Get the latest news from world and India’s leading pharmaceutical companies Pharma Industry, pharmaceutical marketing, generic drugs, and Complete news for Pharmacy and Life Sciences professionals.
Supernus Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, announced that it remains in discussions with the FDA regarding its Supplemental New Drug Application, or sNDA, for migraine.
[adsense:336x280:8701650588]
Valeant Pharmaceuticals International, Inc., a multinational specialty pharmaceutical company, announced that its wholly-owned subsidiary Valeant Canada is expanding its Canadian manufacturing and export capacity with investments totaling $27.5 million in its Steinbach, Manitoba and Laval, Quebec manufacturing facilities.
ARIAD Pharmaceuticals, Inc. announced the initiation of a New Drug Application (NDA) submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food and Drug Administration (FDA). ARIAD is seeking U.S. marketing approval of brigatinib for patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib. Brigatinib received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted orphan drug designation by the FDA for the treatment of ALK+ NSCLC.The Company is seeking accelerated approval for brigatinib from the FDA and plans to request a priority review of the application.
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.
CLICK HERE TO SUBSCRIBE,
PHARMATUTOR's DAILY EMAILS
Do Not Forget to Verify
(Click on Subscription link in your inbox)
--------
