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Bayer-new phase 3 liver cancer data

Bayer-new phase 3 liver cancer data

Bayer has announced that a Phase III trial evaluating its oncology compound Stivarga® (regorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC) has met its primary endpoint of a statistically significant improvement in overall survival. The study, called RESORCE, evaluated the efficacy and safety of regorafenib in patients with HCC whose disease has progressed after treatment with sorafenib. The safety and tolerability were generally consistent with the known profile of regorafenib. Detailed efficacy and safety analyses from this study are expected to be presented at an upcoming scientific congress. [More]
Immunology experts aim to develop point-of-care test for early detection of Lyme disease

Immunology experts aim to develop point-of-care test for early detection of Lyme disease

As part of the EU "ID Lyme" project, the infection immunology working group at the Institute for Hygiene and Applied Immunology at the Center for Pathophysiology, Infectiology and Immunology at the Medical University of Vienna is working on developing of a new test for early detection of Lyme disease (borreliosis). [More]
European Medicines Agency approves first-ever treatment for hereditary factor X deficiency

European Medicines Agency approves first-ever treatment for hereditary factor X deficiency

Bio Products Laboratory, Limited (BPL) today announced that the European Medicines Agency has granted marketing authorisation for Coagadex. [More]
GEMINI LTS study: Patients with active ulcerative colitis report clinical improvements with vedolizumab treatment

GEMINI LTS study: Patients with active ulcerative colitis report clinical improvements with vedolizumab treatment

Takeda Pharmaceutical Company Limited, (“Takeda”) today announced that the interim findings from the GEMINI Long-Term Safety (LTS) study were presented during the 2016 European Crohn's and Colitis Organisation (ECCO) Annual Scientific Meeting in Amsterdam, The Netherlands. [More]
Orexigen Therapeutics, Valeant Pharmaceuticals sign distribution agreement for Mysimba

Orexigen Therapeutics, Valeant Pharmaceuticals sign distribution agreement for Mysimba

Orexigen Therapeutics, Inc. today announced Valeant Pharmaceuticals International, Inc. will commercialize Mysimba (naltrexone HCl / bupropion HCl prolonged release) in Central and Eastern Europe. [More]
Phase 3 study: Sarilumab monotherapy meets primary endpoint in active rheumatoid arthritis patients

Phase 3 study: Sarilumab monotherapy meets primary endpoint in active rheumatoid arthritis patients

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that a Phase 3 monotherapy study met its primary endpoint demonstrating that sarilumab was superior to adalimumab (marketed by AbbVie as HUMIRA) in improving signs and symptoms in patients with active rheumatoid arthritis (RA) at Week 24. [More]
New process for altering ingredients in sunscreen enables the body to produce vitamin D

New process for altering ingredients in sunscreen enables the body to produce vitamin D

For the first time researchers have developed a process for altering the ingredients in a sunscreen that does not impact its sun protection factor (SPF), but does allow the body to produce vitamin D. The findings, published in the peer reviewed journal PLOS ONE, has led to the production of a new sunscreen called Solar D. [More]
Amgen announces approval of cholesterol-lowering medication Repatha (evolocumab) Injection in Japan

Amgen announces approval of cholesterol-lowering medication Repatha (evolocumab) Injection in Japan

Amgen today announced that the Japanese Ministry of Health, Labour and Welfare has approved the cholesterol-lowering medication Repatha (evolocumab) Injection, the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in Japan. [More]
Bayer to present new research findings on Xofigo (radium Ra 223 dichloride) injection at ASCO GU 2016

Bayer to present new research findings on Xofigo (radium Ra 223 dichloride) injection at ASCO GU 2016

Bayer announced today that new research findings on Xofigo (radium Ra 223 dichloride) injection will be presented at the 2016 Genitourinary Cancers Symposium of the American Society of Clinical Oncology (ASCO GU) taking place January 7 – 9 in San Francisco. [More]
Turing Pharmaceuticals emphasizes continued availability of Daraprim

Turing Pharmaceuticals emphasizes continued availability of Daraprim

Turing Pharmaceuticals AG, a privately-held biopharmaceutical company focused on developing and commercializing innovative treatments for serious diseases and conditions, today emphasizes the continued availability of Daraprim and cautions healthcare providers of proposed alternatives to Daraprim. [More]
FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration and the European Medicines Agency have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy. [More]
Turing Pharmaceuticals acquires rights to market Daraprim (pyrimethamine) in the U.S.

