcysteine injection (APP Pharma) generic version of Acetadote

The FDA has given approval for the Abbreviated New Drug Application (ANDA) for acetylcysteine injection, from APP Pharma, indicated to prevent or lessen hepatic injury following an acetaminophen overdose. Acetylcysteine injection will be available as a 20% solution (200mg/mL) in 30mL single-dose glass vials. Acetylcysteine injection is sterile and can be used for I.V. administration. This provides the first generic ...

Plecanatide (Synergy Pharma) success in Phase III trial for Constipation

Synergy Pharmaceuticals, Inc.has announced that plecanatide, its investigational oral drug for the treatment of Chronic Idiopathic Constipation (CIC), was well tolerated and met the primary and key secondary endpoints of a Phase IIb/III clinical study. Full study results will be presented at a major scientific meeting this year.

The randomized, double-blind, placebo-controlled, repeat-dose, dose-ranging study was designed to ...

FDA approves Fulyzaq (Salix Pharmaceuticals) for Diarrhoea in HIV/AIDS

The FDA has approved Fulyzaq (crofelemer 125 mg delayed-release) tablets, from Salix Pharmaceuticals, for the symptomatic relief of Diarrhoea in patients with HIV/ AIDS. Approval is based on a randomized, double-blind, placebo-controlled and placebo-free, multi-center study of 374 HIV-positive patients on antiretroviral therapy (ART), with a history of Diarrhoea for one month or more. The primary efficacy endpoint was the ...

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 Gattex (NPS Pharma) for adult patients with Short Bowel Syndrome

The FDA has approved Gattex (teduglutide), from NPS Pharma, for subcutaneous use for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. The drug was approved in the EU in September 2012 as Revestine. Gattex will be available in the first quarter of 2013.

The FDA's approval of Gattex was based on an international, ...

FDA rejects Ampligen (Hemispherx) as a treatment for Chronic Fatigue Syndrome

The FDA Arthritis Advisory Committee rejected the re-application by Hemispherx for Ampligen (rinatatolimod) as a treatment for Chronic Fatigue Syndrome. The Committee voted 8 votes to 5 votes to reject the drug. The FDA was unimpressed with the clinical trial evidence as to efficacy, but accepted that the drug was safe. There are currently no approved treatments for Chronic Fatigue ...

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, ...

Phase III trial of Stivarga (Bayer HealthCare) finds positive effect in patients with GIST

A new study demonstrates that Stivarga (regorafenib), from Bayer HealthCare, was able to control GIST for nearly four months longer than placebo in patients for whom Gleevec and Sutent were no longer effective, a result that was highly significant statistically. The Phase III international trial involved 199 treatment-resistant GIST patients at 57 hospitals in 176 countries. Of the 199 patients, ...

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....

Positive results in Phase III trials of Naloxegol (AstraZeneca) for patients with Opioid Induced Constipation

Two Phase III trials and one safety extension trial of Naloxegol (naxolol), from AstraZeneca, in patients with non-cancer related pain and Opioid Induced Constipation (OIC) indicates that Naloxegol demonstrated statistically significant results for the primary endpoint, defined as having at least three Spontaneous Bowel Movements (SBM) per week, with at least one SBM per week increase over baseline. KODIAC-04 and ...

Abraxane (Celgene) success in Phase III study of Pancreatic Cancer

In a Phase III study,(the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound),from Celgene, in combination with gemcitabine in treatment-naïve patients with advanced Pancreatic Cancer met its primary endpoint of overall survival. In the study, Abraxane in combination with gemcitabine demonstrated a statistically significant improvement in overall survival compared to patients receiving gemcitabine ...

FDA award orphan status to A 4250 (Albireo) for Primary Biliary Cirrhosis and PFIC

The FDA has awarded A 4250, from Albireo, orphan-drug designation for the treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)and Primary Biliary Cirrhosis (PBC). Orphan designation was granted based on an extensive preclinical data package showing that A4250 has a high potency and a minimal systemic exposure. In addition, substantial benefits were shown in an animal model of cholestasis; the predominant ...

Study analyses role of Avastin (Roche/Genentech) in Colorectal Cancer

A recent paper that analysed the E2300 registration study of Avastin( bevacizumab) from Roche/Genentech, for Colorectal Cancer shows why Avastin has such an unpredictable effect. At least half of colorectal cancer patients, according to the study, who are given the drug derive no benefit. Patients with low levels of the VEGF 165b variant demonstrate both progression free survival and ...

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 rejects Qsiva (Vivus Inc.,) as a treatment for Obesity

On 18 October 2012, the CHMP adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Qsiva (phentermine plus topiramate) from Vivus Inc., intended for the treatment of Obesity.

