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CDER chief on inspection backlog: 2025 will be a 'crucial year'
WASHINGTON, DC — CDER director Patrizia Cavazzoni on Monday stressed that while the agency is looking to reduce its backlog of surveillance inspections, pre-approval inspections will continue to...
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#WCLC24 roundup: ArriVent thinks its drug can fill Tagrisso's gaps;...
Aside from Summit Therapeutics’ shocking win over Merck’s Keytruda, here’s what else you need to know from the World Conference on Lung Cancer, which is currently underway in San Diego: ArriVent...
View ArticleA General Catalyst-backed startup raised $38M to help workers buy health...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) When Thatch hired its first employees in 2022, none of them were happy with the health insurance plan...
View ArticleHouse passes Biosecure Act, sending Chinese biotech ban to Senate
The US House of Representatives on Monday evening passed the Biosecure Act with broad bipartisan support, advancing a controversial bill that could upend many drugmakers’ supply chains. The bipartisan...
View ArticleFDA advisors question whether Iterum's application for a UTI antibacterial is...
An FDA advisory committee raised concerns Monday about whether Iterum’s application for a new oral antibacterial to treat urinary tract infections is restrictive enough to balance the risk of increased...
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Bayer's treatment for menopause symptoms hits primary endpoints in third...
Bayer touted more detailed data from a Phase 3 trial for elinzanetant, a non-hormonal drug candidate that it’s investigating as a treatment for menopause symptoms like hot flashes and night sweats. The...
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Roivant unveils its next deal, hoping for TL1A-sized potential from a shelved...
Nearly a year after agreeing to a $7 billion-plus sale for an inflammatory bowel disease drug candidate, Roivant Sciences is pitching big potential in another drug from the back of a drugmaker’s...
View ArticleExclusive: Bain scoops up $3B for fourth life sciences fund after handful of...
Bain Capital Life Sciences has reeled in about $3 billion for its fourth fund, Endpoints News has learned. The Boston-based firm has been on a spree in recent quarters. Its portfolio companies Aiolos...
View ArticleCentessa to take narcolepsy drug into Phase 2 after no sign of side effects...
Centessa Pharmaceuticals plans to take its orexin receptor 2 agonist into mid-stage testing for narcolepsy after a Phase 1 study showed signs of efficacy. The drug, ORX750, was tested in sleep-deprived...
View ArticleUpdated: Viridian reveals first Phase 3 eye disease data in bid to compete...
Viridian Therapeutics on Tuesday reported topline Phase 3 data for its rare autoimmune disease drug veligrotug as it aims to compete with Amgen and Horizon’s Tepezza. Veligrotug hit on all primary and...
View ArticleIonis’ $500M offering; Terns aims to raise $125M
Plus, news about Chai Discovery, Relay Therapeutics, Incannex Healthcare, PhoreMost, Epsilogen and LIFTT: Ionis prices $500M offering: The veteran RNA biotech is offering 11.5 million shares $IONS at...
View ArticleGSK to shut down UK antibiotic facility following end of Sandoz contract
GSK is closing down a facility and is winding down antibiotic manufacturing operations at another factory as Novartis’ Sandoz chooses to end its four-year contract. The British drugmaker will close...
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Exclusive: A male contraceptive may prevent 99% of pregnancies. Now it’s up...
A reversible male contraceptive could be a lot closer to reality than you think. Earlier this summer, doctors were tantalized by preliminary data showing that an experimental drug safely reduced sperm...
View ArticleRoche's dual GLP-1/GIP results show promising weight loss, but also high...
Roche’s new weight loss candidate has the efficacy the Swiss pharma was looking for. But it also comes with a high rate of side effects that have plagued the drug category. On Tuesday, the drug...
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Lilly's weekly insulin hits primary endpoints in two more late-stage diabetes...
Eli Lilly released two more sets of data for its once-weekly insulin efsitora a week after touting data from another two trials in its late-stage QWINT development program. At the European Association...
View ArticleFDA sends warning letter to Indian drugmaker after finding glass in injections
Indian generic manufacturer Zydus Lifesciences was hit with an FDA warning letter on Tuesday after it shipped vitamin B injections containing glass particles. An inspection from April 15 to April 23 at...
View ArticleCongress spars over whether the Biosecure Act is an overdue crackdown or a...
After the House of Representatives passed a bill to ban biotech and pharma companies from working with a handful of Chinese contractors, opponents of the legislation are raising new questions about the...
View ArticleGilead partners with AI startup Genesis Therapeutics to make small molecule...
A well-funded California biotech startup using AI to design and improve small molecule drug candidates has just struck its third pharma partnership in four years. Gilead announced a new preclinical...
View ArticleOptum's biosimilar business to exclude brand-name Stelara, Humira in 2025
Optum Rx is moving into the biosimilar business with a company it’s calling Nuvaila, and it’s starting out with biosimilars to AbbVie’s blockbuster rheumatoid arthritis drug Humira and J&J’s...
View ArticleAdicet follows other cell therapy biotechs in autoimmune pivot
Adicet Bio is shelving plans to use its lead asset to treat cancer and instead shifting its target to autoimmune diseases. The move, disclosed by the cell therapy-focused biotech in an SEC filing...
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