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In today's Pharmaceutical Executive Daily, the Trump administration misses a statutory deadline to nominate a permanent CDC director, leaving the agency in continued leadership limbo, the FDA grants accelerated approval to Denali Therapeutics' Avlayah as the first therapy designed to cross the blood-brain barrier and treat the neurological manifestations of Hunter syndrome, and a new commentary breaks down what CMS's updated ASP reporting requirements mean for Part B drug manufacturers ahead of a key April deadline.

The White House postponed naming a permanent CDC director as the Trump administration navigates competing political pressures ahead of midterm elections.

FDA has granted accelerated approval to Avlayah, the first therapy engineered to cross the blood-brain barrier and treat the neurological manifestations of Hunter syndrome.

For pharma products, ensuring proper delivery requires the majority of work to occur before the product hits the road.

In today's Pharmaceutical Executive Daily, the FDA issues a warning letter to ImmunityBio over misleading promotional claims about its bladder cancer therapy Anktiva, Merck agrees to acquire Terns Pharmaceuticals in a $6.7 billion deal while Shionogi moves to take full ownership of the Shionogi-Apnimed Sleep Science joint venture, and a new commentary examines the structural pricing problem sitting at the center of the GLP-1 access debate.

eHealth’s vice president of consumer enablement discusses pricing and cost issues with GLP-1s.

The warning letter is directed at promotional claims about Anktiva’s efficacy and use.

Merck is acquiring Terns Pharmaceuticals for $6.7 billion to bolster its oncology pipeline, while Shionogi is set to purchase 50% of Apnimed's ownership of SASS.

While the space has traditionally been dominated by smaller biotechs, that may be changing.

In today's Pharmaceutical Executive Daily, Bayer shares briefly dip after activist investor Inclusive Capital offloads its remaining stake at a loss, Quotient Therapeutics enters a multi-year research collaboration with Merck to discover novel drug targets in inflammatory bowel disease, and Gilead Sciences agrees to acquire privately held Ouro Medicines in a deal valued at up to $2.18 billion.

Inclusive Capital Partners sold a stake worth about 0.9 % of the company.

Merck agrees to multi-year research collaboration with Quotient Therapeutics in a deal worth up to $2.2 billion to use somatic genomics and AI-driven analytics to identify new drug targets for inflammatory bowel disease.

The deal adds OM336, a BCMAxCD3 bispecific T cell engager showing early efficacy in rare antibody-mediated autoimmune diseases, to Gilead's pipeline.

Making changes in the pharma industry in operations is a slightly more expensive process because of larger compliances and regulatory pieces involved.

CMS’s 2026 requirement for manufacturers to submit “reasonable assumptions” alongside ASP data formalizes the role of estimation in drug pricing, increasing scrutiny on how ASP is constructed and shifting reporting toward greater transparency and accountability.
