The CHMP noted that the main studies showed clinically relevant weight loss following treatment with Qsiva but had concerns about the medicine’s long-term effects on the ...

FDA Advisory Committee recommends Gattex (NPS Pharma) for Short Bowel Syndrome

The FDA Gastrointestinal Drugs Advisory Committee voted unanimously to recommend approval of Gattex (teduglutide) from NPS Pharma. It voted 12-0 that the drug delivered meaningful benefits as a treatment for Short Bowel Syndrome (SBS) and that the benefits of the drug outweigh its potential risks.The drug was approved in September 2012 in the EU for Nycomed/Takeda as Revestive...

Ramucirumab (Eli LillY) success iN Phase III trial for Gastric Cancer

The REGARD trial, a Phase III study of ramucirumab (IMC-1121B) from Eli Lilly, in patients with metastatic Gastric Cancer, met its primary endpoint of improved overall survival and also showed prolonged progression-free survival. This trial is the first Phase III data read-out for ramucirumab. The REGARD trial compared ramucirumab and best supportive care to placebo and best supportive care as ...

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 ...

FDA approves Stivarga (Bayer/Onyx Pharma) for metastatic Colorectal Cancer

The FDA has on 27th September 2012 approved Stivarga (regorafenib) from Bayer HealthCare and Onyx Pharma for the treatment of patients with metastatic Colorectal Cancer (mCRC) who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy). The approval of Stivarga is based on results ...

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 ...

RepliGen withdraws application at EMA for SecreFlo an agent for Pancreatic Imaging

EMA has been advised by RepliGen of its decision to withdraw its application for SecreFlo (synthetic secretin human) as an agent for magnetic resonance imaging to improve the detection of pancreatic duct abnormalities in patients with pancreatitis....

Phase II success for resminostat (4SC) in Liver Cancer

4SC AG announced the publication of convincing overall survival data from a Phase II study with its lead anti-cancer drug resminostat applied as a novel combination therapy approach with sorafenib in second-line advanced Liver Cancer at the 2012 annual meeting of the International Liver Cancer Association in Berlin, Germany, on 16 September 2012.

The international, open-label, two-arm SHELTER ...

Evidence of benefit of Promitor (Tate & Lyle) for Nutritional Health

Two new research studies provide evidence that certain higher-fibre diets can in fact be well-tolerated, and that fibre may play an important role in supporting a healthy gut as well as promoting calcium absorption. In a crossover study, 23 adolescents 12-15 years old were given controlled diets over two, three-week sessions separated by a one-week washout period. The diets were ...

European approval for Revestive(Takeda) for Short Bowel Syndrome

Takeda Pharmaceutical Company Limited and NPS Pharmaceuticals, Inc. jointly announced that the European Commission (EC) has granted European market authorization for the medicinal product Revestive (teduglutide), known as Gattex in the US, as a once-daily treatment for adult patients with Short Bowel Syndrome. The marketing authorization follows a positive opinion issued on June 21, 2012, by the Committee for Medicinal ...

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....

Bayer HealthCare submit NDA for BAY 73-4506 as treatment for GIST

Bayer HealthCare has submitted a New Drug Application (NDA) to the FDA for BAY 73-4506 (regorafenib) for the treatment of metastatic and/or unresectable Gastrointestinal Stromal Tumors (GIST) in patients whose disease has progressed despite prior treatment.

The submission is based on data from the pivotal Phase III GRID trial, which showed that regorafenib plus best supportive care (BSC) significantly improved progression-free ...

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 ...

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 ...

Nexium(AstraZeneca) to be OTC marketed by Pfizer

AstraZeneca has entered into an agreement with Pfizer Inc. for the over-the-counter (OTC) rights for Nexium (esomeprazole magnesium) currently approved to treat the symptoms of Gastroesophageal Reflux Disease (GERD). Under the terms of the agreement, Pfizer will acquire the exclusive global rights to market Nexium for the approved over-the-counter indications in the United States, Europe and the rest of ...

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 ...

Ganitumab (Amgen) Phase III trial stopped in Pancreatic Cancer

Amgen has announced a decision to stop the ganitumab (AMG 479) Phase III GAMMA (Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas) trial following the recommendation of an independent Data Monitoring Committee (DMC) overseeing the trial. Based on the review of a pre-planned interim analysis, the DMC concluded that the addition of ganitumab to gemcitabine is unlikely to ...

FDA approves Zaltrap ( Regeneron/Sanofi) for treatment of metastatic Colorectal Cancer

The FDA has approved Zaltrap (ziv-aflibercept) from Regeneron/ Sanofi for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with Colorectal Cancer. Zaltrap is an angiogenesis inhibitor that inhibits the blood supply to tumors. It is intended for patients whose cancer has spread to other parts of the body (metastatic) and whose tumors ...

