Industry News
Pharmaceutical Industry News
The FDA is planning to tighten its…
The FDA is planning to tighten its regulations for vaccines, according to an internal email sent by Vinay Prasad, M.D., who heads up the agency’s Center for Biologics Evaluation and Research (CBER).
The Trump administration has lined…
The Trump administration has lined up another country-specific trade agreement, this time with the United Kingdom. The agreement confers Washington’s biggest break on pharmaceutical import tariffs yet.
Extreme Measures for the Fentanyl Crisis
Readers respond to a guest essay about America’s fentanyl problem. Also: A dark echo at Penn.
On the heels of striking a deal…
On the heels of striking a deal with the Trump administration to reduce the prices of several of its most popular drugs for U.S. patients, Eli Lilly has unveiled additional savings for cash-paying users of
The U.S. has revealed price…
The U.S. has revealed price reductions for the second round of prescription drugs negotiated by Medicare through the Inflation Reduction Act (IRA). Headlining the list of 15 treatments that will undergo price reductions in 2027
The company filed its bid for a…
The company filed its bid for a 7.2 mg Wegovy formulation using its National Priority Voucher from the FDA, which promises to accelerate a regulatory review to around one to two months.
A new FDA approval for a…
A new FDA approval for a first-in-class drug has vaulted Otsuka into the IgAN disease space, an increasingly competitive field targeted by multiple biopharma companies such as Novartis and Vertex.
More than 30 agents conducted a…
More than 30 agents conducted a surprise raid of Sanofi’s headquarters in Paris on Tuesday morning as part of a tax fraud investigation, according to a report from French newspaper Le Monde.
U.S. Announces Negotiated Prices for 15 Drugs Under Medicare
The Trump administration said that had the new prices been in effect last year, Medicare would have saved $12 billion, which would have reduced its spending on those drugs by 44 percent.
Postpartum Prescription of GLP-1 Drugs Has Increased Sharply, Study Finds
By mid-2024, the weight-loss drugs were prescribed for almost 2 percent of new mothers.
The FDA signed off on Imfinzi as…
The FDA signed off on Imfinzi as the first immunotherapy that can treat certain patients with early-stage stomach cancer both before and after surgery, marking the drug's third perioperative nod.
Nominate up-and-coming…
Nominate up-and-coming early-career pharma marketing pros here to be featured in Fierce's "Rising Stars" Q&A series.
Sarepta will study its gene…
Sarepta will study its gene therapy Elevidys with the immunosuppressant sirolimus in non-ambulatory patients with Duchenne muscular dystrophy in the hopes of quelling the liver safety issues that led to a label restriction.
A short film that premiered…
A short film that premiered earlier this month follows three people who, after being diagnosed with chronic lymphocytic leukemia, discover a renewed commitment to living their lives to the fullest.
A survey has found that pharma…
A survey has found that pharma marketing and promotional review professionals are skeptical of the outputs of artificial intelligence models, with 65% of respondents saying they don’t trust the technology to create regulatory compliance submissions.
Novartis has received an FDA…
Novartis has received an FDA approval for Itvisma, an intrathecal version of the company’s gene therapy Zolgensma, to treat older patients with spinal muscular atrophy.
Less than a week after Novartis…
Less than a week after Novartis unveiled a plan to establish a “flagship manufacturing hub” in North Carolina that would add 700 employees to its rolls, the Swiss drugmaker says it is making moves in
The PMCPA has ruled that a…
The PMCPA has ruled that a presentation calling the European Medicines Agency “stupid” brought discredit on the pharma industry.
A few months after SK Life Science…
A few months after SK Life Science began rolling out a road trip-themed TV commercial for its antiseizure medication Xcopri, the FDA is attempting to put the brakes on the ad.
Novo Nordisk has come up short in…
Novo Nordisk has come up short in two phase 3 trials of semaglutide as a treatment for Alzheimer’s disease. But perhaps the larger story associated with the unsurprising result is the market reaction, as Novo's