STAT+: By approving Biogen’s Alzheimer’s drug, the FDA is shifting its rules. That is a giant risk
In order to approve a new Alzheimer’s treatment, the Food and Drug Administration is rewriting…
Category: biotechnology
FAQs: What you need to know about the Alzheimer’s drug Aduhelm
The Food and Drug Administration on Monday approved Biogen’s new Alzheimer’s drug, a decision with…
FDA grants historic approval to Alzheimer’s drug designed to slow cognitive decline
The Food and Drug Administration on Monday approved the first new treatment for Alzheimer’s disease…
Will you accept this capital investment? Biotech and health startups bet on a strange new reality show for crowdfunding
“Mount up! Let’s hear more about this unicorn.” So begins every episode of a new…
STAT+: Fate Therapeutics’ natural killer cells induce responses in blood cancer patients, but for how long?
Fate Therapeutics said Friday that an experimental, off-the-shelf immunotherapy made from so-called natural killer cells…
A landmark Alzheimer’s drug approval would likely deepen racial inequities in dementia care
Come Monday, we should learn whether the Food and Drug Administration will approve the first…
Listen: Fauci’s emails, FDA kremlinology, & covering the CRISPR babies scandal
Who is Anthony Fauci emailing at 3 a.m.? Does the FDA leave legible tea leaves?…
STAT+: German drug maker Morphosys to buy Constellation Pharma in $1.7 billion deal
German drugmaker MorphoSys said Wednesday that it will acquire Constellation Pharmaceuticals for $1.7 billion to…
STAT+: STAT+ Conversations: A look ahead to ASCO 2021
Editor’s note: A livestream of this conversation will be embedded below at 1 p.m. ET….
STAT+: Amgen wins FDA approval for first KRAS-blocking lung cancer drug
The Food and Drug Administration on Friday approved the first drug that benefits patients with…
Scientific panel loosens ’14-day rule’ limiting how long human embryos can be grown in the lab
An influential scientific panel cracked open the door on Wednesday to growing human embryos in…
Opinion: Use single-cell biology to shed light on pediatric diseases currently in the dark
There are few things harder for a physician to say to a patient than “I…
STAT+: Freenome, high-profile liquid biopsy company, quietly replaces its CEO
Freenome, a high-profile startup that aims to develop a blood test to detect colon cancer,…
Opinion: To help solve climate change, look to the biosciences
President Biden’s pledge to cut U.S. greenhouse gas emissions in half by 2030 is an…
Listen: Biotech meme stocks, the lessons of Spanish Flu, & becoming a pandemic celebrity
How do pandemics end? Who gets to be a TV media expert? And where does…
California could become first state to mandate biosecurity screening by mail-order DNA companies
California lawmakers on Thursday will vote on a bill that would require the state’s growing…
STAT+: Allogene’s blood cancer data show durability of off-the-shelf CAR-T cells
There’s little disputing that an off-the-shelf CAR-T cell therapy for cancer would provide flexibility and…
STAT+: With new data, J&J’s CAR-T drug benefits myeloma patients with less advanced disease
When doctors prescribe a personalized cell therapy today, the patient they’re trying to help has…
STAT+: In a step forward for immunotherapy, new Bristol Myers drug slows melanoma in study
An experimental immunotherapy developed by Bristol Myers Squibb prevented metastatic melanoma from worsening when added…
STAT+: Merus drug shows potential as treatment for rare type of pancreatic cancer
A drug from the Dutch biotech Merus designed to disrupt a rare genetic alteration is…
STAT+: Iovance CEO abruptly resigns after FDA setback for its cancer cell therapy
Hours after the biotech company Iovance announced yet another regulatory delay for its investigational cancer…
STAT+: Atlas Venture launches another biotech to tackle vision loss
Call it “Quest for Sight: The Sequel.” In September, the Swiss drug giant Novartis paid…
STAT+: FDA issues major rebuke to CytoDyn over claims on Covid-19 drug
The Food and Drug Administration on Monday took the extraordinary step of issuing a lengthy…
STAT+: Cel-Sci CEO spoke privately with investors last week, raising doubts about long-delayed cancer drug
Cel-Sci CEO Geert Kersten spoke privately with investors last week as part of a “non-deal…
At Illumina, the ‘era of the genome’ has arrived. But what role will the company play?
