Pharma News

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.

[adsense:336x280:8701650588]

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."

On average, an individual having three square meals a day consumes up to 148 grams of sugar. Today, sugar is a pervasive element of our diet in spite of it being linked to various heart diseases as well as an increased risk of diabetes. The World Health Organization recommends cutting down on sugars to not more than 5% of total  daily calorie consumption, or a few teaspoons in contrast to the excessive amounts the average individual tends to consume on a daily basis.

Takeda Pharmaceutical Company Limited has announced that Inisync Combination Tablets, a fixed-dose combination of Nesina (generic name: alogliptin benzoate) and metformin hydrochloride (hereinafter metformin), is now available in Japan for the treatment of type 2 diabetes.

PhaseRx, Inc., a biopharmaceutical company developing mRNA treatments for life-threatening inherited liver diseases in children, announced that its lead candidate, PRX-OTC, which is being developed for the treatment of ornithine transcarbamylase deficiency (OTCD), has received orphan drug designation by the US Food and Drug Administration (FDA).

EMD Serono Inc., the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has accepted for Priority Review EMD Serono's Biologics License Application (BLA) for avelumab. This review relates to avelumab's proposed use in patients with metastatic Merkel cell carcinoma (MCC), based on tumor response results from the JAVELIN Merkel 200 trial. Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody and could be the first treatment indicated for metastatic MCC in the US, if approved. MCC is a rare and aggressive skin cancer, which impacts approximately 2,500 Americans a year.

ARIAD Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration (FDA) has granted Iclusig® (ponatinib) full approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated; and for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I positive Ph+ ALL. Iclusig was initially approved in December 2012 under the FDA’s accelerated approval program, which provides patients earlier access to promising new drugs that treat serious conditions based on a surrogate endpoint while the company conducts additional studies to confirm the drug’s clinical benefit. The therapy was granted the FDA’s orphan drug designation because it is intended to treat a rare disease or condition.