Pharma News

MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, announced that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Tadalafil PharmFilm for the treatment of erectile dysfunction.

Merck  known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or for patients who have relapsed after three or more prior lines of therapy.

Indegene, a global healthcare solutions provider, announced the acquisition of The Encima Group - a pioneer in life science omnichannel marketing automation and analytics and partner to some of the world's largest pharmaceutical organizations. The Delaware Corporation was featured for the 4th consecutive year in the prestigious Inc. 5000 list of fastest-growing private companies in the United States.

Quidel Corporation , a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced  that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its Solana® HSV-1+2/VZV Assay for the qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection.

PharmaCyte Biotech, Inc. a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced that a Pre-Investigational New Drug (Pre-IND) meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has been granted by the FDA. During the meeting with representatives from CBER, they will respond to PharmaCyte’s previously submitted questions to the FDA as part of a Pre-IND information package related to PharmaCyte’s clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

Pharma Major Lupin Limited (Lupin) announced  that its US subsidiary Lupin Pharmaceuticals, Inc. (LPI) has received final approval for its Armodafinil Tablets 50 mg, 150 mg, 200 mg and 250 mg from the United States Food and Drug Administration (FDA) to market a generic version of Cephalon, Inc’s Nuvigil® Tablets 50 mg, 150 mg, 200 mg and 250 mg. LPI shall commence promoting the product in the US shortly.

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KemPharm, Inc., a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced that its Investigational New Drug (IND) application for KP201/IR has been accepted by the U.S. Food and Drug Administration (FDA). KP201/IR, KemPharm’s co-lead product candidate, is a single-entity benzhydrocodone HCl immediate release abuse-deterrent prodrug for the treatment of acute pain.  KemPharm expects to conduct human clinical trials of KP201/IR in 2017.

Boehringer Ingelheim and China Southeast University Institute of Life Sciences announced the start of a joint research project to develop new treatment approaches for hearing loss through regeneration of hair cells from inner ear stem cells. The new collaboration combines the expertise of Professor Renjie Chai, one of the worldwide leaders in the field of hearing loss, with Boehringer Ingelheim’s expertise in drug discovery and clinical development to pave the way for the development of much needed new treatment options for this condition.

In a small double-blind study, Johns Hopkins researchers report that a substantial majority of people suffering cancer-related anxiety or depression found considerable relief for up to six months from a single large dose of psilocybin -- the active compound in hallucinogenic "magic mushrooms."