News

The agency approves Amjevita (adalimumab-atto) for the treatment of inflammatory diseases.

FDA and EMA set up new working group on the development of treatments for rare diseases.

Pfizer announced its decision to remain one company after debating the possibility of splitting Pfizer Innovative Health and Pfizer Essential Health into two, separate publicly traded companies.

HHS entered into a $43.18 million contract with Sanofi Pasteur for the development of a Zika vaccine candidate.

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

Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.

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

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

R-Pharm Group, a private Russian pharmaceutical company, has opened a biopharmaceutical production plant in Yaroslavl, Russia, to produce biologics and biosimilars to treat autoimmune diseases and cancer. The facility, which has a line capacity is 2,000 L of cell culture per production cycle, is ready to be validated to US and Russia FDA and GMP requirements, the company reports.

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

The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.

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.

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

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.

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

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 agency granted accelerated approval to Sarepta’s controversial DMD treatment, under the condition the company conduct additional studies to demonstrate efficacy.

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 has recommended marketing authorization for Ibrance in the European Union.

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

The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.

In response to the EpiPen pricing scandal, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, clarifies FDA’s role in drug pricing.

Bayer will acquire the agricultural company for $66 billion in an all cash transaction.

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.