Pharma News

Roche announced that the US Food and Drug Administration (FDA) has approved Zelboraf® (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation. ECD is a rare, serious blood disease characterized by the abnormal multiplication of certain white blood cells called histiocytes, which can invade normal tissues and organs in the body.

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Torrent Pharmaceuticals Limited and Unichem Laboratories Limited announced that Torrent has entered into a definitive binding agreement with Unichem to acquire its branded business of India and Nepal ("India business") for a consideration of Rs.3600 Crores (Three Thousand Six Hundred Crores only), pursuant to the approval from the Board of Directors of the company earlier today.

A hormone replacement therapy may protect memory for some women, according to a new USC-led study.

The findings by USC researchers are the latest to indicate that hormone replacement therapy may have some benefits, deepening scientific discussions about the pros and cons of the menopausal treatment.

San Francisco, CA—Picture a bare wire, without its regular plastic coating. It’s exposed to the elements and risks being degraded. And, without insulation, it may not conduct electricity as well as a coated wire. Now, imagine this wire is inside your brain.

Gila Therapeutics, recently took a big step toward FDA approval for its new weight control treatment, completing its Phase I clinical trial in August. Gila is developing a novel intra-oral delivery of PYY, a well-known satiety hormone, to help patients reduce caloric intake and lose weight. Previous attempts to use PYY for this purpose have run into issues associated with systemic side effects of nausea and vomiting.

Vedanta Biosciences, an affiliate of PureTech Health developing a new category of therapies for immune and infectious diseases based on rationally designed consortia of human microbiome-derived bacteria, announced that it has exclusively sub-licensed key intellectual property from JSR Corporation to develop and commercialize microbiome-derived cancer immunotherapies based on live biotherapeutics. These live biotherapeutics have been shown to activate CD8+ T cells, a type of white blood cell that is the predominant effector in cancer immunotherapy. The sub-licensed intellectual property is based on the pioneering research of Dr. Kenya Honda, Professor, of Keio University School of Medicine and his collaborators in the University of Tokyo in Japan. An IND filing for the lead product candidate is planned in 2018.

Results from a Phase 3 efficacy study in India of the Serum Institute of India Pvt. Ltd.’s rotavirus vaccine BRV-PV (known as ROTASIIL®) were published in the journal Vaccine. The study showed the vaccine to be safe, well tolerated, and to provide significant efficacy against severe rotavirus gastroenteritis. In 2013, an estimated 47,100 rotavirus deaths occurred in India, 22 percent of all rotavirus deaths that occurred globally.

Diffuse large B-cell lymphoma (DLBCL) is an aggressive cancer and the most frequently diagnosed non-Hodgkin lymphoma worldwide (nearly 40% of cases). Recent advancements indicate that both the prognosis and choice of treatment of DLBCL may depend on identifying its molecular subtype. In a report in the Journal of Molecular Diagnostics, researchers describe their development of a reliable, accessible, rapid, and cost-effective new gene expression signature assay that can enhance lymphoma management by helping to match tumors with the appropriate targeted therapy.

ISR's CRO Quality Benchmarking - Phase IV Service Providers (9th Edition) report provides pharmaceutical sponsors and service providers a Consumer Reports-style analysis of CRO quality. Respondents supplied performance ratings based on their experiences with 24 Phase IV CROs, making this report the most comprehensive assessment of CRO service quality in the industry.

Takeda Pharmaceutical Company Limited announced that data from the pivotal Phase 2 ALTA (ALK in Lung Cancer Trial of AP26113) clinical trial evaluating ALUNBRIGTM (brigatinib) in patients with locally advanced or metastatic anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed on crizotinib will be presented in an oral session at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) on Monday, October 16, 4:30 p.m.- 4:40 p.m. JST. The presentation will share updated safety and efficacy data from the trial as of February 21, 2017, which continue to support previously reported clinical results.