Listen: The latest mask debate, FDA in limbo, & gene therapy’s uncertain upside
When can we stop wearing masks outside? Are we ever getting a permanent FDA commissioner?…
Category: biotechnology
STAT+: Bluebird’s withdrawal of therapy from Germany could chill talks over gene therapy prices across Europe
When Bluebird Bio secured European approval for its gene therapy to treat beta thalassemia in…
STAT+: Genetically targeted drug from Syndax Pharma shows remissions in leukemia patients
Syndax Pharmaceuticals said Tuesday that its genetically targeted cancer drug induced complete remissions in patients…
STAT+: Adagio raises $336 million to advance Covid-19 antibody treatment
Waltham-based Adagio Therapeutics announced on Monday that it has raised $336 million in new funding…
Opinion: STAT+: Developers of microbiome-based drugs face challenges. There are ways to overcome them
Manipulating the human microbiome appears to be an effective approach for treating a range of…
Listen: J&J’s vaccine pause, how to talk about remote risks, & why we don’t have new drugs for Covid-19
How do you describe a one-in-a-million risk? What’s heparin-induced thrombocytopenia? And why’s it so hard…
STAT+: Thermo Fisher buys contract-research company PPD for $17.4 billion
Thermo Fisher Scientific announced Thursday that it will buy PPD, a contract-research company for the…
FDA wants more data on promising ALS drug, frustrating patients seeking faster access
People living with amyotrophic lateral sclerosis, or ALS, in the U.S. will have to wait…
STAT+: Tango Therapeutics to go public in $353 million SPAC deal
Cambridge biotech Tango Therapeutics is going public through a $353 million deal with a special…
STAT+: STAT+ Conversations: A conversation on the latest in neuroscience and CNS drug development
Editors note: A livestream of the conversation will be embedded below at 1 p.m. ET….
STAT+: Cavazzoni to take over influential spot atop FDA drug center
WASHINGTON — Patrizia Cavazzoni has been named the permanent leader of the FDA’s Center for…
STAT+: Sage drug reduces muscle tremor but with significant side effects, study results show
Sage Therapeutics said Monday that its experimental pill was more effective than a placebo in…
Regeneron says antibody cocktail prevented Covid when given as simple injection, not an IV
Regeneron Pharmaceuticals said Monday that a single shot of its monoclonal antibody cocktail reduced the…
STAT+: Lilly’s Retevmo shows success in rare tumors. But can doctors identify the patients who would be helped?
Retevmo, a drug developed by Eli Lilly’s Loxo Oncology unit, shows efficacy in tumors beyond…
STAT+: iTeos Therapeutics debuts first data on TIGIT-targeting cancer immunotherapy
ITeos Therapeutics offered the first look at clinical data for its experimental cancer antibody that…
STAT+: Revolution Medicines seeks to bolster case for its lead cancer drug
Revolution Medicines on Saturday presented updated data to bolster the case for its lead cancer…
STAT+: Researchers see a ‘tractable approach’ to taming chromosomal metastasis
The latest hope for stopping untreatable cancers traces its roots to a turn-of-the-century German zoologist,…
STAT+: Natural killer cells, primed with an antibody, induce remissions in patients with advanced blood cancer
Two patients with advanced Hodgkin lymphoma were told their tumors were so resistant to treatment…
AstraZeneca’s latest vaccine woes, the compassionate use dilemma, & what it’s like to give out Covid vaccines
What’s next for AstraZeneca? Are there any right answers when it comes to compassionate use?…
‘As good a model as I’ve seen’: MIT biologist on new initiative to address gender inequities in biotech
When Nancy Hopkins joined the faculty of the Massachusetts Institute of Technology nearly 50 years…
STAT+: Biotech venture capitalists have more money than ever to invest. What could possibly go wrong?
There’s more money sloshing around in biotech than ever before. Over the past year, several…
STAT+: Fibrogen admits false heart-safety data for experimental anemia pill shared with FDA, investors
Fibrogen acknowledged Tuesday that the company has been touting false heart-safety data for its experimental…
STAT+: MIT scientists launch Future Founders Initiative to solve biotech’s ‘missing women’ problem
A group of prominent MIT scientists that formed to address gender inequities in the biotech…
STAT+: FDA cites lack of evidence in rejecting Acadia Pharma’s bid to expand use of anti-psychosis drug
Acadia Pharmaceuticals said Monday that U.S. regulators had rejected its application seeking to expand the…
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An antitrust expert weighs in on the FTC’s complaint against Illumina
Spare a thought for Illumina. The $56 billion dollar titan of genomics has become the…
STAT+: Data for Delcath’s liver tumor device are positive, but lingering questions cloud path to approval
Delcath Systems said Wednesday that its liver-tumor treatment device achieved the primary goal of a…
STAT+: The biotech scorecard for the second quarter: 18 stock-moving events to watch
Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the second…
STAT+: STAT+ Conversations: A conversation on the future of gene therapy
Editors note: A livestream of the conversation will be embedded below at 1 p.m. ET….
