FDA Approves STELARA; Novartis announces AMG 334; AbbVie’s HCV Regimen; PaizaBio Gains CFDA Approval; WuXi Biologics completes construction

FDA Approves Janssen’s STELARA for the Treatment of Adults With Moderately to Severely Active Crohn’s Disease

Janssen Biotech Inc. received approval from the U.S. FDA for STELARA (ustekinumab), used for the treatment of moderately to severely active Crohn’s disease in adults (18 years or older). The drug is for the patients who have failed or were intolerant to treatment with immune-modulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers. Janssen will work closely with payers, providers and pharmacy benefit managers to ensure STELARA® is broadly accessible and affordable for patients.

Novartis announces AMG 334 significantly reduces monthly migraine days in people with episodic migraine

Novartis announced positive topline results from ARISE, the first Phase III study evaluating the efficacy and safety of monthly subcutaneous AMG 334 (erenumab) 70mg in episodic migraine prevention. The Phase III study met its primary endpoint, showing a statistically significant reduction in monthly migraine days vs placebo.

AbbVie’s Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation

AbbVie, a global biopharmaceutical company, got  Breakthrough Therapy Designation (BTD) from the U.S. FDA for pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P), which is used for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor. The BTD is supported by positive results seen in AbbVie’s Phase 2 MAGELLAN-1 clinical study.

PaizaBio Gains CFDA Approval to Expand Fill/Finish Capacity

PaizaBio gained approval from China’s FDA (CFDA) to add new aseptic injectable production capability at it production facility in Hangzhou, China. This expansion will increase the company’s annual fill/finish capacity from 300 million units to 400 million, including vials, pre-filled syringes and cartridges.  The capacity will focus on small molecule drugs for clinical trials and small batch production and the company anticipates reaching full-scale production by 1Q17.

WuXi Biologics completes construction of Asia’s largest perfusion biologics manufacturing facility using disposable bioreactors

WuXi Biologics, an open-access R&D capability and technology platform company, has announced the opening of a new commercial-scale cGMP biologics perfusion manufacturing facility in Wuxi city, China. The new facility accommodates two 1000L disposable bioreactors for perfusion processes and is the largest perfusion biologics manufacturing facility to date in Asia implementing disposable bioreactors.