STAT+: Feeling remote: Coalition of pharma regulators look to complement on-site inspections beyond Covid
Nearly two years after the Covid-19 pandemic prompted remote inspections of pharmaceutical production plants, an…
Category: Pharmaceuticals
STAT+: Gilead, Bristol jaw over the superiority of rival CAR-T treatments for blood cancer
Competing, bespoke CAR-T cell therapies from Gilead Sciences and Bristol Myers Squibb have each demonstrated…
Opinion: Archaic in-person exam for digital prescribing is holding back health care innovation
At a press conference in 1986, President Ronald Reagan said he felt the nine most…
Virtual care companies rush to ease access to Covid-19 antivirals
As two new antiviral pills for Covid-19 approach emergency authorization, experts are concerned that a…
STAT+: Califf, Biden’s pick to lead FDA, has millions invested in pharma and tech companies
WASHINGTON — Robert Califf, President Biden’s choice to lead the Food and Drug Administration, earned…
STAT+: GlaxoSmithKline’s Emma Walmsley predicts a ‘landmark’ 2022 for the company
Next year will be a “landmark” one for GlaxoSmithKline, according to CEO Emma Walmsley —…
STAT+: A lack of access: Pharma is failing to ensure new antibiotics will be available to poor countries, analysis finds
Although the pharmaceutical industry is making modest progress in countering resistance to superbugs, drug companies…
STAT+: ‘Where’s my prescription?’: California wants to revoke an OptumRx pharmacy license for prescribing lapses
The California Board of Pharmacy is seeking to revoke or suspend a pharmacy license held…
Pfizer to file for emergency authorization for its Covid-19 pill
In an anticipated move, Pfizer (PFE) CEO Albert Bourla said the company plans ask the…
STAT+: Like Merck, Pfizer strikes a licensing deal with the Medicines Patent Pool for a Covid-19 pill
Amid considerable anticipation over its Covid-19 pill, Pfizer (PFE) reached a licensing agreement with the…
8 lingering questions about the new Covid pills from Merck and Pfizer
The past two months have brought extremely good news in the fight against Covid-19. Two…
Opinion: The hurried push by Congress to address drug costs shouldn’t undermine the vast savings from generics and biosimilars
Americans rightfully expect Congress to address the ever-increasing prices of brand-name prescription drugs. But the…
Merck’s Covid-19 antiviral pill receives first authorization in U.K.
LONDON — Britain granted conditional authorization on Thursday to the first pill shown to successfully…
STAT+: CAR-T therapies from Bristol, Gilead superior to standard treatment in blood cancer, studies show
Administering bespoke CAR-T cell therapies from Bristol Myers Squibb or Gilead Sciences provides greater benefit…
STAT+: Alzheimer’s conference preview: Aduhelm debate persists, while field grapples with new targets and directions
When physicians and scientists involved in Alzheimer’s disease gather in Boston next week for an…
Opinion: Listen: An antibiotic expert on her body’s stinging betrayal
Natalie Ma knows a lot about antibiotics. She’s familiar with the consequences of antibiotic resistance…
STAT+: Could Robert Califf’s ties to tech complicate his FDA nomination?
WASHINGTON — Robert Califf spent his first confirmation hearing explaining his entanglements with the drug…
STAT+: Pharmalittle: Pelosi tries last-ditch drug pricing proposal; Merck sees up to $7B in Covid pill sales in 2022
And so, another working week will soon draw to a close. Not a moment too…
Which drug maker spent the most on lobbying this summer? The answer will surprise you
You’re reading the web edition of D.C. Diagnosis, STAT’s weekly newsletter about the politics and…
STAT+: Pharmalittle: FDA panel to review Pfizer Covid shot for kids; Novartis may sell or spin off its Sandoz generic unit
Good morning, everyone, and how are you today? A spot of rain, and then some,…
STAT+: ‘For good rather than evil’: Mark Cuban and an employer’s coalition to launch new PBMs to lower drug costs
As Americans grapple with prescription drug costs, two new companies are being launched in hopes…
STAT+: Pharmalittle: Four Democratic senators may delay Medicare drug price reform; Western Covid vaccine stockpiles to hit 600M doses by year’s end
And so, another working week will soon draw to a close. Not a moment too…
STAT+: Pharmalittle: Power for Medicare to negotiate drug prices grows less likely; FDA OKs mix-and-match Covid booster shots
Top of the morning to you. And a fine one it is. Crystal clear blue…
STAT+: A disrupting force, or ‘just another mail order pharmacy’? How Amazon Pharmacy stacks up a year after launching
It was the launch that sent pharmacy stocks into a tailspin. Within hours of Amazon…
STAT+: Pharmalittle: WHO hopes to buy Covid treatments for $10 a course; Sinema is a big obstacle to drug pricing reform
