The Latest

• 

  Merck & Co. assembles an Alzheimer’s comeback with a next-gen precision focus

  With two molecules in mid-stage trials, the pharma giant is taking another swing at the difficult disease with a greater understanding of its drivers.

  Pharma

• 

  C-suite shuffles ripple through pharma

  Novo Nordisk, Kenvue and Jazz Pharmaceuticals announced changes at the top this month.

  Leadership

• 

  Roche pushes ahead with late-comer strategy in obesity

  The Swiss pharma company announced several updates to its obesity portfolio in its latest earnings report.

  Commercialization

• 

  Dr. Vinay Prasad, controversial FDA official, abruptly departs agency

  Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office got embroiled in controversy over a Duchenne gene therapy.

  Biotech

• 

  Biotech investing is down, but some VC firms are bucking the trend

  Discipline is the name of the game after a glut of over-investing burst the biotech bubble.

  Biotech

• 

  Could bispecifics unseat Keytruda from its oncology throne?

  Signals suggest the drugs could improve on the standard of care, but the market may not make it easy for another megablockbuster to rise to the top.

  Biotech

• 

  From the bench: Researchers make NIH-funded preclinical strides in mRNA and obesity

  The studies are contributing preclinical advances for some of the world’s biggest blockbusters.

  Biotech

• 

  Pharma’s turbo spending spree on US manufacturing

  The industry’s push to expand American drug production isn’t abating as threats of tariffs loom.

  Manufacturing

• 

  How Bristol Myers Squibb uses AI to validate drugs before they’re even in the lab

  The company’s AI approach allows molecule candidates to be vetted for efficacy and other properties early in development.

  Pharma

• 

  Who is Dr. George Tidmarsh, the new director of CDER?

  Despite past criticism of public health policies, Tidmarsh recently praised the FDA and said he’ll focus on boosting review efficiencies.

  Biotech

• 

  Novartis’ Zolgensma sales fall again as gene therapy market woes persist

  Novartis has seen sales decline in a difficult gene therapy market. Is there hope on the horizon?

  Commercialization

• 

  3 major patent losses this year — and a key strategy to fill the gaps

  Despite promising pipelines, most new launches are missing sales targets, forcing pharmas to rethink sales strategies.

  Commercialization

• 

  Why FDA’s CRL release could open the door to lawsuits against pharma

  In a push for “radical transparency” the FDA released 200 CRLs for drugs that were later approved — some of which are now public for the first time.

  Pharma

• 

  J&J accelerates past Stelara’s fall with better-than-expected portfolio growth

  Stelara is faltering due to biosimilar entries, but J&J execs demonstrate they were ready to fill the gap all along.

  Leadership

• 

  FDA invites more data from abroad — with a wary eye on China

  The FDA approved four drugs last year without any U.S. trial participants, but has maintained a tougher stance on China, even as it grows into an R&D powerhouse.

  Biotech

• 

  Biotech IPO momentum gained steam last year, but market ‘turmoil’ has slowed the train again

  The IPO market is a mixed bag in 2025, with some signs of life but several headwinds keeping activity relatively low.

  Biotech

• 

  Q&A

  Need a DTC platform? Here’s how one company built its own.

  Currax Pharmaceuticals was ahead of the curve when it set up a direct access platform for its obesity med. 

  Commercialization

• 

  With Verona deal, Merck wagers on strength of lung drug’s patents

  The main patent for Ohtuvayre, the COPD drug at the heart of Verona’s $10 billion sale, expired in 2020. For Merck to make good on the deal, other secondary patents will need to hold up.

  Commercialization

• 

  Early measles drug R&D kicks into gear as U.S. records record outbreak

  Several companies have announced preclinical efforts to develop the first-ever measles treatment.

  Biotech

• 

  Pricing watchdog will take on the rising cost of drugs at launch

  ICER’s upcoming report could shed light on how the launch price of newly approved drugs affects overall cost and access from a patient perspective.

  Patient

• 

  First 90 Days

  As its cancer vaccine moves through the clinic, Transgene sets sights on manufacturing

  Simone Steiner recently joined the French company to set the stage for launch.  

  Biotech

• 

  Trump says ‘very high’ pharmaceutical tariffs coming soon

  While Trump indicated drug levies would be as high as 200%, he added that pharma firms would first be given time to bring manufacturing back to the U.S.

  Commercialization

• 

  Is biopharma dealmaking getting hot again?

  With pharma’s finger on the M&A button, three of the biggest deals of the year are breadcrumbs that could lead to a full-on resurgence.

  Biotech

• 

  The MEK effect on cancer — a slow and steady approach to drug resistance

  Immuneering Corporation’s investigational MEK inhibitor aims to outpace cancer while reducing resistance and side effects.

  Biotech

• 

  GLP-1 roadblocks: Discontinuation rates soar as insurers clamp down

  As more drugmakers aim for the lucrative weight loss market, patient challenges linger.

  Commercialization

More stories