FDA requests further data in review of Relistor (Salix) for Opioid-induced Constipation

The FDA have provided a Complete Response Letter (CRL) following its review of a Supplemental New Drug Application (sNDA) for Relistor (methylnaltrexone bromide), from Salix, for the treatment of Opioid-induced Constipation in adult patients with chronic, non-cancer pain. The CRL requests additional clinical data. Salix and Progenics intend to request an End-of-Review meeting with the Division of Gastroenterology and Inborn ...

EMA award orphan status to A 4250 (Albireo) for the treatment of Primary Biliary Cirrhosis

The European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on an application for orphan medicinal product status for A 4250, from Albireo, for the treatment of Primary Biliary Cirrhosis (PBC), Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome. A 4250 belongs to a class of inhibitors of the ileal bile acid transporter (IBAT, syn. ...

No benefit of Tarceva (Genentech/Roche) for patients with Liver Cancer

A Phase III trial evaluating the efficacy and safety of the addition of Tarceva (erlotinib), from Genentech/Roche, to sorafenib did not improve overall survival for patients with unresectable Liver Cancer vs. sorafenib alone. The international SEARCH trial randomised 720 patients with advanced Liver Cancer and examined whether the addition of Tarceva to sorafenib prolongs survival as compared to sorafenib alone ...

CHMP recommends Glybera (uniQure) gene therapy for LPLD

uniQure announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion that recommends marketing authorization of Glybera (alipogene tiparvovec) as a treatment for Lipoprotein Lipase Deficiency (LPLD) under exceptional circumstances. LPLD is a very rare, inherited disease. Patients with the disease are unable to handle fat particles in their blood plasma, ...

Brivanib (BMS) fails Phase III trial for Hepatocellular Carcinoma

Bristol Myers Squibb (BMS) announced the results of the phase III BRISK-FL clinical trial of the investigational agent brivanib versus sorafenib as first-line treatment in patients with advanced Hepatocellular Carcinoma (liver cancer). The study did not meet its primary overall survival objective based upon a non-inferiority statistical design. BMS is considering options for the ongoing brivanib development program. Ongoing clinical ...

FDA approves Qsymia (Vivus Inc.) treatment for Obesity

The FDA has approved Qsymia (phentermine and topiramate extended-release) formerly Qnexa from Vivus Inc., as an addition to a reduced-calorie diet and exercise for chronic weight management. The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at ...

EMA approves Axios Stent system (Xlumena) for GI surgery

The EU has given CE Mark approval to market the Axios Stent and Delivery System, from Xlumena, for biliary tract drainage in GI Surgery. The Axios system gives endoscopists a minimally-invasive tool to create a secure connection between the gallbladder or bile duct and the gastrointestinal tract. The Axios Stent is delivered under endoscopic ultrasound guidance using a specially-designed delivery ...

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 ...

FDA approves Erbitux(Eli Lilly/BMS)for first line combination treatment of Kras wild type EGFR expressing metastatic Colorectal Cancer

Erbitux (cetuximab), marketed by BMS/Eli Lilly in the U.S.,in combination with the chemotherapy regimen FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) has been granted full approval by the FDA for the first-line treatment of patients with KRAS mutation-negative (commonly known as KRAS wild-type), epidermal growth factor receptor (EGFR)-expressing metastatic Colorectal Cancer (mCRC) as determined by FDA-approved tests for this use. ERBITUX is not ...

FDA approves Therascreen KRAS RGQ PCR Kit (Qiagen) for use with Colorectal Cancer patients

The FDA has given marketing approval for the Therascreen KRAS RGQ PCR Kit, from Qiagen, to provide guidance on the use of Erbitux (cetuximab) as a treatment in patients with metastatic Colorectal Cancer. The Therascreen KRAS RGQ PCR Kit is a molecular diagnostic kit for detection of 7 somatic mutations in the KRAS gene using real-time PCR on the Rotor-Gene ...

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....

Erbitux (Merck Serono) fails EXPAND trial for Gastric Cancer

Merck Serono has announced the outcome of the Phase III clinical trial EXPAND, which assessed Erbitux (cetuximab) in combination with cisplatin and capecitabine as a 1st-line treatment for patients with advanced Gastric Adenocarcinoma including adenocarcinoma of the gastro-esophageal junction. The trial did not meet its primary endpoint of extending the length of time that patients live without their disease getting ...

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 ...

FDA approves Belviq (Eisai/Arena Pharma) for Obesity

The FDA has approved Belviq (lorcaserin HCl), from Eisai and Arena Pharmaceuticals, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 kg/m2 or greater (Obese), or 27 kg/m2 or greater in the presence of at least one weight related comorbid condition. However the ...

