Industry News

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.

Angiochem, a biotechnology company developing proprietary peptide-drug conjugates uniquely capable of crossing the blood-brain barrier, announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for ANG1005. As a result, the company is in final preparation stages to commence its Phase 3 trial to support a New Drug Application (NDA) for ANG1005 in patients with leptomeningeal carcinomatosis (LC) from breast cancer.

Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host disease (GVHD). There are currently no approved treatments for patients with acute GVHD.

Collegium Pharmaceutical, Inc. announced the commercial launch of Xtampza ER (oxycodone) extended-release (ER) capsules in the United States. Xtampza ER was approved by the US Food and Drug Administration (FDA) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

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Perrigo Company plc announced it has received final U.S. Food and Drug Administration clearance for three milk-based, store brand non-GMO infant formulas.  Shipments to retail customers have already commenced.