Turing Pharmaceuticals acquires rights to market Daraprim (pyrimethamine) in the U.S.

Turing Pharmaceuticals AG today announced that it has acquired the exclusive rights to market Daraprim (pyrimethamine) in the U.S. from Impax Laboratories, Inc. The acquisition by Turing is part of a strategic effort focused on treatments for toxoplasmosis and other serious infectious diseases. The company also announced plans to invest in the development of new drug candidates for toxoplasmosis. [More]
CMC Biologics, River Vision sign manufacturing agreement for Teprotumumab to treat Grave's Orbitopathy

CMC Biologics, River Vision sign manufacturing agreement for Teprotumumab to treat Grave's Orbitopathy

CMC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, and River Vision Development Corporation (River Vision), a private company focused on ophthalmology, announced today that they have entered into an agreement for the process transfer and cGMP production of RV001 (Teprotumumab) – a recombinant monoclonal antibody targeting insulin-like growth factor 1 that is in development for treatment of Grave's Orbitopathy and other indications. [More]
Anika Therapeutics announces positive results from CINGAL phase 3 trial for knee osteoarthritis

Anika Therapeutics announces positive results from CINGAL phase 3 trial for knee osteoarthritis

Anika Therapeutics, Inc.,, a leader in products for tissue protection, healing, and repair based on hyaluronic acid technology, today reported positive results from the CINGAL 13-02 study evaluating the safety of a repeat injection of Cingal for symptomatic relief of osteoarthritis of the knee. [More]
MSD announces EC approval of SIMPONI (golimumab) for treatment of adult patients with nr-axial SpA

MSD announces EC approval of SIMPONI (golimumab) for treatment of adult patients with nr-axial SpA

MSD (Merck & Co., Inc., Kenilworth, New Jersey, USA) today announced that on 22 June the European Commission approved SIMPONI (golimumab) for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA). [More]
GSK welcomes U.S. CDC's vote on use of meningococcal group B vaccines

GSK welcomes U.S. CDC's vote on use of meningococcal group B vaccines

GlaxoSmithKline announced today that the U.S. Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) voted for a Category B recommendation for meningococcal group B vaccination, including BEXSERO (Meningococcal Group B Vaccine), in individuals aged 16 to 23 (with a preferred age of 16-18). [More]
Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Amgen today announced that a Phase 3 study evaluating Vectibix (panitumumab) and best supportive care (BSC) met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) compared to those patients treated with BSC alone. [More]
Allergan agrees to acquire KYTHERA Biopharmaceuticals for $2.1 billion

Allergan agrees to acquire KYTHERA Biopharmaceuticals for $2.1 billion

Allergan plc, a leading global pharmaceutical company, and KYTHERA Biopharmaceuticals, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market, today announced that they have entered into a definitive agreement under which Allergan has agreed to acquire KYTHERA in a cash and equity transaction valued at $75 per KYTHERA share, or approximately $2.1 billion. [More]
Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib. [More]
Pharmacyclics’ Ibrutinib Phase Ib/II data show ibrutinib may be safe and effective in patients with cGVHD

Pharmacyclics’ Ibrutinib Phase Ib/II data show ibrutinib may be safe and effective in patients with cGVHD

Pharmacyclics LLC today announced interim results from the ongoing Phase Ib/II PCYC-1129 study suggesting that ibrutinib (IMBRUVICA) may be a safe and effective treatment for patients with chronic graft-versus-host-disease (cGVHD) who were either refractory to steroid treatment or were steroid-dependent. [More]
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