Positive results for Exjade (Novartis) in patients with Iron Overload

A new clinical study of Exjade (deferasirox), from Novartis, as a treatment for patients with Myelodysplastic Syndrome (MDS) a blood-related malignancy that involves the ineffective production of blood cells, shows beneficial iron reduction. The majority of patients with MDS require red blood cell transfusions for their anemia, but this leaves them at risk for iron overload. The results of this ...

Obesity drug Lorqess (Eisai) shows positive trial results

A new study on the effects of Lorqess (lorcaserin), from Eisai, for the treatment of Obesity shows positive results. The study, titled BLOOM-DM, evaluated 604 obese and overweight participants with Type 2 Diabetes in a double-blind placebo-controlled randomized trial over a one-year treatment period. Although all participants received systematic lifestyle change counseling, those on the medication lost 4.5 – 5.0% ...

VEN 309 (Vetrus Biosciences) fails Phase III for treatment of Haemorrhoids

Ventrus Biosciences, Inc. has reported that its Phase III, randomized, double-blind, placebo-controlled clinical trial of iferanserin (VEN 309) in patients with Haemorrhoidal Disease did not meet its endpoints.The Company will analyze the Phase III data further but believes that its efforts will be better allocated toward the planned completion of its VEN 307 (diltiazem cream) development program in anal fissures ...

CHMP recommends EU approval of Revestive (Nycomed) for treating Short Bowel Syndrome

The CHMP has recommended granting marketing authorisation for Revestive (teduglutide), from Nycomed, as a once-daily treatment for adult patients with Short Bowel Syndrome (SBS). The marketing authorisation application was submitted in March 2011. The CHMP opinion was based upon data from STEPS, the pivotal Phase III study in patients with SBS, who required parenteral nutrition; 43-patients were randomised to a ...

Tivantinib (Daiichi Sankyo.) in Phase II study of Hepatocellular Carcinoma

ArQule, Inc and Daiichi Sankyo Co., have announced at ASCO 2012 (abstract number 4006)- final results from a randomized, placebo-controlled, double-blind, phase II clinical trial with the selective MET inhibitor tivantinib as a single-agent, investigational, second-line treatment in Hepatocellular Carcinoma (HCC). The 107 patients in the trial had unresectable HCC and had disease progression after first-line therapy or were unable ...

Phase III GRID study of BAY 73-4506 (Bayer HealthCare) for GIST meets primary endpoint

The Phase III GRID trial evaluating BAY 73-4506 (regorafenib), from Bayer HealthCare, in patients with metastatic and/or unresectable Gastrointestinal Stromal Tumors (GIST) met its primary endpoint. The median PFS was 4.8 months in the BAY 73-4506 arm versus 0.9 months in the placebo arm. The most common adverse events included hand-foot skin reaction (56.1% vs.15.2%), hypertension (48.5% vs. 16.7%) and ...

Positive data from Phase III trial of Avastin (Genentech/Roche) for Colorectal Cancer patients

Results from ML18147, a Phase III study in metastatic Colorectal Cancer that evaluated Avastin (bevacizumab), from Genentech/Roche, continued with second-line chemotherapy in people who received initial Avastin plus first-line chemotherapy, show the study met its primary endpoint of a significant increase in overall survival. In the study, the relative risk of death was reduced by 19 percent for people who ...

Phase III trial of TAS 102 (Taiho) for Colorectal Cancer begins in June

A global Phase III clinical trial for the novel combination antimetabolite TAS 102, from Taiho, to treat metastatic Colorectal Cancer will begin in June. The trial, named RECOURSE, is a randomized, double-blind, placebo-controlled Phase III trial that compares TAS 102 with best supportive care to investigate the efficacy and safety of TAS 102 when administered to patients with advanced recurrent ...

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 ...

New drug application filed with FDA for BAY 73-4506 (Bayer HealthCare) for metastatic Colorectal Cancer

Bayer HealthCare has submitted a New Drug Application FDA seeking approval for the oral multi-kinase inhibitor BAY 73-4506 (regorafenib) for the treatment of patients with metastatic Colorectal Cancer (mCRC). The submission is based on the results of a pivotal, global Phase III CORRECT trial which showed an improvement of overall survival of 29% and placebo patients were transferred to regorafenib ...

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 ...

VEN 307 success Iin Phase III trial for Anal Fissure Pain

VEN 307(diltiazem crean) from S.L.A.Pharma met the primary endpoint in a pivitol Phase III study, showing a statistically significant reduction in Anal Pain on defecation after four weeks compared to placebo. Both 4% and 2% diltiazem cream arms demonstrated statistically significant improvement over placebo for change in week four NRS for worst anal pain. Reduction in pain score was 0.44 ...

