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After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.

The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.

The company’s investment in new laboratory equipment and personnel will strengthen its cell line development services.

The company doubled capacity for laboratory services at its facility in Itasca, IL.

The company showcased newer products and equipment for cell culture laboratories at Analytica 2018 in Munich, Germany.

EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.

Scientists at Washington University School of Medicine in St. Louis have developed a new method that could help increase the long-term effectiveness of gene therapy.

Research from Gladstone Institutes suggests that transplanting genetically altered interneurons could improve cognitive function for Alzheimer’s disease.

Thermo Fisher Scientific invests $50 Million to expand biologics drug development and manufacturing capabilities in St. Louis, MO.

The new platform is expected to speed up cell line development.

The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.

LNC Therapeutics has appointed a new CEO and is strengthening its R&D for gut microbiome-based drugs.

FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.

The expanded Laboratory Testing Division, located in Cranbury, NJ, will expand the company’s testing services in the United States.

Global investment firm Advent to acquire and invest in Sanofi’s European generics business, Zentiva, to boost its position in European market.

The transaction is part of Merck KGaA’s strategy to actively shape its product portfolio and focus on innovation-driven business.

The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.

The company unveiled three new products to support single-use biomanufacturing and won an award for best technological innovation at INTERPHEX 2018.

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

Johnson & Johnson’s Janssen partners with Bristol-Myers Squibb to advance next-generation therapies for cardiovascular diseases.

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

According to Alexion, the acquisition will help rebuild its clinical pipeline.

Sartorius Stedim Biotech will supply equipment for Penn State’s new Fermentation Facility in the university’s Center of Excellence in Industrial Biotechnology.

A new report gives an overview of the work of the International API Inspection Program.

Kemiex trading network is designed to increase safety in the sourcing of APIs and additives.

A $5.5-million expansion at its Philadelphia, PA clinical supplies facility gives Catalent additional packaging and storage capacity.

The company will build a high-volume manufacturing facility for their glass packaging product in Durham County, NC.

Premier Pharmacy Labs is voluntarily recalling multiple products because of the potential lack of sterility assurance.

Thermo Fisher Scientific and the University of Pittsburgh have established a new pharmacogenomics center of excellence to support translational research that demonstrates the value of PGx in precision medicine.