Nicholas Jacobus

FDA has paused public release of complete response letters while reviewing a citizen petition challenging the legal basis of the practice, stalling a transparency initiative the agency launched less than a year ago.

FDA has approved Sarclisa Escena as the first anticancer treatment administered via an on-body injector, offering multiple myeloma patients and providers a subcutaneous alternative to time-intensive IV infusions across all three of isatuximab's existing indications.

AstraZeneca's Wainua failed to meet the primary endpoint of a late-stage trial in transthyretin-mediated amyloid cardiomyopathy, sending shares down nearly 10% in their largest single-day decline since late 2024.

In today's Pharmaceutical Executive Daily, FDA approves Ennumo, a pharma roundup covers Chemomab Therapeutics' merger with AI-enabled precision medicine company Scipher Medicine and Teva's global licensing agreement with Polpharma Biologics, and Alina Chesnokova of Cencora examines how the rise of cold chain-dependent specialty therapies is fundamentally changing how pharmaceutical manufacturers think about commercialization strategy and supply chain partnerships.

FDA has approved Accord BioPharma's Ennumo as a second pegfilgrastim biosimilar, giving the company what it claims is the world's largest G-CSF biosimilar portfolio from a single manufacture.

Chemomab and Scipher Medicine agreed to merge in an all-stock deal to advance an anti-CCL24 antibody into an AI-guided Phase II rheumatoid arthritis trial, while Teva struck a global licensing deal with Polpharma Biologics for exclusive commercialization rights to a proposed ocrelizumab biosimilar across major markets.

In today's Pharmaceutical Executive Daily, AlzeCure Pharma announces a collaboration with QuantumCell ApS worth more than $2.2 billion for global rights to its Neurostore platform including Alzheimer's candidate ACD856, the Medicare GLP-1 Bridge launches today, giving eligible Medicare Part D beneficiaries access to Wegovy, Foundayo, and Zepbound for a $50 monthly copay through the end of 2027, and Pharmaceutical Executive speaks with Ryan Last of Troutman Pepper Locke on the limits of targeted pharmaceutical tariffs as a reshoring tool and why thin margins on many generic products complicate the policy's effectiveness.

Novo Nordisk has launched the Medicare GLP-1 Bridge, making Wegovy available to eligible Medicare beneficiaries for $50 a month through the end of 2027, giving millions of older adults with obesity a structured pathway to the FDA-approved weight management drug.

AlzeCure Pharma has licensed its NeuroRestore platform and lead CNS candidate ACD856 to QuantumCell ApS, following positive Phase Ib safety and pharmacokinetic data.

In today's Pharmaceutical Executive Daily, FDA selects seven companies for its new PreCheck Pilot Program, Kirsten Whipple examines how the concept of healthspan is emerging from academic obscurity into a powerful consumer driver reshaping pharma's role in aging, and Pharmaceutical Executive speaks with Jeff Talbot of Roseman University of Health Sciences on how Las Vegas is positioning itself as an emerging life sciences hub beyond its casino-driven reputation.

A U.S. House committee has launched national security investigations into Merck, AbbVie, Eli Lilly, Pfizer, and Bristol Myers Squibb over their clinical trial operations in China, seeking answers by July 17 on data protection, military hospital ties, and trial sites in Xinjiang.

FDA selected seven companies to participate in its new PreCheck Pilot Program, offering earlier regulatory engagement and expedited facility review to incentivize domestic drug manufacturing.

In today's Pharmaceutical Executive Daily, a pharma M&A roundup covers Ipsen's up to $1.75 billion acquisition of Kartos Therapeutics and Zymeworks' $929 million acquisition of Theravance Biopharma, Krista Pinto of Eversana argues that fully staffed pharma field teams are still missing revenue targets because the traditional deployment model itself needs to evolve, and EMA's CHMP issues a positive opinion recommending approval of Eli Lilly's Jaypirca for chronic lymphocytic leukemia across all lines of therapy in the European Union.

Zymeworks and Ipsen each announced acquisitions this week, with Zymeworks paying roughly $929 million for Theravance Biopharma to gain commercial COPD royalties and tax assets, and Ipsen committing up to $1.75 billion for Kartos Therapeutics to add navtemadlin.

Once a niche pilot, direct-to-patient drug distribution is now a defining strategic priority, with manufacturers building the right infrastructure standing to capture margin, data, and patient relationships that used to belong to intermediaries.

