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FDA Approves Troxyca ER Capsules with Abuse-Deterrent Properties for the Management of Pain

Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) has approved Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, for oral use, CII for the management of pain severe enough to require daily. ...

AstraZeneca provides update on Phase III trial of Selumetinib in non-small cell lung cancer

  AstraZeneca announced results from the Phase III SELECT-1 trial of the MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment in patients with KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC). ...

Biogen Announces Bioverativ as Name of New Hemophilia-Focused Company

Biogen announced that Bioverativ will be the name of the standalone, publicly-traded global biotechnology company that it expects to launch in early 2017. Bioverativ will be focused on the discovery, research, development and commercialization of treatments for hemophilia and...

Takeda Receives Marketing Authorization in Canada for NINLARO™ (ixazomib) in Relapsed/Refractory Multiple Myeloma

Takeda Pharmaceutical Company Limited announced Takeda Canada has received approval from Health Canada for NINLARO™ (ixazomib) capsules in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior...

FDA Approves Mercks KEYTRUDA® for Patients with Recurrent or Metastatic Head and Neck Cancer

Merck known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200...

Teva Announces Launch of Generic Gleevec® Tablets in the United States

Teva Pharmaceutical Industries Ltd announced the launch of the generic equivalent to Gleevec®1(imatinib mesylate) tablets,100 mg and 400 mg, in the United States for multiple indications approved by the FDA.   Teva remains committed to strengthening...

Momenta Discontinues Further Accrual of its Phase 2 Trial of Necuparanib

  The decision to discontinue enrollment into the study was based on the recommendation from the independent Data Safety Monitoring Board (DSMB) following a planned interim futility analysis conducted once 57 deaths (50% of the target number of...

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