Advanz Pharma faces revocation of European authorization for liver disease...
The conditional marketing authorization for Advanz Pharma’s liver disease treatment Ocaliva has been revoked following a decision by the General Court of the European Union, the company announced...
View ArticleNovartis to cut 139 jobs in NJ as part of commercial refocus
Novartis is laying off 139 employees in East Hanover, NJ, as the company shifts its commercial resources away from two “well-established” medicines. The layoffs will mainly affect members of the...
View ArticleFDA is looking into hematology risks after patients take Bluebird's Skysona...
The FDA said Wednesday that it is investigating "serious risk of hematologic malignancy" following the administration of bluebird bio's Skysona, a gene therapy approved for the rare disease known as...
View ArticleApplied Therapeutics' rare disease drug gets a CRL
The FDA rejected Applied Therapeutics’ experimental treatment for a rare disease called classic galactosemia, citing deficiencies with the application. The company, while “disappointed with the FDA’s...
View ArticleEli Lilly, Pfizer stress independence of telehealth partners in response to...
In response to lawmakers' concerns, Pfizer and Eli Lilly said last week that they do not influence telehealth partners and their clinicians to prescribe their brand-name drugs. Both companies launched...
View ArticleKiromic and SEC settle over undisclosed clinical trial holds
The SEC said Tuesday that it settled charges filed against Kiromic BioPharma, a tiny immuno-oncology startup based in Texas, for failing to disclose clinical holds on two experimental cancer drugs...
View ArticleGSK terminates Phase 2 trial of HBV therapeutic vaccine
GSK has axed a Phase 2 study of a chronic hepatitis B therapeutic vaccine, adding to a string of treatment R&D hurdles for the liver infection. The termination of the study of GSK3528869 was the ...
View ArticleLilly removes body mass ranges from FDA label for weight loss drug
Eli Lilly has removed the commonly used clinical measure of body mass index from the FDA label for its weight loss drug Zepbound, a move that could give physicians greater leeway to decide who should ...
View ArticleOn heels of MariTide data, Danish obesity biotech discloses €80M Series A
Versant is out with its third obesity biotech of the year, leading an €80 million Series A for Antag Therapeutics, a Danish company developing a drug that uses a similar approach as Amgen's...
View ArticleGSK makes another ADC deal, this time with BioNTech's partner DualityBio
GSK is returning to China for another antibody-drug conjugate deal, and it's tapping into a company that already has alliances with BioNTech, Adcendo and others. The UK pharma is ...
View ArticleLilly wins head-to-head weight loss trial against Novo Nordisk
The market for first-generation weight loss treatments has been dominated by two major players, Eli Lilly and Novo Nordisk. But new data provide the clearest evidence yet that one may have an edge. On...
View ArticleAtea blueprints Phase 3 for hepatitis C combo after mid-stage win
Atea Pharmaceuticals touted data from a mid-stage trial studying its hepatitis C drug combo on Wednesday, announcing that it had hit both safety and efficacy primary endpoints. The 275-patient trial...
View ArticleDewpoint partners its ALS program, eyes JPM to raise a Series D
Molecular condensates startup Dewpoint Therapeutics has signed on its latest partner, this time forging a future for its ALS program with Mitsubishi Tanabe Pharma Corporation in a pact worth up to $480...
View ArticleRo’s weight loss business more than doubled in the last year. Now it’s trying...
With direct-to-patient services for obesity drugs facing scrutiny, the telehealth startup Ro is trying to prove that its online weight loss program is up to snuff. To that end, the startup released ...
View ArticleGSK partners with Rgenta on RNA-targeted small molecules for oncology, other...
GSK will team up with Boston-area biotech Rgenta Therapeutics to create oral small molecules that target RNA, the companies said Wednesday morning. The duo will discover and develop splice modulators...
View ArticleUpdated: CEO of UnitedHealth insurance unit shot and killed in New York in...
UnitedHealthcare CEO Brian Thompson was shot and killed in Midtown Manhattan Wednesday morning ahead of the insurer's investor day, according to the company and police. The New York Police Department...
View ArticleGeneDx bets that rare disease data can aid drug discovery
Two years ago, GeneDx was teetering. The genetic testing company had laid off 33% of its staff, shares were down 90% from a year prior, and some investors were skeptical of a turnaround plan. ...
View ArticleRelmada's rapid-acting NMDA depression drug expected to fail second Phase 3
Relmada Therapeutics said Wednesday morning that a Phase 3 study testing its major depression drug, REL-1017, is likely to fail, cratering its stock price. The study’s data monitoring committee said...
View ArticleAstraZeneca's new EVP of international amid China investigation; Janux’s...
Plus, news about Arrakis, Eli Lilly, Everest Medicines, Teva, Rondo Therapeutics, Trevi Therapeutics, Foresee Pharmaceuticals and Revolution Medicines: AstraZeneca taps new leader to run China...
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