In today's Pharmaceutical Executive Daily, an FDA advisory committee votes unanimously in favor of the benefit-risk profile of Moderna's investigational mRNA-1010 seasonal influenza vaccine across both younger and older adult populations, a pharma funding roundup covers Kardigan's upsized $400 million IPO debut on Nasdaq and cAMPfield Therapeutics' $180 million Series A launch, and Pharmaceutical Executive speaks with Brian Hilberdink of Boehringer Ingelheim on redefining what success looks like in obesity care in the GLP-1 era.

Kardigan priced its cardiovascular IPO at $400 million and surged 31% on its Nasdaq debut, while cAMPfield Therapeutics launched the same week with a $180 million Series A to advance prifemilast.

FDA advisory panel voted 9-0 to recommend approval of Moderna's mRNA flu vaccine mRNA-1010 across both the 50-to-64 and 65-and-older age groups, a unanimous outcome that validates the underlying clinical data.

As GLP-1 therapies reshape obesity care, Brian Hilberdink, president of U.S. Human Pharma, Boehringer Ingelheim, argues that lasting progress depends on targeting metabolic health, not just the number on the scale.

In today's Pharmaceutical Executive Daily, Biogen announces its second acquisition of 2026, a deal worth up to $1 billion for private immunology biotech RayThera, FDA approves Utebzi as the first and only oral carbapenem antibiotic for adults with complicated urinary tract infections, and FDA expands the indication for Merck's Capvaxive to include children and adolescents aged 2 through 17 with chronic medical conditions at increased risk for pneumococcal disease.

FDA has expanded Capvaxive's indication to high-risk children and adolescents aged 2 through 17 who have completed a primary pneumococcal series, making it the only conjugate vaccine in the U.S. specifically studied and approved for this population.

FDA has approved Utebzi as the first oral carbapenem antibiotic for complicated urinary tract infections, giving patients and providers an alternative to intravenous-only carbapenem therapy.

Biogen has agreed to acquire private immunology biotech RayThera for up to $1 billion, adding a suite of undisclosed small molecule anti-inflammatory candidates to its pipeline.

Brian Hilberdink, president of U.S. Human Pharma, Boehringer Ingelheim, explains what sets his company's obesity strategy apart in an increasingly crowded field.

In today's Pharmaceutical Executive Daily, FDA staff release briefing documents flagging evidence gaps in Moderna's mRNA flu vaccine, a pharma roundup covers Merck's $510 million collaboration with Protillion Biosciences and Jazz Pharmaceuticals' multi-program antibody discovery deal with AbCellera, and Jack McFeely argues that behavioral and engagement insights are the missing ingredient in patient support programs that struggle to sustain long-term persistence.

FDA scientists have flagged evidence gaps in Moderna's mRNA flu vaccine mFlusiva ahead of an advisory committee vote, raising questions about its performance across influenza strains, high-risk patient subgroups, and co-administration scenarios.

Protillion Biosciences and AbCellera each secured platform-based drug discovery deals this week, with Protillion partnering with Merck on multi-target protein engineering in a deal worth up to $510 million and Jazz Pharmaceuticals committing up to $84 million upfront to AbCellera for T-cell engaging multispecific antibodies in gastrointestinal cancers.

Brian Hilberdink, president of U.S. Human Pharma, Boehringer Ingelheim, notes how the real obstacle in obesity care isn't how a drug is delivered, it's whether patients stay on treatment long enough to achieve lasting metabolic health.

In today's Pharmaceutical Executive Daily, Elicio Therapeutics shares tumble after its Phase II Amplifgy-7P trial of KRAS-targeting immunotherapy ELI-002 7P misses its primary endpoint in adjuvant pancreatic cancer, FDA approves Skinvive by Juvéderm as the first and only hyaluronic acid injectable indicated to reduce neck lines, and Pharmaceutical Executive speaks with Dr. Edward Littler and Dave Watson, the newly paired executive chairman and CEO of Persica Pharmaceuticals, on how they are driving the company's non-opioid pain program PP353 toward Phase III.

FDA has approved Skinvive by Juvéderm as the first hyaluronic acid injectable specifically indicated for neck wrinkles, expanding the Allergan Aesthetics franchise into a new anatomical area.