Industry News

Industry has responded favorably to the recent announcement from the UK's PM that immigration rules should be developed to ensure scientific talent is attracted to the country.

The agency is planning to clean out its drug listing records and urges companies to update any inaccurate active drug listing submission.

Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.

Sponsors should seek early discussions with FDA to ensure an effective and efficient process for demonstrating the interchangeability of a chosen biologic product.

South Korea’s pharma/biotech space is projected to grow to $23.2 billion by 2022, and will likely attract foreign investment, according to a new market report by GlobalData.

The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.

The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.

The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.

Successful process intensification with inline dilution requires effective monitoring and control.

NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.

Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.

Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.

Founding members of the Global Cybersecurity Alliance are Schneider Electric, Rockwell Automation, Honeywell, Johnson Controls, Claroty, and Nozomi Networks.

Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma. 

The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.

The US Pharmacopeial Convention is partnering with the American Association of Colleges of Pharmacy to provide students with free access to quality standards.

FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.

Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.

The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.

The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.

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.

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

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

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