FDA Advisory Comittee recommends Lorqess (Arena/Eisai)for weight loss

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has recommended approval for Lorqess(lorcaserin) as a prescription weight-loss medicine in an 18-4 vote with one abstention. The Committee considered that the available data demonstrated the potential benefits of weight loss with lorcaserin outweigh its possible risks of valvular heart disease, adverse cardiovascular events or malignancies when used long-term in a population ...

Keryx Biopharma returns North American rights to Aeterna Zentaris for perifosine

Keryx BioPharma has returned North American rights to Aeterna Zentaris for the oral anticancer Akt inhibitor, perifosine – a Phase III-stage compound. A Phase III trial called X-PECT evaluating perifosine plus Xeloda (capecitabine) showed a failure to meet the primary endpoint of improving overall survival compared to Xeloda and placebo in the treatment of refractory Colorectal Cancer.The drug remains in ...

Pressure Right (Pressure Point) device effective in reducing postoperative Nausea

A clinical study has shown the acupressure Pressure Right system, from Pressure Point, can enhance the efficacy of an antiemetic drug combination in reducing the incidence of postoperative Nausea and Vomiting among high-risk patients after major surgery. Pressure Right is a single-use, disposable device that is applied to patients’ wrists before induction of anesthesia. It operates by exerting pressure on ...

EU approves Sancuso(ProStraken) for Nausea treatment

ProStrakan, a subsidiary of Kyowa Hakko Kirin, has received EC approval for Sancuso (granisteron transdermal patch0 in Europe. Sancuso is indicated for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of three to five consecutive days, where oral anti-emetic administration is complicated by factors making swallowing difficult....

Phase II study of Vyvanse (Shire) for Binge Eating Disorder

A study to evaluate the safety and efficacy of Vyvanse(lisdexamfetamine dimesylate) Capsules 30, 50 or 70 mg compared to placebo in adults with Binge Eating Disorder at Week 11 as measured by the number of binge days per week as assessed by clinical interview based on patient diary. A binge day was defined as a day during which at least ...

New Europe-focused Phase III Trial of TheraSphere (Nordion) for Liver Cancer

A new Phase III clinical trial for TheraSphere, a yttrium-90 (Y-90) glass microsphere treatment for Liver Cancer, from Nordion, will be focused primarily in Europe, with additional locations to be identified globally. This therapy consists of millions of microscopic, radioactive glass microspheres (20–30 micrometres in diameter) that are infused into the arteries that feed liver tumors. These microspheres then embolize, ...

MORAb-004 (Morphotek/Eisai) begins Phase II study in metastatic Colorectal Cancer

A multi-centre Phase II study evaluating the safety and efficacy of MORAb-004, from Morphotek/Eisai, in the treatment of metastatic Colorectal Cancer that is refractory to all standard therapy has begun. The trial is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of single agent MORAb-004 plus best supportive care as determined by progression-free survival in patients with ...

FDA approves i-Lipo (Chromogenex) for Fat Reduction therapy

The FDA has cleared the i-Lipo low-level laser diode device, from Chromogenex, to market for circumferential reduction or Fat Reduction. The clearance is based on results from a double-blind, placebo-controlled, randomized study of 34 volunteers in which over 70% of participants experienced significant waist reduction. Of the 34 participants, 19 were randomly selected for the treatment group and 15 for ...

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 ...

Amitiza (Sucampo/Takeda) success in Phase III safety trial for OBD

Top line results are reported by Sucampo Pharma from an open-label 439 patient, 36 week, Phase III clinical trial designed to evaluate the long-term safety and efficacy of Amitiza (lubiprostone) for patients with Opioid-Induced Bowel Dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone.Lubiprostone met the primary endpoint of demonstrating overall safety and secondary endpoints, including changes ...

FDA priority review for Zaltrap (Regeneron/Sanofi) for Colorectal Cancer

The FDA has granted priority review of the Biologics License Application for Zaltrap (aflibercept) from Regeneron/Sanofi in combination with the irinotecan-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-containing regimen. A target date for a decision by the agency has been set for August 4. The filing was based on the Phase III VELOUR study ...

Regorafenib (Onyx/Bayer) in Phase GRID study for GIST

Results were announced by Onyx Pharma/Bayer Healthcare from the Phase III trial GRID (GIST - Regorafenib in Progressive Disease) evaluating the investigational compound regorafenib (BAY 73-4506 for the treatment of patients with metastatic and/or unresectable Gastrointestinal Stromal Tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib. The trial met its primary endpoint of statistically ...

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....

