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,…
Category: biotechnology
STAT+: Alzheimer’s scientists critique Cassava Sciences’ study results — overblown, inappropriate, uninterpretable
Independent researchers are expressing doubts about the purported benefits of an experimental treatment for Alzheimer’s…
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…
Listen: Breakthrough infections, the power of lobbying, & pharma’s cinematic villainy
Did we take off our masks too soon? Can Democrats pass a drug pricing bill?…
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+: 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…
STAT+: Kadmon wins approval for drug to treat chronic graft-versus-host disease
Kadmon Pharmaceuticals won approval from the Food and Drug Administration on Friday to market a…
Messenger RNA vaccine pioneer Katalin Karikó shares her long journey to Covid-19 vaccines
In the span of the Covid-19 pandemic, and thanks to the success of two of…
STAT+: Expert panel votes down Fibrogen’s anemia pill due to safety risks, making U.S. approval unlikely
A panel of outside experts convened by the Food and Drug Administration concluded Thursday that…
STAT+: The ins and outs of the rare, controversial way Medicare might pay for Biogen’s new Alzheimer’s drug
WASHINGTON — The Food and Drug Administration last month foisted a nearly impossible decision on…
FDA chief Janet Woodcock acknowledges agency may have misstepped in process leading up to Alzheimer’s drug approval
WASHINGTON — Acting Food and Drug Administration Commissioner Janet Woodcock acknowledged on Wednesday her agency…
STAT+: If everyone already knows about a new biotech startup, why does it ‘launch’?
Biotech companies often linger in a corporate version of Schrödinger’s box — of existence and…
STAT+: Medicare starts process that could limit access to Biogen’s new Alzheimer’s drug
WASHINGTON — Federal officials on Monday announced the agency will start a process that could…
FDA calls for federal investigation into its controversial Alzheimer’s drug approval
The head of the Food and Drug Administration has called for a wide-ranging federal investigation…
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STAT+: FDA, under fire from critics, revises prescribing information for Biogen’s Alzheimer’s drug
The Food and Drug Administration on Thursday changed the prescribing label for Biogen’s Alzheimer’s treatment…
STAT+: The failure of a cancer drug study leaves Cel-Sci on the brink of collapse
The failure of Cel-Sci’s immunotherapy treatment called Multikine to prolong the survival of patients with…
STAT+: Is the Alzheimer’s Association really pushing Biogen to lower its new drug’s price — or is it lip service?
WASHINGTON — The Alzheimer’s Association stunned Washington last month when it urged Biogen to lower…
Listen: A CRISPR milestone, Biogen’s FDA saga, & George Yancopoulos on biotech in 2021
How much can CRISPR really do? Has the FDA been totally honest? And is it…
STAT+: The biotech scorecard for the third quarter: 12 stock-moving events to watch
Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the third…
Calls grow for an investigation into FDA approval of Biogen’s Alzheimer’s drug
WASHINGTON — Former health secretary Donna Shalala called for a federal investigation into the Food…
STAT+: STAT+ Conversations: A conversation about in vivo gene editing to treat rare disease
Editors note: A livestream of the conversation will be embedded below at 1 p.m. ET….