A CRISPR 2.0 pioneer, expecting credit on its own invention, is ruffled by a competitor
Last week, the genome-editing scientists behind base editing, a technology dubbed CRISPR 2.0, gathered for…
STAT+: Humanigen says it drug keeps Covid patients off ventilators. But are some data missing?
A small biotech firm, Humanigen, said Monday that its experimental drug reduced the risk of…
STAT+: Uniqure investigation clears hemophilia B gene therapy as cause of patient’s liver cancer
Uniqure, the Dutch gene therapy company, said Monday that its one-time treatment for hemophilia B…
STAT+: The future of cancer immunotherapy: your questions, answered
Last week, I hosted an hourlong webinar on future directions for cancer immunotherapy. I focused…
STAT+: FDA approves first personalized cell therapy for patients with multiple myeloma
The Food and Drug Administration on Friday approved the first personalized cell therapy to treat…
STAT+: FDA panel says risks of Pfizer pain drug outweigh the benefits
A panel of expert advisers to the Food and Drug Administration on Thursday concluded that…
STAT+: Broad Institute launches $300 million effort to harness AI to fight diseases
The Broad Institute of MIT and Harvard is launching a new, $300 million initiative that…
STAT+: A ‘conditional’ EUA for a CytoDyn Covid treatment? FDA says no such thing exists
Speaking Monday night to investors on a conference call, CytoDyn CEO Nader Pourhassan said the…
STAT Webinar: Future directions for cancer immunotherapy
Drugs that harness the body’s immune system to find and kill cancer cells have improved…
Opinion: STAT+: A Biden-Harris Biomanufacturing Initiative could increase supplies of vaccines, therapeutics in one fell swoop
The coronavirus pandemic is generating pressure on the manufacturing of vaccines and therapeutics. Every day…
STAT+: Microbiome company Finch Therapeutics begins trading publicly, quietly shuffles one of its executives
Microbiome company Finch Therapeutics is, officially, worth about $960 million. Shares in the company began…
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SEC charges co-founders of shuttered microbiome startup uBiome with $60 million fraud
Federal authorities on Thursday charged two co-founders of uBiome, a microbiome startup that rose to…
Listen: Europe’s vaccine safety scare, Lilly’s Alzheimer’s data, & a plea for transparency
Has Europe lost the plot with Covid-19 vaccines? Can the latest treatment for Alzheimer’s disease…
STAT+: Translate Bio suffers a setback with mRNA-based treatment for cystic fibrosis
An inhaled mRNA-based treatment for patients with cystic fibrosis from Translate Bio failed to produce meaningful…
STAT+: In restarted study, Solid Bio reports no serious toxicity in Duchenne patient given ‘safer’ gene therapy
Solid Biosciences said Monday that it has restarted a clinical trial involving its experimental gene…
STAT+: A Rubius drug derived from red blood cells produces anti-tumor responses — and more questions
Two patients with cancer showed partial tumor shrinkage after infusions of a novel immune-boosting treatment…
STAT+: A deep dive into Eli Lilly’s tantalizing Alzheimer’s drug data
Here is some analysis and perspective, not to mention a few burning questions, about the…
STAT+: Eli Lilly releases detailed results on Alzheimer’s drug, as data divide researchers
Eli Lilly’s experimental Alzheimer’s medicine donanemab showed some of the best early results seen by…
STAT+: Bluebird says its gene therapy was ‘very unlikely’ to be cause of patient’s cancer
Bluebird Bio said Wednesday that it was “very unlikely” that its experimental gene therapy for…
STAT+: As Takeda buys Maverick for up to $525 million, R&D chief promises an ‘inflection year’
Takeda on Tuesday announced that it is buying Maverick Therapeutics for as much as $525…
STAT+: Is a leaderless FDA clamping down on drug reviews? Not knowing is weighing heavy on biotech
Seemingly overnight, the Food and Drug Administration appears to be taking a more risk-averse stance…
STAT+: With data on a cancer drug derived from red blood cells looming, Rubius Therapeutics seeks to shed its bumbling image
Rubius Therapeutics is the can’t-do-anything-right biotech spinout from the high-profile venture capital firm Flagship Pioneering….