Pentagon seeks to add WuXi AppTec to military list, bringing fresh uncertainty
WuXi AppTec’s reprieve from a Washington crackdown may not last. The Pentagon has reportedly concluded WuXi AppTec should be added to a list of companies that aid the Chinese military. Such a...
View ArticleHospitals challenge 340B rebate pilot program in Maine federal court
The American Hospital Association has asked a federal court to block a controversial pilot program for the government's 340B rebate model from taking effect on Jan. 1. In a lawsuit filed Monday ...
View ArticleCosmo Pharmaceuticals’ shares rise after Phase 3 win in male pattern hair loss
Cosmo Pharmaceuticals’ shares increased 18% on the Swiss exchange Wednesday morning after it released positive late-stage results from its drug candidate in men with androgenetic alopecia. The...
View ArticlePharvaris’ hereditary angioedema drug gets Phase 3 win
Pharvaris’ on-demand treatment for hereditary angioedema attacks can diminish symptoms significantly faster than placebo, according to topline data from a Phase 3 trial released Wednesday. The drug,...
View ArticleBristol Myers pushes back Cobenfy readout after trial site 'irregularities'
Bristol Myers Squibb’s hotly anticipated Cobenfy readout in Alzheimer’s-associated psychosis will have to wait. Because of “irregularities” at a “small number” of trial sites, the pharma company said...
View ArticleExcelsior Sciences raises $95M for small molecule drug discovery, manufacturing
A New York startup that's looking to accelerate how quickly preclinical small molecule candidates enter clinical trials has corralled $95 million. Excelsior Sciences has raised $70 million in a Series...
View ArticlePfizer-allied molecular glue startup Triana collects $120M Series B
Triana Biomedicines has reeled in a $120 million Series B — $10 million higher than its 2022 Series A — to collect proof-of-concept data for its lead experimental medicine and ...
View ArticleOrion's €180M milestone payment; Iolyx partners dry eye candidate
Plus, news about QurAlis, Clene, ADC Therapeutics and Junevity: 💶 Orion to receive €180M milestone payment: The cash will come from Bayer, on the back of sales of prostate cancer therapy Nubeqa....
View ArticleBlack Diamond reports mid-stage lung cancer data, continues its hunt for a...
Black Diamond Therapeutics reported preliminary Phase 2 data for its EGFR inhibitor in lung cancer, but said it will need to find a partner to be able to move into a registrational program. Instead,...
View ArticleWith Phase 3 Duchenne success, Capricor plots path forward after FDA rejection
Capricor Therapeutics said that its cell therapy for Duchenne muscular dystrophy met both a primary and key secondary endpoint in a Phase 3 trial, boosting the company’s odds for approval as it returns...
View ArticleFDA says it won't release details of claimed Covid vaccine deaths in 'near term'
Details from an investigation by CBER Director Vinay Prasad into 10 alleged child deaths related to Covid-19 vaccines won't be coming soon, an FDA spokesperson told Endpoints News on Wednesday. FDA...
View ArticleFDA seeks to raise user fees for companies running Phase 1 trials outside the US
The FDA wants to incentivize US-based drug development by adding new fees for companies that run their Phase 1 trials outside the country, according to meeting minutes shared by the agency ...
View ArticleFormer FDA commissioners slam Prasad's plan for 'sweeping' vaccine changes
A dozen former FDA commissioners, including several former Trump appointees, issued a scathing rebuke of biologics and vaccines chief Vinay Prasad's plans to overhaul the agency's regulation of...
View ArticleFDA to name Tracy Beth Høeg, who led Covid-shot investigation, to head CDER
FDA Commissioner Marty Makary has appointed Tracy Beth Høeg, a longtime skeptic of Covid-19 vaccines, to be the acting director of the agency's drug unit, Endpoints News has learned. Her appointment is...
View ArticleHome care startup Inbound Health shuts down
Home care startup Inbound Health shut down Monday after a deal to raise more money fell apart, Endpoints News has learned. It's the latest in a string of health tech closures, as investors who once ...
View ArticleClinical trials tech startup Paradigm raises $78M, acquires part of Roche’s...
When Ken Frazier led Merck, one of the challenges of developing Keytruda was getting the blockbuster-to-be immunotherapy to a broad set of patients. Many patients who could have benefited from the drug...
View ArticleDaiichi Sankyo avoids payout in long-running patent dispute with Pfizer’s Seagen
Daiichi Sankyo said a US federal court has ruled in its favor in two patent disputes with Pfizer’s Seagen over a linker technology critical for antibody-drug conjugates. The latest turn of events lets...
View ArticleARCH, Lilly Asia Ventures return to back US-China startup SciNeuro
SciNeuro announced Thursday that it raised $53 million to study a former GSK compound in an eye complication of diabetes as well as dementia. The neuroscience biotech’s second venture funding round...
View ArticleNationwide Children’s SLC6A1 gene therapy shows early promise
A pioneering gene therapy from Nationwide Children's Hospital is bringing rare optimism to a field that has long struggled to develop such treatments for certain neurodevelopment disorders. In...
View ArticleCrescent forms PD-1xVEGF, ADC pact with Kelun, raises $185M
Crescent Biopharma made a set of sweeping moves Thursday morning, notably with its strategy of bringing its PD-1xVEGF to China. Boston-based Crescent signed a two-way deal with Kelun-Biotech, in which...
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