FDA places two Indian manufacturers on import alerts over bare footprints and...
The FDA has prohibited two API manufacturers from shipping products to the US, with the agency reporting it found bare footprints in one producer's facility and that the other had refused access for...
View ArticleBiotech is still trying to make CRISPR a success
This is the first in a series of stories from Endpoints News that looks at the future of CRISPR and its impact on patients, science and business. *** On a sunny September day in 2023, scientists ...
View ArticlePfizer CEO says Trump opportunities outweigh risks
WASHINGTON — Over 500 pharma executives, lobbyists, consultants and other industry members gathered a couple miles from the White House on Tuesday, as top industry leaders took the stage and tried out...
View ArticleAnother Chinese biotech files to go public in Hong Kong; A new ROR1 ADC deal
Plus, news about Harmony Biosciences and Reverb Therapeutics: Genuine Biotech files for HKEX listing: The drug developer, which has multiple locations in China, joins a growing list of biotechs seeking...
View ArticleAscletis’ obesity pill looks similar to Roche’s drug, early data suggest
Ascletis Pharma’s oral GLP-1 allowed patients in an early-stage obesity trial to lose up to 6.3% of their body weight after a month of treatment, the company said Wednesday. A similar ...
View ArticleNvidia, Arc Institute release Evo 2, a new AI model for biology
Nearly a year ago, bioengineering professor Patrick Hsu asked: “Is DNA all you need?” Hsu, co-founder of the Arc Institute, posed that question while helping create Evo, an AI model trained ...
View ArticleGovernment is set to address its lab-developed test rule in court
Attorneys for the government and laboratory diagnostics trade groups have gathered in court on Wednesday to debate a controversial federal rule that brings lab-developed tests under the FDA’s...
View ArticleHims buys at-home testing company Trybe Labs
Hims & Hers bought an at-home lab testing company as it branches out into other clinical areas beyond its recent focus on weight loss. Customers will be able to get their blood tested to check ...
View ArticleCan amylin drugs take over from GLP-1s in obesity? Partnerless Zealand thinks so
Investors who were eager for news of a partnering deal for the Zealand Pharma’s mid-stage asset petrelintide had a disappointing Thursday morning: The company reported 2024 results without a big pharma...
View ArticleEG 427 collects €27M in Series B to advance overactive bladder treatment
A French biotech focused on developing genetic medicines for neurological conditions has secured €27 million in a Series B raise to support its lead program through an early clinical trial. Paris-based...
View ArticleBridgeBio’s heart disease drug Attruby sails past prescription estimates
BridgeBio revealed Thursday that prescriptions for its recently approved rare heart disease drug Attruby substantially beat analyst projections — an update that is likely to further boost confidence in...
View ArticleAstraZeneca buys FibroGen’s China unit for local control of anemia drug
AstraZeneca is furthering its presence in China by gaining complete control of FibroGen's subsidiary in the country for about $160 million. The Thursday morning move gives the UK pharma giant a ...
View ArticleDrug packaging manufacturers brace for impact as EU chemical ban looms
The European Union’s proposed ban on “forever chemicals” is expected to become law this year, and investors are beginning to question drug delivery companies and packaging manufacturers on its...
View ArticleTrump’s picks for NIH, CMS say they’ll unload industry investments
The Trump administration's respective nominees for CMS administrator and NIH director, Mehmet Oz and Jay Bhattacharya, disclosed this week that they will divest dozens of investments in biopharma and...
View ArticleIllumina to lay off about 100 people; Incyte’s new AI partnership
Plus, news about 2048 Ventures and Atai Life Sciences: Illumina to lay off 96 employees in San Diego: The company filed a WARN notice in California dated Feb. 13 and said the layoffs are expected ...
View ArticleCharles River’s $1B revenue; Theratechnologies restarts HIV drug supply
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Charles River Laboratories’ stock {$CRL} was up 7% on Wednesday after...
View ArticleWhy UnitedHealth Group is offering 30,000 voluntary buyouts to its employees
An executive for UnitedHealth Group’s insurance arm told employees that not enough people are leaving the company, leading to plans for voluntary buyouts, Endpoints News has learned. The healthcare...
View ArticleIn single case, spinal muscular atrophy drug given before birth spared baby...
A mother took the spinal muscular atrophy drug Evrysdi before giving birth to a baby with the devastating genetic disease. The baby, who went on to receive gene therapy months before they turned 2, has...
View ArticleHow Keymed steered the China-to-US NewCo model in biotech
Keymed Biosciences is a prime example of a young Chinese biotech churning out pipeline candidates ripe for out-licensing to Western drugmakers. The Chengdu-based company, which already markets its own...
View ArticleFirst meeting of CDC vaccine advisors in the Kennedy era is postponed
A meeting of CDC vaccine advisors has been postponed, according to a senior HHS official. "The ACIP meeting will be postponed to accommodate public comment in advance of the meeting," HHS...
View ArticleRoche unveils plans for its DNA sequencer that's been 18 years in the making
Has drug giant Roche finally cracked DNA sequencing? Roche has recently claimed it can quickly and accurately decode the genome, potentially a major step forward for an industry that’s vital for...
View ArticleDrugmakers tell court to keep hospitals out of their 340B rebate suits
Eli Lilly, Bristol Myers Squibb, Sanofi and Novartis are seeking to block a major hospital trade group from intervening in court cases over their proposed 340B drug rebate models. 340B Health and two...
View ArticleTrump’s HHS defends drug price negotiations in Novartis suit
Lawyers for the government gave the first substantive signal that the Trump administration will continue to defend Medicare drug price negotiations in court. In a Wednesday court brief, attorneys for...
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