STAT+: Pharmalittle: Feds sue Walmart over opioid prescriptions; U.S. buys more Pfizer vaccine doses
Good morning, everyone. Damian Garde here, filling in for Ed Silverman one last time as…
Category: drug development
STAT+: Uniqure’s hemophilia B gene therapy program on hold due to cancer diagnosis in treated patient
UniQure, the Dutch gene therapy company, said Monday that it had temporarily halted the clinical…
FDA approves genetically altering pigs, to potentially make food, drugs, and transplants safer
Genetically engineering pigs so they lack a certain sugar on the surface of their cells…
STAT+: World Trade council fails to act on proposal to waive IP rights to Covid-19 drugs and vaccines
In a widely anticipated meeting, a World Trade Organization council failed to act on a…
STAT+: Federal watchdog urged to investigate the FDA’s handling of Biogen Alzheimer’s drug
A federal watchdog is being asked to investigate the Food and Drug Administration for an…
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STAT+: FDA finds fault with a Bristol plant, but it may not upset key approval of a cancer drug
The Food and Drug Administration found problems during a recent inspection of a Bristol Myers…
STAT+: Divergent results from Agios, Forma trials for their sickle cell disease drugs
Two drug makers — Forma Therapeutics and Agios Pharmaceuticals — are each developing their own…
STAT+: A payoff for U.S. taxpayers? CDC may have claims on remdesivir patents held by Gilead
Six years ago, a team of scientists at the Centers for Disease Control and Prevention…
STAT+: Constellation’s blood cancer drug shows greater benefit, easing concerns about its future
More patients and an improved response rate might once again shift the sentiment on Constellation…
STAT+: J&J’s CAR-T drug maintains strong efficacy in myeloma, shaded by neurotoxicity
More than three-quarters of the multiple myeloma patients treated with an experimental CAR-T therapy from…
STAT+: Genetically targeted drug from Kura Oncology induces remissions in adult leukemia patients
Kura Oncology presented early clinical trial results Saturday showing for the first time that its…
Preliminary but ‘nothing short of great.’ New data on CRISPR treatment for blood diseases suggest cure is possible
Ten patients treated with a CRISPR-based gene-editing therapy for the inherited blood disorders sickle cell…
STAT+: Ovid’s treatment for a rare, untreatable disease fails in a key trial
Ovid Therapeutics’ experimental drug for a devastating rare disease proved no better than placebo in…
How nanotechnology helps mRNA Covid-19 vaccines work
While the first two Covid-19 vaccines relying on messenger RNA technology speed toward regulatory approval…
STAT+: STAT+ Conversations: A conversation on drug pricing, policy, and access
Every week, STAT+ subscribers get access to exclusive conversations with biotech, pharma and health tech…
STAT+: Agios drug for rare form of anemia achieves main goal of late-stage clinical trial
Agios Pharmaceuticals said Tuesday that its experimental drug mitapivat increased hemoglobin levels in patients with…
Opinion: The U.S. must support access to care and incentives for the innovation that transforms it
The deadly spread of Covid-19 around the world has highlighted the importance of innovation and…
STAT+: Startup Spotlight: Bullish on its asthma treatment, Kinaset forges ahead in unusual times
Launching a clinical trial for a drug intended to treat severe asthma during a respiratory…
Opinion: What the biopharma industry is doing to build confidence in Covid-19 vaccines
Over the last few weeks, the United States has surpassed 100,000 Covid-19 cases a day…
STAT+: ‘The trend is irreversible’: How Covid-19 could drive a shift toward decentralized trials
Covid-19 started as a disaster for clinical research, halting or delaying 3 of every 4…
WHO group recommends against using remdesivir to treat hospitalized Covid-19 patients
A World Health Organization panel is now recommending against the use of the antiviral remdesivir…
STAT+: House passes a bill to close a loophole in a law that gives drug makers ‘unfair’ monopolies
Seeking to boost competition in the pharmaceutical industry, the House passed a bill that would…
STAT Plus: New bill would create a subscription payment model to jumpstart antibiotic development
In a bid to combat antimicrobial resistance, two U.S. lawmakers have introduced a bipartisan bill…
STAT Plus: With a new CEO, a small biotech is out to prove Wall Street wrong
G1 Therapeutics, a North Carolina biotech company, is changing CEOs on the eve of an…
STAT Plus: STAT+ Conversations: How Covid-19 will change drug development
Editor’s note: A live stream of the conversation will be embedded below at 1 p.m….
