The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Bayer has completed the sale of its 60% stake in the chemical park operator, Currenta, to funds managed by Macquarie Infrastructure and Real Assets (MIRA). The two companies had entered into an agreement to this effect back in August 2019. Currenta...
The White House Council of Economic Advisers (CEA) has issued an analysis of the US House of Representatives’ proposed legislation (H.R.3, The Lower Drug Costs Now Act) to address the cost of prescription drugs.
The bill, which was introduced in...
The US Senate Committee on Health, Education, Labor & Pensions (HELP) has approved the nomination of Dr. Stephen Hahn of MD Anderson Cancer Center to serve as the next Commissioner of the US Food and Drug Administration (FDA). The vote for his...
Astellas has agreed to acquire Audentes Therapeutics, a San Francisco, California-based adeno-associated virus (AAV)-clinical stage gene-therapy company that focuses on rare neuromuscular diseases, for a total equity value of approximately $3...
Novartis has opened a new cell and gene therapy manufacturing facility at its site in Stein, Switzerland. The site currently houses production for liquid and solid drugs.
Cell and gene therapies require the manufacture of a personal dose for each...
Eli Lilly and Company has opened its first shared innovation lab, located in South San Francisco, designed to support the discovery of innovative medicines through collaboration with local biotech companies. Lilly says that Lilly Gateway Labs will...
AbbVie has signed two agreements with Harpoon Therapeutics, a clinical-stage immunotherapy company, in deals worth up to $820 million involving the discovery and development of T cell engagers targeting both solid tumors and hematologic...
The European Medicines Agency (EMA) hosted a multi-stakeholder workshop earlier this month (November 18 and 19) on its draft policy document, “Regulatory Science Strategy to 2025.”
The draft strategy sets out working proposals on the key areas...
The European Medicines Agency (EMA) has signed a lease agreement for a newly built facility in Zuidas, Amsterdam, The Netherlands. The EMA moved its headquarters from London to Amsterdam, as of March 2019 as a result of the UK’s plan to withdraw...
Roche has extended its tender offer period relating to its pending $4.3-billion acquisition of Spark Therapeutics, a Philadelphia-based gene-therapy company, from November 25, 2019 to December 10, 2019. Roche had previously extended the offer...
Novartis has agreed to acquire The Medicines Company, biopharmaceutical company focused on cardiovascular diseases, for $9.7 billion.
With the acquisition, Novartis would gain The Medicines Company’s investigational twice-yearly administered...
Alkermes, a developer of treatments for central nervous system diseases and oncology, has completed its acquisition of Rodin Therapeutics, a company developing small molecules for treating neurologic diseases, in deal worth up to $950 million ($100...
A roundup of developments and latest news from China (Dollar Tree), Germany (Bayer), India (Zydus Cadila), and the United States (Entera Bio, Torrent Pharma).
China
FDA Issues Warning Letter to Retailer Dollar Tree for GMP Violations for OTC...
Amgen has completed its $13.4-billion acquisition of Celgene’s Otezla (apremilast), a drug for treating moderate-to-severe plaque psoriasis and psoriatic arthritis. Celgene had divested the drug in connection with its $74-billion acquisition by...
Merck and Co. has acquired Calporta Therapeutics, a developer of small-molecule agonists for treating Niemann-Pick C disease, a rare genetic disorder characterized by an inability of the body to transport cholesterol and other fatty substances...
