STAT+: Older Americans bore the brunt of antibiotic-resistant infections, study finds
Older Americans were disproportionately affected by several different types of infection for which antibiotics were…
Category: drug development
STAT+: Northwest Bio marks ignominious anniversary of brain tumor study delay with silence
Northwest Biotherapeutics has buried data from its completed brain cancer clinical trial for so long…
STAT+: Vedanta touts positive new data for its C. diff microbiome therapeutic — but is it too late?
Vedanta Biosciences is touting positive new Phase 2 results for a microbe-based treatment for C….
Opinion: A likely new treatment for Covid-19 was made possible by government-funded innovation
Last week, Merck and Ridgeback Biotherapeutics announced Phase 3 results of molnupiravir, an oral antiviral…
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…
Virtual Event: The evolving landscape for biosimilars
Editor’s note: A livestream of the event will be embedded below at 1 p.m. ET….
Opinion: Repurposing drugs can speed new treatments for Covid-19
As the summer of 2021 started to unfold, many Americans thought the pandemic was beginning…
STAT+: FDA tells drug makers to redo studies run by two contract research firms due to data integrity issues
In a rare move, the U.S. Food and Drug Administration has notified an untold number…
STAT+: STAT+ Conversation: Selling Cellarity
Editor’s note: A livestream of the conversation will be embedded below at 1 p.m. ET….
STAT+: Is a Beyondspring drug helping lung cancer patients live longer? Study results trigger debate
Beyondspring’s stock price tripled in August after the New York drug maker said its experimental…
Opinion: Congress is about to legislate a future without new medicines. We have a better plan
One of the fundamental principles on which the U.S. economy is based is that the…
Opinion: Aduhelm backlash threatens to reverse progress in FDA’s reviews of rare and ultra-rare disease drugs
The FDA’s approval of Aduhelm to treat Alzheimer’s disease has unleashed criticism about the decision…
STAT+: In new remarks, Cassava Sciences’ CEO shifts defense of embattled treatment for Alzheimer’s
Cassava Sciences CEO Remi Barbier on Monday shifted his defense of the company’s embattled treatment…
.jpg)
STAT+: After a decade at Facebook and Google, a tech exec tries his hand at drug development
After building Facebook’s search bar into a pivotal part of its platform, Tom Stocky is…
STAT+: Biogen trials for Alzheimer’s drug excluded much of the targeted patient pool, study finds
A new analysis finds that the clinical trials conducted by Biogen (BIIB) for its controversial…
STAT+: The future of Apellis Pharma’s eye disease treatment is clouded by divergent study results
Apellis Pharmaceuticals has a good news-bad news problem involving its experimental treatment for geographic atrophy…
In the hunt for novel antibiotics, will new technology overtake underwater exploration?
LAKE SUPERIOR — Choppy, windswept waves slap at the hull as our boat nears the…
Opinion: New antivirals are sorely needed. A public-private partnership can get us there
The U.S. government’s announcement that it is investing $3 billion into research on antiviral medicines…
STAT+: Flagship, Orbimed, ARCH, Alta top list of high-performing biotech venture capital firms
Flagship Pioneering is on track to return its investors’ money an eye-popping 15 times over,…
STAT+: Ellis Unger, an outspoken FDA veteran, resigns
WASHINGTON — A top FDA official known for speaking out against controversial drug approval decisions,…
Gene therapy’s next steps
Editor’s note: A livestream of the event will be embedded below at 1 p.m. ET…
Opinion: Congress should fix FDA’s accelerated approval program for the next 30 years
The Food and Drug Administration’s approval of the Alzheimer’s drug Aduhelm has sparked a broader…
STAT+: Veterans Affairs declines to cover Biogen Alzheimer’s drug over effectiveness and safety concerns
The Department of Veterans Affairs has decided not to cover a new Alzheimer’s drug from…
STAT+: ‘Things are so messed up’: Patient access to antibiotics is lacking even in the wealthiest countries
Although 18 innovative antibiotics were approved by regulators in the wealthiest nations over the past…
STAT+: STAT+ Conversation: Blueprint for cancer drugs
Editor’s note: A livestream of the conversation will be embedded below at 1 p.m. ET….
STAT+: Will controversy over new Alzheimer’s drug spell the end for the FDA’s faster approval process?
