mailitics

Category: drug development

  • Vinay Prasad, key Makary ally and a focus of controversy at the FDA, is leaving the agency

    Vinay Prasad, key Makary ally and a focus of controversy at the FDA, is leaving the agency WASHINGTON — Vinay Prasad, a top official at the Food and Drug Administration who has been at the center of recurring public controversies, is exiting the agency for a second time. Prasad will leave the FDA at the…

  • STAT+: Moderna’s reset hinges on oncology

    STAT+: Moderna’s reset hinges on oncology Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Seems as though investors are still rewarding sheer weight loss over tolerability in the obesity drug race. The FDA moved at a rapid clip with a new myeloma…

  • STAT+: FDA warns more telehealth firms about compounded GLP-1s

    STAT+: FDA warns more telehealth firms about compounded GLP-1s Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. Moderna is avoiding what would have been a high-profile trial, but will still have to pay up. That and more news below. Let’s…

  • STAT+: Moderna to pay Roivant up to $2.25 billion to settle patent lawsuit behind mRNA vaccines

    STAT+: Moderna to pay Roivant up to $2.25 billion to settle patent lawsuit behind mRNA vaccines Moderna has agreed to pay Roivant up to $2.25 billion to settle claims that the mRNA vaccine developer infringed on Roivant’s patents in its Covid-19 shot. Roivant will receive $950 million and then another $1.3 billion if Moderna’s attempts…

  • STAT+: Prime Medicine to seek approval for gene-editing treatment after two-patient trial

    STAT+: Prime Medicine to seek approval for gene-editing treatment after two-patient trial Prime Medicine said Tuesday it will ask the Food and Drug Administration to approve a gene-editing treatment that has been given to only two patients. The application will test an agency that has promised to speed new gene-editing treatments to patients but has…

  • STAT+: A Merck cancer drug to watch

    STAT+: A Merck cancer drug to watch Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! The impact of President Trump’s “most-favored nation” drug-pricing push can be hard to decipher, but the policy is starting to look less like a slogan and…

  • STAT+: Novo doubles down on oral peptides

    STAT+: Novo doubles down on oral peptides Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. By the time this newsletter sends, I’ll be on a plane headed towards vacation. See you next week! The need-to-know this morning Alkermes CEO Richard…

  • STAT+: Novo reports ‘triple G’ obesity drug study results

    STAT+: Novo reports ‘triple G’ obesity drug study results Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. I hope everyone on the East Coast is staying warm. Let’s get into the news today. How low can obesity drug prices go?…

  • STAT+: Novo’s next-gen obesity drug stumbles in Lilly comparison study

    STAT+: Novo’s next-gen obesity drug stumbles in Lilly comparison study Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. We’ve got some big acquisition news today, and also some politics — specifically a look at how pharma lobbyists, who have longed considered the…

  • STAT+: Element Biosciences launches table-top sequencer capable of $100 genome

    STAT+: Element Biosciences launches table-top sequencer capable of $100 genome Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Grail’s Galleri blood test just failed a make-or-break NHS trial, missing its primary endpoint and reviving the uncomfortable question: Does earlier detection actually change…

  • STAT+: Psilocybin data could be good enough for approval

    STAT+: Psilocybin data could be good enough for approval Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good day! Today: A look at growing GLP-1 competition in China, a drug reviewed as part of the FDA’s shiny new fast-track voucher hits a roadblock,…

  • STAT+: Pediatricians confront HHS in vaccine showdown

    STAT+: Pediatricians confront HHS in vaccine showdown Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. The FDA’s surprise refusal to even review Moderna’s mRNA flu vaccine is sending a chill through biotech: Companies are openly wondering whether the regulatory goalposts are shifting…

  • STAT+: FDA’s rejection of Moderna threatens to stifle broader vaccine industry

    STAT+: FDA’s rejection of Moderna threatens to stifle broader vaccine industry The Food and Drug Administration’s refusal to review Moderna’s flu vaccine this month has renewed fears that Trump administration policies could paralyze the vaccine industry, dissuading companies from developing new shots in the U.S. and leaving the country flat-footed in the event of future…

