STAT Plus: Seres announces positive late-stage results for its microbe-based drug
Four years after a devastating clinical trial failure, Seres Therapeutics seems to have found success….
Category: drug development
Opinion: Yes, we need a vaccine to control Covid-19. But we need new treatments, too
Hopes for a relatively quick return to normalcy are riding high on promising news about…
STAT Plus: The FDA is finalizing its long-awaited rules for CBD
A version of this story first ran in D.C. Diagnosis, STAT’s weekly newsletter about the…
Following court ruling, NIH warns drug and device companies to post missing trial data
WASHINGTON — Hundreds of drug companies, medical device manufacturers, and universities owe the public a…
STAT Plus: Gilead faces renewed pressure to pursue remdesivir-like compound to fight Covid-19
In an unusual move, a pair of academics is escalating an effort to convince Gilead…
STAT Plus: In a blow to Catalyst, judge recommends tossing its lawsuit against FDA
A federal court judge recommended tossing out a lawsuit filed by Catalyst Pharmaceuticals (CPRX) that…
STAT Plus: CytoDyn CEO claims Covid-19 drug success while describing data suggesting study failure
CytoDyn CEO Nader Pourhassan used a conference call on Thursday evening to claim success with the…
STAT Plus: Cancer drug is the first potential therapy to emerge from 23andMe and GlaxoSmithKline collaboration
The pharmaceutical giant GlaxoSmithKline is starting human trials of the first medicine, a cancer drug,…
Opinion: Pandemics wreak devastation — but spark biomedical innovation
There are no “silver linings” in the dark cloud of Covid-19. Yet if history repeats…
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STAT Plus: Harry Reid and Alex Trebek tried Patrick Soon-Shiong’s experimental cancer therapy. Can their results be duplicated in a clinical trial?
Former Senate Majority Leader Harry Reid’s pancreatic cancer went into remission. “Jeopardy!” host Alex Trebek,…
STAT Plus: ‘Inactive’ drug ingredients are not always inactive, study finds
What’s in that pill you just swallowed? The label on the bottle lists the drug’s…
Pharma promises lawmakers, again and again, industry won’t cut corners with Covid-19 vaccines
The pharmaceutical industry does not want you to worry about the safety or efficacy of…
STAT Plus: Pharmalittle: Covid-19 vaccines may need two doses; lawmakers grilling pharma execs own their stocks
Good morning. Elizabeth Cooney here again, subbing for the vacationing Ed Silverman as the week…
STAT Plus: CytoDyn’s Covid-19 drug troubles escalate: Efficacy data are missing from study
CytoDyn released safety data on its experimental drug for Covid-19 on Tuesday, but efficacy data…
STAT Plus: Cancer startup aims precision medicine at rare genetic driver
A company focused on developing precision medicines to treat patients whose cancers are driven by…
Acadia fails in attempt to expand use of antipsychotic to treat patients with depression
Acadia Pharmaceuticals reported negative results Monday from a pair of late-stage clinical trials seeking to…
STAT Plus: Corbus Pharma is nearing the readout of a pivotal drug study. Here’s what you need to know
Four years ago, Corbus Pharmaceuticals claimed success in a mid-stage clinical trial of its lead…
STAT Plus: Startup Spotlight: Glympse Bio hopes its test will show whether drugs are actually working
Cambridge, Mass.-based startup Glympse Bio has raised more than $45 million for its nanoparticle-based biosensors,…
STAT Plus: The founder of Adimab believes he can combat Covid-19 — and whatever pandemic comes next
One of biotech’s most respected entrepreneurs is betting the novel coronavirus won’t be the last…
STAT Plus: Sanofi and MD Anderson team up to accelerate cancer drug testing
In another sign of its renewed emphasis on cancer, Sanofi (SNY) said Tuesday it will…
STAT Plus: European Parliament backs WHO effort to create a Covid-19 technology access pool
In an overwhelming vote, the European Parliament late last week voted to support a World…
STAT Plus: Pharma trade group scolds Gilead again for misleading information about a rival HIV drug
For the second time in less than two years, Gilead Sciences (GILD) has been reprimanded…
STAT Plus: Applied Therapeutics amends investor deck, bolstering accusations made by anonymous critic
One week after the New York City drug developer Applied Therapeutics announced it was working…
STAT Plus: Two dozen big drug makers launch a $1 billion fund to develop new antibiotics
In response to heightened concerns over antibiotic resistance, two dozen of the world’s largest pharmaceutical…
STAT+ Conversations: A conversation with Eli Lilly
Editor’s note: A livestream of the conversation will be embedded below at 1 p.m. ET. …
STAT Plus: Lobbyists tied to President Trump represent more than a dozen companies working on Covid-19
More than a dozen companies developing Covid-19 vaccines, therapies or diagnostics — including several of…
