STAT+: Pharmalittle: We’re Reading About a Review of Alzheimer’s Drugs, FDA Interest in Compounded Peptides, and More
A Senate‑Democrats report released ahead of a drug‑pricing hearing shows that companies which signed pricing deals with former President Trump have continued to raise drug prices, with new therapies averaging $353,000 a year and combined profits climbing to $177 billion in his second term. The same briefing notes a new Cochrane review concluding that the clinical benefit of recent Alzheimer’s monoclonal‑antibody drugs is negligible, sparking criticism from experts who argue the analysis groups dissimilar drugs together. The report highlights ongoing tension between policy promises to curb costs and market realities, while the Alzheimer’s findings raise questions about the future of anti‑amyloid therapies.
STAT+: Pharmalittle: We’re Reading About FDA Seeking More Data on a Lilly Obesity Pill, a Pharma 340B Win, and More
U.S. FDA has asked Eli Lilly to provide additional safety data on its newly approved obesity drug Foundayo, mandating post‑marketing trials for cardiovascular events, delayed gastric emptying, and a lactation study. The pill, a GLP‑1 agonist, received accelerated approval through the...
STAT+: Flawed Study on the Antidepressant Paxil Came with a Cautionary Note — if You Knew How to Find It
The Journal of the American Academy of Child & Adolescent Psychiatry issued an expression of concern in late 2025 about a 2001 study that linked the antidepressant Paxil to outcomes in adolescents. The notice followed a formal request to retract...
STAT+: Pharmalittle: We’re Reading About an FDA Push for Trial Transparency, a Novo-OpenAI Deal, and More
The FDA has dispatched reminder letters to more than 2,200 companies and researchers, warning that failure to post required clinical trial results to the federal database could trigger fines. An internal review found that nearly 30% of studies likely subject...
STAT+: Maryland State Affordability Board Sets Its First Price Cap for a Medicine
Maryland's Prescription Drug Affordability Board announced its first price cap, targeting the type‑2 diabetes drug Jardiance. Starting January 2027 the state will limit a 30‑day supply to $204, roughly $6.80 per pill. The cap, modeled after Medicare’s maximum fair price...
STAT+: Pharmalittle: We’re Reading About a Pancreatic Cancer Pill, FDA Rejecting a Replimune Drug Again, and More
Revolution Medicines reported that its KRAS‑targeting oral pill daraxonrasib more than doubled median overall survival for metastatic pancreatic cancer patients, achieving 13.2 months versus 6.7 months on standard chemotherapy. The company will leverage a FDA priority‑review voucher to seek accelerated...
STAT+: Pharmalittle: We’re Reading About Top Pharma Lobbyist Stepping Down, Genes and GLP-1 Drugs, and More
Steve Ubl, longtime chief executive of the Pharmaceutical Research and Manufacturers of America (PhRMA), announced he will step down at the end of the year after more than a decade leading the industry’s primary trade group. His tenure spanned the...
STAT+: Pharmalittle: We’re Reading About FDA Seeking New Powers over DTC Ads, an EU Pledge to Fight AMR, and More
Activist hedge fund Shah Capital, Novavax’s second‑largest shareholder with a 9% stake, announced it will vote against the company’s board nominees and executive compensation at the upcoming annual meeting. The fund is pressing the vaccine maker to accelerate cost‑cutting, launch...
STAT+: Pharmalittle: We’re Reading About FDA Backing Domestic Production, Another Gilead Deal, and More
The FDA, leveraging the Trump administration’s budget, unveiled proposals to boost domestic drug development and manufacturing, including streamlined early‑stage trials and a rule letting U.S. generic makers challenge brand patents a month before foreign competitors. Commissioner Marty Makary framed the...
STAT+: Merck’s Experimental HIV Prevention Pill Could Be Made for Less than $5 a Year, Researchers Say
Merck’s experimental HIV‑prevention pill MK 8527 could be manufactured for less than $5 per patient annually, according to a recent cost‑analysis. The drug is in two late‑stage clinical trials that will report efficacy data in the second half of 2027. Earlier...
STAT+: Pharma Companies and Patient Groups Seek to Exempt Orphan Drugs From Colorado Pricing Limits
Colorado lawmakers are advancing a second bill in two years that would carve out orphan drugs—medicines for rare diseases—from any price caps imposed by the state Prescription Drug Affordability Board. The board, created to curb soaring prescription costs, could otherwise...
STAT+: Pharmalittle: We’re Reading About an FDA Delay Forcing a Biotech to Close, a Neurocrine Deal, and More
In February, Kezar Life Sciences secured an FDA agreement for a clinical trial on autoimmune hepatitis, but the meeting was cancelled four months late, prompting the biotech to begin winding down. Meanwhile, U.S. physicians are increasingly prescribing oral GLP‑1 weight‑loss...
STAT+: Makary Marks One Year at FDA with Focus on Achievements in Speech to Staff
FDA Commissioner Marty Makary marked his one‑year anniversary by reflecting on the agency’s milestones and acknowledging the “challenging start” caused by the Trump administration’s 2025 layoff of roughly 3,500 FDA employees. He highlighted progress across drug approvals, safety initiatives, and...
STAT+: Government Watchdog Urges FDA to Finalize Guidance for Advisory Committee Conflicts of Interest
The Government Accountability Office (GAO) reports that the FDA has still not finalized the financial conflicts‑of‑interest (COI) guidance for its advisory committees, despite a law mandating it 13 years ago. The agency also fails to publicly disclose how it evaluates...
STAT+: Pharmalittle: We’re Reading About Pharma Delaying Launches in Europe, Lilly and Biogen Deals, and More
U.S. pressure to lower prescription‑drug prices is prompting several manufacturers to postpone the launch of new medicines in Europe. President Trump’s push for most‑favored‑nation pricing ties U.S. costs to European rates, creating a pricing dilemma for firms. At the same...
