STAT+: Medicare puts out new details for covering the Alzheimer’s drug Leqembi, as the health system readies for potential approval
WASHINGTON — The health care system is on the precipice of broad access to a treatment…
Category: STAT+
FDA grants conditional approval to Sarepta’s gene therapy for Duchenne muscular dystrophy
The Food and Drug Administration granted conditional approval Thursday to the first gene therapy for…
STAT+: The strategy behind the pharmaceutical industry’s flurry of lawsuits challenging drug pricing reform
WASHINGTON — The pharmaceutical industry has been filing a lawsuit here, there, and pretty much everywhere….
STAT+: Pharmalittle: Europe regulator raised safety signal on Novo drugs; U.S. seeks new trial over royalties on Gilead HIV prevention pills
Top of the morning to you. Gray skies are hovering over the Pharmalot campus right…
STAT+: U.S. seeks a new trial over royalties on Gilead HIV prevention pills
The U.S. government asked a federal judge to overturn a recent case in which a…
STAT+: Doctors’ lobby doubles down on the fight against expanding open access to research
Doctors’ lobbyists in Washington tend to focus their energies on ensuring Medicare pays well, and…
STAT+: European companies outline opposition to proposed overhaul of pharma policy
BRUSSELS — Leaders of European pharmaceutical companies on Wednesday said that a proposed overhaul of…
STAT+: Drug middlemen catch flak at another congressional hearing
Drug middlemen once again were on the hot seat at a congressional hearing on Wednesday….
STAT+: PhRMA sues Biden administration over Medicare drug price negotiation program
WASHINGTON — After losing the drug pricing fight on Capitol Hill, PhRMA is taking its battle…
STAT+: Pharmalittle: Novo Nordisk sues spas, clinics over compounded Wegovy; top lobbyist leaves PhRMA
Hello, everyone, and how are you this fine, sunny morning? The middle of the week…
STAT+: After promising early data, gene therapy trial for Huntington’s takes puzzling turn
Last year, after a string of high-profile trial failures, the Huntington’s disease community got positive…
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STAT+: One of biotech’s biggest financiers launches small-molecule startup, in spite of IRA’s looming shadow
It’s been nearly a year since Congress passed the Inflation Reduction Act, raising a chorus…
STAT+: Top federal lobbyist at PhRMA leaves
WASHINGTON — The top federal lobbyist for the brand drug lobby PhRMA is leaving, two…
STAT+: Exact Sciences touts accuracy of updated Cologuard cancer test, but experts want more data
An updated version of Exact Sciences’ stool-based colorectal cancer screening test detected cancer accurately in…
STAT+: Novo Nordisk sues spas and clinics for selling versions of Wegovy and Ozempic for weight loss
In the latest fracas over obesity drugs, Novo Nordisk filed lawsuits alleging several medical spas,…
STAT+: Pharmalittle: Opaque conflicts permeate prescription drug benefits; Sanofi prevails in Zantac arbitration
Rise and shine, everyone, another busy day is on the way. We can tell by…
STAT+: Eli Lilly to acquire DICE Therapeutics in $2.4 billion deal
Eli Lilly said Tuesday that it will purchase DICE Therapeutics, a small company developing an…
STAT+: ‘It’s beyond unethical’: Opaque conflicts of interest permeate prescription drug benefits
Employers across the country — from big names like Boeing and UPS to local school…
STAT+: How drug pricing reforms are affecting Bayer’s investments
WASHINGTON — Pharma companies have long been warning Democrats’ drug pricing reforms could discourage investment in…
STAT+: The FDA is testing new nutrition labels on the front of food packages
WASHINGTON — The FDA wants to make it easier for consumers to know if the…
STAT+: Pharmalittle: Bristol Myers sues HHS over Medicare drug negotiations; Lilly reports new shortages of Mounjaro diabetes drug
Good morning, everyone, and welcome to another working week, albeit an abbreviated one for many,…
STAT+: Trade group scolds drugmaker for ‘unethical’ attempt to gain info about rival product
In a notable move, a U.K. trade group has rebuked Leo Pharma for a “serious…
STAT+: Pharmalittle: FDA cites another troubled plant at company contributing to cancer drug shortages; USDA to push food producers over antibiotic claims
And so, another working week will soon draw to a close. Not a moment too…
STAT+: USDA to push food producers to substantiate claims that animals are raised without antibiotics
The U.S. Department of Agriculture is launching a program to ensure food producers substantiate claims…
STAT+: Pharmalittle: PBMs are targeted in yet another congressional bill; access to new Alzheimer’s drug may not happen quickly
Rise and shine, another busy day is on the way. However, this is also shaping…
STAT+: Instead of credible data, PDS Biotech delivers ‘results might get better, later’ promises
Tumor response rate is a common way to assess the efficacy of a cancer drug….
