Industry News

Avinger, Inc., a leading developer of innovative treatments for Peripheral Artery Disease (PAD),  announced that the company has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Lightbox L250 imaging console. With this new FDA clearance, the Lightbox L250 now provides detailed measurement of vessels with a few simple taps to a touch screen, helping further improve visualization inside the vessel before, during, and after Pantheris™ Lumivascular atherectomy procedures for the treatment of PAD.

Eisai Co., Ltd. and Keio University  announced they have entered into a new joint research agreement for the discovery and development of new drugs targeting dementia. For this collaborative research, a research lab will be established, and researchers from Eisai and Keio University will work together to identify and validate novel drug targets and biomarkers that could potentially lead to the development of new therapeutics and preventive medicines for dementia.

Roche announced that the primary endpoint has been met for the phase III HAVEN 1 study evaluating emicizumab prophylaxis in people 12 years of age or older with haemophilia A and inhibitors to factor VIII. The study showed a statistically significant reduction in the number of bleeds over time in people treated with emicizumab prophylaxis compared to those receiving no prophylactic treatment. The study also met all secondary endpoints, including a statistically significant reduction in the number of bleeds over time with emicizumab prophylaxis treatment in an intra-patient comparison in people who had received prior bypassing agent prophylaxis treatment. The most common adverse events with emicizumab were injection site reactions, consistent with prior studies.

Janssen Biotech, Inc. (Janssen) announced the submission of two Supplemental Biologics License Applications (sBLAs) to the US Food and Drug Administration (FDA) seeking approval of Simponi Aria (golimumab) for the treatment of adults living with active psoriatic arthritis and the treatment of adults living with active ankylosing spondylitis (AS).

Biocartis Group NV (‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART),  announced the 510(k) submission to the U.S. Food and Drug Administration (FDA) of its rapid, fully automated molecular diagnostics platform Idylla™, consisting of the Idylla™ Instrument and the Idylla™ Console.

Novartis announced the signing of an exclusive option, collaboration and license agreement with Conatus Pharmaceuticals Inc., a biotechnology company focused on the development of novel medicines to treat liver disease. This agreement will enable Novartis and Conatus to jointly develop emricasan. Emricasan is an investigational, first-in-class, oral, pan-caspase inhibitor for the treatment of non-alcoholic steatohepatitis (NASH) with advanced fibrosis (scarring) and cirrhosis. This collaboration has the potential to expand treatment options for people in various stages of fatty liver disease, where no approved medicines currently exist.

Novartis has entered into a definitive agreement for the acquisition of Encore Vision, Inc., a privately-held company in Fort Worth, Texas, USA, focused on the development of a novel treatment in presbyopia. This acquisition would add a first-in-class disease modifying topical treatment for presbyopia to the Novartis ophthalmology pipeline, providing a potentially disruptive innovation to patients in a new therapeutic area of high unmet need and high prevalence. The transaction is subject to customary closing conditions, including regulatory approval. The financial details of this transaction are not disclosed.

Vernalis plc and Tris Pharma, Inc. are pleased to announce that the U.S. Food and Drug Administration ("FDA") has accepted the CCP-08 New Drug Application ("NDA") for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act ("PDUFA") target date for conclusion of its review of 4 August 2017.

Cipla Ltd, a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients, has received final approval for its Abbreviated New Drug Application (ANDA) for Fenofibrate Tablets USP 48mg and 145mg, from the United States Food and Drug Administration (USFDA).

Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies today announced its plans to acquire a branded oncology product, Odomzo, from Novartis. The agreement has been signed between subsidiaries of both the companies and will close following anti-trust clearance and further closing conditions. The agreement has been signed for an upfront payment of US$ 175 million and additional milestone payments.