Pharma News

Emergent BioSolutions Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review Emergent’s supplemental Biologics License Application (sBLA) seeking approval of the manufacture of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55, the company’s large-scale manufacturing facility. FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 15, 2016.

Mylan NV, a global pharmaceutical company, announced that it has successfully completed the acquisition of the non-sterile, topicals-focused specialty and generics business (the business) of Renaissance Acquisition Holdings, LLC (Renaissance).

Sagent Pharmaceuticals, Inc., a leading provider of affordable pharmaceuticals to the hospital market,  has entered into a definitive agreement with Teva Pharmaceutical Industries Ltd. (Teva) and Actavis LLC to acquire a portfolio of five Abbreviated New Drug Applications (ANDAs) in the US for $40 million. The acquired portfolio includes products that are being divested by Teva as a precondition to its closing of the acquisition of Allergan's generics business.

 A new study undertaken by IMS Health has revealed that the price of stents in India is not the highest contributor to the overall angioplasty cost. According to IMS Health, stent prices contribute only 20 – 25% to the overall angioplasty procedure costs. The study also found that prices of stents declined by 6-10% per year over the last four years (2011-15) across private healthcare establishments, whereas procedure costs increased by 2-7%.

In a press conference in Mumbai today, the Indian Internet Pharmacy Association (IPA) called for the regulators and the government to help ensure there is an end to the harassment faced by the new entrepreneurs in this space. The IPA has explained its business model in detail and is demanding a level field for all players in the pharmacy space, without favour or bias. They seek clarity on guidelines to enable legitimate players to develop their business in this space and bring in the much needed innovation and technology driven transparency in this sector, leveraging best practices from across the world.

Multiple sclerosis (MS) is an autoimmune disorder that results in demyelination of neurons. The FDA-approved drug fingolimod (Gilenya, FTY-720) modulates signaling by the bioactive lipid sphingosine-1-phosphate (S1P), which is linked to MS pathogenesis.

The competition is fierce and only the strongest survive the obstacle course within the female reproductive tract. Of the millions of sperm that enter the vagina, only about 10 or so make it to the oocyte or egg, demonstrating how rigorous the natural sperm selection process really is. So how is it possible to select only the best sperm for assisted reproductive technologies such as in vitro fertilization? That's what a researcher at Florida Atlantic University is aiming to do with his microfluidic technology for reproductive medicine.

New Haven, Conn. A new study by a Yale researcher may support the use of a device for patients suffering from irregular heart rhythms.

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People with diabetes often suffer from wounds that are slow to heal and can lead to ulcers, gangrene and amputation. New research from an international group led by Min Zhao, professor of ophthalmology and of dermatology at the University of California, Davis, shows that, in animal models of diabetes, slow healing is associated with weaker electrical currents in wounds. The results could ultimately open up new approaches for managing diabetic patients.