Industry News

- Read more about ARIAD Completes Rolling Submission of NDA for Brigatinib to the U.S. FDA
ARIAD Pharmaceuticals, Inc. announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food and Drug Administration (FDA). ARIAD is seeking U.S. marketing approval of brigatinib for patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant or intolerant to crizotinib.
- Read more about 30-day mortality following chemotherapy for breast and lung cancer : Study Says
For the first time, national data on 30-day mortality for patients with breast and lung cancer treated with chemotherapy have been collected and analysed in order to help clinical teams review and improve patient care, and identify groups of patients who may have additional needs.
- Read more about Molecularly shutting down cancer cachexia
Healthy fat tissue is essential for extended survival in the event of tumor-induced wasting syndrome (cachexia). In Nature Medicine, researchers at Helmholtz Zentrum München show that selective manipulation of an enzyme can stop unwanted metabolic processes.
- Read more about U.S. FDA Approve Genmab’s Arzerra with Fludarabine & Cyclophosphamide
Genmab A/S announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra®) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). The application, which received Priority Review in May 2016, was submitted to the FDA by Novartis under the ofatumumab collaboration between Novartis and Genmab.

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- Read more about Santhera Receives FDA Grant for Ongoing Phase I Trial with Omigapil
Santhera Pharmaceuticals announces that the Office of Orphan Products Development (OOPD) at the US Food and Drug Admin-istration (FDA) has granted Santhera an award of USD 246,000 in support of its ongoing Phase I trial with omigapil (CALLISTO) in patients with congenital muscular dystrophy (CMD). Santhera is conducting CALLISTO in collaboration with the US National Institutes of Health (NIH). The FDA awards grants through the Orphan Products Grants Program to sup-port the clinical development of products for use in rare diseases where no current therapy exists.
- Read more about Cempra Present Solithromycin at FDA Antimicrobial Drugs Advisory Committee Meeting
Cempra, Inc., a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has scheduled a meeting of the Antimicrobial Drugs Advisory Committee on November 4, 2016 in Silver Spring, Maryland to discuss the safety and efficacy of solithromycin to treat community-acquired bacterial pneumonia (CABP).
- Read more about Amgen’s New Repatha (evolocumab) Analyses Results Presented At ESC Congress 2016
Amgen announced data presented at the European Society of Cardiology (ESC) Congress 2016 showing Repatha® (evolocumab) consistently reduced low-density lipoprotein cholesterol (LDL-C) in patients across cardiovascular (CV) risk subgroups or with familial hypercholesterolemia (FH).
- Read more about Orexigen Therapeutics come under Agreement with Valeant Canada for Contrave
Orexigen Therapeutics, Inc. announced that Valeant Canada, a subsidiary of Valeant Pharmaceuticals International, Inc., or its affiliates, will commercialize Contrave® (naltrexone HCl / bupropion HCl extended release) in Canada. Under the terms of the agreement between Valeant and Orexigen's wholly owned subsidiary Orexigen Therapeutics Ireland Ltd., Valeant will be responsible for obtaining Canadian regulatory approval and for all commercialization activity and expenses. Orexigen will supply Contrave tablets to Valeant Canada or its affiliates for an agreed transfer price and certain potential regulatory and sales milestone payments. Orexigen expects Valeant to file with Health Canada for regulatory approval by January 2017.
- Read more about Takeda launches new AtM strategy for patients
Takeda Pharmaceutical Company Limited announced the launch of a bold, new Access to Medicines (AtM) strategy, aimed at increasing access to its innovative and potentially life-saving medicines for patients with some of the highest unmet medical needs. For decades, the company has provided product, funding and access in many parts of the world, based on regional needs. The new AtM strategy builds on that by focusing on geographies and therapy areas with the highest unmet need.
- Read more about Cynapsus Receives FDA Fast Track Designation for APL-130277
Cynapsus Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for APL-130277, a product candidate for the treatment of OFF episodes in patients with Parkinson’s disease (PD).