For Francis deSouza, the CEO of DNA sequencer manufacturer Illumina, the hardest moments of the…
STAT+: Abandoned Trump order on the bioeconomy highlights a path forward for Biden — but with mixed reviews
WASHINGTON — The Trump administration came remarkably close to shoring up the scattershot way the…
STAT+: Fibrogen’s data manipulation scandal came with questions. There need to be answers
Fibrogen is reeling from the worst case of data manipulation in years, but six weeks…
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STAT+: Ginkgo plans a $17.5 billion merger with SPAC that took DraftKings public
Ginkgo Bioworks, one of the hottest biotech startups in Massachusetts, said Tuesday that it plans…
Reawakened immune cells show promise in mice against zombie cells tied to diseases of aging
Scientists have started to test whether natural killer, or NK, cells can be trained to…
STAT+: Flagship startup Laronde hopes to use ‘endless RNA’ to produce new treatments
In 2017, scientists at Flagship Pioneering were exploring different kinds of ribonucleic acid, or RNA,…
STAT+: Moderna’s CEO says he ‘didn’t lose a minute of sleep’ over potential waiver of vaccine patents
Moderna chief executive Stephane Bancel on Thursday shrugged off the Biden administration’s support for suspending…
STAT+: Two drug makers, two commercial launches — with divergent results
Biocryst Pharma did it. Aurinia Pharma did not. The “it” is a successful, commercial drug…
STAT+: CRISPR Therapeutics, Nkarta to jointly develop engineered natural killer cells as cancer treatments
Off-the-shelf treatments for cancer made from genetically engineered T cells and natural killer, or NK,…
STAT+: Dyno raises $100 million to bring artificial intelligence to gene therapy
Dyno Therapeutics, a Cambridge biotech that uses artificial intelligence techniques to develop gene therapies, said…
STAT+: ‘In their own bubble’: How a cancer center promoted an exclusive experimental drug to attract patients
A new medication for children with a rare and life-threatening cancer called neuroblastoma had a…
STAT+: The long wait for Cel-Sci to finally admit its cancer drug doesn’t work
Eventually, Cel-Sci will have to disclose the results of its Phase 3 cancer clinical trial….
STAT+: Roger Perlmutter, former Merck R&D head, becomes CEO of super-microscopy startup
Roger Perlmutter, previously the head of research at Merck, said Wednesday he will become the…
STAT+: Roivant Sciences to go public through $7.3 billion SPAC deal
Roivant Sciences, the biotech company once pitched as a Berkshire Hathaway for the pharmaceutical industry,…
STAT+: Sarepta’s more potent Duchenne treatment shows promise, greater toxicity, in small study
Sarepta Therapeutics said Monday that a second-generation medicine for patients with a certain type of…
STAT+: Amgen’s KRAS cancer drug had a bad week, but worry about pricing, not safety
Investors do not like surprises with negative overtones, so they reacted badly when Amgen announced…
STAT+: Eli Broad, whose gift established a science powerhouse, dies at 87
Eli Broad, the billionaire entrepreneur whose philanthropy enabled the creation of the Broad Institute of…
STAT+: U.S. government has invested $6 billion in Moderna’s Covid-19 vaccine
The federal government has now invested about $6 billion in the Covid-19 vaccine from Moderna,…
STAT+: Trillium moves ‘don’t eat me’ cancer drug into new studies, but future clouded by modest tumor responses
Trillium Therapeutics on Wednesday is announcing an expanded slate of clinical trials meant to advance…
STAT+: How one major distributor is prioritizing scarce pipette tips
Scientists across the spectrum — at universities, at public health labs, at biotechs — are…
How blackouts, fires, and a pandemic are driving shortages of pipette tips — and hobbling science
The humble pipette tip is tiny, cheap, and utterly essential to science. It powers research…
STAT+: Flagship-backed fertility company Ohana Biosciences shutters, lays off most employees
Flagship Pioneering-backed fertility company Ohana Biosciences is winding down. Employees were told Tuesday during an…
STAT+: Eli Lilly’s earnings fall short after stock’s dramatic run
Eli Lilly posted earnings Tuesday that surprised and disappointed investors, as both sales and profit…
Opinion: STAT+: More pharma companies should make the move toward B Corps sustainability
The gradual global shift towards sustainability, with an increased focus on climate change and environmental…
STAT+: The field is exploding, but microbiome therapeutics still face a wave of challenges
Even as drug makers are poised to introduce actual medicines to change a person’s microbiome…
STAT+: New data point to benefits of Bristol’s novel psoriasis pill, but safety issues will be scrutinized
Last November and then again in February, Bristol Myers Squibb said its oral drug designed…