Pharma News

The Center has approved proposals for the creation of 100 Ayurveda, Unani, Siddha and Homeopathy (AYUSH) hospitals nationwide, AYUSH Minister of State Shripad Yesso Naik said.

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Dr. Reddy’s Laboratories Ltd.announced that it has launched Bivalirudin for
Injection, 250 mg/vial, a therapeutic equivalent generic version of Angiomax® (Bivalirudin) for Injection, approved by the U.S. Food and Drug Administration (USFDA).

Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA has received final approval from the USFDA to market Nystatin Topical Powder USP, 100,000 units per gram.

Intraocular lenses used in cataract surgeries are being sold at a rate that is 10 times higher than the market price, Food and Drug Administration officials said in a report presented to the department of pharmaceuticals.

Fibrocell Science, Inc. a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, announced that the remaining two patients in the NC1+ cohort have been dosed in the Phase 1 portion of the Phase 1/2 clinical trial of FCX-007 for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB), a devastating genetic skin disease with a high mortality rate. The cohort consists of three patients.

Cell Design Labs, Inc. announced the issuance of U.S. Patent No. 9,670,281, entitled “Binding-triggered transcriptional switches and the methods of use thereof.” This patent, issued to UC San Francisco (UCSF) and exclusively licensed to Cell Design Labs, broadly covers composition of matter for proprietary synNotch™ constructs, cells genetically modified with synNotch receptors and methods for treating diseases.

The Drug Controller General of India (DCGI) on relaxed guidelines for the production of pediatric HIV drugs, whose supply was affected by regulatory issues. The regulator approved the child-friendly and thermally stable pellet formulation of Lopinavir / Ritonavir without feasibility studies, but said it would control post-marketing surveillance.

Zydus Cadila has informed that the USFDA has given final approval to market Mesalamine Delayed- Release Tablets USP, 1.2 g in the US market. Zydus Cadila was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda® (mesalamine).

AstraZeneca and its global biologics research and development arm, MedImmune, will present the latest research from the Company’s Cardiovascular and Metabolic Diseases (CVMD) therapy area, including for Farxiga (dapagliflozin) and Bydureon (exenatide extended-release) for injectable suspension, with more than 50 abstracts at the American Diabetes Association’s (ADA) 77th Scientific Sessions in San Diego, USA 9-13 June 2017.

Alkermes plc announced the initiation of ENLIGHTEN-Early, a supportive study in the ENLIGHTEN clinical development program for ALKS 3831, an investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia.