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While it’s impossible to make apples-to-apples comparisons of the many obesity candidates with so many differences across clinical trials, we at BioSpace are giving it our best shot.
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Regulations aiming to lower the cost of vital medicines will instead end up restricting access and disincentivizing R&D.
The Trump administration’s ever-changing tariffs and Most Favored Nation drug pricing are part of a blizzard of unclear, potentially illegal tactics that leave observers throwing their hands in the air.
Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the regulator that it got it wrong. Capricor plans to resubmit the application based on deramiocel’s existing dataset.
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Read our takes on the biggest stories happening in the industry.
The HHS secretary recently canceled $500 million worth of BARDA contracts around mRNA vaccine research. But the U.S. government has already spent billions on this work, which has saved millions of lives.
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Washington has had notable life sciences job growth over the past 10 years, according to a Life Science Washington report. The association’s CEO and a biopharma CEO discuss what makes the state stand out, including its talent pool, AI leadership and entrepreneurship support.
In this episode presented by Cresset, BioSpace’s head of insights Lori Ellis discusses clinical trial fail rates and AI’s potential to reduce preclinical costs with Mutlu Dogruel, VP of AI and Mark Mackey, CSO of Cresset.
Stealth BioTherapeutics originally submitted elamipretide for approval in January 2024, only to receive a rejection in May of this year. In addition to accepting the biotech’s resubmission, the FDA has promised to take action on the candidate by Sept. 26.
President Donald Trump first threatened pharma tariffs in February and recently said they were imminent. Johnson & Johnson’s new investment adds to a $55 billion pledge made by the company in March.
Hundreds of HHS Staffers Accuse RFK Jr. of ‘Sowing Public Mistrust’ Against CDC After Shooting at HQ
In an open letter, Health and Human Services employees asked the Secretary to stop and disavow the spread of health misinformation, particularly about vaccines, infectious diseases and federal health agencies.
The delays, first revealed in Regeneron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants.
In late May, a patient died after receiving Rocket Pharmaceuticals’ investigational gene therapy for Danon disease, spurring the hold. After lowering the dose and changing the regimen of immune modulators patients receive, the company has received FDA clearance for the trial to continue.
The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new guidance follows the surprising return of CBER Head Vinay Prasad, who has previously argued for prioritizing OS.
With its structural changes, CSL expects to generate $500 to $550 million in annualized savings over the next three years.
The CDC no longer recommends COVID-19 vaccines for healthy children and healthy pregnant women, a position that has been opposed by leading medical societies.