Pharma News

In the 1950s, thalidomide (Contergan) was prescribed as a sedative drug to pregnant women, resulting in a great number of infants with serious malformations. Up to now, the reasons for these disastrous birth defects have remained unclear. Researchers at the Technical University of Munich (TUM) have at last identified the molecular mechanism of thalidomide. Their findings are highly relevant to current cancer therapies, as related substances are essential components of modern cancer treatment regimens.

Hologic, Inc. announced that the U.S. Food and Drug Administration (FDA) granted emergency use authorization for the company's new, diagnostic assay for Zika virus infection. The Aptima® Zika Virus assay is a molecular diagnostic tool for the qualitative detection of RNA from Zika virus in human serum and plasma specimens. The Aptima Zika Virus assay has not been FDA cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.

ARIAD Pharmaceuticals, Inc.  announced that it has completed two distribution agreements for Iclusig®(ponatinib) outside of the United States. In Latin America, ARIAD and Pint Pharma International S.A., a company focused on innovative treatments for patients in Latin America with cancer, rare diseases, and genetic disorders, have entered into an agreement for Pint Pharma to commercialize Iclusig inArgentina, Brazil, Chile, Colombia and Mexico.

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.

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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.

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%.