News
A spokesperson for the FDA said the agency is “considering a wide range of options to support American innovation.”
FEATURED STORIES
AI is changing the nature of leadership in biopharma. Here’s how executives can not only adapt, but lead the way.
The company cut back in areas while investing in internal and external opportunities to offset the loss of exclusivity on a product that until recently accounted for 20% of innovative medicine sales.
To tailor cancer therapies to individual patients, Moderna, BioNTech and other companies are rethinking how they optimize manufacturing schedules and resources.
Job Trends
Pfizer Inc. announced the election of Cyrus Taraporevala to its Board of Directors, effective immediately.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
THE LATEST
Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs.
The Phase III results impressed Guggenheim Partners analysts both in terms of efficacy and safety. If approved, atacicept would become the first APRIL/BAFF inhibitor for IgAN to make it to the market.
The FDA previously placed two clinical studies on hold, including the Phase III trial in which the liver toxicity occurred. Intellia is working with experts to create a risk management program for nex-z.
Darzalex Faspro’s approval for smoldering multiple myeloma could allow for earlier intervention and reduce the risk of progression to active disease.
The nausea and other gastrointestinal side effects of weight loss drugs like Novo Nordisk’s Wegovy or Eli Lilly’s Zepbound will limit how much these drugs can help patients and stunt the overall obesity market unless we approach the problem head on.
The FDA awards a second round of Commissioner’s National Priority vouchers to six larger biopharma companies. And this time, with the exception of Eli Lilly’s orforglipron, the vouchers are for drugs that are already on the market.
The agreement will also secure a $150 price for future weight loss pills from Novo Nordisk and Eli Lilly—at least initially.
The company reported $200 million in net losses for the third quarter, but an aggressive and highly successful cost-cutting campaign is helping to stem the downward trend.
The highest dose of Eli Lilly’s eloralintide led to 20.1% weight loss after 48 weeks in a Phase II trial, exceeding analyst expectations and highlighting a “potentially best in class profile,” according to BMO Capital Markets.
In this episode presented by PII, BioSpace’s head of insights discusses how to relieve clinical trial patients of technological burden to improve compliance with guests Oliver Eden and Travis Webb.