Pharma News

Evoke Pharma, Inc., a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, announced that the US Food and Drug Administration (FDA) has conditionally accepted the proprietary brand name, "Gimoti," for the Company's product candidate, EVK-001 (metoclopramide nasal spray). A request for proprietary name review for Gimoti will be included if and when Evoke submits a New Drug Application (NDA) for the product candidate.

GenVec, Inc., a clinical-stage gene delivery company, announced that it was notified by its collaborator, Novartis, that the Food and Drug Administration (FDA) has lifted the clinical hold on the phase 1/2 clinical trial of CGF166 in patients with severe to profound hearing loss.

AbbVie and Bristol-Myers Squibb Company announced a clinical trial collaboration to evaluate the safety, tolerability and efficacy of AbbVie's investigational biomarker-specific antibody drug conjugate Rova-T (rovalpituzumab tesirine) in combination with Bristol-Myers Squibb's Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a treatment for relapsed extensive-stage small cell lung cancer (SCLC).

Allergan plc, a leading global pharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion for TRUBERZI (eluxadoline) in the European Union. TRUBERZI is an oral medication that relieves the main symptoms of irritable bowel syndrome with diarrhoea (IBS-D) in adults. In two pivotal trials, TRUBERZI significantly reduced two of the most bothersome symptoms of IBS-D, abdominal pain and diarrhoea, with sustained relief demonstrated over six months.  TRUBERZI was generally well tolerated with the most common side effects being nausea, constipation, and abdominal pain.

Merck, known as MSD outside the United States and Canada, announced two regulatory milestones for the company’s investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live attenuated): the U.S. Food and Drug Administration (FDA) has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) status.

Shire plc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the marketing authorization for the use of ONIVYDE® (irinotecan pegylated liposomal formulation) also known as nal-IRI or MM-398, for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy.

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Scientists at The University of Nottingham have demonstrated for the first time that it is possible to selectively sequence fragments of DNA in real time, greatly reducing the time needed to analyse biological samples. 

If Dr. Kalipada Pahan's research pans out, the standard advice for failing students might one day be: Study harder and eat your cinnamon! 

Pahan a researcher at Rush University and the Jesse Brown Veterans Affairs Medical Center in Chicago, has found that cinnamon turns poor learners into good ones--among mice, that is. He hopes the same will hold true for people. 

The launch was followed by an intense panel discussion on the importance of the concept of e-Pharmacies and the deliberations on the need of guidelines / policies to ensure legitimate players delivering the benefits of the model to consumers, thereby, enabling wider access to medicines and improving public health. The panel’s participants included officials from the Ministry of Health & Family Welfare, Central Drugs Standard Control Organization, World Health Organization (WHO), and consumer activists. The event witnessed an engaging discussion between the concerned stakeholders of the Government as well as the industry.