Category: The Readout

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 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+: 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 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 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 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 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 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 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+: 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+: 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+: 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  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+: 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 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 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 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+: 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 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 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…

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 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…

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 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+: 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 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 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 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+: 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 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+: 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 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+: 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 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+: 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+: 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+: 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+: 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+: 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 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 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 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? 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+: Veru update shows FDA still values weight loss over body composition 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 news on a gene therapy for Huntington’s disease, so let’s get straight to it. Uniqure hails ‘groundbreaking’…

STAT+: Doctors are more tied to pharma as trust erodes 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 read about a big acquisition fueled by obesity, doctors shifting their views on biopharma marketing, see a rare disease drug win approval after…

STAT+: U.S. pressures U.K. as pharma pauses investments there 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 moves to potentially dismantle FDA ad comms, see the U.S. pressuring the U.K. over its stringent drug-pricing policy, and more.  The…

STAT+: Pig kidneys to enter FDA-backed human trial next year Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello there. Today, we learn the FDA is advancing a trial for gene-edited pig organs in humans, see geographical discrepancies in lung cancer trial…

STAT+: Trump pressures drugmakers amid CDC turmoil 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 from the holiday weekend. Today we have some candor in ALL CAPS from Trump on Covid vaccines, glowy data from Ionis that could lead to…

STAT+: Third Rock tops STAT’s annual VC ranking 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 colleague Allison DeAngelis has been working for months on our annual VC rankings report. Read on for what she found. Third Rock tops…

STAT+: Supreme Court lets Trump slash NIH research funds 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. The Supreme Court is allowing the Trump administration to cut $783 million in research grants tied to DEI work. Also, STAT just unveiled…

STAT+: Was the reaction to Viking’s oral data overblown? 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 learned yesterday that Walmart has recalled some of its frozen shrimp after the FDA warned that they may have been contaminated with…

STAT+: FDA delays decision on Regenxbio 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. Good morning. Today we look at what some people in the industry are calling a “pharm to table” trend. Read on to learn more about it.…

STAT+: Who are the richest people in health care right now? 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 examine the plush pay packages of health care’s top CEOs in 2024. Also, we discuss Stealth BioTherapeutics’ efforts to rally…

STAT+: Eli Lilly says it will hike list prices for drugs abroad. Now what? 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 march-in rights return to the headlines, ponder how Eli Lilly’s plan to hike list prices in Europe…

STAT+: Stoke Therapeutics release new data on Dravet syndrome 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. As AI becomes more widely used in health care, could it actually lead doctors to lose some of their skills? One new…

STAT+: Trump demands drugmakers slash U.S. price now 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, and happy birthday to me! Today, we see the Senate Appropriations Committee look to increase NIH funding, despite the Trump administration’s request to slash…

STAT+: FDA panel stirs backlash for SSRI use during pregnancy 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 how Duchenne patients and their families are responding to the shelving of Sarepta Therapeutics’ gene therapy, see an FDA panel…

STAT+: FDA opens applications for 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. Good morning. We’ve got more developments with Sarepta today. My colleagues got exclusive comments from a senior FDA official — read on for what the official said.…

STAT+: Questions about the FDA’s ‘radical transparency’ efforts Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Happy Friday. Today, we talk about the stem cell fire sale at CIRM, and about the FDA’s move to release a limited batch of complete response letters. FDA…

STAT+: Brawl over Eylea gets biosimilar industry’s attention Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello! Today, we talk about a cool experimental enzyme therapy, observe more patent maneuvers over Eylea, and see an ‘underdog’ startup get a huge seed round to…

STAT+: Khosla Ventures sets sights on $4 billion in new funds Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello, friends! We’re back. Hope you are having a delightful summer (or winter, I suppose, depending on your hemisphere). Today, we talk about morale…

STAT+: Vertex stem cell therapy spurs insulin independence Good morning! Today, we get deeper into the ousting of Nicole Verdun at the FDA, see promise from Vertex’s cell therapy for diabetes, and unpack the story of developing the newly approved Gilead PrEP drug lenacapivir. The need-to-know this morning Novo Nordisk terminated its marketing relationship with…

STAT+: HHS tries pushing pharma to the negotiating table 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’re hearing more about President Trump’s “most-favored nation” plan for drug pricing, Recursion’s case for why the company laid off 20% of…

After groundbreaking CRISPR therapy, a homecoming Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello! Baby KJ is back home! Also, we discuss the questionable efficacy of ctDNA blood tests, see what Vinay Prasad has to say at NORD, and more.  Read…

Pluvicto pushes earlier in prostate cancer play 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, STAT’s Matthew Herper chats with J&J’s R&D chief, we see the radiopharmaceutical Pluvicto being considered earlier for prostate cancer, and more.  Read the rest… Meghana…

Illumina’s PromoterAI unlocks rare disease clues in noncoding genome 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 discuss how one Brown contrarian and cancer researcher wants $50 billion for the NCI, we see a UniQure case study that…

Post-TIGIT flop, iTeos Therapeutics is shuttering 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 look at the implications of BARDA cutting a major vaccine contract with Moderna, hear why former FDA chief Scott Gottlieb thinks agency layoffs will impede…

Lilly to acquire biotech developing pain drugs 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 seeking nominations for our annual Wunderkinds list, which aims to honor some of the most promising early-career scientists out there. If you have someone in mind, submit…

GSK drug’s new approval sets up competition with Dupixent 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. Apologies that this newsletter is coming late to you this morning — we had some technical difficulties. But we’ve still got the news…

FDA approves Verastem’s ovarian cancer treatment 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 talk about the FDA’s new artificial intelligence effort in the wake of mass layoffs, see AI darling Insitro cut staff, and more. Read the rest… Meghana…

More proposed cuts to the NIH 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 talk about Arkansas making a bold move to curb PBM power, analyze Trump’s executive order in regards to drug prices, and more. Read the rest… Meghana…

Pfizer discontinues its experimental GLP-1 pill 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 interesting new gene-editing data from Verve, see the NIH starting to convene advisory councils again, and more. Read the rest… Meghana Keshavan Go to statnews

NIH hit with chaos, cuts, and contractor purge Hello. Today, we dive into the implications of the ongoing cuts to various health and science agencies….It’s a doozy. Oh, and if you like talking about neuroscience and happen to be near San Diego this weekend, come hang with me and my colleagues at STAT@AAN: The Future…

Emotional whiplash for PTC Therapeutics 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 process the shockwaves in biotech following the ouster of CBER chief Peter Marks, see a radiopharmaceutical expand its reach, and more. Read the rest… Meghana Keshavan…