News

The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.

The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.

The collaboration between the two companies aims to finish all necessary work needed to file for a first-in-human study by early 2019.

The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.

AbbVie and the International Myeloma Foundation will partner to study the role of a genetic mutation in outcomes of patients with multiple myeloma.

The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.

The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.

ISPE announced BioMarin Pharmaceutical, Shire, Vetter, and Wyeth Pharmaceuticals as FOYA Category winners.

An expanded pharma services supply chain facility in Germany boosts Thermo Fisher’s Pharma Services footprint in Europe.

The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.

Emerson will provide Ireland’s National Institute of Bioprocessing Research and Training with technologies to help the institute prepare students for the transition to manufacturing digitization in the biopharmaceutical industry.

The companies intend to jointly develop and commercialize Lenvima (lenvatinib mesylate) as a monotherapy and an in-combination therapy for treating multiple cancer types.

Biogen will acquire an AMPA receptor potentiator for cognitive impairment associated with schizophrenia in a deal worth approximately $590 million.

Sartorius Stedim Biotech has launched a new automated parallel bioreactor system for perfusion culture.

Sartorius has delivered to ABL’s Strasbourg facility, a GMP viral vector manufacturing package solution that includes single-use bioreactors and an automation platform for normal flow filtration, tangential filtration, and mixing.

The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.

The contract development and manufacturing organization has expanded biologics capacity at its facility in Berkeley, CA.

Sensors and devices being developed by nGageIT Digital Health Solutions can track patient use of oral solid-dosage or injectable drugs.

The new 73,000-square-foot facility is one of several expansions to support the company’s biologics testing capabilities.

The $11.6-billion acquisition strengthens Sanofi's position in hematology and specialty medicines.

Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.

The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).

The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.

Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.

GlobalData reports the need to shift away from egg-based manufacturing of vaccines in light of influenza-related deaths.

The agency has approved a new HIV treatment for patients with "limited treatment options".

Grand River Aseptic Manufacturing announces first planned investment in capacity expansion.

Fluid Imaging has introduced a new imaging flow microscope at Pittcon 2018 in Orlando, FL.