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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.

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.

In today's Pharmaceutical Executive Daily, Pfizer warns shareholders to reject an unsolicited mini-tender offer from Tutanota LLC seeking to purchase up to one million shares at a potentially below-market price, the FDA grants expanded approval to Rhythm Pharmaceuticals' Imcivree as the first approved treatment for acquired hypothalamic obesity, and a new commentary makes the case that AI-powered roleplay data is an untapped source of commercial intelligence for pharma field teams.