Raj Indupuri, CEO, eClinical Solutions,pharma’s biggest AI adoption hurdles lie in scaling beyond pilots, ensuring data ...

PE: How long will it take for the market to be impacted by FDA's ANDA Prioritization Pilot? Botha: It’s a relative window. It ...

Pfizer's lawsuits target Metsera, its directors, and Novo Nordisk for breach of contract and antitrust violations, focusing on Novo Nordisk's acquisition proposal. The first lawsuit claims Novo ...

Head of FDA’s drug center George Tidmarsh is the latest member to see his name in headlines. On Friday, October 31, FDA ...

Marcel Botha, CEO of 10XBeta, discusses FDA’s new pilot authorization program for abbreviated new drug applications (ANDA) and what impact it will have on manufacturing and the supply chain.

Along with the company’s investment plans in Puerto Rico, Lilly also announced plans to build a $5 billon manufacturing plant ...

Advanced CGTs are expanding to larger patient populations, requiring strategic distribution approaches centered on patient needs. Effective channel strategies, broadening access, and reducing ...

In today’s Pharmaceutical Executive Daily, we cover Eli Lilly’s plan to submit its oral GLP-1 candidate for FDA priority review, the departure of senior FDA official George Tidmarsh, and growing ...

Gabriela P. Baron ([email protected]) is a member of the New York bar and a graduate of New York University School of Law and Vassar College. She is Senior Vice President at Conduent Legal ...

The US Health Resources and Services Administration (HRSA) revealed the initial nine drugs to be included in the 340B rebate model. The decision comes after pharma companies filed suit in regard to ...

Eli Lilly will submit orforglipron to be part of FDA’s new national priority voucher program, according to a new report. 1 The company believes it to be a strong candidate for the program.

In today’s Pharmaceutical Executive Daily, we cover Novo Nordisk’s unsolicited proposal to acquire Metsera, renewed legal action against Tylenol’s manufacturer following statements from Robert F.