Industry News

Egalet Corporation  announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for August 4, 2016, to review the new drug application (NDA) for ARYMO™ ER (morphine sulfate) extended-release tablets, an abuse-deterrent, oral morphine product candidate. ARYMO ER was developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Oncolytics Biotech Inc. announced that, following submission to the US Food and Drug Administration (FDA) for review, the Investigational New Drug (IND) application containing the protocol titled "Phase 2 study of Reolysin (pelareorep) in combination with Folfox6, bevacizumab and pembrolizumab in female patients with KRAS-mutant colorectal cancer metastatic to the liver" is now active.

Ritter Pharmaceuticals, Inc., a pharmaceutical company developing novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases, announced that it recently has been issued US patent number 9,370,532 by the US Patent & Trademark Office.

Lonza announced  that it recently acquired Triangle Research Labs (TRL) from PBM Capital Group. TRL is a fast-growing hepatocyte provider with products supporting in vitro evaluation of metabolism, drug-drug interactions, drug transporter activity, toxicity of drug candidates and other applications. Triangle Research Labs has facilities based in Research Triangle Park, North Carolina (USA).

Novartis announced that The New England Journal of Medicine (NEJM) published data for PKC412 (midostaurin) demonstrating an overall response rate, defined as a major or partial response, of 60% (95% confidence interval [CI], 49-70%; P<0.001) in patients with advanced systemic mastocytosis (SM). The median duration of response for all responders in the primary efficacy population was 24.1 months (95% CI, 10.8-not estimated [NE].

Ahmedabad-based Torrent Pharmaceuticals Ltd entered a  binding agreement to acquire a manufacturing unit of Hyderabad-based Glochem Industries Ltd. The Visakhapatnam unit, approved by the US Federal Drug Administration (FDA) and European regulatory authorities, is a multi-product facility which can manufacture advance intermediates and active pharmaceutical ingredients (APIs). With the latest acquisition, Torrent Pharma, which currently has five formulation manufacturing units, will have three API units for the regulated markets. The acquisition will help the firm in vertically integrating its abbreviated new drug application (ANDA) filings in the future, it said in a statement.

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AbbVie , a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted a fourth Breakthrough Therapy Designation (BTD) for ibrutinib (IMBRUVICA®) as a potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.

Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) accepted for review the company’s Biologics License Application (BLA) for OCREVUS™ (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), and granted the application Priority Review Designation with a targeted action date of December 28, 2016.

Pfizer Inc. announced two additional phase 3 bococizumab trials, SPIRE-HR (HighRisk) and SPIRE-FH (Familial Hypercholesterolemia), met their primary endpoint, demonstrating a significant reduction in the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at 12 weeks compared to placebo among adults at high and very high risk for cardiovascular events who were receiving a maximally tolerated dose of a highly effective statin.