Abbvie Inc.'s chief scientific officer Michael Severino told BioWorld Today that "a dedicated group of scientists who really understood the biology and how to use the tools" worked for two decades to come up with Venclexta (venetoclax), which won accelerated approval by the FDA Monday for patients with chronic lymphocytic leukemia (CLL) who exhibit the 17p deletion.

The FDA's accelerated go-ahead Monday for Venclexta, the first BCL-2 inhibitor to win market clearance, gave hope not only to patients with CLL with the 17p deletion but also to those with other cancers and to more companies that are developing drugs that target BCL-2.

Durect Corp. said Friday it was still “working through the logistics” of changes wanted by the FDA in the already-started phase III trial called Persist with Posimir, an extended-release form of bupivacaine delivered via depot for pain after surgery, and Wall Street nicked the shares only slightly as the focus remains on Remoxy (oxycodone), for which the new drug application (NDA) was resubmitted last month.

Bind Therapeutics Inc.'s lead docetaxel compound from the Accurin platform is "certainly not the future story" of the company, CEO Andrew Hirsch told BioWorld Today, "and I'm not convinced was the best application of the platform, given some of the limitations of the payload."

"We have cracked the code of atopic dermatitis [AD] disease pathology," Bola Akinlade, director of clinical sciences at Regeneron Pharmaceuticals Inc., told BioWorld Today, and with partner Sanofi SA the company is lined up to score what could be drug launch number three in as many years.

Genocea Biosciences Inc.'s latest, 12-month, dose-optimization phase II results with its GEN-003 vaccine immunotherapy for genital herpes compare well with those achieved by way of currently available, daily, oral medicine, and a phase IIb efficacy trial with the injectable alternative goes on.

Centrexion Therapeutics Inc. CEO Jeffrey Kindler told BioWorld Today his firm owns “one of the largest pipelines, if not the largest, in non-addictive chronic pain treatment,” thanks to the acquisition of three oral analgesic prospects from Boehringer Ingelheim GmbH (BI).

As expected, Acadia Pharmaceuticals Inc.'s Nuplazid (pimavanserin) for psychosis associated with Parkinson's disease (PDP) passed muster with the Psychopharmacologic Drugs Advisory Committee of the FDA, which largely followed the course suggested by briefing documents and members gave their blessing.

With their new deal nailed down, Dr. Reddy's Laboratories Ltd. is "keenly interested in getting going immediately" in psoriasis with XP23829, the oral fumaric acid ester (a prodrug of monomethyl fumarate), Xenoport Inc. spokeswoman Jackie Cossmon told BioWorld Today.