
Regulatory
Latest Content

Pharmaceutical Executive Daily: Disc Medicine Receives CRL from FDA for Bitopertin

Edwards Life Sciences Lifts Anti-Copycat Policy

FDA Issues CRL to Disc Medicine for Eythropoietic Protoporphyria Treatment Bitopertin

Scaling Medical Digital Transformation in Global Pharma While Ensuring Local Fit

How to Bring a Breakthrough Rare Disease Product to Patients in Record Time: Q&A with Brian Laird

Shorts










Podcasts
Videos
All News

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.

Bridging the Data Gap: How Digital Behavioral Insights Can Transform HCP Targeting in Specialty Care
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.
























