News

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

Metabolic-disease biotech Amicus Therapeutics announced a manufacturing agreement with Catalent’s Paragon Gene Therapy unit for gene therapy manufacturing.

The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.

Amicus Therapeutics has entered into a strategic gene therapy development and manufacturing collaboration with Brammer Bio, which is a part of Thermo Fisher Scientific.

FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.

New figures published by the ABPI have revealed the continuation of significant investment by the pharmaceutical industry into R&D in the United Kingdom.

Lonza Pharma & Biotech announced a binding contractual commitment for the purchase of a sterile drug product fill and finish facility.

Pfizer has successfully completed its acquisition of Therachon, a privately held clinical-stage biotechnology company.

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FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.

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

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

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

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.

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

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

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

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

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.

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.

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.