A quarantined Ted Cruz proposes to speed approvals for coronavirus drugs and vaccines
Although Sen. Ted Cruz (R-Texas.) is quarantined at home after coming into contact with someone…
Category: drug development
STAT Plus: Engage touts long-awaited positive data for its inhaler for seizures
After scrabbling for early financing, Engage Therapeutics has some positive clinical data to show the…
STAT Plus: Coronavirus fears may slow clinical trials and delay regulatory steps
Initially, plans for the huge clinical trial were proceeding apace. After months of groundwork, about…
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STAT Plus: Clinical research company sued over stolen trade secrets after employee filmed dogs used in experiments
Nearly two years ago, Charles River Laboratories (CRL) paid $800 million for a company called…
STAT Plus: This biotech went public during the stock market’s worst week since 2008
Concerns about the coronavirus outbreak made last week one of the markets’ worst since the…
STAT Plus: New estimate says developing a drug costs $1.3 billion, which is a lot, but less than companies often say
Estimates of how much it cost to invent and test a new medicine have been…
STAT Plus: Turned away from five clinical trials, a cancer patient waits for one that will take him
It’s hard enough for any cancer patient to get into clinical trials. It’s even harder…
STAT Plus: Allakos is running clinical trials in reverse, critics say, raising questions about its digestive disease drug
Allakos (ALLK) is embroiled in a clinical trial controversy with potentially billions of dollars at…
Federal judge rules clinical trial sponsors must publish a decade’s worth of missing data
WASHINGTON — For years, government research agencies have misinterpreted a law that requires them to…
STAT Plus: New partnership tries to make up for missing drug data in cost-effectiveness analyses
The Institute for Clinical and Economic Review, ICER, a nonprofit that has become a central…
STAT Plus: With strong data on lead drug, Kadmon and CEO Harlan Waksal plot their redemption
Months and even years after a successful bone marrow transplant, when patients in remission finally…
Aided by machine learning, scientists find a novel antibiotic able to kill superbugs in mice
For decades, discovering novel antibiotics meant digging through the same patch of dirt. Biologists spent…
STAT Plus: Lawmakers to Trump: Don’t give ‘monopolies’ to companies that develop coronavirus treatments with taxpayer funds
Nearly four dozen lawmakers asked the White House to ensure any treatment for the fast-moving…
How many? The coronavirus is prompting a burst of clinical trials in search of a treatment
The coronavirus sweeping across China has triggered a burst of research activity aimed at finding…
Claws of health? Lobster blood could play role in new drugs
PORTLAND, Maine — Maine lobsters have long delighted tourists as the state’s most beloved seafood….
STAT Plus: Biotech founder who said his painkiller would replace opioids sentenced to 7 years in prison
The founder of a biotech who said his company had developed a painkiller that would…
STAT Plus: Insulin makers object to FDA proposal for speeding arrival of biosimilar insulins
Amid growing rancor over the cost of insulin, two of the largest manufacturers are objecting…
STAT Plus: U.S. biotechs fear the coronavirus outbreak will delay their China-based research
Biotech investors and executives are growing worried that restrictions intended to contain the coronavirus epidemic…
STAT Plus: With new combination drug data, Exelixis takes another shot at prostate cancer treatment
In 2014, the Bay Area biotech company Exelixis (EXEL) tried to develop a drug for…
STAT Plus: Two more failed Alzheimer’s drugs sharpen focus on Biogen’s chances for aducanumab
As U.S. regulators consider whether to approve the first new treatment for Alzheimer’s disease in…
The vodka trial: In search of a treatment for vocal disorders, a researcher puts patient anecdotes to the test
Mondays are vodka days. For the members of Dr. Kristina Simonyan’s lab, this is not…
STAT Plus: Gilead loses its challenge to a pair of U.S. patents over an HIV prevention pill
In a setback to Gilead Sciences (GILD), a federal panel rejected its bid to invalidate…
STAT Plus: FDA and FTC vow to attack anti-competitive practices that limit biosimilar uptake
As frustration mounts over the slower-than-expected uptake of biosimilars in the marketplace, two U.S. federal…
If biotech had a Mount Rushmore, whose heads would you chisel in the granite?
If someone sculpted a Mount Rushmore of biotech CEOs, who’d be on it? The question…
STAT Plus: Most innovative cancer drugs take too long to reach patients in the U.K.