WASHINGTON — For most of its history, the Food and Drug Administration’s shortcut pathway for…
STAT+: After leaving patients in limbo, Pfizer agrees to sell a discontinued glaucoma drug
After months of controversy, Pfizer (PFE) has reached a deal to sell a decades-old eye…
Billions in new research funding sparks a lobbying frenzy among patient advocates
WASHINGTON — President Biden’s vision for an ambitious new government research center is never quite…
STAT+: Bayer inks a $1.5 billion deal for a biotech with a proprietary drug discovery platform
In a bid to quickly broaden its drug discovery abilities, Bayer (BAYRY) has reached a…
Alzheimer’s patients are in limbo as hospitals, insurers grapple with whether to offer Aduhelm
For all the explosive controversy over the approval of the first treatment for Alzheimer’s disease…
Opinion: STAT+: Stifling biopharma mergers would kill the innovation economy that generates new therapies
The headlines speak of a biotech boom with news of company launches, oversubscribed private financings,…
Retired neurologist with Alzheimer’s knows firsthand the risks of Aduhelm
Daniel Gibbs had received only four monthly doses of Biogen’s experimental Alzheimer’s drug in a…
.jpg)
STAT+: Congress presses the FDA to move faster on ALS drugs
WASHINGTON — Lawmakers pressed a top Food and Drug Administration official Thursday for answers on…
STAT+: New research exploring centenarians’ gut microbiomes reveals a potential clue to their longevity
New research into the microbiomes of centenarians reveals a potential clue to their longevity, adding…
Opinion: With Aduhelm, history can repeat itself by following cancer’s success
The Food and Drug Administration’s approval of Biogen’s Alzheimer’s drug Aduhelm has stirred intense controversy,…
STAT+: Here’s why simply approving Aduhelm can’t guarantee a golden age of Alzheimer’s R&D
Since the controversial approval of the Alzheimer’s drug Aduhelm, both the Food and Drug Administration…
STAT+: Lawmakers ask Defense Department about using a controversial maneuver to lower drug prices
Three years ago, Congress directed the Department of Defense to take steps to lower the…
STAT+: Pharmalittle: Biogen yanks Alzheimer’s paper from JAMA over edits; Pfizer sees $33.5 billion in Covid-19 vax sales
Top of the morning to you, and a fine one, it is. Delicious cool breezes…
STAT+: Animal rights activists get new ammunition in their battle over a controversial rodent test
In what animal rights activists see as a significant development, a pair of U.K. health…
STAT+: Pharmalittle: Pharma lobbies Congress on global tax proposal; the FDA doc at center of Aduhelm controversy
Rise and shine, everyone, another busy day is on the way. We can tell because…
STAT+: Pharmalittle: A race to develop Covid-19 pills is underway; Russian trolls target Pfizer vaccine
Good morning, everyone, and welcome to another working week. We hope the weekend respite was…
STAT+: Microbiome therapy companies face the fallout of failed Seres trial
A frost may be setting in across the microbiome therapeutics space after another clinical trial…
Opinion: Patient advocacy organizations and FDA drug approval: lessons from Aduhelm
In the wake of last month’s controversial Food and Drug Administration approval of Biogen’s Aduhelm,…
STAT+: Seres Therapeutics’ microbiome therapy for ulcerative colitis falls short in Phase 2 trial
Seres Therapeutics’ highly anticipated clinical trial in ulcerative colitis failed to meet its primary endpoint,…
STAT+: Accelerated approval, the path used to greenlight Biogen Alzheimer’s drug, has a checkered track record, critics say
If ever there were a cautionary tale for the Food and Drug Administration’s approval of…
STAT+: Cytokinetics drug improves blood flow in patients with inherited form of heart disease
Cytokinetics said Monday that its experimental drug demonstrated statistically significant improvements in blood flow for…
Too close for comfort: FDA shouldn’t loosen conflict rules for its expert panels
Never mind the conflicts, there are drugs to approve. In a sorry turn of events,…
Extending the reach of gene therapies means hurdling not just scientific barriers but prices, too
While Covid-19 struck a blow to a vast number of clinical trials around the world,…
STAT+: ‘Aduhelm left room’: Lilly CEO eyes competition with Biogen Alzheimer’s drug
Though a rival’s Alzheimer’s drug reached the market first, the CEO of Eli Lilly spoke…
STAT+: FDA extends shelf life for glaucoma drug discontinued by Pfizer, but patients remain concerned
In a bid to calm anxious patients, the Food and Drug Administration has extended the…