Pharma News

The Union Cabinet, chaired by Prime Minister Narendra Modi has approved the proposal of the Department of Health Research in the Ministry of Health and Family Welfare for setting up of a National Resource Facility for Bio-medical Research (NARF) at Genome Valley in Hyderabad by the Indian Council for Medical Research (ICMR).

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The merger of the world's two largest beer manufacturers represents a major threat to global health, warn health experts, adding that the funders and regulators must respond more effectively to this threat. Last month, Belgium-based Anheuser-Busch InBev (AB InBev) and London-based SABMiller agreed in principle to merge.

Low levels of vitamin D may limit immune recovery in HIV-positive adults undergoing treatment, says a new study. Those infected with HIV often struggle with declining health because their immune systems can not effectively respond to common pathogens.

Zydus Cadila has received US health regulator's nod to initiate phase II clinical trials of Sarolitazar, its new drug for treating high fat levels in body due to diabetes, obesity, and sedentary habits.

Sandoz, a Novartis company and the global leader in biosimilars, announced  that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Neulasta® (pegfilgrastim) - a recombinant human granulocyte colony-stimulating factor (G-CSF).

Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Almotriptan Tablets USP, 6.25 mg and 12.5 mg, the generic version of Janssen Pharmaceutical's AXERT®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used for the acute treatment of migraine attacks in adult patients with a history of migraine with or without aura. In adolescents age 12 to 17 years, it is indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).

Novartis  announced positive first results from the Phase III FLAME head-to-head trial examining the rate of chronic obstructive pulmonary disease (COPD) exacerbations. Once-daily Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg met its primary endpoint (non-inferiority) and furthermore demonstrated superiority to twice-daily Seretide® (salmeterol/fluticasone) 50/500 mcg in reducing the rate of all COPD exacerbations (mild/moderate/severe) over one year of treatment.

Dr. Reddy's Laboratories announced that it has completed the purchase of worldwide exclusive intellectual property rights for Fondaparinux sodium, its generic anti-coagulant drug, from its Australian partner, Alchemia Limited. Earlier, the company had signed a term sheet for this transaction in September, 2015.

Mylan  announced the U.S. launch of Nevirapine Extended-release Tablets, 100 mg, the generic version of Boehringer Ingelheim's Viramune XR®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in children 6 to less than 18 years of age. The launch adds to Mylan's growing portfolio of ARV medicines across the globe, and represents the company's continued commitment to stem the tide of HIV/AIDS. Nearly 50% of those being treated for HIV/AIDS in the developing world, for example, rely on a Mylan product.

Mylan N.V. announced the U.S. launch of Glipizide Extended-release Tablets, 5 mg and 10 mg, the generic version of Pfizer's GLUCOTROL XL®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.