Listen: Merck v. USA, the best of ASCO, and Leqembi at the FDA
Are drug prices protected by the Constitution? Will Medicare embrace Alzheimer’s disease treatments? And should…
Category: biotechnology
STAT+: If AI invents a new medicine, who gets the patent?
Pharmaceutical and biotech companies are increasingly using artificial intelligence to discover and make drugs and…
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STAT+: After gene therapy deaths, Astellas brings in potentially safer treatment for muscle disorder
Astellas Pharma said Thursday it will license and develop a new gene therapy for a…
STAT+: ‘We don’t agree’ on drug pricing policy, FDA chief tells biotech leaders
BOSTON — The drug industry has spent the past year speaking against new mechanisms that…
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STAT+: While other states, countries have biotech envy, Massachusetts can’t find enough workers
While other states and nations came to the global BIO 2023 convention in Boston this…
STAT+: ASCO showcased the payoff for new cancer medicines: longer lives
CHICAGO — Well, that’s a wrap. The biggest meeting in cancer research — and, really,…
STAT+: Biotech’s trade secrets face growing threat from foreign influences, science leaders warn
BOSTON — While most panel discussions at the Biotechnology Innovation Organization’s international convention tend to…
STAT+: Novocure’s electric fields device prolongs survival in lung cancer, but doubts remain
CHICAGO — A medical device made by Novocure that creates electric fields in the lungs…
Academia’s postdoc system is teetering, imperiling efforts to diversify life sciences
For young life scientists hoping to land a prestigious faculty job in academia, postdoctoral research…
STAT+: FDA oncology head wants advisory panels to keep voting on new drugs
CHICAGO — As commissioner of the Food and Drug Administration, Robert Califf has made clear…
STAT+: Ted Love, BIO’s first Black board chair, aims to rehab biotech’s image in Washington
WASHINGTON — Ted Love has pretty much done everything there is to do in biotech. He’s…
STAT+: Gilead’s CAR-T therapy prolongs survival in key blood cancer trial
CHICAGO — Yescarta, the CAR-T therapy made by the Kite unit of Gilead Sciences, prolonged…
STAT+: Bellerophon Therapeutics trial fails despite innovative digital endpoint
In an important reminder that plugging digital tools into a clinical trial will not magically…
Akero’s NASH drug combined with Ozempic cut liver fat in small study
GLP-1s, a class of drugs including Ozempic and Wegovy that have become widely popular for…
STAT+: Keytruda’s benefits, a breast cancer win, the ‘dom-zim doublet’: Weekend wrap-up from ASCO
CHICAGO — The annual meeting of the American Society of Clinical Oncology is back in…
STAT+: Biotechs face challenges as the industry’s annual bash returns to Boston
The world has changed since 2018 when the Biotechnology Innovation Organization last brought its annual…
STAT+: Targeted drug greatly slows progression of a brain cancer
CHICAGO – An experimental drug dramatically slowed the growth of glioma, a type of brain…
STAT+: Immunogen drug prolongs survival of women with advanced ovarian cancer
CHICAGO — An antibody that delivers chemotherapy directly to tumor cells extended the lives of…
STAT+: Novartis drug reduces breast cancer recurrence, but experts may debate results
Kisqali, a breast cancer pill made by Novartis, reduced the risk of recurrence of the…
Listen: Fake medical devices, real cancer drugs, & curious Ozempic effects
Why are fake medical devices more lucrative than real ones? Is Ozempic a neurological treatment?…
STAT+: Tempus launches an AI ‘assistant’ for thousands of oncologists
Tempus, a company that combines DNA sequencing for cancer with artificial intelligence, said Thursday that…
STAT+: Pharmalittle: Pfizer touts study data for hemophilia drug; former Novartis execs cleared of bribery in Greece
Good morning, everyone, and how are you today? We are doing find, thank you, especially…
STAT+: European regulatory panel weighing against approval of Amylyx’s ALS therapy, company says
LONDON — A European regulatory panel has taken a negative view of whether an ALS…
STAT+: Bristol drug reduces reliance on transfusions for people with chronic blood disorder
In a study reported Thursday, a medicine from Bristol Myers Squibb nearly doubled the treatment…
Listen: ChatGPT in medicine, a boom in weight loss pills, & Sarepta at the FDA
