FDA begins sharing rejection letters drugmakers often kept secret
Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.
Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.
The medications still amount to around $500 per month for those without insurance—out of reach for many patients. And even for people with insurance, coverage remains uneven.
The combination offers a potential solution to one of the key problems that’s emerged with popular obesity shots.
Most of the money would go to state and local governments to address the nation’s addiction and overdose crisis, but potentially more than $850 million would go directly to individual victims.
Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months.
1Elevan Biopharmaceuticals plans to relocate to a vacant industrial building near Interstate 69 and East 121st Street, where it expects to build a workforce of at least 120 employees over the next decade.
Indiana Attorney General Todd Rokita said the agreement addresses the devastating impact of Purdue Pharma’s aggressive marketing of opioid products under the Sackler family’s ownership, which “fueled the worst drug crisis in U.S. history.”
The Indianapolis-based drugmaker sees orforglipron as a potential global breakthrough treatment for weight loss and other conditions because it comes in pill form, not an injection.
Persist AI announced a $12 million Series A funding round to support its new Cloud Lab platform, allowing companies to use its lab remotely for research and development.
Lilly in February announced plans to add four U.S. manufacturing sites at yet-to-be-determined sites as part of a roughly $27 billion investment.
SiteOne Therapeutics is developing a non-opioid therapy that targets sodium ion channels in the human body to treat pain and sensory hyperexcitability disorders.
The findings were released Thursday by the American Society of Clinical Oncology and will be discussed at its annual meeting.
The Danish pharmaceutical company, which competes heavily with Indianapolis-based Eli Lilly and Co. in the weight-loss market, is leaving by “mutual agreement” with the company’s board of directors.
Experts say more research needs to be done to understand what drove the reduction, but they mention several possible factors.
The sweeping executive order sets a deadline for drugmakers to lower the cost of prescription drugs in the United States or face new limits over what the government will pay.
People taking Eli Lilly and Co.’s obesity drug, Zepbound, lost nearly 50% more weight than those using rival Novo Nordisk’s Wegovy in the first head-to-head study of the medications.
The proposal, expected to be announced by President Trump on Monday, will face fierce opposition from the pharmaceutical industry.
The idea, floated by the White House as a way to help pay for the president’s tax cut plan, blindsided the pharmaceutical industry and has prompted a furious lobbying campaign.
CVS Health’s pharmacy benefits manager said weight-loss drugs from rival drugmaker Novo Nordisk will become the preferred options on its standard formulary, or list of covered drugs, as of July 1.
The U.S. Department of Justice accused the pharmacy of illegally filling millions of prescriptions in the last decade for opioids and other controlled substances.