KRX-0401 (Keryx/Aeterna Zentaris) fails X-PECT trial for Colorectal Cancer

Aeterna Zentaris Inc. has announced that the Phase III "X-PECT" (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment) clinical trial evaluating perifosine + capecitabine (Xeloda) in patients with refractory advanced Colorectal Cancer did not meet the primary endpoint of improving overall survival versus capecitabine + placebo. The trial involving 468 patients in 65 sites in the U.S was conducted by ...

MMX mesalamine (Shire) fails Phase III study for Diverticulitis

Shire has announced results of the PREVENT2 trial, a phase III investigational study of once-daily SPD476, MMX mesalamine (Lialda-USA; Mezavant XL-EU) in patients with a history of Diverticulitis. The study, conducted in 10 countries worldwide including the United States, did not meet the primary endpoint in reducing the rate of recurrence of Diverticulitis over a 2-year treatment period. In addition, ...

JAMA publishes Glivec (Novartis) follow up data in GIST

The Journal of the American Medical Association (JAMA) has published a Phase III study that showed significant survival benefits for patients meeting the study inclusion criteria who received three years of treatment with Glivec (imatinib)from Novartis after surgery to remove KIT (CD117)-positive Gastrointestinal Stromal Tumors (KIT+ GIST) compared to one year of treatment. The study results were first presented at ...

Gastro-AD soy supplement launched

Lallemand Health Ingredients presents Gastro-AD, a food supplement based on non-GMO soy fermented by proprietary Lactobacillus strain L. delbrueckii R-187, with excellent track-record of safe and effective use for gastric comfort and the relief of occasional heartburn, backed by several published studies. Gastro-AD represents a 100% natural and safe alternative to heartburn products management with the extra nutritional benefits and ...

FDA approves LINX Reflux Management System (Torax Medical Inc.) for GERD

The FDA on 22 March 2012 approved the LINX Reflux Management System from Torax Medical Inc., for people diagnosed with Gastroesophageal Reflux Disease (GERD) who continue to have chronic symptoms, despite the use of maximum medical therapy for the treatment of reflux.The LINX Reflux Management System is a sterile, single-use, surgically placed device used to treat the symptoms associated with ...

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 ...

OncoGenex/Teva initiate Phase III trial for custirsen for Prostate Cancer

OncoGeneX and Teva plan to initiate a new Phase III study to evaluate the ability of custirsen (OGX-011) to improve survival for patients with Prostate Cancer when combined with recently approved, second-line chemotherapy, Jevtana (cabazitaxel). The new study will be conducted in lieu of the Prostate Cancer Saturn Study, which aimed to assess durable pain palliation as a primary endpoint. ...

CT colonography shown to be comparable to standard colonoscopy

Computerized tomographic colonography (CTC), also known as virtual colonoscopy, is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps in people ages 65 and older. This is consistent with results of the ACRIN National CT colonography Trial, published in the New England Journal of Medicine in 2008, which demonstrated CT colonography can serve as a ...

FDA approves C20 Invendoscope (Invendo Medical)

The FDA has provided 501(K) approval for the new C20 Invendoscope colonoscopy system including the SC20 single-use colonoscope, from Invendo Medical. This device is not pushed or pulled, but uses a computer-assisted gentle drive technology to move through the colon. This reduces forces on the colon wall. The C20 is a fully integrated unit with positioning arm attached to a ...

TH-302 (Threshold/Merck Serono) success in Phase IIb Pancreatic Cancer trial

TH-302 a hypoxia targetted drug from Threshold Pharma/Merck Serono has produced a significant 63% extension in progression-free survival in a Phase IIb study in Pancreatic Cancer. The pancreatic cancer study combined TH-302 with gemcitabine for first-line treatment of advanced disease, with a primary endpoint of progression-free survival (PFS). The primary efficacy analysis performed on 149 patients showed median PFS of ...

FDA Advisory Committee recommends Qnexa(Vivus Inc.) for treatment of Obesity

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has voted 20-2 that the benefits of Qnexa (phentermine/topiramate) from Vivus Inc.,outweigh the risks in the treatment of Obesity. The committee recommended that Vivus should conduct a post-marketing study with regards to the potential cardiovascular side effects of Qnexa. The company has also proposed a risk evaluation and mitigation strategy which includes ...

FDA Advisory Committee recommends Qnexa(Vivus Inc.) for treatment of Obesity

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has voted 20-2 that the benefits of Qnexa (phentermine/topiramate) from Vivus Inc.,outweigh the risks in the treatment of Obesity. The committee recommended that Vivus should conduct a post-marketing study with regards to the potential cardiovascular side effects of Qnexa. The company has also proposed a risk evaluation and mitigation strategy which includes ...

