News

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The draft guidance describes a benefit-risk assessment framework for evaluating applications for opioid analgesic drugs.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

Be The Match BioTherapies and TrakCel have announced a collaboration to provide integrated solutions for companies developing cell and gene therapies.

Biotech company Genmab signed an agreement with Johnson & Johson’s Janssen Biotech to develop a monoclonal antibody product using Genmab’s HexaBody technology.

The agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed.

The companies have signed a strategic multi-year manufacturing agreement for the future commercial production a late-phase investigational cell therapy.

The companies will use emerging data technologies to create a new virtual innovation lab to develop both scientific and commercial solutions.

The company is voluntarily recalling all unexpired products that are intended to be sterile because of a lack of sterility assurance.

Catalent will manufacture products for Bristol-Myers Squibb while adding sterile biologics fill/finish and oral solids manufacturing and packaging capacity.

Lyophilization Services of New England acquired a sterile injectables manufacturing facility in León, Spain.

New CDMO facility supports early-stage API manufacturing and scale up.

Centre for Process Innovation (CPI) is set to host an event in Darlington, UK, on June 26, 2019 to showcase the results of a £11.2-million (US$14.03-million) collaborative project to optimize biotherapeutic development.

Congress is weighing in on drug pricing with a range of measures that differ in style and substance.