Pharma News

Kyowa Hakko Kirin Co., Ltd. announced KRN23, an investigational recombinant fully human monoclonal IgG1 antibody against the phosphaturic hormone fibroblast growth factor 23(FGF23), has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of X-linked hypophosphatemia (XLH) in pediatric patients one year of age and older. Kyowa Hakko Kirin and Ultragenyx entered into a collaboration and license agreement in August 2013 to develop and commercialize KRN23.

Accuray Incorporated announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Radixact™ Treatment Delivery Platform. Accuray also received 510(k) clearance for its new treatment planning and data management systems, Accuray Precision™ Treatment Planning System and iDMS™ Data Management System. These next generation hardware and software solutions which, together, make up the new Radixact system, enable faster, more efficient delivery of extremely precise treatment to a wider range of cancer patients, including those undergoing retreatment.  The new Radixact system represents a major step forward in the evolution of the TomoTherapy® System in treatment speed and ease of use.

QT Vascular Ltd., together with its subsidiaries, a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, announced it has received 510(k) clearance from the US Food and Drug Administration (“FDA”) for the sale and distribution of the Chocolate XD™ PTCA catheter for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion including in-stent restenosis.

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.

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.