All News

Following a Type A meeting with the FDA’s Center for Biologics Evaluation and Research, Moderna’s flu vaccine candidate mRNA-1010 has been accepted for formal review after the company revised its regulatory strategy.

In today’s Pharmaceutical Executive Daily, the FDA approves a monthly dosing schedule for Rybrevant Faspro, HHS Secretary Robert F. Kennedy Jr. revises the agency’s leadership team, and industry expert Sandy Tammisetty discusses what it takes to deliver actual value in today’s pharmaceutical landscape.

HHS Secretary Robert F. Kennedy Jr. reorganized senior leadership at the department to streamline management and advance the administration’s health policy priorities.

The new once-monthly dosing schedule for Rybrevant Faspro in combination with Lazcluze offers a more convenient option and also maintains efficacy and safety comparable to the prior bi-weekly regimen.

Without new legislation, pilot programs, or years of rulemaking, the agency could use enforcement discretion to create a fast, risk-based pathway for low-risk early-stage trials.

As the pharma industry continues to experiment with AI implantation, certain areas are showing more promise than others.

Model N’s SVP details the implications of the various deals major pharma companies are striking with the government over drug pricing.

In today’s Pharmaceutical Executive Daily, the FDA issues a Complete Response Letter for Disc Medicine’s bitopertin in EPP, Edwards Lifesciences lifts its anti-copycat policy, and industry leaders examine how to scale global medical digital transformation while ensuring local fit.

Following the decisions=, the European Commission decided to close a long-running antitrust investigation

Most medical digital pilots are designed for success in controlled conditions.

EVERSANA’s president of Patient Services discusses using technology to bring a personalized approach to change care.

In today’s Pharmaceutical Executive Daily, Eli Lilly builds a $1.5 billion stockpile of Orforglipron ahead of an FDA decision, PTC Therapeutics withdraws and plans to resubmit its Translarna NDA, and a former AstraZeneca executive is charged with multiple offenses in China.

As therapeutic complexity increases, life sciences companies should cultivate open mindsets toward innovative data sources beyond traditional claims and electronic medical record data.

Eli Lilly's $1.5 billion pre-launch inventory of orforglipron signals an aggressive manufacturing strategy aimed at avoiding supply shortages and capturing early share in the competitive obesity market.

From lessons in risk-taking—and building “from zero”—to career-defining pivots, Leonard Mazur, CEO of Citius Pharmaceuticals, reflects on 50-plus years in pharma.

The withdrawal is due to data shared from FDA reflecting that data included in the NDA submission is unlikely to meet the required threshold of evidence.

Phesi’s founder and CEO discusses recent trends in clinical trials.

Kim Boericke, CEO, Veristat, discusses how Veristat is adapting clinical trials by using data, AI, and operational planning to optimize site selection, manage complex cell and gene therapy logistics, and streamline analytics.

Special Guest Op-Ed: What a decade of collaboration and shared effort reveals about the future of drug development.

Pharm Exec’s 21st Annual Pipeline Report examines emerging drug development classes, treatment modalities, and expansion pursuits in five therapeutic settings ripe for next-gen innovation.

The indictment of AstraZeneca’s former China chief Leon Wang marks a significant development in Beijing’s probe into drug importation and insurance practices, adding legal pressure even as the company works to stabilize its business in the region.

Sanofi named Belén Garijo as its next CEO, signaling a leadership shift aimed at sharpening execution and R&D productivity as the company moves beyond the strategic overhaul of the past six years.

Kim Boericke, CEO, Veristat, touches on how early strategic consulting, data analytics, and automation help optimize trial design, define realistic patient populations, and generate faster insights.

What’s missing from many care strategies today is the actual voice of the patient.

In today’s Pharmaceutical Executive Daily, the FDA issues a refusal-to-file letter to Moderna for its seasonal influenza vaccine as the company secures a long-term agreement in Mexico, industry leaders assess China’s evolving role in global pharma strategy, and the FDA makes a decision on Keytruda in platinum-resistant ovarian cancer.

THX Pharma’s licensing deal with Biocodex pairs late-stage rare disease assets with commercial infrastructure and non-dilutive funding, highlighting how biotech companies are sharing risk and leveraging partnerships to advance ultra-rare pediatric programs toward market.

The approval of Keytruda (pembrolizumab) and Keytruda Qlex was supported by Phase III KEYNOTE-B96 data showing statistically significant improvements in progression-free and overall survival in patients with PD-L1–positive platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma.

The shifting landscape amid China's biotech rises presents both opportunities and geopolitical challenges for growth strategies.