Pharma News

AbbVie , a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein being developed by AbbVie in partnership with Genentech and Roche.

CymaBay Therapeutics, Inc, a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, announced that it has successfully concluded its end-of-phase 2 meeting discussions with the U.S. Food and Drug Administration (FDA) on the Phase 3 development program for arhalofenate.

NextSource Biotechnology, LLC announced  that Gleostine® (lomustine) 5 mg capsules has been approved by the U.S. Food and Drug Administration (FDA) and is now commercially available in the United States.

Oncolytics Biotech Inc. ("Oncolytics") announced that the first patients have been treated  in a Phase 1b study of pembrolizumab (KEYTRUDA®) in combination with REOLYSIN® (pelareorep) and chemotherapy in patients with advanced pancreatic adenocarcinoma (REO 024). 

Delcath Systems, Inc., a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announces that the Company has reached a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of Delcath's new Phase 3 clinical trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with hepatic dominant ocular melanoma. The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that, if met, would support the submission for regulatory approval of Melphalan/HDS.

Genmab announced  that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of Arzerra® (ofatumumab) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL).  The application was submitted by Novartis under the ofatumumab collaboration between the two companies.

Eli Lilly and Company  and Incyte Corporation  announced that Lilly has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of oral once-daily baricitinib for the treatment of moderately-to-severely active rheumatoid arthritis (RA).

Zogenix Inc. received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the development program for the Company’s investigational product, ZX008, as a treatment of seizures associated with Dravet syndrome, a rare and catastrophic form of childhood epilepsy.

The role of advanced diagnostics in detecting genital tuberculosis, which is linked to infertility in humans, was extremely important, an expert said here on Thursday.

Eating healthier fats could save more than a million people dying from heart disease, says recent research adding that the types of diet changes needed would differ greatly between countries.