  • STAT+: A change at the top of Sanofi

    STAT+: A change at the top of Sanofi Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Vinay Prasad is tightening the screws at the FDA, overruling staff and signaling a tougher stance on vaccines and gene therapies — which, as Adam Feuerstein…

  • STAT+: FDA refuses to review Moderna’s influenza vaccine

    STAT+: FDA refuses to review Moderna’s influenza vaccine The Food and Drug Administration refused to review Moderna’s application for a new influenza vaccine, the company said Tuesday, a surprise decision that could  raise concerns about the agency’s posture toward drug companies and the Trump administration’s policies on vaccines. Moderna, revealing the rejection, took the unusual…

  • STAT+: Hims faces mounting regulatory pressure

    STAT+: Hims faces mounting regulatory pressure Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning! Hope you enjoyed yesterday’s Bad Bunny performance. My son’s take on the Super Bowl: “Why would anyone want to watch something so boring?”  Today, we get…

  • STAT+: FDA Commissioner Marty Makary tries to soothe staff concerns over voucher program

    STAT+: FDA Commissioner Marty Makary tries to soothe staff concerns over voucher program WASHINGTON — At an employee town hall on Tuesday, Food and Drug Administration leaders tried to quell staff and external concerns about a controversial new program to fast-track certain drugs.   “This pilot is an effort to make our review processes patient-centric,” said…

  • STAT+: Pfizer unveils data on Metsera drug

    STAT+: Pfizer unveils data on Metsera drug Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. Did Pfizer overpay for the obesity biotech Metsera? It’s probably still too early to tell, but we have some new data this morning. The need-to-know this…

  • STAT+: AstraZeneca looks to China for obesity drug candidates 

    STAT+: AstraZeneca looks to China for obesity drug candidates  Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Oh, hi. Today, we discuss delays in the launch of TrumpRx. Also, Sanofi is deprioritizing its mRNA flu vaccine.  The need-to-know this morning Regeneron Pharmaceuticals…

  • STAT+: AI biotech founded by ex-Google CEO Eric Schmidt is raising $150 million

    STAT+: AI biotech founded by ex-Google CEO Eric Schmidt is raising $150 million Hologen, a secretive AI startup co-founded by former Google CEO Eric Schmidt, is seeking to raise $150 million in a Series A fundraising round, STAT has learned.  Hologen describes itself as a “frontier medical AI company, a drug development & diagnostics company,…

  • STAT+: Launch of Wegovy pill looks to be going strong so far

    STAT+: Launch of Wegovy pill looks to be going strong so far Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! Today, we see a new synthetic biology startup, backed by Frances Arnold and Bob Langer. Plus, it’s still early, but Novo…

  • STAT+: Insurers blame drugmakers, hospitals for high prices

    STAT+: Insurers blame drugmakers, hospitals for high prices Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we see insurers telling Congress that hospital and drugmakers are to blame for health care pricing issues, and read about ways in which some drug…

  • STAT+: Novo strikes deal for diabetes cell therapies

    STAT+: Novo strikes deal for diabetes cell therapies Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We’re breaking down some of the key parts of a sweeping new health care bill today. The need-to-know this morning Johnson & Johnson kicked…

  • STAT+: FDA delays reviews for two drugs in new voucher program

    STAT+: FDA delays reviews for two drugs in new voucher program Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello hello! Hope you survived JPM week and are now recuperating with some electrolytes and a sleep mask. (But don’t forget our virtual…

  • STAT+: On Day 1 of JPM, no blockbuster headlines, but biotech newsmakers still move markets

    STAT+: On Day 1 of JPM, no blockbuster headlines, but biotech newsmakers still move markets This is the online version of The Readout, STAT’s flagship biotech newsletter. Sign up to get it in your inbox. Hello from sunny San Francisco, where #BiotechVibeWatch2026 has begun. This is Allison DeAngelis, joined here by STAT’s Adam Feuerstein, Matthew Herper, and…

