Medicine

The Food and Drug Administration on Tuesday approved Vertex Pharmaceuticals’ CRISPR-based medicine Casgevy for the inherited blood condition beta thalassemia, expanding its use six weeks after issuing a landmark clearance in…

Guarded optimism seems to be the mood of the biopharmaceutical industry to start 2024. Last year brought a stock market slide and layoffs for more than 150 drug companies. Financial…

Over the span of five months, biotechnology startup Aiolos Bio launched, raised initial funding from venture investors and negotiated a $1 billion buyout by GSK. The acquisition, announced by GSK…

The J.P. Morgan Healthcare Conference, a yearly temperature taker for the biotechnology industry, had a different feel in 2024. For the first time in awhile, young drugmakers and their backers…

Dive Brief: The use of GLP-1-based drugs to treat obesity and diabetes has no “clear relationship” with the risk of suicidal thoughts or actions, the Food and Drug Administration said…

Chris Gibson, the CEO of Recursion Pharmaceuticals, thinks the future of drug discovery lies within a ChatGPT-like interface. At a J.P. Morgan Healthcare Conference reception co-hosted with Nvidia, the tech…

A group of high-profile scientists and billionaire financiers are building a new biomedical research institute that they claim will offer a new model for studying disease biology and developing new…

European regulators will seek outside advice before making a decision on approval of Eisai and Biogen’s Leqembi medicine for Alzheimer’s disease. The Committee for Medicinal Products for Human Use opted…

Dive Brief: The number and amount of biotechnology financings dipped in 2023, with venture firms investing 25% fewer dollars in companies compared to the year prior, according to new quarterly…

The mood shifts on the third day of the J.P. Morgan Healthcare Conference. Deals have been announced and news peters out. The most closely-watched companies have already presented. Investors and…

The arrival of powerful new drugs for obesity has reshaped the pharmaceutical industry, transforming Eli Lilly and Novo Nordisk into the sector’s most valuable companies and sending others scrambling to…

Biotechnology’s embrace of artificial intelligence was never more literal than Tuesday at the J.P. Morgan Healthcare Conference, when AI drug discovery specialist Recursion handed out umbrellas in front the Westin…

For the first time, the Food and Drug Administration has authorized a U.S. state to import prescription drugs from Canada, granting Florida preliminary clearance to bulk purchase medicines from wholesalers…

A California-based company has raised tens of millions of dollars to support its mission of bringing an ecstasy-based therapy to patients with post-traumatic stress disorder. MAPS Public Benefit Corp. formed…

Dive Brief: Allogene Therapeutics, a leading developer of “off-the-shelf” cell therapies for cancer, will deprioritize two of its most advanced clinical trials as part of a new plan to improve…

CRISPR specialist Intellia Therapeutics on Thursday said it will lay off about 15% of its workforce as it pauses some early-stage research. The cuts come a little over three months…

To build a new biotechnology startup, Alex Aravanis looked to the past. The former Illumina and Grail executive has spent decades examining the human genome, starting with his postdoctoral studies…

Dive Brief: Canada’s health regulators have approved Pfizer’s gene therapy for hemophilia B, the company said Wednesday, making it the first time the drugmaker has received regulatory clearance for such…

The Food and Drug Administration closed out 2023 with rejections of three drugmaker applications for first approval or expanded use, handing Amgen, Zealand Pharma and Merck & Co. complete response…

Dive Brief: Swiss pharmaceutical company Novartis has formed a new collaboration with partner Voyager Therapeutics, agreeing Tuesday to license one experimental gene therapy and the tools to develop another. Novartis…

A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications. 

Dive Brief: Sanofi will stop developing one of its top cancer drug prospects after the experimental treatment fell short in a late-stage study in advanced lung cancer, the company said…

Dive Brief: Weeks after installing a new CEO, BioMarin Pharmaceutical is overhauling oversight of the company at the board level. Facing pressure from activist investor Elliott Investment Management, BioMarin’s board…

Dive Brief: Gene therapy developer MeiraGTx is selling its remaining financial interest in an eye-disease treatment partnered with Johnson & Johnson, announcing Thursday it is receiving $65 million up front…

Dive Brief: The Food and Drug Administration on Thursday approved a new medicine for a form of the rare disease transthyretin amyloidosis, clearing AstraZeneca and Ionis Pharmaceuticals’ Wainua for adults…

Sarepta Therapeutics has asked the Food and Drug Administration to expand approval of its gene therapy for Duchenne muscular dystrophy, banking on the regulator’s flexibility in reviewing conflicting clinical trial…

Bristol Myers Squibb has agreed to acquire Karuna Therapeutics in a deal worth $14 billion, betting that the biotechnology company’s schizophrenia drug will become a top-selling medicine. Per deal terms…

Dive Brief: Clene Nanomedicine on Thursday said the Food and Drug Administration doesn’t believe the company has gathered enough evidence to support an accelerated approval of its experimental drug for…

