STAT+: Doctors Without Borders Calls Gilead ‘Unconscionable’ for Refusing to Sell HIV Prevention Drug to the Organization
Doctors Without Borders has condemned Gilead Sciences for refusing to sell its long‑acting HIV prevention drug lenacapavir directly to the humanitarian organization. The company had previously negotiated a limited‑supply request, while a separate deal with the Global Fund aims to deliver the medication to 2 million low‑ and middle‑income patients. Lenacapavir, administered as an injection every six months, offers near‑complete protection as pre‑exposure prophylaxis. The standoff raises concerns about access for vulnerable populations outside the Global Fund framework.
STAT+: Health Care Jobs Growth Is Stagnating at the Biggest For-Profit Firms
STAT’s analysis of the 50 largest publicly traded health‑care firms shows that job growth at these for‑profit giants has stalled over the past five years, even as the broader health‑care sector continues to expand the U.S. labor market. Health insurers...
STAT+: Pharmalittle: We’re Reading About a Merck Acquisition, the Rise of Former Loxo Execs at Lilly, and More
The U.S. Federal Trade Commission has filed a proposed settlement with CVS Caremark, accusing the pharmacy‑benefit manager of artificially inflating insulin prices and limiting patient access. The deal, which still requires FTC chair approval, mirrors a recent settlement with Cigna’s...
STAT+: Drug Company Penalties for Paying Kickbacks to Doctors Failed to Dent Bottom Lines, Analysis Finds
A JAMA Network Open study examined 64 pharmaceutical kickback settlements from 2000 to 2025, uncovering $10.25 billion in penalties. The drugs at the center of those cases generated $458.6 billion in U.S. sales, meaning fines represented just 2.2 percent of related revenue. The...
STAT+: FDA Slams Soon-Shiong and ImmunityBio for Making ‘False and Misleading’ Claims About a Drug
The FDA sent a March 13 warning letter to ImmunityBio, a company controlled by biotech magnate Patrick Soon‑Shiong, after finding multiple false and misleading statements about its bladder‑cancer drug Anktiva. The agency highlighted that television ads and a podcast claimed the...
STAT+: Pharmalittle: We’re Reading About a Trump Drug Pricing Flaw, a Gilead Deal, and More
A senior Trump administration health official warned that the president’s most‑favored‑nation (MFN) drug‑pricing strategy may unintentionally raise prices abroad rather than lower them in the United States. The flaw arises because manufacturers could postpone launching new drugs in foreign markets,...
STAT+: Pharmalittle: We’re Reading About Iran War’s Impact on Pharma Supply Chain, a Pfizer Lyme Vaccine, and More
The ongoing Iran‑Israel conflict has not yet crippled global pharmaceutical supply chains, but it threatens the modest 0.3% of worldwide drug output and 0.6% of active‑pharmaceutical‑ingredient (API) production that originates in the region. Disruptions to key shipping lanes, especially the...
STAT+: Novartis Picks up Experimental Breast Cancer Therapy for $2B
Novartis announced the acquisition of experimental breast‑cancer drug SNV4818 from Synnovation Therapeutics for a $2 billion upfront payment, with up to $1 billion in milestone‑based earn‑outs. The oral agent is in a Phase 1/2 study targeting mutant PI3Kα in HR‑positive, HER2‑negative tumors while...
STAT+: Trump’s Medicare Director Seeks to Rein in Expectations for TrumpRx
Chris Klomp, the HHS Medicare director, warned that President Trump’s TrumpRx drug‑discount platform is not intended for the majority of Americans with health insurance. He clarified that the program targets cash‑pay patients, leaving the 170 million commercially insured and 68 million Medicare...
STAT+: Novo Nordisk’s High-Dose Wegovy Approved in the U.S.
Novo Nordisk announced FDA approval of a high-dose formulation of its obesity injectable Wegovy in the United States. The approval was granted through a new FDA priority review voucher program, which Novo earned via a price‑cut deal with the Trump...
STAT+: Pharmalittle: We’re Reading About a Lilly Weight Loss Trial, TrumpRx Shortcomings, and More
Eli Lilly’s late‑stage trial of the injectable retatrutide showed a 1.9% drop in HbA1c and a 15.3% weight loss after 40 weeks, outperforming placebo and matching its blockbuster Mounjaro. The drug targets the roughly 60% of type‑2 diabetics who are also...
STAT+: A Maryland Legislator Wants Pharma and Patient Groups to Disclose Ties to Disease Awareness Campaigns
A Maryland bill would force pharmaceutical companies and patient advocacy groups to disclose any financial ties when they run disease‑awareness advertisements. The legislation requires drugmakers to state whether they sell or are developing a treatment for the condition featured, and...
Opinion: Semaglutide Is Going Off-Patent in India. But Will People Who Need It Be Able to Get It?
Semaglutide’s patent will lapse in India on March 24, 2026, unlocking generic competition that could slash prices by up to 90%. The GLP‑1 drug, sold as Ozempic and Wegovy, has been shown to cut major cardiovascular events by 20%. Indian regulators, however,...
