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- Read more about USPTO ruling favours Mylan against Teva's Copaxone 40 mg/mL patents
Mylan NV announced that the US Patent and Trademark Office (USPTO) has ruled in favour of Mylan in its inter partes review (IPR) proceeding and found all claims of two related Copaxone 40 mg/mL patents to be unpatentable. The US Patent Nos. are 8,232,250 and 8,399,413, which are owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd. A decision by the PTAB on Mylan's third petition seeking inter partes review of US Patent No. 8,696,302 is expected on or before September 1, 2016.
- Read more about Mallinckrodt’s Synacthen® Depot IND Application Receives FDA Fast-Track Designation
Mallinckrodt plc announced the U.S. Food and Drug Administration (FDA) has granted the company's request for a Fast Track designation for its Investigational New Drug (IND) application for Synacthen® Depot in the treatment of Duchenne muscular dystrophy (DMD). Synacthen Depot is a depot formulation of Synacthen (tetracosactide), a synthetic 24 amino acid melanocortin receptor agonist. Synacthen Depot is approved and marketed outside of the U.S. for certain autoimmune and inflammatory conditions, but has never been approved for use in patients in the U.S.
- Read more about Evgen Pharma plc receive CTA for Phase II Study in Breast Cancer
Evgen Pharma plc announced that it has received a Clinical Trial Approval (CTA) from the UK’s regulatory agency for the commencement of its Phase II clinical trial of SFX-01 in breast cancer.
- Read more about EMA accept Biocon & Mylan MAA for Proposed Biosimilar Trastuzumab
Mylan N.V. and Biocon Ltd. announced that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Application (MAA) for a proposed biosimilar Trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe. Last month, Mylan's MAA for the proposed biosimilar Pegfilgrastim was accepted for review by EMA.
- Read more about U.S. FDA provide update on Zealand pharma’s iGlarLixi, for type 2 diabetes patients
Zealand Pharma (Zealand) announced that Sanofi has submitted updated information on the pen delivery device for iGlarLixi to the U.S. Food and Drug Administration (FDA) as part of the New Drug Application (NDA) for the product. IGlarLixi is a once-daily, fixed-ratio combination of lixisenatide (AdlyxinTM) and insulin glargine 100 Units/mL (Lantus®) for the treatment of adults with type 2 diabetes.
- Read more about Pfizer Acquire Medivation
Pfizer Inc. and Medivation, Inc. announced that they have entered into a definitive merger agreement under which Pfizer will acquire Medivation for $81.50 a share in cash for a total enterprise value of approximately $14 billion. The Boards of Directors of both companies have unanimously approved the merger, which is expected to be immediately accretive to Pfizer’s Adjusted Diluted EPS upon closing, approximately $0.05 accretive in the first full year after close with additional accretion and growth anticipated thereafter. Pfizer does not expect the transaction to impact its current 2016 financial guidance.
- Read more about FDA Approves Pfizer’s TROXYCAER Capsules
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, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. TROXYCA ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. However, abuse of TROXYCA ER by these routes is still possible. It is the only oxycodone with oral abuse-deterrent features described in the labeling.

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- Read more about AstraZeneca’s & Lilly’s AZD3293 receive FDA Fast Track designation
AstraZeneca and Eli Lilly and Company (Lilly) today announced they have received US Food and Drug Administration (FDA) Fast Track designation for the development programme in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III clinical trial.
- Read more about Xenetic Biosciences collaborate with Excivion Ltd. to Develop Combined Zika and Dengue Vaccine
Xenetic Biosciences, Inc. announced that it has commenced a collaboration with Excivion Ltd. to develop a vaccine against Zika and dengue viruses. As part of the collaboration, Xenetic’s proprietary IMUXEN Technology will be used to develop the vaccine. Excivion is a private UK company that has developed a proprietary antigen design platform for viral vaccines which it is applying to flavivirus infections.
- Read more about U.S. FDA approved Expanded Indication on Edwards SAPIEN 3 Transcatheter Heart Valve
Edwards Lifesciences Corporation announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients suffering from severe, symptomatic aortic stenosis who have been determined by a Heart Team to be at intermediate risk for open-heart surgery. The SAPIEN 3 valve is the first transcatheter aortic valve replacement (TAVR) therapy to obtain this indication in the United States.