The $21.4-billion acquisition will create stand-alone business within Danaher’s life-sciences portfolio.

A draft guidance document provides recommendations for submitting bioavailability information in investigational new drug and new drug applications.

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg after NDEA is found in finished product manufactured with API made by Hetero Labs Limited.

The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has issued a recommendation for the suspension of fenspiride medicines across the whole of the European Union.

ACG Group highlighted its expanded footprint in Brazil through the launch of a new capsules manufacturing plant in Pouso Alegre-Minas Gerais.

Valitacell and Solentim, have announced a collaboration aimed at the acceleration of discovery and development of biologic drugs and advanced cell therapies.

A multi-partner collaboration has been announced, which will target the acceleration of the development of automated microfluidic systems for rapid and high-throughput gene editing in mammalian cell lines.

In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.

Mustang intends to combine an oncolytic virus with an interleukin-13 Rα2-(IL13Rα2)-specific chimeric antigen receptor to potentially enhance efficacy in treating glioblastoma multiforme.

The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.

India’s Bharat Biotech is set to acquire GlaxoSmithKline’s Chiron Behring Vaccines, a World Health Organization-prequalified global manufacturer of rabies vaccines.

As part of its support for novel nicotine replacement therapies, the agency published guidance on the development of these products.

The USP Quality Institute’s third fellow in its Fellowship in Quality Medical Products program will study the role of poor-quality medicines in fostering antimicrobial resistance.

The company will invest an additional $60 million to expand its manufacturing facility in Durham County, NC.

The agency clarified the process for development programs for regenerative medicine therapies.

Ireland’s National Institute for Bioprocessing Research and Training received funding from the Science Foundation Ireland’s Technology Innovation Development Award program for monoclonal antibody research.

The acquisition would strengthen Charles River’s contract research capabilities.

In a deal worth $530 million, the companies will develop and commercialize an anti-epileptic drug candidate in Europe.

The “hands-on” seminar will be held June 12–13, 2019 and will feature educational sessions and demonstrations in the company’s process laboratory.

Catalent adds position of president and chief operating officer to lead sales and quality efforts.

The partnership will expand Lonza’s offering of hematopoietic cell lines.

The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.

A taskforce evaluated the advantage of using Big Data in the evaluation of the benefits versus risks of medications.

The guidance explains the process of applying for competitive generic therapy designation.

The drug is approved in the United States specifically for treating acquired thrombotic thrombocytopenic purpura, a rare blood-clotting disorder.

The approval expands use of the drug, Egaten (triclabendazole), which has been by the WHO since 2005 for treating liver fluke infestation.

FDA came away with the largest boost in its annual budget in a decade as part of the final spending package approved by Congress this week.

The approval expands the indications for Sprycel (dasatinib) in Europe.