Opinion: STAT+: How I’m helping companies think through whether they should cover GLP-1s like Ozempic for employees
We have a knack in the U.S. for blurring behavior and medicine. Look at weight….
STAT+: Federal advisory group rejects proposal to make medical device tracking easier
Every medical device has its own unique code, allowing manufacturers to keep track of their…
STAT+: Health insurance stocks tumble after UnitedHealth says Medicare enrollees are getting more care
A top executive at UnitedHealth Group said Tuesday that the health insurance and services conglomerate…
STAT+: Pharmalittle: A not-so-new Biogen?; ALS Association and 15 chapters part ways over organizational clashes
Rise and shine, everyone. The middle of the week is upon us. Have heart, though….
Muzzled for years, vindicated MIT professor says fraud investigation into his lab did lasting damage
For three years, nine months, and one week, Ram Sasisekharan lived under a gag order….
STAT+: Bitter infighting leads 15 chapters to break away from leading ALS advocacy group
After a bitter dispute, the ALS Association has settled a lawsuit filed by 15 chapters…
STAT+: Biogen’s boardroom scandal saddles CEO with first crisis
This was supposed to be the new Biogen. When Chris Viehbacher, a respected pharmaceutical executive,…
STAT+: Key House Republican escalates rhetoric against PBMs
WASHINGTON — A key House Republican ramped up his criticism of pharmacy benefit managers Tuesday,…
STAT+: Sanders wants NIH to adopt ‘reasonable pricing’ language for drugs that agency research helps develop
In another bid to lower prescription drug prices, U.S. Sen. Bernie Sanders (I-Vt.) issued a…
STAT+: Moving past regulatory obstacles, Protagonist Therapeutics looks to pivotal trial for its rare blood disorder therapy
FRANKFURT, Germany — Protagonist Therapeutics has run into some speed bumps as it’s developed its…
STAT+: Pharmalittle: Exec nominated to Biogen board is mother of outgoing director’s child; telehealth company pauses Wegovy ads amid shortages
Top of the morning to you, and a fine one it is. Sunny skies and…
STAT+: Biotech executive nominated to Biogen board is mother of director’s child, records show
Biogen, a biotech giant plagued by years of boardroom strife, said late Monday that the…
STAT+: Transplant patients say new Medicare guidance puts their donated organs at risk
Margaret Gamble was supposed to receive a blood test in the mail in May. It’s…
STAT+: Pharmalittle: U.S. Chamber sues over Medicare price negotiations; FDA seeks new supplier for scarce cancer drug
Good morning, everyone, and welcome to another working week. We hope the weekend respite was…
STAT+: The inside story of how data integrity issues roiled a biotech seen as ‘Moderna 2.0’
In February 2022, Diego Miralles, then-CEO of a buzzy new biotech called Laronde, gathered his…
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STAT+: Novartis to buy Chinook Therapeutics, developer of kidney disease therapies, in $3.2 billion deal
LONDON — Novartis said on Monday it would purchase Chinook Therapeutics for $3.2 billion upfront,…
STAT+: Francis deSouza’s tenure at Illumina is a lesson in how not to handle CEO succession
The sudden resignation of Francis deSouza as the CEO of Illumina Sunday represents anything but…
STAT+: Kura Oncology highlights leukemia remission data as it enrolls larger trial
FRANKFURT — A genetically targeted cancer drug from Kura Oncology has helped put more patients’…
STAT+: Chamber of Commerce tries new legal arguments to challenge Medicare drug-price negotiation
WASHINGTON — The U.S. Chamber of Commerce sued the federal government over its new Medicare drug-price…
STAT+: Drug companies and pharmacies reach $17.3 billion settlement over opioid crisis
Two large drugmakers and two of the biggest pharmacy chains finalized a $17.3 billion deal…
STAT+: ‘Stung’ by Pear’s bankruptcy, a state Medicaid program pauses on digital therapeutics
WASHINGTON — After getting burned by the high-profile implosion of a digital health company, a senior…
STAT+: Trailing other sickle cell drug makers, Editas still sees opportunity for its CRISPR therapy
FRANKFURT — Even as other cutting-edge genetic therapies for sickle cell disease move closer to…
STAT+: Pharmalittle: FDA panel to review Alzheimer’s treatment; FDA advisers back approval of RSV drug for children
And so, another working week will soon draw to a close. Not a moment too…
STAT+: Updated data show long-term benefits of CRISPR treatment for sickle cell, beta thalassemia
FRANKFURT — Updated results released Friday highlighted the lasting benefits of a CRISPR-based medicine for…