The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
The US Food and Drug Administration (FDA) is providing updated and more detailed information about the status of FDA inspections in China and the agency’s oversight of imported products from China, which have been impacted by the novel coronavirus...
Sanofi plans to create a new European company dedicated to the production and marketing to third parties of active pharmaceutical ingredients (APIs). Sanofi expects the new manufacturing company to bring in EUR 1 billion ($1.1 billion) in sales by...
Mallinckrodt and its specialty generics-focused subsidiaries Mallinckrodt LLC, SpecGx LLC and certain other affiliates (collectively, “Specialty Generics”) have reached a $1.6-billion global agreement in principle that would resolve all...
Eli Lilly and Company has completed its previously announced acquisition of Dermira, a biopharmaceutical company that develops new therapies for chronic skin conditions, for approximately $1.1 billion.
Lilly says the acquisition expands...
Gilead initiates Phase III studies for remdesivir, an investigational antiviral drug, Moderna ships batch of vaccine for Phase I study, and GSK provides adjuvants.
Gilead Sciences Initiates Studies of Investigational Antiviral Remdesivir for...
Pharmaceutical groups, including Medicines for Europe, address the impact on starting regulatory materials, intermediates, and APIs in the EU after the coronavirus outbreak in China.
Medicines for Europe address impact
In a letter to the European...
Merck KGaA has agreed to sell its allergy business, Allergopharma, to Dermapharm Holding, a manufacturer of off-patent branded medicines for selected markets in Germany, for an undisclosed purchase price.
The transaction encompasses the...
The latest news from pharma companies on vaccine and antibody development for the novel coronavirus, including from Sanofi and Regeneron Pharmaceuticals.
Sanofi Joins with HHS for Coronavirus Vaccine Development
Sanofi Pasteur, the vaccines...
The US Food and Drug Administration (FDA) Commissioner Stephen Hahn outlined the agency’s supply-chain surveillance plan in the wake of the coronavirus (COVID-19) outbreak in China, including the steps the agency is taking to mitigate potential...
The US Food and Drug Administration (FDA) reports that its first bilateral enforcement operation with the Government of India stopped approximately 500 shipments of illicit and unapproved prescription drugs and combination medical devices over the...
Roche has completed its previously announced acquisition of Promedior, a Lexington, Massachusetts-based clinical-stage biopharmaceutical company focused on developing drugs for fibrotic diseases, in an approximate $1.4-billion deal (upfront cash...
Audentes Therapeutics, an Astellas company focused on developing adeno-associated virus-based genetic medicines, plans to invest $109 million to build a new 135,000-square-foot gene-therapy manufacturing facility in Sanford, North Carolina.
The...
Health experts, researchers, and major funders met at the World Health Organization headquarters in Geneva this week (week of February 10, 2020) to prioritize research and funding to address the coronavirus outbreak.
They met to assess the current...
Johnson & Johnson’s Janssen reports it will further expedite its investigational coronavirus (COVID-19) vaccine program through an expanded collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the...
A roundup of developments from Australia (CSL), Germany (Bayer), India (Lupin, Wockhardt), and the US (GE).
Australia
CSL Partners with University of Queensland to Develop Coronavirus Vaccine
CSL, a biotechnology company for vaccines and...
