STAT+: The U.S. Supreme Court will review a contentious Amgen patent case, but not one involving Bristol. Why?
In a surprising move, the U.S. Supreme Court rejected a bid by a Bristol Myers…
Category: drug development
STAT+: After years of lax oversight, the NIH is starting to contact institutions about unreported clinical trial results
In recent weeks, the U.S. National Institutes of Health has begun emailing academic institutions that…
STAT+: A ‘blank check’: Bill to boost antibiotic development blasted as a ‘flawed’ giveaway to pharma
Amid mounting concern over antibiotic resistance, a coalition of academics and advocacy groups is urging…
STAT+: A leaked version of a U.K.-India free trade deal sparks alarm over access to medicines
A leaked draft version of a trade agreement being negotiated between the United Kingdom and…
Here’s why we’re not prepared for the next wave of biotech innovation
The first time I remember hearing the words “biology’s century,” it was a sales pitch….
STAT+: Novel solution to biotech’s market valuation woes: Just give the cash back
It’s tough times to be a public biotech, especially a small one. As the market…
STAT+: Death of patient in closely watched Alzheimer’s trial raises concern about risk for some groups
The experimental Alzheimer’s drug lecanemab, hailed after it slowed patients’ cognitive decline in a clinical…
STAT+: Milestone Pharma’s nasal spray rapidly restores normal heart rhythm, achieving goal of key study
Milestone Pharmaceuticals said Monday that an experimental nasal-spray medicine acted quickly to treat people experiencing…
STAT+: Alphabet’s AI predicted the structure of 200 million proteins. Can it really speed up drug discovery?
Every two years since 1994, scientists have come together for an experiment — better described…
STAT+: Differences in countries’ regulations keep some cell and gene therapies from reaching patients
CARLSBAD, Calif. — Biotech companies developing cutting-edge cell and gene therapies often are tripped up…
STAT+: For Swedish professor and his tiny biotech, Alzheimer’s drug means vindication and a fortune
Last month, word spread that a drug was finally shown to slow Alzheimer’s disease, and…
STAT+: Merck touts positive results on key drug from $11.5 billion Acceleron merger
Merck said Monday the key drug from its $11.5 billion purchase of the biotech Acceleron…
Opinion: The new law that could stealthily transform biomedical innovation
Buried deep within the Inflation Reduction Act’s drug-price negotiation provisions is language that could open…
Opinion: How can the latest Alzheimer’s therapy reach patients? Follow this trustworthy process
The press release issued by pharmaceutical companies Eisai and Biogen on Sept. 27 might someday…
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STAT+: Many trials to confirm benefits of drugs granted accelerated approvals are running late
Amid heightened debate over a regulatory program for speeding the approval of some medicines, a…
An Alzheimer’s therapy scores winning results, but what could it mean for patients?
The news Tuesday night that a clinical trial of an experimental Alzheimer’s therapy had succeeded…
STAT+: Some European regulators are starting to take steps to ensure clinical trial results are reported
Regulators in half a dozen European countries are now taking steps to enforce requirements that…
STAT+: Researchers show they can quickly turn CAR-T cells on and off, raising hopes for safer cancer treatments
Researchers reported Wednesday that they could quickly and reliably turn CAR-T cells on and off…
STAT+: Have researchers hit a wall in the hunt for severe Covid drugs?
It seemed interminably slow then, what with all the haze and fear of fresh plague,…
The meth crisis is worse than ever, but new treatments might be around the corner
When it comes to meth addiction, Thomas Robey has long been at a loss. As…
STAT+: Pharmalittle: The ‘godfather’ of biotech trying to save Biogen; pharma companies grapple with ADHD drug shortages
Happy Monday, folks — Allison DeAngelis here. Ed is away from the Pharmalot campus this…
STAT+: Major Indian generic drugmaker closes a U.S. facility after years of manufacturing problems
After a decade of manufacturing problems, a U.S. federal court ordered a unit of Wockhardt,…
STAT+: ‘A blind eye’: NIH fails to ensure clinical trial results are reported and funds researchers who don’t file results
The U.S. National Institutes of Health failed to ensure that results of roughly half of…
STAT+: Blueprint Medicines drug reduces mastocytosis symptoms in a new study, meeting investor expectations
A drug made by Blueprint Medicines markedly improved symptoms of a rare immune system disorder…
STAT+: A treatment for monkeypox was approved under the FDA’s ‘Animal Rule.’ Here’s what that means
Take a look at the list of conditions that have treatments available thanks to what’s…
STAT+: Serious liver side effects detour Amgen’s effort to expand use of its KRAS-blocking lung cancer drug
A clinical trial run by Amgen that combined its KRAS-targeting cancer drug called Lumakras with…
STAT+: FDA’s decision to review a Biogen ALS drug is met with skepticism and uncertainty on Wall Street
Once again, the U.S. Food and Drug Administration made a surprise move regarding an experimental…
STAT+: ‘No magic bullet’: For drugmakers and the FDA, clinical trials on ultra-rare diseases pose thorny challenges
Walker Burger is beside himself with worry. The 33-year-old relies on an experimental medicine to…
STAT+: Contract research organization to transfer 4,000 beagles from facility cited for inhumane care
A contract research organization reached a final settlement with the U.S. government to transfer about…
STAT+: ‘Eye-opening’: The pandemic accelerated antimicrobial resistance across the U.S.