STAT+: Asthma Patients Suffered as GSK Pursued ‘Egregious’ Price Hikes, Senator Says
GlaxoSmithKline replaced its Flovent HFA and Flovent Diskus inhalers with an identical authorized‑generic version priced substantially higher. The move was designed to sidestep Medicaid rebate requirements, prompting health plans and pharmacy benefit managers to erect new access hurdles. Senator Maggie...
STAT+: Trump Is Getting More Credit than Biden for Efforts to Lower Drug Prices
A recent KFF poll shows 41% of Americans believe the Trump administration’s policies will lower prescription drug costs, outpacing awareness of the Biden‑era Medicare price‑negotiation law. Support is sharply partisan—79% of Republicans versus 11% of Democrats share this view. Only...
STAT+: Pharmalittle: We’re Reading About the FDA Warning Novo Nordisk, Lilly Investing in China, and More
Astellas Pharma leveraged the Trump administration’s push for lower U.S. drug prices to argue for higher reimbursement for its eye drug Izervay in Japan, winning a more generous price level. Meanwhile, a review of FDA adverse event reports found that...
STAT+: GOP Senator Is Investigating the FDA over Rejections of Rare Disease Drugs
Sen. Ron Johnson (R‑Wis.) announced an investigation into the FDA’s rejections of rare‑disease treatments, requesting the agency’s complete response letters for drugs targeting ataxia, Sanfilippo syndrome and similar conditions. Johnson argues the FDA’s cited deficiencies are often “nitpicky,” suggesting an...
STAT+: What’s Next for RFK Jr.’s MAHA Allies on Vaccine Policy?
Vinay Prasad, the director of the FDA's Center for Biologics Evaluation and Research, announced his abrupt departure after a series of contentious decisions on rare‑disease drug approvals. His exit has reignited debate over the agency’s approach to vaccine safety and...
STAT+: Pharmalittle: We’re Reading About a U.S. Senator Probing FDA, BioNTech Founders Leaving, and Much More
BioNTech co‑founders Ugur Sahin and Özlem Türeci will leave the company by year‑end to launch an unnamed mRNA‑focused venture, with BioNTech retaining a minority stake and licensing key technology. The split allows BioNTech to concentrate on its late‑stage cancer pipeline...
STAT+: Large Drugmakers Are Developing Fewer Antibiotics, Analysis Finds
A new analysis shows the world’s largest pharmaceutical firms cut antimicrobial development by 35% over the past five years, dropping from 92 to 60 candidates. Only five of the 39 pipeline projects aimed at WHO priority pathogens include pediatric formulations...
STAT+: Eli Lilly Launches Program for Employers to Subsidize Cost of Obesity Drug Outside Insurance
Eli Lilly introduced a new employer‑focused program allowing companies to subsidize the cash price of its obesity medication Zepbound. The drug can be purchased directly from LillyDirect for $449 per month, and employers can contribute a fixed amount, such as $50...
Opinion: AI Could Revolutionize Antibiotics — but the Market Is Standing in the Way
Antibiotic resistance now kills roughly 4.9 million people each year, and the last truly novel class of antibiotics was introduced over three decades ago. Artificial intelligence promises to accelerate the discovery of new antimicrobial agents by scanning vast chemical spaces and...
STAT+: Gilead and South Africa Are Negotiating a License for Local Production of New HIV Drug
Gilead Sciences is in talks with the South African government to issue a voluntary licence for the local manufacture of lenacapavir, a novel HIV‑prevention drug. The agreement would enable South African firms, identified with help from Unitaid and the US...
STAT+: Pharmalittle: We’re Reading About Moderna’s $2.25 Billion Settlement, FDA Warning Letters, and More
Moderna agreed to settle Roivant's patent claims for up to $2.25 billion, paying $950 million upfront and a contingent $1.3 billion if its liability‑shifting strategy fails. The deal averts a Delaware jury trial that many analysts feared would be costly and damaging. Simultaneously,...
STAT+: Virginia Lawmakers Push a New Approach to a Prescription Drug Affordability Board
Virginia lawmakers are proposing a prescription‑drug affordability board that will use Medicare’s annually negotiated drug list as its benchmark. The board would also impose upper payment limits, creating a ceiling on what insurers pay for those medicines. This strategy would...
STAT+: Trump’s Drive to Get Europe to Pay More for Drugs Creates Uncertainty for Countries, Patients
President Trump has pressed European nations to raise their drug spending, arguing that higher foreign prices would allow the United States to lower its own prescription costs. While no clear price hikes have materialized yet, the demand has sparked uncertainty...
STAT+: Minnesota Report Shows Large Hospitals Continue to Dominate the 340B Drug Discount Program
Minnesota’s Department of Health reports that hospitals and clinics in the state earned at least $1.34 billion in 2024 from the 340B drug discount program. Participants received $3.045 billion in discounted medicines but paid $1.53 billion plus $165 million in administration fees. The largest...
STAT+: Trump Most-Favored Nation Drug Pricing Deals End After Three Years for some Companies
President Trump’s "most‑favored nation" (MFN) drug pricing agreements, touted as a safeguard against excessive prescription costs, have been revealed to run for three years for several participants. SEC filings show that 16 pharmaceutical firms have entered these deals, each with...
