STAT+: FDA’s vaccines and biologics chief talks Covid-19, 2022 priorities, and getting back to gene, cell therapy review
WASHINGTON — No part of the Food and Drug Administration has been challenged by the…
Category: drug development
STAT+: Pharmalittle: Japan panel nixes Biogen Alzheimer’s drug; Oxfam urges SEC to probe Moderna over patent dispute remarks
Good morning, everyone, and welcome to the middle of the week. Congratulations on making it…
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STAT+: 4 epilepsy-focused biotech companies to watch
More companies than ever before are training their sights on developing treatments for epilepsy, which…
STAT+: AbbVie asks the U.S. International Trade Commission to investigate Alvotech’s plans for a biosimilar Humira
In its latest bid to defend its franchise product, AbbVie (ABBV) has filed a complaint…
Opinion: It’s not the mission of universities to perpetuate inequity. Why do Emory and others do that?
As billions of people in the Global South continue to confront Covid-19 unprotected because they…
Pfizer’s Covid pill remains 89% effective in final analysis, company says
Paxlovid, Pfizer’s pill to treat Covid-19, retained its 89% efficacy at preventing hospitalization and death…
STAT+: More potent version of Global Blood sickle-cell drug improves hemoglobin response in small study
Global Blood Therapeutics said Monday that an experimental treatment for sickle cell disease nearly doubled…
STAT+: In a do-over study, Bellus Health cough treatment shows positive results
Results released Monday from a Phase 2 study of a chronic cough treatment being developed…
Opinion: Don’t let ‘shelved assets’ gather dust. Make them into new lifesaving drugs
Life-science companies have changed the world with the breakthrough vaccines and therapeutics they created —…
STAT+: Roche two-armed antibody posts strong tumor responses in lymphoma study, rivaling CAR-T therapy
An off-the-shelf bispecific antibody developed by Roche induced high and durable response rates in patients…
Opinion: STAT+: Maintaining trust in science is crucial to public health. Here’s how the biopharma industry can help
Against declining trust in traditional news sources and institutions that provide data and information, the…
STAT+: Biogen’s reckoning: How the Aduhelm debacle pushed a troubled company and its fractured leadership to the brink
The shocking revelation came in a Saturday afternoon email, restricted to a tight circle of…
STAT+: Targeting prices for accelerated approval drugs may have limited impact on overall drug spending
As U.S. regulators approve more medicines under the accelerated approval pathway, Medicare and Medicaid continue…
STAT+: Stoke Therapeutics drug, targeting genetic cause of childhood epilepsy, reduces seizure activity
An experimental drug from Stoke Therapeutics reduced the frequency of convulsive seizures in children with…
STAT+: Former Immunomedics executives are charged with insider trading
Two former executives at Immuomedics were charged with insider trading by U.S. authorities in connection…
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STAT+: In a medical first, Vertex drug successfully targets the underlying cause of a genetic kidney disease
An experimental pill from Vertex Pharmaceuticals reduced levels of a damaging urine protein by nearly…
STAT+: Injecting cancer patients with genetically engineered viruses could be a ‘rock star’ therapy. Why hasn’t it taken off?
Stacy Erholtz had run out of options. At the age of 49, she had already…
STAT+: Pfizer sues former employee for allegedly stealing Covid-19 vaccine documents
Amid the intense race to develop Covid-19 products, Pfizer (PFE) accused a former employee of…
FDA approves first drug for genetic cause of dwarfism
The Food and Drug Administration approved the first treatment for the most common cause of…
STAT+: Watch: Experts challenge Eli Lilly exec on effectiveness of Alzheimer’s drug
Months after the Food and Drug Administration approved Biogen’s Alzheimer’s drug Aduhelm, Eli Lilly hopes…
STAT+: By selling bonds tied to drug access and climate goals, Teva takes pharma in a new direction
In a first-of-its-kind move by a drug maker, Teva Pharmaceuticals (TEVA) recently sold $5 billion…
STAT+: Gilead licenses cancer drugs from Arcus in potentially lucrative but risky bet on its cancer business
Gilead Sciences said Thursday that it has exercised an option to license four cancer drugs…
STAT+: ‘Can’t get much worse:’ What a European rejection of an Alzheimer’s drug would mean for Biogen
In a potentially huge setback for Biogen (BIIB), a European regulatory panel signaled that it…
STAT+: In a sudden move, Al Sandrock, the man behind Biogen’s Aduhelm, to retire
Al Sandrock, Biogen’s top scientist and the face of its years-long campaign to develop a…
STAT+: ‘Quite puzzling’ results in Alzheimer’s study cloud future of tau-targeting antibody treatment
