Fierce Pharma

After Jenny Pearson’s daughter Elise first had a seizure at 16 months old, an MRI came back clean—her brain “looked beautiful,” Pearson recalled to Fierce. But a follow-up scan a year later, just days before Thanksgiving, showed her frontal lobe was now awash with white splotches. A genetic test the week before Christmas gave a troubling diagnosis: Alexander disease.

Daiichi Sankyo subsidiary American Regent is launching a recall of three lots of generic epinephrine as it becomes one of the latest manufacturers to face headaches over particulate contamination in its drug products.

Pharma The Top Line Fierce 50 podcast The 2026 Fierce 50 includes people and organizations working on very different problems across biopharma and healthcare, from designing new proteins and developing cancer medicines to protecting vaccine science, improving health literacy and expanding representation in medicine.

Move over AbbVie and Johnson & Johnson, we have a new and surprising leading drug in the pharma ad spending space. According to data from iSpot.TV, UCB’s immunology drug Bimzelx jumped 17 positions month-over-month to claim the top spot as the highest pharma drug ad spend in August. This is the first time UCB’s med has ever taken the lead with a meaty $31.5 million in spend, up from the $5.5 million the company spent in July.

GSK, Roche and Novartis continued Big Pharma's dealmaking spree with Asian companies. Three midsized Asian biopharmas reached “most favored nation” deals with the White House. Akeso and Summit Therapeutics' ivonescimab delivered a head-to-head overall survival win against Keytruda. And more. 1.

The month of September 2025 marked a low point for relations between the U.K. government and Big Pharma. Over a handful of days, a series of industry heavyweights pulled back from R&D investment commitments across the country. The root of the crisis appeared to be the government’s move to increase the proportion of sales of newer branded medicines that pharmas must pay back to the U.K.’s taxpayer funded National Health Service (NHS) from 15.5% to 31.3%.

Following a string of customer complaints, a Form 483 and a recall this past spring, a Fresenius manufacturing unit in Utah is contending with a warning letter from the FDA. The FDA reprimand, dated Aug. 25 and posted to the agency’s website this week, follows an inspection of Fresenius Medical Care’s plant in Ogden, Utah, in early March of this year.

Novartis is taking social media by storm with a multiple sclerosis (MS) campaign that urges patients to #KnowYourMS, a message backed by British Olympian Laviai Nielsen. Throughout the summer, the company has been posting a blend of patient stories and short branded videos across its social channels to amplify its patient advocacy push in MS and inspire patients to bring up concerns about their condition with their doctors.

While a positive advisory committee meeting seemed to up the odds of approval for Replimune’s twice-snubbed melanoma drug in July, the fate of vusolimogene oderparepvec was anything but certain. In the end, however, two votes of confidence from leaders at the FDA’s Office of Clinical Evaluation and the Oncology Center of Excellence sealed its fate, overruling review staffers’ concerns and paving the way for last month’s accelerated nod for Tudriqev.

CMI Media Group is adding to its spread of media services through a new specialty communications business that introduces a slate of new cutting-edge marketing tools. The new business unit is centered on medical affairs, which CMI described as the industry’s essential “third pillar,” it explained in a Sept. 2 press release.