STAT+: Pharmalittle: We’re Reading About FDA and a ‘Smear Campaign,’ Cigna Buying a Large Pharmacy, and More
The FDA’s leadership, led by Commissioner Marty Makary, defended recent rejections of rare‑disease cell and gene therapies and described top official Vinay Prasad as a target of a media smear campaign. Makary praised Prasad’s scientific rigor while acknowledging pressure from...
STAT+: Justice Department Backs AbbVie in Its Bid to Overturn a Colorado Law Guiding a Drug Discount Program
The U.S. Department of Justice filed an amicus brief supporting AbbVie in its effort to overturn a Colorado statute that prohibits pharmaceutical manufacturers from limiting discounts under the federal 340B drug pricing program when hospitals use contract pharmacies. The Colorado...
STAT+: GSK Picks up Pulmonary Hypertension Drug with 35Pharma Acquisition
GlaxoSmithKline announced a $950 million cash acquisition of 35Pharma, a privately held biotech focused on lung diseases. The deal brings the experimental compound HS235, slated to enter pulmonary arterial hypertension (PAH) trials, into GSK’s pipeline. PAH has become a lucrative target,...
STAT+: Bayer Sues J&J over ‘False and Misleading Claims’ About Competing Prostate Cancer Treatments
Pharmaceutical giant Bayer has filed a lawsuit against Johnson & Johnson, accusing the latter of false advertising around its prostate‑cancer drug Erleada. Bayer claims J&J’s February 2 press release and website slides used flawed data to portray Erleada as more effective...
STAT+: Novo Nordisk’s Next-Gen Obesity Drug Stumbles in Comparison Study
Novo Nordisk’s next‑generation obesity drug CagriSema failed to demonstrate non‑inferiority to Eli Lilly’s tirzepatide in the 84‑week REDEFINE 4 study, achieving 20.2% weight loss versus 23.6% for tirzepatide. The open‑label trial showed the two treatments were not statistically equivalent. Following the announcement,...
STAT+: Pharma Lobbyists Focus on a Surprising New Target: The FDA
Health Secretary Robert F. Kennedy Jr. has pledged to purge industry influence from the FDA, yet the Trump administration’s injection of political priorities has reshaped the agency’s operating environment. Under the current administration, discussions that once were deemed off‑limits between...
STAT+: Pharmalittle: We’re Reading About an FDA Official’s Speech, a Grail Cancer Blood Test, and Much More
FDA drug‑center head Tracy Beth Høeg used her first staff address to flag two priority areas: the safety of antidepressants taken during pregnancy and the use of monoclonal antibodies that protect infants from RSV. She also signaled a continued interest...
STAT+: Texas Attorney General Sues Sanofi for Allegedly Providing Kickbacks to Doctors to Prescribe Its Drugs
Texas Attorney General Ken Paxton filed a lawsuit alleging Sanofi paid kickbacks to physicians by offering free nursing staff and insurance‑support services. The alleged scheme was designed to steer prescriptions toward Sanofi’s drugs for chronic conditions such as diabetes, multiple...
STAT+: Pharmalittle: We’re Reading About the FDA Pushing OTC Meds, Its New Trial Standards, and Much More
The FDA, under Commissioner Marty Makary, is pushing to expand over‑the‑counter (OTC) availability for safe prescription drugs such as nausea treatments and vaginal estrogen. Simultaneously, the agency proposes dropping the long‑standing requirement for two pivotal clinical trials, moving to a...
Opinion: My Biggest GLP-1 Ethical Problem: Patients Who Don’t Want to Stop
GLP‑1 agonists have moved from scarcity to abundance, reshaping weight‑management practice. In 2023, shortages forced clinicians to ration these drugs, often off‑label for obesity. Today, the surplus creates a new dilemma: patients seeking extreme, unsustainable weight loss and refusing to...
STAT+: New FDA Guidance for Antibiotic Use in Food-Producing Animals Prompts Criticism over Antibiotic Resistance
The FDA’s Center for Veterinary Medicine issued new guidance urging drugmakers to add explicit duration limits to medically important antibiotics used in food‑producing animals. Currently, about 28% of these drugs are administered continuously for approved indications, but the guidance seeks...
Opinion: I Was a Moderna Exec when the Covid Vaccine Rolled Out. That Spirit of Possibility Is No More
Former Moderna executive Richard Hughes IV reflects on the exhilaration of the COVID‑19 vaccine launch, describing a once‑vibrant "spirit of possibility" that drove rapid innovation. He recounts his personal journey from unknown outsider to key player in a global health...
STAT+: At Drugmakers’ Forum, Oz Gets a Friendly Embrace, While Makary Faces Tough Questions
At a PhRMA‑hosted forum, CMS Administrator Mehmet Oz engaged warmly with Pfizer CEO Albert Bourla, championing vaccines and proposing closed‑door policy talks and even suggesting industry executives consider government jobs. In contrast, FDA Commissioner Marty Makary was sharply questioned by...
