The FDA’s decision further pushes the timeline for Shin Nippon to enter a crowded U.S. market for migraine drugs that include treatments from Pfizer, Abbvie, and Eli Lilly.
Tag Archive for: drug manufacturing
2023 was a breakthrough year for cell and gene therapies, with seven FDA approvals in the U.S. and one in the European Union, according to the Alliance for Regenerative Medicine. Looking to 2024, the Washington, D.C.–based advocacy organization predicted that the sector could see up to 17 approvals in the U.S. and EU.
Continued fallout from the IRA, heightened antitrust enforcement and the rise of AI will all shape the first wave of biotech mergers and acquisitions coming this year.
The troubled Indian pharma company received its second FDA warning letter in months, which this time cited quality control and data integrity lapses at its manufacturing facility in Gujarat, India.
Novo Nordisk is diverting manufacturing capacity away from its older GLP-1 drug Victoza in order to cater to sky-high Ozempic demand.
To help cope with the high demand for weight-loss treatments, Eli Lilly is reportedly investing $2.17 billion in a German manufacturing facility after last week’s FDA approval of Zepbound for chronic weight management.
The project will be fully funded by the medicines giant, which has seen surging demand for its diabetes drug Mounjaro, now also being used off-label for weight loss, according to sources familiar with the matter.
The temporary ban happens amid a shortage of the medicine, according to a royal decree published in the country’s Official Gazette.
Novo Nordisk on Friday announced that it is investing more than $6 billion to boost manufacturing capacity in its home country of Denmark to meet current and future demand for products targeting serious chronic diseases.
Novo depends upon a number of companies to help produce Wegovy, but it has released scant details on its supply chain for the weight-loss medicine and its diabetes drug Ozempic containing the same active ingredient.