Pharma News

Sanofi and Boehringer Ingelheim announced the signing of contracts to secure the strategic transaction initiated in December  2015 which consists of an exchange of Sanofi’s animal health business (“Merial”) and Boehringer Ingelheim’s consumer healthcare (CHC) business. This step marks a major milestone before closing of the transaction which is expected by year-end 2016 and remains subject to approval by all regulatory authorities in different territories. The integration of Boehringer Ingelheim’s Consumer Healthcare (CHC) business into Sanofi and Merial into Boehringer Ingelheim would start after closing.

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Opdivo for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen. As part of the Breakthrough Therapy Designation submission, the Company shared for the FDA’s review results from Phase 2 study CA209-275 and other supportive data investigating Opdivo in these previously treated bladder cancer patients.

Biocon and its partner, Quark Pharmaceuticals, have received approval from the Drug Controller General of India (DCGI) to proceed with the study, the first ever clinical trial of a siRNA therapy in India.

ASLAN Pharmaceuticals announced the designation as an Orphan drug of its pan-HER inhibitor varlitinib (ASLAN001) by the US Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for gastric cancer. Varlitinib previously received Orphan Drug Designation for cholangiocarcinoma in August 2015.

Teva Pharmaceutical Industries Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for CINQAERO® (reslizumab), a humanized interleukin 5 antagonist monoclonal antibody for add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Genmab  announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion for the use of Arzerra® (ofatumumab) as maintenance therapy for patients with relapsed chronic lymphocytic leukemia (CLL).  The Marketing Authorization Application (MAA) was submitted by Novartis in July 2015 under the ofatumumab collaboration between Novartis and Genmab.

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Supernus Pharmaceuticals, Inc., a specialty pharmaceutical company, announced the issuance on June 21, 2016 of a seventh patent (number 9,370,525) by the United States Patent and Trademark Office (USPTO) covering Oxtellar XR, its novel once-daily extended-release oxcarbazepine product. The patent provides protection for the product with expiration that is no earlier than 2027.

Researchers at the Universitat Autònoma de Barcelona (UAB) with the collaboration of the Institute for Bioengineering of Catalonia (IBEC), led by the professor of the UAB Department of Genetics and Microbiology Esther Julián, announced one year ago that the cells of the Mycobacterium brumae offer an improved alternative to current bladder cancer treatments such as BCG (an immunotherapy based on the Mycobacterium bovis), which can cause infections.

 the 94th General Session & Exhibition of the International Association for Dental Research, researcher W. Peter Holbrook, University of Iceland, will present a study titled "Development of Drugs for Local Treatment of Oral Conditions." The IADR General Session is being held in conjunction with the 3rd Meeting of the IADR Asia Pacific Region and the 35th Annual Meeting of the IADR Korean Division.