Resistance to medicines for combating superbugs has considerably worsened during the pandemic, with deaths and…
STAT+: With ‘do-over’ NASH results, Intercept will seek approval for first-ever treatment for fatty liver condition
Intercept Pharmaceuticals said Thursday that an extensive re-analysis of a large clinical trial involving its…
STAT+: Marijuana-induced high blunted by Anebulo Pharma pill, early study shows
Anebulo Pharmaceuticals said Tuesday that a single dose of its experimental pill blunted the effects…
STAT+: Can Biogen’s backup plan for Alzheimer’s succeed?
Everyone needs a backup plan, including one of the biggest biotech companies in town. So…
STAT+: ‘A slippery slope’: Pfizer sells a contraceptive and donated to political groups that could come after the company
Generally speaking, a company would not want to contribute to a politician whose actions could…
STAT+: ‘A slippery slope’: Drugmakers that sell contraceptives donated to political groups that could come after them
Generally speaking, a company would not want to contribute to a politician whose actions could…
STAT+: A Celldex treatment induces symptom relief in patients with chronic hives
An experimental drug from Celldex Therapeutics induced complete symptom relief in half of patients with…
STAT+: Uniqure’s Huntington’s gene therapy lowers key protein in small trial
A gene therapy for Huntington’s disease made by the Dutch biotech firm Uniqure showed early…
Opinion: Needed: a clearer explanation of why diversity in clinical trials is important
Increasing the diversity of clinical trial participants is all the rage these days. The numbers…
Opinion: Reformulating drugs helps profits more than patients
Prescription drug prices remain stubbornly high in the U.S. even though making drugs more affordable…
STAT+: FDA oversight of pharma manufacturing facilities plunges during the pandemic
Each year, the Food and Drug Administration tracks its progress inspecting pharmaceutical manufacturing facilities and…
STAT+: Third Rock Ventures plots next chapter after raising $1.1 billion fund
Third Rock Ventures has raised $1.1 billion for its largest-ever fund, the biotech venture capital…
STAT+: In a first-of-its-kind deal, major drugmaker licenses antibiotic production for low-income countries
In a first-of-its-kind arrangement, Shionogi has reached an agreement with the Global Antibiotic Research and…
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STAT+: FDA approved more cancer drugs than EMA, but they may not have always benefited patients
Amid rising pressure to endorse new medicines, U.S. regulators greatly outpaced their European counterpart in…
STAT+: In early trial, drug shrinks tumors in majority of children with most common form of brain cancer
Day One Biopharmaceuticals reported Sunday that an experimental molecule shrank tumors by at least 50%…
STAT+: Former Lilly manager files whistleblower lawsuit over manufacturing failures at production plant
A former Eli Lilly human resources officer sued the drug company after claiming she lost…
STAT+: Promising results reported for new generation of CAR-T immunotherapy for myeloma
CHICAGO — Three companies presented Phase 1 clinical trial results on new CAR-T therapies for…
STAT+: Documents show problems at Novartis facility where cancer drug production was halted
Earlier this month, Novartis took the surprising step of voluntarily suspending production of two therapies…
Opinion: Preparing for the next pandemic: Time to follow a social business model for patent-free global medicine production
The World Health Assembly, which is meeting in Geneva for the first time since the…
STAT+: Key Senate committee proposes a council to ensure FDA better coordinates on accelerated approvals
WASHINGTON — The Senate is taking pains to avoid another Aduhelm controversy. In new bipartisan…
STAT+: ViiV will make it easier for generic companies to copy its HIV prevention shot, but it’s not clear when
In response to criticism, ViiV Healthcare has agreed to license its long-acting injectable HIV prevention…