Nicholas Jacobus

Gerren McHam, vice president of Government and External Affairs, API Innovation Center,argues that closing the gap between federal reshoring policy and manufacturer investment requires more than incentives.

In today's Pharmaceutical Executive Daily, Novo Nordisk sues Eli Lilly over GLP-1 advertising it calls misleading, President Trump announces a phased tariff plan for imported generic drugs, and a new commentary argues pharma's AI investment is missing the areas of drug discovery where it matters most.

President Trump announces a zero tariff on imported generic drugs through August 2026 before a phased escalation to 200% by 2029.

Gerren McHam, vice president of Government and External Affairs, API Innovation Center, explains how geopolitical disruptions like the Strait of Hormuz situation have accelerated the organization's push to develop a national fragility index.

In today's Pharmaceutical Executive Daily, FDA grants emergency use authorization for Seegene's multiplex PCR assay, a Pfizer medical lead makes the case for continued antiviral use among Covid-19 high-risk patients, and Nuvation Bio's CEO discusses the company's oncology pipeline and philosophy of developing better drugs rather than more of them.

FDA has granted Emergency Use Authorization to Seegene USA's Allplex multiplex PCR assay, making it the first U.S.-authorized test to simultaneously detect and differentiate HSV-1, HSV-2, VZV, and monkeypox virus in a single reaction.

Dr. Gurinder S. Sidhu, senior medical director and U.S. Antiviral Medical Lead, Pfizer, discusses how Covid-19 remains a serious threat to the roughly 75% of American adults who qualify as high-risk, and pushes back against clinician complacency.

Gerren McHam, vice president of Government and External Affairs, API Innovation Center, outlines why reshoring API manufacturing requires more than investment incentives.

In today's Pharmaceutical Executive Daily, Invivyd's chief scientific officer discusses a platform designed to predict future viral variants ahead of time, Bristol Myers Squibb expands its AI compute infrastructure with Nvidia to build what it calls the most powerful AI factory in life sciences, and FDA clears Consano Bio's IND for a non-opioid biologic targeting chronic sciatica.

FDA has cleared Consano Bio's IND for C-1101, a platelet-derived biologic delivered via single epidural injection, enabling U.S. expansion of a Phase I trial targeting chronic sciatica.

Bristol Myers Squibb is deploying Nvidia's DGX SuperPOD with Vera Rubin NVL72 systems to build what it claims is the most powerful AI computing infrastructure in life sciences.

Robert Allen, Ph.D., Chief Scientific Officer, outlines how the company's Invymab platform uses viral surveillance and predictive modeling to design monoclonal antibodies against likely future variants rather than current strains.

Gerren McHam, vice president of Government and External Affairs, API Innovation Center, breaks down how China's new export control regulations expose drugmakers to operational risks that have yet to draw significant industry attention.

In today's Pharmaceutical Executive Daily, FDA converts Fabhalta's accelerated approval to full approval for IgA nephropathy, a Pharmaceutical Executive commentary argues AI-driven patient support still can't replace human connection, and Jasper Therapeutics closes its acquisition of Kira Pharmaceuticals in a deal combining a three-asset immunology pipeline.

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.