Brivanib (BMS) fails in Phase III Colorectal Cancer Trial

According to a National Cancer Institute of Canada and Australasian Gastro-Intestinal Trials Group CO.20 Phase III study, overall survival was no better for advanced Colorectal Cancer patients with KRAS-normal tumors treated with brivanib alaninate, from BMS, plus cetuximab than for those treated with cetuximab alone. Although the combination appeared to improve response rates and progression-free survival, suggesting that brivanib may ...

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 Sancuso (ProStraken) for Nausea

The CHMP has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Sancuso 3.1 mg/24 h transdermal patch from ProStraken Limited which is intended for the prevention of Nausea and Vomiting associated with moderately or highly emetogenic Chemotherapy. The active substance of Sancuso is granisetron.The benefits with Sancuso as compared to an oral formulation ...

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....

RP-G28 success in Phase II trial fro lactose Intolerance

Ritter Pharma announced results of a Phase II trial for which showed RP-G28 improved digestive symptoms associated with Lactose Intolerance, including abdominal pain, and also reduced breath hydrogen production (a commonly used diagnostic test for lactose maldigestion). An abstract summarising the results is being presented orally at the annual international Digestive Disease Week (DDW) 2012 meeting in San Diego, California ...

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 ...

Afinitor (Novartis) fails Gastric Cancer study

Novartis reported the results of the 656 patient GRANITE-1 Phase III randomised, double-blind, multicentre study which showed that Afinitor (everolimus) monotherapy did not significantly improve overall survival in patients with advanced Gastric Cancer who had previously been treated with one or two lines of systemic chemotherapy....

Eloxatin (Sanofi) improves Colon Cancer survival

Stage III Colon Cancer patients in the general population who receive adjuvant treatment for the disease have an improved rate of survival when Eloxatin (oxaliplatin) is added to 5-fluorouracil. It's known that adding Eloxatin to adjuvant 5FU improve outcomes of patients with stage III Colon Cancer in randomised clinical trials (RCTs) but the effect of this therapy outside RCTs is ...

Inferanserin (Ventrus BioSciences) in Phase III for treatment of Haemorrhoids

Ventrus Biosciences Inc. expects to report in June 2012 the results of a pivotal Phase III trial of inferanserin (VEN 309) a highly selective peripheral 5-HT2A receptor antagonist and topical treatment for Haemorrhoids. The Phase III trial is being conducted in 600 patients at 70 centres in the USA and its primary endpoint will be cessation of bleeding by day ...

Bayer HealthCare plans to file regorafenib at the FDA for Metastatic Colorectal Cancer in 2012

The 760 patient CORRECT trial of the oral multikinase inhibitor, regorafenib, from Bayer Healthcare was halted for the treatment of Metastatic Colorectal Cancer after showing an improvement of overall survival of 29% and placebo patients were transferred to regorafenib therapy. Bayer now reports that patients on regorafenib therapy lived 6.4 months longer compared with 5 months for those on placebo. ...

CHMP recommends extension of Erbitux (Merck Serono) indication in Colorectal Cancer

The CHMP recommends extension of the label for Erbitux (cetuximab) from Merck Serono/BMS for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic Colorectal Cancer as first in line therapy with the FOLFOX chemotherapy in addition to its use in combination with irenotecan-based chemotherapy....

Napo Pharma terminates agreement wit Salix Pharma for crofelemer for Chronic Diarrhoea in AIDS patients

Napo Pharma has terminated its agreement with Salix Pharma for failure of Salix Pharma to proceed with an application to the FDA for crofelemer for chronic diarrhoea in people living with HIV/AIDS, despite a successful Phase III result. Napo has filed a lawsuit against Salix seeking $150 million for breach of contract....

Qnexa (Vivus Inc) Phase III results published in Obesity

Phase III data for Qnexa ((phentermine plus topiramate) from Vivus Inc., of the 56-week EQUIP study have been published in Obesity, the peer-reviewed journal of The Obesity Society. The trial evaluated the efficacy and safety of Qnexa in 1,267 severely obese (BMI >/= 35 kg/m2) patients in the USA. In addition to an average weight loss of 14.4% of initial ...

CORRECT trial for regorafenib success in Colorectal Cancer

Positive results are announced from the Phase III CORRECT trial of regorafenib ,a multi kinase inhibitor,from Bayer Healthcare, for the treatment of Metastatic Colorectal Cancer in patients whose disease has progressed after standard therapies. The Data Monitoring Committee has halted the study and placebo patients were transferred to regorafenib therapy. The trial met its primary endpoint of statistically significantly improving ...

CHMP rejects Glybera for Lipoprotein Lipase Deficiency

The Committee for Medicinal Products for Human Use (CHMP) has refused, a second time, to approve the gene therapy product Glybera (alipogene tiparvovec)from Amsterdam Molecular Therapeutics' for patients with lipoprotein lipase deficiency. The CHMP considered that there was insufficient evidence that its benefits outweigh its potential risks....

