Pharma News

Adamis Pharmaceuticals Corporation announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review the Company’s New Drug Application (“NDA”) for its Epinephrine Pre-filled Syringe (“PFS”) product candidate for the emergency treatment of anaphylaxis.  Filed on December 15, 2016, the resubmission was intended to address the issues raised by the FDA in the agency’s June 2016 Complete Response Letter (“CRL”).  The FDA indicated that it considered the resubmission to be a complete response to the CRL.

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Union Minister for Chemicals & Fertilizers and Parliamentary Affairs, Shri Ananth Kumar presided over the signing of Memorandum of Understanding (MoU) between the Bureau of Pharma PSUs of India (BPPI) and National Yuva Cooperative Society Ltd. (NYCS) here today, with the objective to setup 1000 Pradhan Mantri Bhartiya Janaushadhi Kendras in both urban and rural places of the country, as a part of "Mission 3000" kendras by March 2017. Shri Mansukh L. Mandaviya, Minister of State for Road Transport & Highways, Shipping, Chemicals & Fertilizers, was also present on the occasion.

Jazz Pharmaceuticals plc announced that the first patient has been enrolled in a Phase 3 clinical trial comparing the efficacy and safety of defibrotide versus best supportive care (BSC) in the prevention of hepatic veno-occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant (HSCT) who are at high risk or at very high risk of developing VOD.  The defibrotide clinical trial will be conducted across approximately 100 medical centers in the United States (U.S.), Canada, Asia Pacific and countries in the European Union (EU). 

Hikma Pharmaceuticals PLC (Hikma, the fast growing multinational pharmaceutical group, announces that its wholly owned US subsidiary, Roxane Laboratories, Inc. (Roxane), has received an approval from the US Food and Drug Administration for its Sodium Oxybate Oral Solution, 500 mg/mL, the generic equivalent to Xyrem®. 

Biogen has agreed to enter into a settlement and license agreement with Forward Pharma, subject to the approval of Forward Pharma’s shareholders and other customary conditions. The license agreement will provide Biogen an irrevocable license to all intellectual property owned by Forward Pharma.

AstraZeneca has recently provided an update on its Immuno-Oncology (IO) late-stage clinical development programme in 1st-line non-small cell lung cancer (NSCLC), including a refinement of the phase III Mystic trial.

A new mouse model of early Ebola virus (EBOV) infection has shown National Institutes of Health (NIH) scientists and colleagues how early responses of the immune system can affect development of EBOV disease. The model could help identify protective immune responses as targets for developing human EBOV therapeutics.

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Scientists have long puzzled over cholesterol. It's biologically necessary; it's observably harmful - and nobody knows what it's doing where it's most abundant in cells: in the cell membrane.