News

The facility will support gene therapy production and continued development of PTC’s pipeline of investigational medicines.

The acquisition will boost Bayer’s cell-therapy development programs, with an initial focus on neurology, cardiology, and immunology.

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 company has launched new services for mammalian cell bank manufacturing under GMP conditions.

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.

FDA, Health and Human Services, and the Trump Administration back cheaper foreign drugs to cut pharma costs.

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

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

Olon began construction of a GMP facility for biologic APIs in Capua, Italy.

Cytena Bioprocess Solutions, a new Cytena subsidiary in Taiwan, will provide bioprocess solutions for pharmaceutical companies and research institutes.

Abcam has acquired the entire live cell line and lysates portfolio of gene-editing therapy developer, EdiGene.

Sartorius Stedim Biotech has unveiled a new single-use vessel for its ambr 250 modular benchtop automated mini bioreactor system that has been specifically designed for therapeutic cell lines.

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. 

Catalent recently held a groundbreaking ceremony at its Bloomington, Indiana pharmaceutical fill/finish site.

The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.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

Gilead Sciences gains rights to clinical and preclinical programs in Galapagos’ portfolio through a 10-year global research and development collaboration.

Boehringer Ingelheim will combine assets from its cancer immunology portfolio with the KISIMA immunization platform from AMAL Therapeutics.

The new cleanroom, designed and built by WHP, is part of ADC Bio’s new bioconjugation facility in the UK.

Oncology drug discovery and development company, ADC Therapeutics, has closed its Series E financing expansion, in which it raised $103 million.

Werum IT Solutions will provide a standardized, scalable, and compliant platform to blood centers for the cell and gene therapy processes.

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 Applications Center of Excellence in Durham, NC, will offer development studies for JSR Life Sciences customers.

Agilent Technologies Inc. announced that it signed a definitive agreement to acquire BioTek Instruments, a company that handles the design, manufacture, and distribution of innovative life science instrumentation for $1.165 billion.