Bio/Pharma News

Additional Data Needed for Incyte’s Baricitinib

April 17, 2017

FDA denies the NDA for the RA drug developed by Eli Lilly and Incyte, citing the need for more data.

Bristol-Myers Squibb and Nordic Bioscience Collaborate on Fibrosis Biomarker Technology

April 17, 2017

The two companies will develop translational biomarkers for fibrotic diseases, including non-alcoholic steatohepatitis (NASH).

Bristol-Myers Squibb Inks Licensing Deals with Biogen, Roche

April 13, 2017

BMS is licensing two investigational compounds in separate deals with Roche and Biogen for a total of $470 million in upfront payments.

GlaxoSmithKline Recalls 600,000 Asthma Inhalers in US

April 07, 2017

The recall was issued because of a defective delivery system; the units affected had possible package leakage.

Finch and Takeda Collaborate on IBD Therapies

April 07, 2017

The companies will work to co-develop FIN-524, a live biotherapeutic product composed of cultured bacteria strains.

Janssen Signs Deal with PeptiDream

April 07, 2017

Janssen will have access to PeptiDream’s proprietary Peptide Discovery Platform System technology, which will be used to identify peptides against multiple metabolic and cardiovascular targets.

FDA Approves Teva’s Deuterated Drug for Chorea Associated with Huntington’s Disease

April 05, 2017

Deutetrabenazine is the first deuterated product approved by FDA, approval represents the first new treatment option for chorea associated with Huntington’s disease in nearly a decade.

Dipharma Strengthens Pipeline with Stable, Fast-Dissolving Carglumic Acid Tablets

April 04, 2017

Carglumic acid is used in the management of rare, life-threatening inborn metabolic disorders affecting the urea cycle.

EMA Grants Orphan Drug Designation to Epidiolex for Treatment of Lennox-Gastaut Syndrome

April 03, 2017

GW Pharmaceuticals plans to submit a regulatory filing to FDA and EMA following two positive Phase III trials of Epidiolex in patients with Lennox-Gastaut Syndrome.

Novartis Receives FDA Priority Review for CAR-T Therapy

March 30, 2017

The company received priority review for its investigational CAR-T therapy to treat leukemia.