Nicholas Jacobus

FDA has converted Fabhalta's accelerated approval to a traditional approval for IgA nephropathy after confirmatory Phase III data showed the oral complement inhibitor slowed annual kidney function decline.

Jasper Therapeutics has closed its all-stock acquisition of Kira Pharmaceuticals and raised $132 million in concurrent financing, combining a three-asset immunology pipeline.

In today's Pharmaceutical Executive Daily, FDA approves Merck's Lipfendra as the first oral PCSK9 inhibitor for high cholesterol, Eli Lilly agrees to acquire AtaiBeckley for up to $3.8 billion, and a Pharmaceutical Executive podcast explores how better questions, not just more data, define strong biopharma leadership.

FDA has approved Merck's Lipfendra as the first oral PCSK9 inhibitor, giving patients with high LDL cholesterol a once-daily pill alternative to injectable therapies.

Eli Lilly has agreed to acquire AtaiBeckley for up to $3.8 billion, adding a pipeline of neuroplastogen-based treatments.

In today's Pharmaceutical Executive Daily, Steer Bio discusses its regenerative cell therapy platform for cancer-related lymphedema, FDA approves Celcuity's Revtorpyk as the first pan-PI3K and mTORC1/2 inhibitor for advanced breast cancer, and Insilico Medicine enters a strategic alliance with Bora Pharmaceuticals worth up to $2.5 billion.

FDA has approved Celcuity's Revtorpyk as the first pan-PI3K and mTORC1/2 inhibitor, clearing it for HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation.

Insilico Medicine and Bora Pharmaceuticals entered a strategic alliance to pair Insilico's AI drug discovery platform with Bora's development and manufacturing infrastructure.

In today's Pharmaceutical Executive Daily, AstraZeneca acquires global rights to Dizal Pharmaceutical's lung cancer drug Zegfrovy in a deal worth up to $1.5 billion, FDA approves a subcutaneous formulation of Leqembi for early Alzheimer's disease, and a pharmacy executive weighs in on the education gap facing patients starting GLP-1 therapies.

AstraZeneca acquires global rights to approved EGFR exon 20 inhibitor Zegfrovy, Chai Discovery strikes an undisclosed AI antibody collaboration with Novartis, and Innovent Biologics licenses its CD40L antibody IBI355 to Spero Therapeutics.

FDA has approved a subcutaneous formulation of Leqembi, giving early Alzheimer's patients the option to self-administer the anti-amyloid therapy at home via weekly autoinjector.

In today's Pharmaceutical Executive Daily, a new industry analysis warns that direct-to-patient pharma platforms are scaling faster than the safety infrastructure needed to support them, FDA issues a complete response letter to Elevar Therapeutics over manufacturing deficiencies in its liver cancer combination therapy, and Insilico Medicine deepens its partnership with China Medical System Holdings in a new AI-powered drug discovery collaboration worth up to $177 million.

Insilico Medicine has deepened its partnership with China Medical System Holdings with a second CNS-focused collaboration in three months, pairing Insilico's PandaOmics-identified mechanism with CMS's clinical and commercial infrastructure in a deal worth up to $177 million in milestones.

FDA issued a complete response letter to Elevar Therapeutics for its rivoceranib and camrelizumab combination in first-line hepatocellular carcinoma, rejecting the application over manufacturing deficiencies rather than clinical concerns.

In today's Pharmaceutical Executive Daily, FDA quietly pauses its real-time public release of complete response letters, FDA approves Sanofi's Sarclisa Escena as the first anticancer treatment in the U.S. to be administered via an on-body injector, and AstraZeneca shares fall nearly 10 percent after its Phase III Cardio-TTRansform trial of Wainua in transthyretin-mediated amyloid cardiomyopathy fails to meet its primary endpoint.

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.