Industry News

Sandoz, a Novartis division and the global leader in biosimilar medicines, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira®*.

Agilent Technologies Inc. announced it has acquired Cork, Ireland-based Luxcel Biosciences ("Luxcel"), a developer of real-time fluorescence plate-reader based in vitro cell assay kits. This acquisition expands Agilent's cell analysis portfolio with the addition of easy-to-use assay kits that are compatible with industry standard plate-readers.

AIDS Healthcare Foundation (AHF), the largest global AIDS organization and a vocal critic of runaway drug pricing and drug profiteering, blasted Gilead Sciences, Inc. over newly instituted price hikes of 6.9% on three key HIV/AIDS treatments despite the fact that the patent for a key component of each treatment—tenofovir—expired in mid-December.

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Biosimilar Trastuzumab, co-developed by Biocon Ltd. and Mylan N.V. has been approved by ANVISA, the Brazilian regulatory agency, through their partner Libbs Farmaceutica (Libbs), a leading Brazilian pharmaceutical company.

Hetero, one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs, announces the launch of its fourth biosimilar drug ‘Adalimumab’ under the brand name ‘MaburaTM’ in India. The product will be marketed and distributed by Hetero Healthcare in the country.

The U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.

Teva Pharmaceutical Industries Ltd announced the exclusive launch of a generic version of Reyataz®1 (atazanavir) capsules in the U.S.

Lupin announced that it has received final approval for its Calcipotriene Topical Solution, 0.005% (Scalp Solution) from the United States Food and Drug Administration (FDA) to market a generic version of Dovonex Scalp Solution, 0.005% of Leo Pharmaceutical Products Ltd.

Rhizen  Pharmaceuticals S.A., an nounced  that the U.S. Food and Drug Administration  (FDA) has granted orphan - drug designation for  the active moiety of Tenalisib  (RP6530),  the Company’s  highly selective and orally active  dual PI3K delta/gamma  inhibitor, for treatment of  peripheral T - cell l ymphoma  (PTCL).

Dr. Reddy’s Laboratories Ltd that it has launched Melphalan Hydrochloride for Injection, a therapeutic equivalent generic version of Alkeran® (melphalan hydrochloride) for Injection in the United States market approved by the U.S. Food and Drug Administration (USFDA).