Rise and shine, another busy day is on the way. However, this is also shaping…
STAT+: Pfizer will use a warranty to refund the cost of a lung cancer drug if it doesn’t work
In an unusual bid to address prescription drug costs, Pfizer (PFE) is promising to offer…
Watch: Merck’s Covid pill could transform treatment. Here’s how it works
Earlier this month, study results showed that molnupiravir, Merck’s investigational antiviral pill, cut hospitalization rates…
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Two scientists win chemistry Nobel for discovering a new way to construct molecules, speeding up drug development
Scientists Benjamin List and David MacMillan won the Nobel Prize in chemistry Wednesday for discovering…
What we know — and don’t know — about Merck’s new Covid-19 pill
The announcement that a pill from Merck and partner Ridgeback Biotherapeutics kept Covid patients out…
Opinion: FDA’s naming rule for biosimilars has undermined Congress and health care
I recently tried to order white blood cell growth factor (pegfilgrastim) biosimilar for one of…
STAT+: The biotech scorecard for the fourth quarter: 19 stock-moving events to watch
The year is almost over! Here is STAT’s biotech scorecard, our regular ledger of stock-moving…
STAT+: Pfizer loses a lawsuit alleging the U.S. illegally limits use of patient copay assistance programs
In a setback to the pharmaceutical industry, a federal judge ruled that programs Pfizer (PFE)…
For the first time, WHO committee recommends action on high-priced essential medicines
For the first time, a World Health Organization committee has recommended the global agency form…
STAT+: Inflation and rebates caused wholesale prices on medicines to drop in second quarter
Amid continued political pressure on the pharmaceutical industry, a new analysis finds brand-name drug makers…
Opinion: Even me-too drugs matter when it comes to new medicines
As the government wrestles with lowering health care costs, one strategy gaining momentum is allowing…
STAT+: Defense Department watchdog criticizes oversight of military’s pharmaceutical supply chain
Amid mounting concerns over the U.S. pharmaceutical supply chain, a Department of Defense watchdog found…
STAT+: Compound pharmacies win court battle over an FDA plan for monitoring shipments
A U.S. federal court judge has ruled that an effort by the Food and Drug…
STAT+: Pharmalittle: J&J says its Covid-19 shot is more effective in two doses; India plans to resume Covid-19 vaccine exports
Top of the morning to you, and a fine one it is. Sunny skies and…
STAT+: Former Mylan IT exec pleads guilty to insider trading on earnings, drug approvals, and merger
A former Mylan information technology executive pleaded guilty to an insider trading scheme in which…
STAT+: Pharmalittle: FDA scientists skeptical on boosters; moderate Democrats sink Pelosi’s drug pricing proposal
Good morning, all, I hope everyone is off to a good start. Ed is out…
STAT+: After a court let them off the hook, generic Zantac makers plan to seek legal expenses from consumers
A few months ago, a federal court judge dismissed all claims against more than a…
STAT+: FDA commissioner, two senators raise concerns about patent abuse by pharmaceutical companies
In a bid to address the high cost of medicines, Food and Drug Administration Commissioner…
STAT+: Cancer drug indications remain on labels even after trials fail to confirm their benefits
One-third of the uses for cancer drugs granted speedy approvals remained on product labeling even…
Opinion: Outdated rule increases Medicare’s costs for generic drugs by $26 billion a year
Public outcry about the shockingly high cost of brand-name drugs and a demand for new…
STAT+: Older job seekers claim that Lilly favors millennials when it comes to hiring sales reps
In order to win the attention of physicians, Eli Lilly (LLY) has deliberately sought to…
STAT+: ‘A step in the right direction for national security’: An antibiotic plant reopens in Tennessee to make penicillin
Amid a push to bolster antibiotic manufacturing in the U.S., a facility that closed last…
STAT+: FDA, drug makers propose new pilots aimed at speeding rare disease drugs, as part of user fee update
WASHINGTON — The Food and Drug Administration and the drug industry have jointly agreed to…
STAT+: After company protest, FDA agrees to review controversial drug to prevent premature birth
In an unexpected turn of events, the Food and Drug Administration will hold a hearing…
Opinion: Waiving intellectual property rights would compromise global vaccination efforts
The resurgence of Covid-19 cases in the United States and around the world, in large…
STAT+: As use of widely prescribed stimulants increases, experts see troubling parallels to opioid crisis
A new study found that the number of adults who used two widely prescribed stimulants…