  • STAT+: Key scientist from Baby KJ team launches startup to scale personalized CRISPR medicines

    STAT+: Key scientist from Baby KJ team launches startup to scale personalized CRISPR medicines In between bites of thin, crispy slices of pizza at Berkeley’s Pizzeria da Laura, gene editing researcher Fyodor Urnov and venture capitalist Johnny Hu began hatching a plan for a different kind of CRISPR company. It was spring 2024 and Urnov,…

  • STAT+: Former NIH genomics director Eric Green to join Illumina as CMO

    STAT+: Former NIH genomics director Eric Green to join Illumina as CMO Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. The Readout heads to the J.P. Morgan Healthcare Conference next week, which means it will hit your inboxes in the afternoon instead…

  • STAT+: China expected to soon surpass U.S. in bio innovation

    STAT+: China expected to soon surpass U.S. in bio innovation Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. It’s an exciting week not only for biotech M&A, but also for my city (Chicago) as we gear up for our big game…

  • STAT+: Insilico inks cancer drug deal with Servier after IPO

    STAT+: Insilico inks cancer drug deal with Servier after IPO Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Welcome back and happy new year! We have plenty of fresh coverage to start the week. We can also report that our upcoming STAT@JPM…

  • The top medical advances of 2025

    The top medical advances of 2025 It has been a tough year for medicine. The U.S. research enterprise has been scrambled by a series of political decisions with long-reaching consequences. But make no mistake: Science didn’t stop, and medicine has had its share of major advances. As I have written for years, this is biology’s…

  • Best of STAT 2025

    Best of STAT 2025 What a year! Yes, it was our 10th anniversary, but it also brought an unprecedented blizzard of news, and while we weren’t added to a Signal chat on war plans, we did have a giant health insurer email us internal strategy documents by mistake. Our coverage featured everything from a piece…

  • Trump administration’s plan to shrink vaccine schedule sends health sector scrambling

    Trump administration’s plan to shrink vaccine schedule sends health sector scrambling WASHINGTON — A possible Trump administration effort to change the childhood vaccine schedule has left hospital leaders, health policymakers, and pediatricians scrambling to navigate what could be the most significant changes to the American vaccine program in decades. The administration had planned to announce…

  • STAT+: FDA initiates priority voucher for J&J’s ‘Tec-Dara’ combo

    STAT+: FDA initiates priority voucher for J&J’s ‘Tec-Dara’ combo Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. Apparently the drunk raccoon I mentioned a few weeks ago is a repeat offender.  Onto the biotech news today. Continue to STAT+ to read the…

  • STAT+: Sobi bets big on next-gen gout drug

    STAT+: Sobi bets big on next-gen gout drug Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we discuss the implications of a child’s tragic death after receiving a brain-focused gene therapy, hear Siddhartha Mukherjee opine on why the next frontier in…

  • FDA approves first new kind of drug to target gonorrhea in decades

    FDA approves first new kind of drug to target gonorrhea in decades A new kind of oral antibiotic to treat gonorrhea has secured Food and Drug Administration approval, the second time in two days that a new drug for the common sexually transmitted infection has come through licensure. Neisseria gonorrhoeae, the bacterium that causes gonorrhea,…

  • STAT+: In a first, a nonprofit wins FDA approval for rare disease gene therapy

    STAT+: In a first, a nonprofit wins FDA approval for rare disease gene therapy The Food and Drug Administration this week granted approval to a new gene therapy for a rare immune disorder, the maker of which is notably not a drug company, but an Italian charity.  The authorization of Waskyra on Tuesday for Wiskott-Aldrich…

  • STAT+: Terns leukemia drug could succeed Novartis blockbuster

    STAT+: Terns leukemia drug could succeed Novartis blockbuster Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Today we discuss why comparing U.S. vaccine policy to Europe’s is a red herring, why the revolving door at the FDA between government and industry needs modernized…

