News

FDA and USP take sides in debate on biologic drug standards.

Will EMA’s draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?

The Wellcome Global Monitor has demonstrated an overall positive trust in science but some concerns still remain on attitudes on vaccines.

The Galien Foundation has selected nominees for its award, which recognizes those therapies and technologies with the greatest potential impact on human health.

Research from the Institute for Research in Biomedicine offers insight into the source of asymmetry between nucleic acid hybrids.

The companies will join forces to develop new immuno-oncology therapies in a deal worth up to $470 million.

FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.

FDA approved first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system.

The companies will work to develop a liver tissue model for screening the toxicity of drugs.

More than 30 lots of losartan drug products have been recalled due to contaminated API manufactured by Hetero Labs.

Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent’s expanding gene therapy footprint.

CHMP has recommended that the indication of Victoza (liraglutide) be extended to include its use in pediatric patients with Type 2 diabetes.

ABPI and BIA have issued responses to the recently published governmental guidance on European Union exit preparedness.

The Gyrolab E. coli HCP Kit quantifies host cell protein impurities from Escherichia coli expression systems used in biotherapeutic production.

Three months following his departure from FDA, former commissioner Scott Gottlieb joins Pfizer’s board of directors.

Cytek Biosciences’ Cytek Aurora advanced flow cytometry system uses five lasers to enable seeing more than 30 colors from a single sample.

SCIEX added new innovations to improve laboratory workflows and data acquisition from samples.

The new flow cytometer system boasts enhanced sensitivity and user-friendly features.

The new platform from Berkeley Lights allows scientists to more easily analyze large numbers of cells in a short period of time.

The new flow cytometer offers full automation and enhanced software to alleviate bottlenecking.

A survey conducted by Agilent Technologies and research and consulting firm Frost & Sullivan revealed pressing issues and objectives experienced by lab leaders around the world.

The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.

In anticipation of the loss of patent exclusivity for Humira, AbbVie makes $63-billion move to acquire Allergan.

The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.

FDA sent a warning letter to Spectrum Laboratory Products, Inc. after an inspection found CGMP and misbranding violations.

The draft guidance describes a benefit-risk assessment framework for evaluating applications for opioid analgesic drugs.

The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.

During its biannual meeting in Amsterdam, ICH approved four new regulatory observers and reviewed the progress made on global harmonization efforts.

CMA has issued a statement of objections provisionally finding that four pharmaceutical companies have broken competition law.

IVERIC bio and Catalent Biologics have entered into a strategic manufacturing agreement for gene therapy product candidates to treat orphan inherited retinal diseases.