Pharma News

Researchers have been trying for decades to develop a vaccine against the globally endemic hepatitis C virus (HCV). Now scientists at The Scripps Research Institute (TSRI) have discovered one reason why success has so far been elusive.

Inovio Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its proposed phase III clinical program for VGX-3100.

Martindale Pharma, the UK-based international specialty pharmaceutical company, announced the regulatory approval of its clobazam oral suspension product, Epaclob in France, Ireland, Germany and Italy and Silocalm in Denmark, Spain and Iceland following the successful completion of a decentralised procedure (DCP).

Mersana Therapeutics, Inc., a biotechnology company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) based on its proprietary Fleximer® platform technology,  announced that the U.S. Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) application to begin Phase 1 clinical trials for its lead oncology drug candidate XMT-1522.The compound is Mersana’s first pipeline product, and defines a new class of HER2-targeted therapies.

Bristol Meyer Squibb Companyannounced  that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of Opdivo to patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC) that has progressed on or after platinum-containing therapy. The FDA granted the application priority review and previously granted Opdivo Breakthrough Therapy Designation for mUC in June 2016, reinforcing the need for new treatment approaches in this patient population. The FDA action date is March 2, 2017.

Qiagen NV,  a leading global provider of sample to insight solutions, announced the launch of QIAscout, a novel instrument for isolation of viable single cells from samples to enable cost-efficient, accurate single-cell analysis for next-generation sequencing (NGS), polymerase chain reaction (PCR) and other downstream applications. The QIAscout instrument, the size of a hand-held mobile device, adds to Qiagen’s sample to insight portfolio of solutions for single-cell analysis in research fields such as oncology, immunology, neurobiology and stem-cell biology.

Gilead Sciences, Inc. announced the top-line results from three phase 2 studies of GS-4997 (selonsertib), an investigational inhibitor of apoptosis signal-regulating kinase 1 (ASK1), in nonalcoholic steatohepatitis (NASH), pulmonary arterial hypertension (PAH) and diabetic kidney disease (DKD). GS-4997 demonstrated anti-fibrotic activity in an open-label phase 2 clinical trial that included 72 patients with NASH and moderate to severe (F2-F3) liver fibrosis, who received treatment with GS-4997 (18 mg or 6 mg orally once daily) alone or in combination with simtuzumab (SIM), an investigational antibody directed against lysyl oxidase-like-2 (LOXL2), or SIM alone (125 mg administered via weekly subcutaneous injections) for 24 weeks.

CEL-SCI Corporation announced  that company received the Partial Clinical Hold letter from the U.S. Food and Drug Administration (FDA). CEL-SCI has started working on a response to the FDA and will work diligently with the FDA to seek to have the partial clinical hold lifted.