Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.

The company will add a new clinical services facility at Central Park on Bridgend Industrial Estate.

NICE estimates asfotase alfa will cost £367,000 per patient per year.

The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.

R-Pharm facility in Yaroslavl, Russia, is designed to produce biological drugs with GE Healthcare's FlexFactory manufacturing platform.

Dow and Colorcon extend and broaden the scope of the Controlled Release Alliance.

Researchers from the Wyss Institute explain a potential method for transporting and producing temperature-sensitive pharmaceuticals at a reduced cost.

A process-specific preventative maintenance program improves productivity and reliability.

The company announced that an August 2016 FDA inspection of the company’s facility resulted in no form 483s.

Genentech’s biologics drug substance plant is the overall winner of the International Society for Pharmaceutical Engineering’s 2016 FOYA Awards.

Clinical biotechnology company Moderna Therapeutics will build an integrated clinical manufacturing facility for mRNA production in Norwood, Massachusetts.

CRT and SV Life Sciences launched Artios Pharma, a new company formed to develop drugs targeting the DNA damage response to cancer.

Mucodel reported that the study met its objectives, and effectively delivered a dose of naloxone using an oromucosal route.

The companies will collaborate on mRNA-based cancer vaccine development.

Mylan CEO Heather Bresch appeared before the House Committee on Oversight and Government Reform on Sept. 21, 2016 to explain the company’s decision to increase the price of EpiPen more than 400%. The meeting comes after multiple members of Congress raised concerns about the price of the life-saving drug, which is used to treat anaphylaxis.

The certification follows a successful inspection by the MHRA, with no critical or major observations. The site is now ready to start production.

The company said it has plans to address global health challenges including vaccines, antimicrobial resistance, and preparation for future pandemics.

Walmsley will succeed Andrew Witty as CEO of the British drug maker.

CPhI announced the finalists in all 12 categories for the 2016 excellence in pharma awards.

The agency clarifies how FDA determines when a risk evaluation and mitigation strategy is necessary.

On Sept. 19, 2016, FDA announced that it has granted accelerated approval to Exondys 51 (eteplirsen), an injection for the treatment of Duchenne muscular dystrophy (DMD). The drug is marketed by Sarepta Therapeutics in the United States and is currently the only approved treatment for DMD. In light of the approval, Sarepta shares catapulted 76%, Seeking Alpha reported.

GE Healthcare’s GE BioPark Cork will hold four KUBio manufacturing facilities; GE will also collaborate with NIBRT for biopharmaceutical training.

Adaptimmune entered into a manufacturing agreement with PCT for the manufacture of its SPEAR T-cell therapies.

The autoinjector is based on core technology licensed from Bespak.

The company will debut its multi-dosage weight checker at the October show.

CPhI outlines trends from the conference in Seoul.

EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.

The agency recommended approval of 11 drugs, including three cancer drugs, in September.