FDA warns hospitals against using Pfizer's remaining potassium injections for...
In an update to a warning issued last year, the FDA said Wednesday it remains concerned about the risk of aluminum toxicity associated with a Pfizer subsidiary’s unapproved potassium phosphate...
View ArticleUpdated: Chinese government indicts Japanese Astellas employee for espionage
A Japanese employee of Astellas Pharma who was detained in March 2023 in Beijing by Chinese authorities has now been indicted on suspicion of espionage, according to reporting by Reuters and other...
View ArticleBiogen, Eisai’s Leqembi wins UK approval, but not immediate NHS coverage
Biogen and Eisai’s Leqembi has been authorized by the UK’s Medicines and Healthcare products Regulatory Agency for Alzheimer’s disease, but a negative opinion from the local cost-effectiveness watchdog...
View ArticleClik here to view.
Versant, Novartis launch Borealis Biosciences for RNA therapies in kidney...
Five years to the day after launching Chinook Therapeutics, Versant Ventures is back with a second generation of that kidney disease biotech and has a partner in Chinook’s acquirer, Novartis. The...
View ArticleClik here to view.
Digital health startup Sesame starts offering compounded weight loss shots
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Customers of Sesame, a digital marketplace that connects patients to doctors in person and online, can...
View ArticleClik here to view.
How Walgreens plans to revive retail pharmacy within three years
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) As Walgreens retreats from primary care, it’s turning its focus back to its core business and embarking...
View ArticleFujifilm Diosynth opens new UK facility; Bora completes Emergent factory buy
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Fujifilm Diosynth Biotechnologies has opened its new manufacturing...
View ArticleQ&A: GSK CSO Tony Wood on staying out of obesity, 'careful' cancer ambitions,...
When Tony Wood became GSK’s top scientist in mid-2022, the British pharma was waging battle. GSK was fighting Zantac-related litigation in court while struggling to calm investor jitters as its stock...
View ArticleClik here to view.
Illumina Ventures sets out for $300M third fund
A venture firm with Illumina as its majority investor is charging ahead with its next batch of capital as the DNA sequencing company endeavors on its own three-year return-to-growth strategy. Illumina...
View ArticleLiquidia sues FDA over exclusivity decision to delay Yutrepia's full approval
Liquidia has filed a lawsuit against the FDA over its decision to grant three years of exclusivity to United Therapeutics’ drug Tyvaso, which competes against Liquidia’s Yutrepia, the company announced...
View ArticleClik here to view.
FDA closes the door on Intarcia's eight-year bid for diabetes drug-device combo
The FDA on Thursday issued an order denying Intarcia’s appeal over its rejected type 2 diabetes combo product, ending nearly eight years of back-and-forth on the application. Intarcia received complete...
View ArticleClik here to view.
FDA approves reformulated Covid boosters for fall season
The FDA cleared a new round of Covid-19 boosters from Moderna and Pfizer/BioNTech that this time target the KP.2 variant. The updated vaccines are expected to be available in the coming days, Moderna...
View ArticleAutoimmune biotech Zenas files for IPO amid summer lull for public debuts
Zenas BioPharma filed for an initial public offering on Thursday, marking a rare move for biotech startups this summer. The late-stage autoimmune biotech follows only a few other drug developers to...
View ArticleFDA to host adcomm on PD-L1 as a predictive biomarker for checkpoint inhibitors
The FDA is assembling its Oncologic Drugs Advisory Committee next month to discuss whether a biomarker should be used to select patients with certain stomach and esophageal cancers for treatment with...
View ArticleClik here to view.
Oncology biotech Bicara unveils IPO pitch same day as Zenas
For a while, there were none. Suddenly, there were two. Bicara Therapeutics filed Thursday afternoon for an initial public offering, just a few hours after fellow Boston-area drug developer Zenas...
View ArticleClik here to view.
Gene insertion startup Tome Biosciences stops lab work as CEO shifts focus to...
Tome Biosciences, a high-profile gene editing startup spun out of MIT, is halting its lab work and looking to sell itself or find a partner to continue developing its technology, CEO Rahul Kakkar told...
View ArticleClik here to view.
Genmab makes two C-suite additions as COO leaves; James Sabry leads a...
Anthony Mancini → There are substantial leadership changes at Genmab, starting with the departure of COO Anthony Mancini. Peer Review covered Mancini’s appointment in March 2020 following a 24-year...
View ArticleClik here to view.
Jazz will still file anti-seizure med Epidiolex in Japan despite trial setback
Jazz Pharmaceuticals’ oral cannabidiol drug Epidiolex has disappointed in a late-phase test in Japanese children with seizures, but the company will still file there based on its global dataset....
View ArticleNovo's innovation hub expands to Bay Area; SIGA's new Tpoxx order
Novo Nordisk’s Bio Innovation Hub goes west: The Danish pharma’s early-stage R&D unit is partnering with MBC BioLabs, an incubator in the San Francisco Bay Area that has helped launch more than 300...
View ArticleCDER chief says 'standards have not changed,' explaining increase in CRLs for...
The FDA initially rejected nearly half of all biologics applications received last year, many for quality-related CMC issues that need to be improved upon, according to CDER Director Patrizia...
View Article