Industry News

Eli Lilly and Company and Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the new drug application (NDA) for investigational baricitinib, a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis (RA). The NDA for baricitinib was submitted to the FDA in January 2016.

Abbott has announced the US launch and the first commercial uses of the new ensite precision cardiac mapping system and advisor FL circular mapping catheter, sensor enabled to map cardiac arrhythmias during ablation treatments. The first commercial use of the system after US Food and Drug Administration (FDA) clearance occurred at the Intermountain Heart Institute at Intermountain Medical Center in Salt Lake City during ablation procedures conducted by electrophysiologist John Day, M.D.

Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.

Sangamo Therapeutics, Inc. .  the leader in therapeutic genome editing, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SB-318, a genome editing product candidate for the treatment of Mucopolysaccharidosis Type I (MPS I), a rare lysosomal storage disorder. Orphan drug designations are granted to drugs and biologics intended to treat rare diseases. The designation provides incentives to advance development of rare disease drugs and for commercialization of those drugs that progress to approval.

RedHill Biopharma Ltd. announced that RHB-104 has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA for the treatment of Nontuberculous Mycobacteria (NTM) infections. The QIDP designation was granted under the FDA's Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections.

Icagen, a drug discovery services and products provider, has announced an agreement with Japan-based drug discovery sales specialist On Target Co., Ltd, granting the right to broker Icagen's products and services in the important territory. The agreement is expected to facilitate the ability of Japanese researchers to access Icagen's expansive portfolio of drug discovery offerings, including Icagen's rich historic expertise in ion channel services and cell lines, transporter investigation and assay services, high throughput screening, computational chemistry, and management of integrated drug discovery Target-to-Lead projects.

The Scripps Research Institute (TSRI), a leading non-profit biomedical research institute,  announced a research collaboration and license agreement with Pfizer Inc. to pioneer new DNA-encoded library (DEL) technology, including new synthetic chemistry for the creation of next-generation DELs, a potentially transformative technology for early stage drug discovery research.

Heightened activity in the amygdala - a region of the brain involved in stress - is associated with a greater risk of heart disease and stroke, according to a study published in The Lancet that provides new insights into the possible mechanism by which stress can lead to cardiovascular disease in humans.

OmniActive Health Technologies Ltd. announced that it has acquired 85 per cent stake, and has entered into definitive agreements to acquire the balance stake, in Bangalore-based leading health and nutrition active natural ingredients player Indfrag Ltd (Indfrag). The acquisition includes all products related to Indfrag’s Food and Nutrition business. 

This is in line with OmniActive’s programme to create global partnerships which help expand the portfolio of high quality authenticated ingredients for the dietary supplement and functional food industries.

Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company, announced results from AbbVie’s phase 3 CERTAIN-1 study of 8 weeks of treatment with AbbVie’s investigational, pan-genotypic, ribavirin (RBV)-free regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in Japanese patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection without cirrhosis. Top-line results from the study demonstrated 99 per cent (n=105/106) of patients without cirrhosis, who represent the majority of HCV patients, and without the Y93H variant, achieved sustained virologic response at 12 weeks after treatment (SVR12). The one patient who did not reach SVR12 in this intent to treat (ITT) population was lost to follow-up. All 23 patients with the Y93H variant were assigned to the G/P arm of this comparator study, and 100% achieved SVR12.