Nicholas Jacobus

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.

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.

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.

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.

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.

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.

Pfizer urges shareholders to reject an unsolicited mini-tender offer from Tutanota LLC, who is seeking to purchase up to 1 million Pfizer shares at $32.00-per-share.

This is the agency's first approved treatment for acquired hypothalamic obesity.

Charles DeYoung,Director of Patient Support Operations, Caretria, discusses how CareTria is reshaping patient support in a complex healthcare environment.

In today's Pharmaceutical Executive Daily, Novartis agrees to acquire a pan-mutant-selective inhibitor from Synnovation Therapeutics in a deal worth up to $3 billion while Collegium moves to acquire Azstarys from Corium Therapeutics, the FDA grants accelerated approval to Wegovy HD, a higher-dose version of Novo Nordisk's semaglutide injection, supported by Phase III data showing roughly 21% mean weight loss, and an analysis on agentic AI and what it means for commercial operations in life sciences.

Novartis agreed to acquire SNV4818 in a deal worth up to $3 billion, while Collegium Pharmaceutical is set to acquire Azstarys for up to $785 million.

FDA has approved Wegovy HD, a higher-dose 7.2 mg injectable semaglutide, based on Phase III data showing a mean weight loss of 20.7% in adults with obesity.

The episode explores how regulatory signals across drug approvals, trade policy, AI governance, and drug pricing shape business strategy and investor decisions before formal rules are ever finalized.

Ankit Jain, CEO, Co-Founder, Infinitus, notes the the emerging themes at Access USA 2026, including regulatory shifts, the collapse of the traditional hub model, and the proliferation of fragmented AI point solutions.

In today's Pharmaceutical Executive Daily, a new analysis finds that TrumpRx is listing prices for roughly a third of its featured drugs higher than what patients in the United Kingdom pay, two biotech companies focused on next-generation T-cell engager therapies close significant funding rounds, and Pharmaceutical Executive sits down with Jeanne Marrazzo of the Infectious Diseases Society of America on the worsening U.S. measles outbreak and what it means for the future of vaccine confidence.

A comparison of TrumpRx.gov prices against UK National Health Service pharmacy payouts found that drugs from several major manufacturers remain significantly cheaper under the British system.

Ankit Jain, CEO, Co-Founder, Infinitus touches on the approach to human oversight in an effort to build trust in autonomous patient access workflows by keeping humans and AI in a continuous feedback loop.

Ankit Jain, CEO, Co-Founder, Infinitus, discusses how AI-native patient access infrastructure appears to be less about replacing care teams and more about eliminating the friction between diagnosis and therapy initiation.

Matthew Turner, President of Patient Affordability, Paysign, discusses Paysign's approach to measuring copay program value in an effort to move beyond simple redemption counts toward a more complete picture of patient adherence.

Matthew Turner, President of Patient Affordability, Paysign, touches on how evolving payer tactics appear to be pushing manufacturers toward more sophisticated, partnership-driven program designs.

Matthew Turner, President of Patient Affordability, Paysign discusses how next-generation copay assistance appears to be less about consolidating services under one vendor and more about assembling best-in-class partnerships.

In today's Pharmaceutical Executive Daily, a federal judge blocks RFK Jr.'s reconstituted vaccine advisory committee and halts its policy changes, a new analysis breaks down what recent Gartner predictions on AI mean for healthcare marketers, and the FDA approves Icotyde as the first oral targeted therapy for moderate-to-severe plaque psoriasis.

The funding rounds are part of a broader effort to advance next-generation T-cell engager platforms targeting cancers.

FDA has approved Icotyde as the first oral targeted therapy for moderate-to-severe plaque psoriasis, offering adults and adolescents a once-daily pill that blocks the IL-23 receptor.

Vera Pomerantseva, Director of Product Management for RBQM, eClinical Solutions, mentions how eClinical Solutions positioned its elluminate platform as part of an effort to help sponsors meet heightened evidence and oversight demands.

New technologies are impacting the speed-to-therapy within hub services.

Manufacturers are rethinking patient assistance program architecture amid the economic pressures of the Inflation Reduction Act.

Jeanne Marrazzo, MD, FIDSA, MPH, CEO of the Infectious Diseases Society of America discusses the growing measles outbreak in the United States, which has surpassed 730 cases and represents the largest surge in decades.