Lykos’ MDMA-assisted therapy stumbles at adcomm amid questions about study,...
An FDA advisory committee voted against backing Lykos Therapeutics’ MDMA-based therapy for post-traumatic stress disorder, a blow to the biotech company’s efforts to bring the first ecstasy-based...
View Article#EASL24: Vir's early Phase 2 hepatitis D data show reduction, removal of...
Vir’s chronic hepatitis D treatment reduced the presence of the virus RNA as well as normalized certain liver enzyme levels across 24 weeks in a mid-stage test. In the Phase 2 SOLSTICE study, some...
View Article#EASL24: Lilly details mid-stage win for tirzepatide in MASH with fibrosis data
Eli Lilly has unveiled fibrosis results from a Phase 2 test of tirzepatide in patients with metabolic dysfunction-associated steatohepatitis, or MASH, which could help further increase the blockbuster...
View ArticleBioNTech co-founder Özlem Türeci on ‘hip’ ADCs and the power of combo therapies
CHICAGO — Özlem Türeci took a seven-year break from attending the American Society of Clinical Oncology’s annual meeting. She’d been busy with the Covid-19 pandemic as co-founder and chief medical...
View ArticleRadiopharmaceutical company Telix aims for $202M IPO
Amid booming interest in radiopharmaceuticals, Telix Pharmaceuticals is planning to become a publicly traded company in the US. The biotech, based in North Melbourne, Australia, on Wednesday disclosed...
View ArticleCytokinetics CEO addresses acquisition rumors, says buyer walked away, SEC...
Cytokinetics CEO Robert Blum disclosed publicly for the first time rumors of a potential buyout that fell through late last year, according to a new securities filing. The rumors first arose during the...
View ArticleRayzeBio warned of potential isotope supply issues before BMS deal
RayzeBio advised investors last year it could face problems securing actinium isotope from a Russian supplier that it relies on for international studies. Bristol Myers Squibb announced plans in...
View ArticleArriVent inks ADC deal with Alphamab; Annexon's $125M offering
Plus, news about Equillium and Structure Therapeutics: ArriVent, Alphamab team up on multi-ADC collab: The companies will work together to develop multiple antibody-drug conjugates using Alphamab’s...
View ArticleClik here to view.
AI is unlikely to take off among CDMOs at the same scale as biopharma...
With AI drumming up interest in drug discovery and R&D, Endpoints News asked insiders how CDMOs are thinking about using AI tools in manufacturing. Their response? AI uptake is stymied by tough...
View ArticleFDA hands Chinese drug manufacturer a Form 483 noting employees destroyed...
Employees of Chinese drugmaker Jiangsu Hengrui Pharmaceuticals “diverted” FDA inspectors as colleagues tore up and threw away documents in a “rapid-like manner” at a manufacturing facility, according...
View ArticleOregon jury says J&J owes talc claimant $260M
An Oregon jury awarded a talc claimant $260 million in a verdict against Johnson & Johnson on Monday. The case was brought by a 49-year-old mother of three named Kyung Lee, who claimed J&J’s...
View ArticleClik here to view.
Amgen's Uplizna succeeds in Phase 3 trial for rare autoimmune disease
Amgen released new Phase 3 data Wednesday for its rare disease drug Uplizna in an autoimmune condition, bringing it potentially closer to another FDA approval. The results may put additional pressure...
View ArticleSenate Finance Chair presses HHS to crack down on cybersecurity in wake of...
Senate Finance Committee Chair Ron Wyden (D-OR) is urging HHS to take a stronger stance on healthcare companies’ cybersecurity practices as the healthcare system is still piecing together what happened...
View ArticleClik here to view.
Amarin names new CEO as Patrick Holt departs
Amarin has its third new CEO since 2021 following the resignation of Patrick Holt. The company announced Wednesday that the board of directors promoted Aaron Berg, EVP and president of the US business,...
View ArticleClik here to view.
Lilly exec says developing new therapies for lupus is 'in scope'
Despite prior setbacks, Lilly executives said they’re pressing ahead with new research in lupus at a time when other companies are taking to cell therapy to crack the hard-to-treat disease. Paul...
View ArticleFormer Sanofi R&D leader Frank Nestle to lead Deerfield’s growing drug...
The healthcare investment firm Deerfield Management recruited a top pharma scientist to lead its growing research arm, which has sprawling connections to many of the nation’s top academic centers,...
View ArticleITM nabs €188M to boost isotope manufacturing, advance cancer pipeline
Radiopharma company and radioisotope supplier ITM, or Isotopen Technologien München, raised €188 million ($204 million) to boost in-house manufacturing of lutetium-177 as well as to push its Phase 3...
View ArticleClik here to view.
Virtual physical therapy programs can be just as good as in-person care,...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Many virtual programs used to treat common musculoskeletal problems improve pain and function, while...
View ArticleWho are the women making a mark in biopharma R&D? Nominate them for...
It’s one of our favorite times of the year: You can now nominate someone to be spotlighted in Endpoints News’ annual Women in Biopharma R&D special report. Last year, we passed the 100 mark on the...
View ArticleSeres will sell microbiome pill to partner Nestlé to pay off debt and stay open
Seres Therapeutics has signed an agreement with its commercialization partner Nestlé Health Science to sell the remaining rights to its microbiome pill and focus on developing a second drug for...
View Article