New clinical trial results may temper early hope for an experimental Genentech treatment that targets…
Largest psilocybin trial finds the psychedelic is effective in treating serious depression
Eagerly awaited results of the largest-ever study of psilocybin were announced Tuesday, with Compass Pathways…
Opinion: Drug pricing bill’s unintended consequences will distort drug development
After months of wrangling, Democratic lawmakers have agreed on a drug pricing bill. The House…
STAT+: A controversial drug for premature births, which FDA wants withdrawn, is tied to elevated cancer risk
The key ingredient in a controversial medicine used to prevent premature births is associated with a…
Experimental Pfizer pill prevents Covid hospitalizations and deaths
An experimental antiviral pill developed by Pfizer reduced the risk of death and hospitalization by…
STAT+: Alphabet has a new drug discovery company building on DeepMind’s AI chops
Alphabet is plunging into the drug discovery business. Over the last year, the tech behemoth…
STAT+: Alzheimer’s conference preview: Aduhelm debate persists, while field grapples with new targets and directions
When physicians and scientists involved in Alzheimer’s disease gather in Boston next week for an…
STAT+: Centessa drug shows early promise for inherited lung disease, but liver safety issue seen in small study
An experimental “corrector” drug from Centessa Pharmaceuticals normalized the levels of a target protein in…
STAT+: The loudest physician proponents of Aduhelm have all taken money from Biogen
WASHINGTON — A small group of physicians with deep, at times undisclosed, financial ties to…
Opinion: My company is developing new antibiotics. My resistant infection showed me we need them now
I biked to work in a rainstorm one day in October 2019. As a longtime…
STAT+: Rafael Pharma drug fails to prolong survival of patients with pancreatic cancer in large study
Rafael Pharmaceuticals said Thursday that its experimental treatment for pancreatic cancer failed to prolong the…
STAT+: Be careful who you sue: CytoDyn knowingly submitted an incomplete drug application to FDA, new documents show
CytoDyn and its CEO Nader Pourhassan have known the company’s long-delayed HIV drug was in…
Public-private partnership launched to accelerate gene therapies for rare diseases
The National Institutes of Health and U.S. Food and Drug Administration unveiled a public-private partnership…
STAT+: Feds probe Novartis over Entresto marketing and compensation to doctors
In what might become a new scandal for Novartis, federal investigators recently demanded information from…
STAT+: 6 things to know before the readout of Rafael Pharma’s pancreatic cancer drug study
Pancreatic cancer is hard to detect early and notoriously resistant to treatment, making it the…
STAT+: Cortexyme’s bacteria-fighting Alzheimer’s drug fails primary goal, but company sees a path forward
A novel approach to treating Alzheimer’s disease failed to preserve memory and function in a…
Latest psilocybin patent highlights the swirling battle over psychedelics intellectual property
One of the leading companies racing to develop psychedelics as legal medicines was granted a…
Opinion: How Moderna nearly lost the race to develop a Covid-19 vaccine
Moderna Inc. has emerged as a biotech power — and a household name — thanks…
STAT+: Licensing biotech breakthroughs is a contentious, painful slog. Can the process be fixed?
Students, employees, and professors at a research institution generally pledge that in the event they…
STAT+: Biogen’s Aduhelm sales fall dramatically below Wall Street’s expectations
Biogen made just $300,000 from the Alzheimer’s disease treatment Aduhelm in the first full quarter…
Atea’s antiviral pill fails to clear Covid-19, forcing a re-think
Atea Pharmaceuticals said Tuesday that its antiviral pill for Covid-19 failed to combat the virus…
STAT+: Biogen drug for rare form of ALS fails pivotal study — another setback for fatal disease with few treatments
Biogen reported disappointing results Sunday from a late-stage clinical trial involving its experimental treatment for…
Opinion: In the calm before the superbug storm, the world needs to prepare
Failing to plan, it’s been said, is planning to fail. By this standard, the United…
STAT+: New data on CRISPR Therapeutics’ off-the-shelf CAR-T cancer therapy shows more remissions, no major safety issues
More of the cancer patients who received CRISPR Therapeutics’ experimental, off-the-shelf CAR-T cell therapy showed…
Mouse experiments with a decades-old drug suggest a new approach to Alzheimer’s treatment
A generic drug used widely to treat swelling associated with hypertension and heart failure showed…
STAT+: Disappointing tumor responses, more side effects, seen with latest Amgen KRAS combination studies
Combining Amgen’s KRAS-blocking cancer drug Lumakras with other targeted medicines led to higher rates of…