  • STAT+: Early update shows Wave’s RNA drug cut visceral fat

    STAT+: Early update shows Wave’s RNA drug cut visceral fat Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! With STAT reporting from ASH this year, we have some stories in the blood space. Also, a potential Dupixent competitor is in the…

  • STAT+: Fulcrum study suggests improved efficacy for higher dose sickle cell pill

    STAT+: Fulcrum study suggests improved efficacy for higher dose sickle cell pill Fulcrum Therapeutics said Sunday that a higher dose of its experimental pill for sickle cell disease was more effective at inducing an alternative form of the oxygen-carrying molecule hemoglobin — boosting hopes it could one day provide a simple and effective treatment for…

  • STAT+: Incyte study results suggest a new approach to treating myelofibrosis

    STAT+: Incyte study results suggest a new approach to treating myelofibrosis ORLANDO, Fla  — An experimental drug from Incyte achieved meaningful spleen response rates and improvements in disease symptoms in patients with advanced myelofibrosis, according to study results reported Sunday.  The data, while preliminary, should bolster the company’s efforts to develop a new type of…

  • STAT+: A promising sickle cell pill and a new way to treat myelofibrosis

    STAT+: A promising sickle cell pill and a new way to treat myelofibrosis This is the online version of ASH in 30 Seconds, STAT’s report from the American Society of Hematology meeting. Sign up for the email version here.  It’s Day 2 of the ASH meeting. Let’s get straight into the news.  Fulcrum study suggests…

  • STAT+: ‘Remarkable’ drug results against an aggressive leukemia

    STAT+: ‘Remarkable’ drug results against an aggressive leukemia This is the online version of ASH in 30 Seconds, STAT’s report from the American Society of Hematology meeting. Sign up for the email version here.  We hear most of the country is freezing. We wouldn’t know. We’re in Orlando, Fla. where the temps are in the…

  • STAT+: Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks

    STAT+: Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks NEW YORK — Vinay Prasad, the Food and Drug Administration’s top vaccines regulator, blamed “misleading media narratives” for the escalating criticism of his leadership amid turmoil and plummeting morale at the agency. Prasad’s remarks, delivered Thursday at a New York investor conference closed…

  • STAT+: A drug that was ‘engineered with AI’ enters Phase 3 testing

    STAT+: A drug that was ‘engineered with AI’ enters Phase 3 testing Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. My colleagues will be in Orlando later this week for the American Society of Hematology meeting. Sign up for their newsletter…

  • STAT+: Sarepta cleared to test new safety regimen for Duchenne drug

    STAT+: Sarepta cleared to test new safety regimen for Duchenne drug Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We discuss some big news that the Trump administration dropped last night. And we’ll be taking a break this Thursday and Friday. We’ll…

  • STAT+: Lilly hits trillion-dollar valuation as GLP-1 era peaks

    STAT+: Lilly hits trillion-dollar valuation as GLP-1 era peaks Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! We’re closing in on CMS’s deadline for 2027 Medicare-negotiated drug prices. Plus, we see a break from precedent in how the FDA selects priority review…

  • STAT+: Recursion seeks to deliver results, and a VC sees a wave of M&A coming

    STAT+: Recursion seeks to deliver results, and a VC sees a wave of M&A coming Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We’ve got some spicy comments from Mark Cuban, and a pair of biotech Q&As. Let’s get to…

  • STAT+: FDA review staff was excluded from voting on whether to approve first priority voucher drug

    STAT+: FDA review staff was excluded from voting on whether to approve first priority voucher drug WASHINGTON — The Food and Drug Administration has promised companies that earn a Commissioner’s National Priority Voucher a one- to two-month drug review, culminating in a one day “tumor board” style meeting where leaders decide whether to approve the drug. …

  • STAT+: Many poor countries where experimental drugs are tested fail to benefit after approval, analysis finds