Can AI diagnose a disease? Are Wegovy’s days numbered? And what makes AI hallucinate? We…
STAT+: Illumina shareholders elect one Icahn ally to board, as company holds off broader challenge
Shareholders in the DNA-sequencing firm Illumina on Thursday voted to replace the company’s chairman with…
STAT+: Annexon’s trial of an eye disease drug missed by a mile. The company saw a bull’s eye
Annexon Biosciences said Wednesday that its experimental treatment for an eye disease called geographic atrophy…
STAT+: FDA delays decision on Sarepta’s gene therapy for Duchenne muscular dystrophy
The Food and Drug Administration is delaying by one month a decision on the approval…
STAT+: Battle for the soul of Illumina is also a referendum on its CEO
On Thursday Illumina, the largest and most important maker of DNA sequencing technology, whose innovations…
FDA budget battles, prisons’ sobering Covid response & BIO’s CEO search is on
You’re reading the web edition of D.C. Diagnosis. Sign up here to receive this newsletter…
STAT+: Achieve Life Sciences drug helps smokers quit in trial but would face stiff competition if approved
Seattle biotech Achieve Life Sciences on Tuesday announced an experimental drug meant to help people…
STAT+: Biotech launches with $300 million, joint venture to expedite RNA drug development
Biotech venture capital may be pacing at a six-year low, but one startup just managed…
Novo says oral version of Ozempic leads to 15% weight loss
An oral version of semaglutide, the drug marketed as Ozempic and Wegovy, led to dramatic…
STAT+: In its first tough test, CRISPR epigenome editing cuts cholesterol levels in monkeys
A defanged form of CRISPR, which doesn’t slice or nick DNA, but rather alters the…
STAT+: FDA advisers vote against approving Intercept’s NASH drug
A panel of expert advisers to the Food and Drug Administration voted Friday against approving…
STAT+: FDA approves first treatment for skin condition that causes persistent wounds, a redosable gene therapy
The Food and Drug Administration on Friday approved the first treatment for a devastating condition…
STAT+: FDA official offers insights into whether gene therapy makers could use common manufacturing process
WASHINGTON — A Food and Drug Administration official provided some insights this week into the…
Gene therapy death not caused by CRISPR, investigators confirm
Terry Horgan, the 27-year-old patient who died eight days after receiving a CRISPR therapy custom-built…
Listen: The FTC v. Amgen, Sarepta’s future, & Galapagos’ turnaround
Does the FTC have it out for pharma? What does it take to make an…
STAT+: In Belgium, a native son returns to resurrect the drugmaker Galapagos — and ‘to get the trust back’
There is, according to Wall Street, no worse investment in biotech than Galapagos NV. The…
STAT+: Could an upcoming Supreme Court case make the FDA slower?
WASHINGTON — The Food and Drug Administration could take longer to write regulations and make…
STAT+: CVS Health to close clinical trial unit two years after launch
WOONSOCKET, R.I. — Two years after its launch, CVS Health is planning to close down…
STAT+: PTC Therapeutics’s PKU drug succeeds in trial, but bigger hurdles for company are ahead
Biotech firm PTC Therapeutics said Wednesday that its drug for phenylketonuria, or PKU, met its…
STAT+: A new startup looks to turn the workhorse of gene therapy against cancer
In 1980, Life and Time magazines introduced America to a new cancer wonder drug: interferon,…
STAT+: FTC files lawsuit to block Amgen’s purchase of Horizon Therapeutics
The Federal Trade Commission on Tuesday sued to block Amgen’s $27.8 billion acquisition of Horizon…
AstraZeneca is third member to leave PhRMA in five months
WASHINGTON — AstraZeneca has decided to leave the brand drug lobbying powerhouse PhRMA halfway through…
STAT+: FDA advisory panel narrowly recommends approval for Sarepta’s gene therapy for Duchenne
For an archived version of a live blog about Friday’s FDA advisory panel hearing, click…
Tracking the FDA advisory panel on Sarepta’s gene therapy for Duchenne muscular dystrophy
The Food and Drug Administration is convening a meeting of outside experts on Friday to…
STAT+: Senate panel passes a suite of drug pricing bills — but fails to advance one major PBM reform
WASHINGTON – The Senate health committee on Thursday passed a package of bills aimed at…
Listen: Pharma vs. PBMs, Sarepta at the FDA, & a bold idea gone awry
Is there a Bermuda Triangle of drug prices? Do FDA advisers matter? And when should…