STAT Plus: Catalyst loses lawsuit accusing the FDA of unfairly approving a rival rare disease drug
In a blow to Catalyst Pharmaceuticals (CPRX), a federal judge dismissed its lawsuit accusing the…
STAT Plus: Public funding underwrote much of the development of J&J’s drug for TB, analysis finds
Amid ongoing debate over taxpayer dollars used to generate medicines, a new analysis contends that…
STAT Plus: FDA proposes a ‘modest’ change to a rule for policing off-label marketing
After years of controversy, the Food and Drug Administration has issued a proposed rule to…
STAT Plus: The world is racing toward Covid-19 drugs. In normal times, it takes years to get new antivirals out the door
Researchers may be racing to develop new Covid-19 treatments, but normally it has taken slightly…
STAT Plus: Amgen’s KRAS-blocking cancer drug shows durable responses, with tempered expectations
Amgen said Sunday that patients with advanced lung cancer who were given its drug to…
STAT Plus: Patent board delivers blow to University of California over its CRISPR invention claims
Making a key ruling in a long-running battle over lucrative patent rights, a government patent…
STAT Plus: Casma Therapeutics raises another $50 million to target muscular dystrophy
Casma Therapeutics, a Cambridge biotech trying to develop new medicines based on discoveries about how…
STAT Plus: Korro Bio raises $90 million to fix mutations that cause diseases
Korro Bio, a Cambridge biotechnology firm, said Thursday it has raised more than $90 million…
23andMe’s next challenge: ensuring its customers can get drugs developed with their data
23andme has long been known as a consumer genetic testing unicorn. But CEO Anne Wojcicki…
STAT Plus: ‘The race is on’: China’s I-Mab gets boost from AbbVie to develop a new cancer immunotherapy
HONG KONG — In November 2014, a little less than six years ago, Chinese scientist…
STAT Plus: Amarin loses appeal over heart drug patent, dashing its commercial hopes
Amarin failed to convince a federal appeals court to revive key patents covering its heart…
Prominent biotech leaders release Covid-19 guidelines calling for FDA independence, data transparency
WASHINGTON — A group of prominent biotech CEOs are calling on their peers and the…
STAT Plus: FDA cites Mylan for ‘repeated failures’ at manufacturing plants in India
For the second time in less than a year, the Food and Drug Administration has…
Amid pressure from scientists, NIH will study Gilead’s remdesivir-like compound against Covid-19
The National Institutes of Health plans to independently explore whether a Gilead Sciences (GILD) compound,…
Wary hemophilia patients say they’re willing to wait longer for a safe gene therapy
The Food and Drug Administration’s rejection of a gene therapy for hemophilia A on Wednesday…
STAT Plus: Stunning FDA rejection signals potential new hurdles for gene therapies
The Food and Drug Administration’s unexpected rejection of a gene therapy for the bleeding disorder…
STAT Plus: After FDA rejection of a key drug, is Gilead still a turnaround story?
The surprise decision by the FDA to reject a Gilead Sciences (GILD) drug for treating…
STAT Plus: Pharmalittle: FDA surprises BioMarin and Gilead by rejecting key drugs; J&J pays $6.5 billion to buy Momenta
Top of the morning to you. Another busy day is unfolding here on the Pharmalot…
STAT Plus: Turning Point releases positive data for targeted cancer drug, points to more rapid FDA filing
Turning Point Therapeutics, a San Diego developer of targeted cancer drugs, released positive data Wednesday…
STAT Plus: In a shocking decision, FDA rejects BioMarin’s gene therapy for hemophilia
The Food and Drug Administration on Wednesday rejected a one-time therapy for hemophilia A, delaying…
STAT Plus: J&J to buy Momenta Pharma in a bid to bolster autoimmune disease pipeline
Health care giant Johnson & Johnson said Wednesday that it is acquiring Momenta Pharmaceuticals, gaining…
STAT Plus: FDA finalizes penalties for trial sponsors that don’t share data, but critics say the effort falls short
After a year of deliberation, the Food and Drug Administration released final guidelines for penalizing…
STAT Plus: Unity Biotechnology fails early test, raising doubts its ability to develop drugs to reverse aging symptoms
Unity Biotechnology said Monday that its experimental treatment for osteoarthritis failed to improve knee pain…
Opinion: We need new antimicrobials to prevent the next infectious disease crisis
Imagine if scientists had seen Covid-19 coming years in advance yet did little to prepare….
Inspired by llamas’ unique antibodies, scientists create a potent anti-coronavirus molecule
Inspired by a unique kind of infection-fighting antibody found in llamas, alpacas, and other camelids,…