Vivus re-submiots Qnexa to the FDA for Obesity treatment

Vivus has resubmitted its new drug application to the FDA for its obesity treatment Qnexa (phentermine/topiramate), for a narrower patient population, which would include overweight men and women of non-childbearing potential. Vivus expects a final FDA decision in the second quarter of 2012. The question of potential birth defects associated with topiramate is being met with a new trial called ...

FDA approves Ferriprox for Iron Overload in Thalassemia patients

The FDA has approved Ferriprox from ApoPharma a subsidiary of generic manufacturer Apotex Inc, as a treatment for Iron Overload due to blood transfusions in patients with thalassemia when current chelation therapy is inadequate. This treatment can be vital for thalassemia patients of whom approximately one quarter are not able to manage Iron Overload with currently available treatment. Iron Overload ...

China's FDA approves PCR KRAS Assay For Colorectal Cancer

China's State Food and Drug Administration has approved China Medical technologies real-time PCR-based V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) assay as a companion diagnostic test for the use of a targeted drug for the treatment of Colorectal Cancer patients. The PCR KRAS Assay is a diagnostic test used to detect specific mutations in the KRAS gene using a ...

Resection with Erbitux boosts survival in Colorectal Cancer patients with Liver Metastases

Adding Erbitux (cetuximab)from Merck Serono/BMS, to conventional chemotherapy improves overall survival (OS) in Colorectal Cancer patients with complete resection of liver metastases that were initially deemed inoperable. The results, presented at the 2011 European Multidisciplinary Cancer Congress, were based on a 110-patient CELIM study which randomised patients to Erbitux plus FOLFOX (leucovorin, fluorouracil, and oxaliplatin) or Erbitux plus FOLFIRI (leucovorin, ...

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 ...

Decalth PHP brings benefits to patients with Liver Cancer

Results from a Phase III study of Decalth PHP System (melphalan), from Decalth Systems, have demonstrated that the treatment significantly extends the time patients with melanoma of the eye (ocular or uveal melanoma), which has spread to the liver, can live without the disease progressing. Data presented at the 2011 European Multidisciplinary Cancer Congress showed that the length of time ...

FDA agrees with Orexigen the form of CV risk trial for Contrave

The FDA had requested a cardiovascular outcomes trial (CVOT) for Contrave (naltrexone HCl/bupropion)which Orexigen had rejected. After a meeting with the FDA the form of the CVOT has been agreed. The trial will take two years to complete and will be conducted with obese patients who have CV risk. Submission to the FDA can be made on the basis of ...

FDA agrees form of CV risk trial for Contrave

The FDA had requested a cardiovascular outcomes trial (CVOT) for Contrave (naltrexone HCl/bupropion)which the company had rejected. After a meeting with the FDA the form of the CVOT has been agreed. The trial will take two years to complete and will be conducted with obese patients who have CV risk. Submission to the FDA can be made on the basis ...

Cellnovo recieves CE mark for Type 1 Diabetes management system

Cellnovo has received CE Mark approval for its Cellnovo mobile diabetes management system, aimed at patients with Type 1 Diabetes. Cellnovo's system uses mobile, wireless technology, and includes an insulin patch pump, a wireless, touch screen handset with a built-in blood glucose monitor, and an extendable applications software system. According to the comany, the system's rechargeable patch pump is the ...

Qnexa to be re-filed at FDA for Obesity

Vivus will resubmit its application to the FDA for Qnexa (phentermine plus topiramate), by the end of October,which is about two months before top-line results are expected from the firm's retrospective observational study assessing fetal outcomes in the offspring of women exposed to topiramate(forming part of Qnexa) during the first trimester of pregnancy. Results of the study are expected by ...

FDA advisors recommend approval of Ferriprox for Iron Overload

The FDA's Oncologic Drugs Advisory Committee has voted 10 - 2 to recommend that the FDA grant accelerated approval of Ferriprox (deferiprone), from ApoPharma. The drug is an oral iron chelator, for the treatment of patients with transfusional Iron Overload when current chelation therapy is inadequate. This can be vital for Thalassemia patients of whom approximately one quarter are not ...

Novartis discontinues Tasigna trial in GIST

Novartis is discontinuing a Phase III trial of Tasigna (nilotinib) for investigational use in the first-line treatment of gastrointestinal stromal tumors (GIST) based on the recommendation of an independent data monitoring committee. Interim results showed Tasigna is unlikely to demonstrate superiority compared to Glivec (imatinib), the current standard of care in this setting. The trial was a randomized, open-label, multicenter ...