The co-founders of mRNA specialist BioNTech – husband and wife team Uğur Şahin and Özlem Türeci – have said they are leaving to set up a new company.
‘BlackSanta’ EDR Killer Targets HR Workflows
A campaign by Russian-speaking cyberattackers hijacks workflows to deliver security-busting malware, allowing attackers to steal data without detection.
China is going after the world’s most expensive drugs: Endpoints Signal
Gene therapies were supposed to be competition-proof. They are scientifically complex, require bespoke manufacturing, often go after small patient populations and can cost millions per dose. But that assumption is being tested by a wave …
FDA widens use of leucovorin without new trial data
The FDA approved the now-generic drug leucovorin to treat patients with a form of cerebral folate deficiency, satisfying a monthslong effort to widen the drug’s use for a condition whose symptoms can resemble a form …
Lundbeck names AI head in quest to become ‘bionic’ company
Lundbeck has appointed Markus Kede to the newly created role of chief AI officer, charged with driving its ambition to become a ‘bionic’ company.
Patients want price transparency, e-commerce experience from pharma DTP platforms: survey
Pharmas’ direct drug sale platforms could be the key to bridging the sizable gap between patients’ awareness of certain medications and actual prescription numbers, a new survey suggests.
BMS eyes another celmod filing in myeloma after phase 3 win
Bristol Myers Squibb now has positive phase 3 data under its belt for celmod mezigdomide, as it waits for an FDA verdict on lead drug iberdomide.
Breakout Ventures closes $114M fund, plans 20 investments
Breakout Ventures has raked in a new $114 million fund and aims to dole out money to about 20 companies, bolstering the VC’s early-stage investment strategy. The latest fund announced Tuesday is the firm’s first …
Filana leaves Cassava roots behind amid branch into epilepsy
Cassava Sciences has rebranded as Filana Therapeutics, shedding the baggage associated with the old name as the biotech plants itself in a new therapeutic area.
BioNTech co-founders to exit company and start a new one
Uğur Şahin and Özlem Türeci are set to leave BioNTech by the end of the year and establish a new company dedicated to next-generation mRNA innovations. BioNTech itself will narrow its focus to its late …
FDA cuts testing requirements for biosimilars once again
The FDA has issued additional guidance that aims to make it easier for drugmakers to bring biosimilars of patent-expired biologic drugs to market.
Quality assessment of large language model–generated prior authorization letters in nephrology
BackgroundPrior authorization (PA) is a major source of administrative burden, treatment delay, and clinician burnout. Artificial intelligence (AI), particularly large language models (LLMs), is increasingly used to assist with clinical documentation, yet its reliability for payer-facing administrative tasks remains uncertain.ObjectiveTo evaluate the quality of PA letters drafted by ChatGPT-5 for commonly used medications requiring PA […]