Despite giddy advances in treating cancer, a new analysis finds needed medicines have been reaching…
STAT Plus: ‘The gurus of sperm’: Ohana Biosciences is taking a different approach to fertility
“Ohana” means family in Hawaiian — and the new Cambridge, Mass.-based biotech that took that…
How fast can biotech come up with a vaccine for the latest outbreak?
The deadly outbreak of a novel coronavirus has sparked a race among biotech companies, each…
STAT Plus: What does the latest twist in the Sarepta saga mean for the future of the FDA? We discuss
Earlier this week, the Food and Drug Administration released documents that reveal a schism within…
STAT Plus: European court upholds controversial EMA transparency rules for clinical trial data
After months of anticipation, the European Court of Justice has sided with the European Medicines…
STAT Plus: Pharma is making some effort to fight superbugs, but progress is ‘patchy’
Amid rising concern over a lack of antibiotics, a new analysis finds most drug makers…
STAT Plus: Could a drug for arthritis in dogs also fight cancer in people?
Drugs for diabetes, inflammation, alcoholism — and even for treating arthritis in dogs — can…
STAT Plus: ‘We have a tragedy of the commons’: How a VC thinks his new company can lower drug prices
A venture capitalist made some waves early in the J.P. Morgan Healthcare Conference when he…
STAT Plus: Startup Spotlight: With a different method for gene therapy, Generation Bio eyes an IPO
Seven years ago, one of Generation Bio’s scientific founders couldn’t convince any top-tier journals to…
Opinion: Innovation in biotech R&D: New resources offer new hope
Public optimism about American health care seems in short supply if you read the news,…
Opinion: What roulette and basketball can teach Biogen about aducanumab
Say that one day you see me walk up to a roulette table and win…
Opinion: Welcome to the bioengineering culture clash
Bioengineering, once viewed primarily as an academic discipline, is growing up. Our ability to engineer…
STAT Plus: Blueprint gains approval for its first drug, a treatment for a rare gastrointestinal cancer
Blueprint Medicines won approval Thursday of its first drug, a precision medicine that dramatically shrank…
STAT Plus: Regeneron drug reduces bone growth for patients with ultra-rare skeletal disease
Patients with the ultra-rare disease FOP grow bone where it doesn’t belong, creating a life-threatening…
Opinion: A new biotechnology and pharmaceutical industry commitment to patients and the public
We,the undersigned leaders in the biotechnology and pharmaceutical industries, academia, and life science investors, recognize…
Opinion: Improving the next generation of drugs through patient-centric design for clinical trials
When a process works, it’s natural to try to repeat it rather than recreate or…
3 challenges to watch in global health in 2020
New Year’s Day may usher in a new decade, but our crystal ball suggests some…
The debate over America’s drug-pricing system is built on myths. It’s time to face reality
America’s drug-pricing system is broken. Any system in which the list price of insulin triples…
New study in mice points to why melanoma spreads — and perhaps how to prevent metastasis
In some melanoma patients, the tumor cells stay in the skin where they started, never…
Opinion: Manufacturing: the next breakthrough in gene therapy
I never thought I’d see the day when words like “process,” “scale,” and “automation” would…
STAT Plus: After Ice Bucket campaign, researchers have optimism about insights into ALS puzzle
Five years after Pete Frates helped launch the Ice Bucket Challenge to raise awareness and…
Opinion: Do large pharma companies provide drug development innovation? Our analysis says no
Large pharmaceutical companies oppose legislation being considered by Congress to lower the prices of prescription…
STAT Plus: Bristol-Myers CMO on cell therapies: ‘This is the best time to be in drug development’
ORLANDO, Fla. — In June, Dr. Samit Hirawat was appointed chief medical officer of Bristol-Myers…
STAT Plus: Vindicated. New J&J CAR-T myeloma data confirm strong efficacy, ease doubts raised by Chinese version
ORLANDO, Fla. — One year ago, a Chinese scientist stepped up to a podium at…
STAT Plus: New data show Bluebird, Bristol CAR-T drug could be pioneering myeloma therapy. Competitors may be close behind
ORLANDO, Fla. — On the eve of a major blood disease research meeting here, Bluebird…
Opinion: Aducanumab: the beginning of the end of Alzheimer’s disease?
In histories written about Alzheimer’s disease, 2019 will turn up as a landmark year, one…