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 catch up. Analysts predict that so-called GLP-1 drugs like Lilly’s Zepbound and Novo’s Ozempic will become some of the most lucrative products ever sold. Their…
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 St. Francis to combat the inevitable San Francisco rain. AI, and its role in drug development, has been a major topic of discussion at the…
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 there. The decision is a major policy shift for the agency, which has long resisted drug importation efforts on grounds that it couldn’t ensure the…
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 a decade ago as a subsidiary of the Multidisciplinary Association for Psychedelic Studies, a nonprofit that both researches and promotes the use of psychedelics for…
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 on other cell-based medicines. The biotechnology company is dialing back work on a pair of studies that were designed to support approval of its therapy,…
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 after Intellia, one of the first companies founded to turn the gene editing technology into medicines, received a green light from U.S. regulators to begin…
Biotechnology is often described as an “innovation” industry, dependent on companies’ ability to invent and develop new medicines. By that metric, 2023 was a good year. The FDA’s main review office approved 55 novel drugs, the most since 2018, while the agency’s biologics division cleared 15 more. The clearances offer some counterbalance to a prolonged…
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 a genetic medicine. The gene therapy, which Pfizer licensed nine years ago from Spark Therapeutics, will compete with CSL’s Hemgenix, a similar treatment that gained…
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 letters for medicines to treat cancer, low blood sugar and chronic cough. The rejections came at the end of a year in which the regulator’s…
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 will pay the biotechnology company $100 million in cash upfront, including $20 million in stock, in a deal that could be worth as much as…