    STAT+: Many poor countries where experimental drugs are tested fail to benefit after approval, analysis finds Numerous medicines are not accessible in many of the countries where they were tested before approval by the Food and Drug Administration, raising concerns about whether pharmaceutical companies are adhering to ethical standards, a new study finds. The researchers reviewed 172…

  • STAT+: Johnson & Johnson acquires Halda Therapeutics for $3 billion, a big win for a buzzy new technology

    STAT+: Johnson & Johnson acquires Halda Therapeutics for $3 billion, a big win for a buzzy new technology Johnson & Johnson said Monday it will purchase Halda Therapeutics and its experimental prostate cancer drugs for $3.05 billion, marking the first major buyout for a startup built around a field that has attracted significant investment but not…

  • STAT+: Pfizer closes $10 billion Metsera deal

    STAT+: Pfizer closes $10 billion Metsera deal Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! If you’re still wondering “What the heck happened with Moderna?” the latest episode of the video series STATus Report spells it out quite nicely. Also, a KFF…

  • STAT+: Makary, Prasad outline pathway for bespoke gene therapy

    STAT+: Makary, Prasad outline pathway for bespoke gene therapy Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we learn AbbVie has ended its partnership with Calico, the FDA outlines how bespoke gene-editing treatments can make it through the regulatory pipeline,…

  • STAT+: Kura Oncology secures approval for leukemia drug, its first

    STAT+: Kura Oncology secures approval for leukemia drug, its first The Food and Drug Administration on Thursday approved a drug made by Kura Oncology to treat patients with a certain type of genetically altered leukemia.  The medicine will be sold under the brand name Komzifti.  The FDA cleared the drug to treat patients with relapsed…

  • STAT+: Why is Eli Lilly worth nearly $1 trillion?

    STAT+: Why is Eli Lilly worth nearly $1 trillion? Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We’ve got big FDA news to get into today — let’s get straight into it. FDA names Richard Pazdur as top drug regulator   The…

  • STAT+: Chinese government’s support for biotech fuels huge rally

    STAT+: Chinese government’s support for biotech fuels huge rally Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning, we just had our first snow of the season in Chicago, I just ordered a pie for Thanksgiving, and I’m still in denial that…

  • STAT+: FDA announces next round of priority review vouchers

    STAT+: FDA announces next round of priority review vouchers WASHINGTON — The Food and Drug Administration on Thursday announced the second batch of companies being granted a “Commissioner’s National Priority Voucher,” a ticket to speedier reviews of drug candidates aligned with U.S. priorities.  The announcement came as the Trump administration unveiled agreements with Eli Lilly and…

  • STAT+: Pfizer’s view on the Metsera bidding war

    STAT+: Pfizer’s view on the Metsera bidding war Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We’re hosting a virtual event tomorrow about the rise and unraveling of Moderna. My colleagues Jason Mast and Damian Garde will be there to talk about…

  • STAT+: Scandal and controversy take toll on FDA credibility

    STAT+: Scandal and controversy take toll on FDA credibility Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We’ve got another busy week of earnings — Pfizer reported this morning and Novo Nordisk will be reporting tomorrow. We’ll be watching for any…

  • STAT+: Lawsuit against top FDA drug regulator is packed with incendiary texts, emails

    STAT+: Lawsuit against top FDA drug regulator is packed with incendiary texts, emails On the day the top drug regulator at the Food and Drug Administration resigned amid an investigation into his conduct, he also faced an explosive lawsuit that includes a series of incendiary texts and emails he is said to have sent to…

  • STAT+: FDA’s top drug regulator placed on leave amid investigation

    STAT+: FDA’s top drug regulator placed on leave amid investigation WASHINGTON — George Tidmarsh, the Food and Drug Administration’s top regulator of drugs, has been placed on administrative leave after being accused of using his regulatory authority to inflict financial harm on a former business associate, STAT has learned.  FDA Commissioner Marty Makary relieved Tidmarsh of…

  • STAT+: Alnylam raises guidance as sales of heart drug match expectations

    STAT+: Alnylam raises guidance as sales of heart drug match expectations Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning! Today, we have a deep probe into Moderna’s travails from STAT’s tireless Jason Mast. Also, a pharma bidding war, thoughts on psychedelic regulation,…

