Pharma News

The GlaxoSminthKline to sell it's thane based property to Oberoi Realty Limited in Rs. 555 crores. The proposed property in 60 acres located in thane, Maharashtra.

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Janssen Research & Development, LLC (Janssen) presented new longer-term data from the open-label extension of the VOYAGE1 trial demonstrating consistent rates of skin clearance with TREMFYA™ treatment through week 100 among patients with moderate to severe plaque psoriasis receiving the subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody. The longer-term findings from the Phase 3 VOYAGE 1 study presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress showed more than 80 percent of patients receiving TREMFYA™, including those initially treated with placebo or the anti-tumor necrosis factor (TNF)-alpha agent Humira® (adalimumab) achieved at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90), or near complete skin clearance, and an Investigator’s Global Assessment (IGA) score of clearedor minimal disease at week 100. The findings, presented during an EADV late-breaker session, follow the recent European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of TREMFYA™, and the United States Food and Drug Administration (FDA) approval of TREMFYA™ in July.

Merck KGaA, Darmstadt, Germany, and Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for BAVENCIO® (avelumab) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. BAVENCIO will have marketing authorization in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. BAVENCIO is expected to become commercially available to patients in Europe by prescription within the coming months, with initial launches in Germany and UK expected as early as October 2017.

Pfizer filed suit in the U.S. District Court for the Eastern District of Pennsylvania against Johnson & Johnson (J&J).

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Sun Pharma and includes its subsidiaries or associate companies) announced that one of its wholly owned subsidiaries has received approval from the US Food and Drug Administration (FDA) for a new label for Odomzo® (sonidegib), an oral hedgehog inhibitor indicated for the treatment of patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Nitroglycerin Sublingual Tablets USP, 0.3 mg, 0.4 mg, and 0.6 mg, the generic version of Nitrostat® Sublingual Tablets, 0.3 mg, 0.4 mg, and 0.6 mg, of Pfizer, Inc.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Desonide Ointment, 0.05%, the generic version of Desonide Ointment, 0.05%, of Perrigo New York Inc.

The U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

Cadila Healthcare Limited an innovation-driven global healthcare company has entered into an exclusive agreement for the technology know-how for varicella vaccine production in the Russian Federation with Pharm Aid Ltd., headquartered in Russia. The exclusive agreement was signed at the BIOTECHMED conference in Gelendzhik, Russia. Pharm Aid Ltd, has been set up by Nacimbio together with Ishvan Pharmaceuticals Ltd., for the localization of innovative vaccine production in Russia.

The U.S. Food and Drug Administration granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.