STAT+: Inside ‘Project Onyx’: How Biogen used an FDA back channel to win approval of its polarizing Alzheimer’s drug
It was perhaps the most contentious drug approval in decades, shocking drug company executives, insurance…
STAT+: In a first for genome editing, Intellia Therapeutics reports positive early data on in vivo CRISPR therapy
In a major milestone for the still-young field of genome editing, Intellia Therapeutics said Saturday that…
Listen: FDA inner workings, GSK’s foggy future, & the alarming rise in colorectal cancer
How does the FDA handle unprecedented decisions? What’s it like to go on “Good Morning…
STAT+: In reversal, Eli Lilly now intends to seek fast approval for Alzheimer’s treatment
Eli Lilly said Thursday that it will seek a fast U.S. approval for its drug…
STAT+: FDA’s Woodcock is just ‘not that concerned’ about the criticism over Biogen’s Alzheimer’s drug, Aduhelm
WASHINGTON — The Food and Drug Administration has been without a permanent commissioner for six…
STAT+: Bipartisan pair of senators calls on Congress to examine expensive new Alzheimer’s drug
WASHINGTON — Sens. Elizabeth Warren (D-Mass.) and Bill Cassidy (R-La.) want Congress to take a…
STAT+: Arcus’ anti-TIGIT immunotherapy shows ‘encouraging’ tumor response, but likely leaves investors wanting more
Arcus Biosciences said Wednesday that a two-drug combination that includes an anti-TIGIT antibody delivered “encouraging…
Newly disclosed FDA documents reveal agency’s unprecedented path to approving Aduhelm
Chastened after a decisively negative review from outside advisers, the Food and Drug Administration convened…
STAT+: Key science officials detail their plans for a new research agency — and Congress is getting closer to funding it
WASHINGTON — Two key federal health officials are pitching a new branch of the National…
STAT+: Powerful Democrat’s new drug pricing manifesto hints at a carveout for small biotechs
WASHINGTON — Sen. Ron Wyden (D-Ore.), the influential chair of the Senate Finance Committee, is…
STAT+: Athira Pharma CEO placed on leave amid allegations of altered images in her research papers
The chief executive of Athira Pharma, a biotech developing treatments for Alzheimer’s and other neurodegenerative…
Listen: The Covid vaccine booster debate, 23andMe hits Wall Street, & biotech’s call of the decade
Is 23andMe a tech company? Do we really need booster shots of Covid-19 vaccines? And…
Virtual Event: Biotech: Where are we now?
Editor’s note: A livestream of the event will be embedded below at 1 p.m. ET….
STAT+: Sage antidepressant achieves goals of large study, but questions about benefit linger
Sage Therapeutics said Tuesday that an experimental pill designed to alleviate depression with a two-week…
STAT+: Scientists CRISPR patients’ own immune cells in bid to shrink hard-to-treat GI tumors
Last year, researchers at the University of Pennsylvania, led by immunotherapy pioneer Carl June, showed…
STAT+: GSK pays up big for rights to TIGIT-targeted cancer immunotherapy from Iteos
Iteos Therapeutics said Monday that it has sold ownership rights to an experimental anti-TIGIT cancer…
‘I’m just winging it’: Faced with confusing data on the new Alzheimer’s drug, doctors scramble to advise their patients
Their phones are ringing off the hook and their email inboxes are filling up with…
STAT+: A CRISPR treatment for blood diseases shows curative promise in small study
Twenty-two patients with inherited blood disorders were free of severe pain and the need for…
Listen: Every angle on the FDA’s polarizing approval of Biogen’s Alzheimer’s drug
Was the FDA right to approve Aduhelm? What’s a fair price for a debatable drug?…
STAT+: Vertex shelves second drug for inherited lung disease, raising concerns about future growth
Vertex Pharmaceuticals said Thursday that an experimental protein “corrector” drug — the highest-priority medicine in…
STAT+: In potential big step forward for CAR-T, Bristol Myers says its therapy outperformed stem cell transplant in blood cancer
The treatment known as CAR-T, in which white blood cells are genetically modified to attack…
Watch: SPACs are all the rage, but what are they? STAT explains
Wall Street’s hottest new trend is a 1980s retread: Private firms are merging with so-called…
STAT+: Biogen, FDA at odds over timing of crucial confirmatory trial of Alzheimer’s drug
Biogen and the Food and Drug Administration are at odds over the timing of a…
STAT+: Biogen isn’t worried about backlash to ‘bewildering’ price of Alzheimer’s drug
Amid a firestorm of controversy around its decision to charge $56,000 a year for an…
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Elation, pride, and a slew of questions: Clinical trial participants reflect on their own complicated reactions to Aduhelm approval
For the roughly 3,500 people who volunteered as clinical trial participants for the Alzheimer’s therapy…
STAT+: Biogen’s big day is a Wall Street windfall for biotechs in Alzheimer’s
As Biogen soared Monday on the surprise Food and Drug Administration approval of its hotly…
An extra twist in the FDA’s Alzheimer’s decision: no limits on which patients can get the drug
As if the saga of aducanumab needed another twist, the Food and Drug Administration tossed…
STAT+: ‘The price is bewildering’:The price of Biogen’s Alzheimer’s drug may lead payers to erect roadblocks
The Food and Drug Administration’s approval on Monday of an Alzheimer’s drug developed by Biogen…
STAT+: Why Biogen may be sitting on the most lucrative product in pharmaceutical history
Biogen’s quest to win approval for a new Alzheimer’s disease treatment once seemed futile. Now…