UroGen touts long duration of response for its bladder cancer chemotherapy gel
In a Phase 3 study, patients who saw a complete response at three months after receiving UroGen Pharma’s therapy had an 82% chance of having no cancer progression another year later. UroGen’s...
View ArticleUltragenyx to seek accelerated approval for rare disease gene therapy
Ultragenyx moved one step closer to establishing a new surrogate biomarker for accelerated approval in rare disease gene therapies. The biotech said Wednesday it will seek accelerated approval for its...
View ArticleSiegfried nabs US site from Curia; Merck KGaA pumps €62M more into its HQ
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Siegfried is acquiring a manufacturing facility in Grafton, WI, from...
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Radiopharma execs warn that lutetium could be at risk of shortage
The radioisotope lutetium-177 is at risk of slipping into shortage due to rapidly increasing demand, outdated manufacturing infrastructure and vulnerable supply chains, some radiopharma manufacturer...
View ArticleAlchem faces fines over price-fixing allegation from the European Commission
Alchem International has been accused by the European Commission of being a part of a “cartel” of companies to fix prices for a pharmaceutical ingredient. According to the Commission, Alchem “may have...
View ArticleTelehealth startup Done's execs arrested and charged for alleged Adderall...
Top executives at the telehealth startup Done Global have been arrested and charged for allegedly peddling easy access to Adderall and other potentially addictive stimulants, in many cases when they...
View ArticlePharma industry praises Supreme Court's rejection of abortion pill challenge
The Supreme Court has unanimously rejected an attempt by doctors and anti-abortion groups to limit the use of the abortion pill mifepristone. The Court on Thursday held that the plaintiffs failed to...
View ArticleStakeholders weigh in on potential reforms to FDA advisory committee process
The FDA on Thursday heard feedback from a slew of stakeholders on potential upcoming changes to the advisory committee process — and the reviews were mixed. The meeting was held to glean public input...
View ArticleBristol Myers' cancer drug Augtyro wins new accelerated approval in solid tumors
Bristol Myers Squibb’s 2022 buyout of Turning Point Therapeutics for $4.1 billion continues to score wins at the FDA. On Thursday, the agency announced that a drug acquired as part of the deal,...
View ArticleTelix Pharmaceuticals pulls Nasdaq listing plans just before trading was to...
Telix Pharmaceuticals is no longer going to list on the Nasdaq, the company announced Thursday evening, pulling its US IPO shortly before it was to start trading. Telix was planning for a roughly $200...
View ArticleXtalPi raises $115M from Hong Kong IPO to expand AI drug R&D services
Chinese AI drug discovery company XtalPi has landed on the Hong Kong stock exchange after nearly $115 million ($896.13 million HKD) from an IPO. XtalPi, which is listing under the name QuantumPharm,...
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Bill Haney gives up CEO post at Skyhawk, becomes chairman; Bayer parts ways...
Bill Haney → Bill Haney has helped Skyhawk Therapeutics stand out in the wave of biotechs looking to drug RNA, taking over from fellow co-founder Kathleen McCarthy early in its history and engineering...
View Article#ADA24: Innovent details Phase 3 weight loss data from Lilly-partnered GLP-1...
Innovent Biologics has lifted the curtain on late-stage data from its next-generation “double-G” drug in overweight or obese Chinese patients after the company teased in January that the trial...
View Article#EHA24: Roche details overall survival data on bispecific antibody Columvi
Roche released detailed data at the European Hematology Association congress for its CD20xCD3 bispecific antibody Columvi in earlier lines of large B cell lymphoma, showing just how much the drug...
View ArticleStephen Squinto talks writing checks and next-gen obesity drugs as JP Morgan...
Over a year and a half since its inception, JP Morgan’s life sciences investment arm has closed its first biotech venture capital fund with over $500 million. JP Morgan Life Sciences Private Capital...
View ArticleTakeda signs option deal for TKI inhibitor; Enveda's $55M raise
Plus, news about IN8bio, Rezolute, BeiGene and NewBridge: Takeda, Ascentage ink option deal: The deal involves a compound called olverembatinib, which Takeda described as an oral BCR-ABL TKI inhibitor...
View ArticleAutoimmune CAR-T data dump: Kyverna, Cabaletta shares fall after unveiling...
In 30 patients with a number of autoimmune conditions who received Kyverna Therapeutics’ CAR-T cell therapy, 21 were able to stop taking their immune disease medications. The results mark one of the...
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Vaxart wins $453M in BARDA funding for oral Covid-19 vaccine
The Biomedical Advanced Research and Development Authority (BARDA) has granted up to $453 million to Vaxart to revive its work on an oral Covid-19 vaccine, backing a technology that had seemingly...
View ArticleRare pediatric disease vouchers face uncertain future after September
Congress has until the end of September to reauthorize a voucher program that’s meant to incentivize new drug development for rare pediatric diseases. But the program faces a tough congressional...
View ArticleEnding 'product hopping' and other patent changes could save US $3B over a...
The Congressional Budget Office predicted that a patent reform bill introduced last year could result in federal savings of more than $3 billion over the next 10 years. The Affordable Prescriptions for...
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