Dive Brief: Argenx lost a quarter of its value Wednesday after reporting the second research setback in two months for its bid to expand use of its only approved drug.…

Dive Brief: GSK is deepening its investment in cancer treatments called antibody-drug conjugates, announcing Wednesday plans to pay $185 million to China-based Hansoh Pharma to license an experimental drug that…

Merit Cudkowicz has spent her career treating some of the most unforgiving illnesses. She’s watched Alzheimer’s disease steal memories and Huntington’s disease take control of muscles. But the cruelest may…

Dive Brief: Shares of UniQure dipped more than 10% Tuesday morning after the biotechnology company released more data from a small study testing an experimental gene therapy for Huntington’s disease.…

Dive Brief: DNA sequencing company Illumina said Sunday it will divest Grail, the liquid biopsy maker it fought to hang onto after purchasing the business for $8 billion more than…

Dive Brief: The Novo Nordisk Foundation, which owns a controlling stake in drugmaker Novo Nordisk, said Monday it will invest 1.8 billion Danish kroner, or about $260 million, to fund…

Dive Brief: Venture capital group Pivotal Life Sciences has raised its second fund, securing $389 million to invest in young drugmakers, the firm announced Monday. Pivotal, which has offices in…

European drug reviewers appear likely to recommend against clearing a new medicine from Apellis Pharmaceuticals in another stumble for a first-of-its-kind treatment the Food and Drug Administration approved earlier this…

Dive Brief: Days after winning U.S. approval of the first CRISPR gene-editing medicine, Vertex Pharmaceuticals is clearing up potential intellectual property questions about the sickle cell disease therapy by signing…

Amgen has a new top scientist, announcing Thursday the appointment of Novartis veteran and prolific biotechnology startup founder Jay Bradner alongside another change to its leadership team. Bradner led the…

The committee that recommends whether drugs should be approved in Europe has thrown its support behind the first medicine based on CRISPR gene editing technology, issuing on Friday a positive…

Dive Brief: The Food and Drug Administration on Thursday broadened use of a drug Merck & Co. acquired in a $1 billion buyout four years ago, clearing Welireg for use in…

Dive Brief: An experimental cancer vaccine from Moderna and Merck & Co. continued to show promise in treating melanoma, with newly released evidence showing that a combination of the shot…

Dive Brief: Vir Biotechnology on Thursday announced a restructuring that will result in a 12% reduction in its workforce as well as the closure of some of its research and…

Pfizer on Wednesday upped the target for its cost-cutting program, revealing the additional spending cuts alongside a sales forecast for 2024 that disappointed Wall Street analysts and sent shares down…

The U.S. Supreme Court announced Wednesday it will review a lower-court ruling that would restrict access to the widely used abortion pill mifepristone, bringing a high-profile battle over reproductive rights…

Dive Brief: AstraZeneca on Tuesday reached a deal to acquire vaccine developer Icosavax in a deal worth up to $1.1 billion.  Per deal terms, AstraZeneca will acquire Icosavax’s shares at $15…

Dive Brief: Sanofi terminated a licensing deal with biotechnology company Maze Therapeutics Monday after the Federal Trade Commission filed a lawsuit alleging that the collaboration was designed to extend the French…

SAN DIEGO — At the American Society of Hematology’s annual meeting, pharmaceutical branding is inescapable. Johnson & Johnson’s and GSK’s new logos are splashed across the side of phone charging…

The life sciences industry is evolving rapidly in response to macroeconomic shifts, regulatory changes, cost pressures, large data volumes and increasing competition. Leading organizations are investing in process mining technology…

The last line of this century’s most important biomedical research paper contained a hint of the scientific revolution to come. An ancient bacterial defense system, the researchers wrote in 2012,…

SAN DIEGO — An experimental sickle cell disease drug being developed by Pfizer has shown enough potential to advance further into testing, highlighting the expanding pipeline of therapies for the…

SAN DIEGO —The 65th annual meeting of the American Society of Hematology got a dramatic introduction. On Friday, as researchers and doctors arrived here, the Food and Drug Administration approved…

The Food and Drug Administration on Friday approved a gene editing treatment for the blood disease sickle cell, following a few weeks behind regulators in the U.K. to clear the…

The first gene therapies for sickle cell disease may treat the inherited blood condition for many years, if not a lifetime. They will also cost several million dollars. On Friday,…

Dive Brief: Spyre Therapeutics, a biotechnology spinout working on antibody drugs for diseases of the gut, announced Friday a $180 million fundraising from a group of blue-chip investors. In June,…

Dive Brief: Biotechnology startup Artbio said Thursday it raised $90 million in a Series A financing that highlighted investors’ appetite for an emerging class of cancer medicines known as radiopharmaceuticals.…