  • STAT+: FDA moves to ease path for biosimilars as Trump seeks to cut drug costs

    STAT+: FDA moves to ease path for biosimilars as Trump seeks to cut drug costs WASHINGTON — The Trump administration announced a draft framework Wednesday that officials say will speed cheaper versions of biologic drugs to market with the aim of making medicine more affordable and accessible for patients. The framework will shorten the path…

  • STAT+: Natera, known for spotting cancer recurrence, wades into early detection

    STAT+: Natera, known for spotting cancer recurrence, wades into early detection Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. It seems everyone I know has been getting sick lately — hope you are all taking care of yourselves! Onto the news…

  • STAT+: Eli Lilly, NVIDIA team up to build pharma’s biggest AI supercomputer

    STAT+: Eli Lilly, NVIDIA team up to build pharma’s biggest AI supercomputer Eli Lilly announced a partnership with chipmaker NVIDIA on Tuesday to build what it claims will be the “most powerful supercomputer owned and operated by a pharmaceutical company.” Lilly’s technology investment is meant to help the drugmaker tap into the potential of artificial…

  • STAT+: Novartis to buy RNA-focused Avidity in $12 billion deal

    STAT+: Novartis to buy RNA-focused Avidity in $12 billion deal LONDON — Novartis said Sunday it would buy Avidity Biosciences, which is developing RNA-based therapies for neuromuscular diseases, for roughly $12 billion in cash.  The deal, at $72 a share, represents a 46% premium on Avidity’s closing share price on Friday of $49.15.  With the…

  • STAT+: Ro wants to measure ‘food noise’ in obesity care

    STAT+: Ro wants to measure ‘food noise’ in obesity care Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning, you’ve made it Friday! We’ve got some more news to get through before heading into the weekend. FDA delivers split decision on…

  • STAT+: How the first nine drug companies won priority review vouchers from Marty Makary’s FDA

    STAT+: How the first nine drug companies won priority review vouchers from Marty Makary’s FDA WASHINGTON — Commissioner Marty Makary wants the Food and Drug Administration to move more quickly. The launch of a new priority review voucher program in June was no exception.  The agency promised winners a one- to two-month review of their drug…

  • STAT+: FDA delivers split decision on GSK’s blood cancer drug Blenrep, approving its use in some cases

    STAT+: FDA delivers split decision on GSK’s blood cancer drug Blenrep, approving its use in some cases The Food and Drug Administration on Thursday delivered a split decision on a blood cancer drug from GSK, approving its use in one combination regimen but rejecting another.  The mixed ruling is the latest twist in the turbulent…

  • STAT+: Alector’s dementia drug fails to slow patient decline in late-stage trial

    STAT+: Alector’s dementia drug fails to slow patient decline in late-stage trial An experimental drug from Alector Inc. failed to slow the decline of patients with frontotemporal dementia in a late-stage study, the company announced Tuesday. Alector said it would lay off 49% of its employees as a result. The company employed 238 people as…

  • STAT+: At ESMO, AstraZeneca and Gilead square off in triple-negative breast cancer

    STAT+: At ESMO, AstraZeneca and Gilead square off in triple-negative breast cancer BERLIN — Patients with a highly aggressive form of breast cancer will likely have new treatment options for the first time in years after AstraZeneca and Gilead Sciences both presented successful trial results here Sunday, dual achievements that will also leave clinicians having…

  • STAT+: mRNA Covid shots may boost the effects of certain cancer treatments, study suggests

    STAT+: mRNA Covid shots may boost the effects of certain cancer treatments, study suggests mRNA-based Covid vaccines from Pfizer-BioNTech or Moderna may have an unexpected benefit for cancer patients who undergo immunotherapy.  A new study suggests that these vaccines might boost the effects of immunotherapy drugs, perhaps by alerting the immune system and helping direct…