STAT Plus: Immunomedics’ breast cancer drug delays tumor growth, prolongs survival in clinical trial
Immunomedics reported clinical trial results Monday showing its newly approved medicine, Trodelvy, reduced the risk…
STAT Plus: Bellus Health suffers setback with clinical trial failure of chronic cough drug
Bellus Health is reporting Monday negative results from a mid-stage clinical trial of its experimental…
STAT Plus: Africa Union urges member countries to remove intellectual property barriers to Covid-19 vaccines
Amid growing concern over access to Covid-19 medical products, the organization that represents dozens of…
STAT Plus: Pharma trade group scolds AstraZeneca for bad behavior over an advisory board
A U.K. pharmaceutical industry trade group has publicly reprimanded AstraZeneca (AZN) for failing to uphold…
STAT Plus: FDA rejects Intercept Pharma’s drug for NASH
Intercept Pharmaceuticals said Monday that the Food and Drug Administration rejected its drug to treat…
STAT Plus: A preliminary new method could restore the brain cells Parkinson’s disease patients lost
Researchers developed a new method for transforming brain cells that can completely eliminate Parkinson’s disease…
STAT Plus: FDA urged to heighten safety warnings on common type 2 diabetes drugs
A consumer advocacy is urging the Food and Drug Administration to heighten warnings about a…
STAT Plus: As approval decision nears, fate of Intercept’s NASH drug clouded by murky FDA review delays
On Friday, the Food and Drug Administration is supposed to announce its decision on whether…
STAT Plus: Myovant endometriosis drug meets its goal in a second late-stage trial, company says
A combination pill from Myovant Sciences met its primary goal of reducing pain from endometriosis,…
STAT Plus: The new Janet: The FDA turns to a quiet problem-solver who brings expertise — and a little controversy
WASHINGTON — Janet Woodcock, one of the FDA’s most powerful regulators, has an almost mythic…
Lawmakers push Covid-19 bills to prevent price gouging, track federal funds used to discover drugs
Amid ongoing concern that Covid-19 therapies and vaccines may be unaffordable, a bipartisan group of…
STAT Plus: A crucial study of Bellus Health’s chronic cough drug reads out soon. Here’s what you need to know
Bellus Health, a small Canadian drug maker, is seeking to develop a potential blockbuster medicine…
STAT Plus: Finch touts positive results for its microbiome pill for C. diff infections
Three-quarters of the people who got Finch Therapeutics’ microbe-based pill for potentially deadly C. difficile…
STAT Plus: A ‘semi-wartime’ effort: Thermo Fisher COO on adapting the business to a Covid-19 world
Way back in January, Thermo Fisher Scientific (TMO), the world’s largest maker of scientific tools,…
STAT Plus: Clinical trial costs to develop a new drug may actually be rather modest — or so one study suggests
For years, the pharmaceutical industry has maintained that the costs to develop medicines accounts for…
STAT Plus: BioMarin’s hemophilia gene therapy continues to prevent bleeding at four years
BioMarin’s experimental hemophilia gene therapy, which is expected to be approved by U.S. regulators in…
STAT Plus: Momenta Pharma drug improves symptoms in patients with myasthenia gravis
Momenta Pharmaceuticals reported Monday that in a mid-stage clinical trial, an experimental medicine significantly improved…
STAT Plus: A would-be chain of cancer centers wants to treat patients with Right to Try drugs, raising ethical questions
In an unusual move, a private equity firm is soliciting investors to help create a…
STAT Plus: As efficacy of Constellation’s blood cancer drug wanes, the debate over its future ratchets higher
The response rate to an experimental myelofibrosis drug is falling, Constellation Pharmaceuticals, the drug’s maker,…
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STAT Plus: Agios drug demonstrates strong response in patients with inherited blood disorder
Agios Pharmaceuticals on Friday reported positive results from the first clinical trial of its lead…
STAT Plus: New data in sickle cell show biotech companies tackling disease in novel ways
Sickle cell disease features prominently at this year’s virtual meeting of the European Hematology Association,…
STAT Plus: A patient’s microbiome could have a major impact on how drugs affect them, new research confirms
The unique array of bacteria in a person’s gut can dramatically change how well they…
STAT Plus: As biotech drifts from amyloid hypothesis for Alzheimers, some see reason to cling on
Two biotech CEOs are cautiously optimistic about the controversial amyloid hypothesis, which suggests a sticky…
STAT Plus: The coronavirus pandemic is reigniting a fierce debate over compounded drugs
In hopes of alleviating potential drug shortages and other issues wrought by the coronavirus pandemic,…