Pharma News

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.  

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Rosuvastatin Calcium Tablets, 5 mg (base), 10 mg (base), 20 mg (base), and 40 mg (base), the generic version of Crestor® Tablets, 5 mg, 10 mg, 20 mg, and 40 mg of IPR Pharmaceuticals, Inc. (IPR).

Gilead Sciences, Inc. announced that two phase 3b switch studies evaluating Odefsey (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) for the treatment of HIV-1 infection met their primary objectives. The ongoing studies were designed to explore the efficacy and safety of Odefsey among virologically suppressed adult patients switching from the tenofovir disoproxil fumarate (TDF)-based regimens Complera (emtricitabine 200mg/rilpivirine 25mg/tenofovir disoproxil fumarate 300mg) (Study 1216) or Atripla (efavirenz 600mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) (Study 1160). Odefsey combines Gilead's emtricitabine and tenofovir alafenamide with rilpivirine, marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Type II variation application for once-daily Truvada^® (emtricitabine 200 mg/tenofovir disoproxil 245 mg) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP. Truvada was approved by the EMA in 2005 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and is currently the most prescribed antiretroviral medicine in Europe as part of combination therapy.