  • STAT+: Roche, Celcuity detail successful advanced breast cancer studies

    STAT+: Roche, Celcuity detail successful advanced breast cancer studies BERLIN — They may be working on vastly different scales — the biotech Celcuity has a market cap of about $2 billion, while Roche reaped more than $60 billion in sales last year — but both companies unveiled data here Saturday that they hope will win…

  • STAT+: Biotech leaders say uncertainty at FDA threatens drug development

    STAT+: Biotech leaders say uncertainty at FDA threatens drug development BOSTON — Replimune Group and Capricor Therapeutics both seemed on track to receive long-awaited drug approvals from the Food and Drug Administration earlier this year.  Then, amid tumult at the agency as the Trump administration took power, their applications were rejected. The companies’ CEOs talked…

  • STAT+: J&J reportedly in talks to buy Protagonist

    STAT+: J&J reportedly in talks to buy Protagonist Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. My colleagues were hard at work throughout the weekend reporting on major firings across the CDC. We’ve also got a ton of biopharma news…

  • STAT+: Kailera Therapeutics, an obesity drug startup, raises $600 million

    STAT+: Kailera Therapeutics, an obesity drug startup, raises $600 million Investors announced one of the biggest private financing rounds of the year for a biotech company Tuesday, pouring $600 million into obesity startup Kailera Therapeutics.  Bain Capital’s private equity group led the financing, which also included Royalty Pharma, the sovereign wealth fund in Qatar, and the…

  • STAT+: FDA declares Novo Nordisk plant, key to drug manufacturing for some biotechs, out of compliance

    STAT+: FDA declares Novo Nordisk plant, key to drug manufacturing for some biotechs, out of compliance A troubled Indiana contract manufacturing plant recently acquired by Novo Nordisk is considered to not be in compliance with the Food and Drug Administration standards, a serious designation that could further delay the approval of drugs made in the…

  • STAT+: Sarepta to seek approval for gene therapy in rare form of muscular dystrophy

    STAT+: Sarepta to seek approval for gene therapy in rare form of muscular dystrophy An experimental gene therapy from Sarepta Therapeutics increased levels of the gene missing in an ultra-rare form of muscular dystrophy, according to data the company presented Friday. The company has said it plans to file for approval in the disease, known…

  • STAT+: Billionaire-backed VC firm launches, led by former Flagship associate

    STAT+: Billionaire-backed VC firm launches, led by former Flagship associate Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. At the start of this week, my editor said the news flow was looking slow. He’s jinxed us yet again. Let’s get…

  • STAT+: Orca submits T cell therapy for FDA approval

    STAT+: Orca submits T cell therapy for FDA approval Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. We’ve got some exciting news of our own this morning: the return of Damian Garde, who once authored this very newsletter and who is coming…

  • STAT+: TCGX closes $1.3 billion fund amid investor surge

    STAT+: TCGX closes $1.3 billion fund amid investor surge Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. Today, we talk about the big regulatory changes afoot in Europe, how telehealth upended the drug market, and more. The need-to-know this morning …

  • STAT+: A second generic version of the abortion pill mifepristone approved by FDA

    STAT+: A second generic version of the abortion pill mifepristone approved by FDA Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hullo! Today, we talk about Amgen’s positive new PCSK9 data, learn more about the new NIH office meant to reduce reliance…

  • STAT+: Which biotechs are affected by the government shutdown?

    STAT+: Which biotechs are affected by the government shutdown? Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. I can’t believe it either, but we’re in the fourth quarter of the year. We’ve got a guide for you on the key…

  • STAT+: U.K. is urged to probe drugmakers for conspiring to scrap or halt investments amid pricing disputes

    STAT+: U.K. is urged to probe drugmakers for conspiring to scrap or halt investments amid pricing disputes The U.K.’s antitrust regulator has been asked by patient advocacy groups to investigate several large drugmakers and their U.K. lobbying organization for “suspected” and “coordinated” efforts to drive up the prices of medicines. The backdrop to the complaint…