The White House on Thursday took steps to pressure pharmaceutical companies to lower the price of drugs developed with federal funding, backing a plan that would enable the government to…

Dive Brief: Venture capital activity in biotechnology is undergoing a “recalibration towards pre-pandemic investment norms,” according to a new quarterly report from Pitchbook that tracks global funding and dealmaking in…

Fujifilm said Tuesday it will invest $200 million in cell therapy manufacturing, earmarking the new funds for an area of drug research it expects to grow considerably in the coming…

Dive Brief: Pfizer and partner Valneva announced Monday that they have finished enrolling participants in a Phase 3 trial evaluating their experimental vaccine for Lyme disease.  The announcement ends a…

The Biotech Innovation Organization on Tuesday named Amicus Therapeutics co-founder and longtime leader John Crowley as its new CEO, taking over a spot interim chief Rachel King has held for…

Shares in EyePoint Pharmaceuticals more than tripled Monday morning after the Massachusetts-based biotechnology company announced summary results from a mid-stage study of an experimental eye disease drug it’s developing. EyePoint’s…

Dive Brief: The Food and Drug Administration granted conditional approval to Eli Lilly’s oral cancer drug Jaypirca in two types of blood cancer, expanding its use from a rare type…

The Food and Drug Administration’s top scientist Namandjé Bumpus will assume the role of principal deputy commissioner when longtime agency leader Janet Woodcock retires from that role in early 2024,…

Dive Brief: A contract research organization working for biotechnology company Acelyrin is disputing suggestions that it may be responsible for the failure of a high-profile study released in September. On…

AbbVie is expanding its investment in targeted cancer medicines, announcing Thursday a $10.1 billion deal to acquire ImmunoGen, a pioneer in the field of so-called antibody-drug conjugates, and its newly…

Dive Brief: Concentra Biosciences has made an unsolicited bid to acquire all outstanding shares of LianBio, a biotechnology company focused on bringing medicines to China and other Asian markets. Concentra,…

Europe’s drug regulator has more questions about the safety and potential risks of a new, widely popular class of medicines. Known as GLP-1 agonists, the class includes Novo Nordisk’s Ozempic,…

Dive Brief: Pfizer will not advance a twice-daily dose of an experimental obesity drug into further testing after results from a mid-stage study showed high rates of gastrointestinal side effects…

Flagship Pioneering is looking to raise $3 billion for its eighth venture fund, a sign the high-profile company creator continues to see investor interest in the biotechnology sector despite a…

Dive Brief: Gilead Sciences is laying off about 7% of employees at cell therapy unit Kite Pharma in a restructuring it said is meant to better align the division’s organization…

Dive Brief: Cigna and Humana are in talks to merge, according to the Wall Street Journal. The two health insurers are discussing a stock-and-cash deal that could be finalized by…

Bristol Myers Squibb has agreed to spend at least $100 million to expand a partnership aimed at creating RNA-based medicines for cardiovascular diseases. The deal, announced Tuesday, shows Bristol Myers…

The Food and Drug Adminsitration is investigating whether CAR-T cell therapies like Novartis’ Kymriah or Gilead’s Yescarta are linked to the risk of new blood cancers after receiving reports of…

An overhaul of U.S. tax law six years ago saved big pharmaceutical companies billions of dollars and reshaped how they profit from lucrative drug patents held overseas. Policy changes now…

Dive Brief: Novo Nordisk on Thursday said it will invest more than 16 billion Danish kroner, or about $2.3 billion, to expand a drug production site in Chartres, France, as…

Bayer is stopping a large clinical trial testing its experimental blood thinner asundexian in people with irregular heartbeats because it didn’t work as well as Bristol Myers Squibb’s Eliquis, the…

By the numbers   FY2024 Q2 revenue: $7.98 billion 5.3% year-over-year growth   Medical Surgical revenue: $2.14 billion 7% year-over-year growth   Diabetes revenue: $610 million 9.7% year-over-year growth Medtronic…

Roche’s Genentech unit is partnering with computing giant Nvidia in a multiyear deal that highlights the pharmaceutical industry’s growing hopes of using artificial intelligence to speed up the process of…

Dive Brief: Quotient Therapeutics, a biotechnology company focused on studying the role of somatic mutations in disease, emerged from stealth Tuesday with $50 million from Flagship Pioneering. The company aims…

Dive Brief: Merck & Co. will pay as much as $610 million to acquire private biotechnology company Caraway Therapeutics in a deal that expands Merck’s research presence in neurodegenerative disease.…

Freeline Therapeutics, a U.K.-headquartered developer of gene therapies, has agreed to be taken private in a deal with British investment firm Syncona, the companies announced Tuesday. Syncona, which already owned…

Evelo Biosciences, a biotechnology company launched by Flagship Pioneering to develop microbiome drugs, is shutting down, according to a regulatory filing. The move follows setbacks for the company, which was…