Industry News
Biotechnology Industry News
The FDA has named Tracy Beth…
The FDA has named Tracy Beth Høeg, M.D., Ph.D., as acting director of its Center for Drug Evaluation and Research, continuing the rapid rise of a physician who rose to prominence during the pandemic.
The FDA has proposed cutting fees…
The FDA has proposed cutting fees for early-stage companies conducting clinical development in the U.S. instead of abroad.
Capricor Therapeutics has notched…
Capricor Therapeutics has notched a key win in its efforts to bring Duchenne muscular dystrophy cell therapy deramiocel to market, hitting the primary endpoint in a phase 3 trial.
Triana Biomedicines has tapped…
Triana Biomedicines has tapped Pfizer Ventures and a number of other existing and new investors to secure a $120 million series B the biotech will use to take its lead molecular glue degrader into the
A phase 3 trial of Pharvaris’…
A phase 3 trial of Pharvaris’ deucrictibant has hit its primary endpoint, positioning the biotech to file for approval of a challenger to KalVista Pharmaceuticals’ Ekterly in a rare genetic disease.
Laboratoires Théa has penned a…
Laboratoires Théa has penned a deal potentially worth up to $280 million to get its hands on Iolyx Therapeutics’ phase 3-ready eye disease drug.
Muvon Therapeutics has linked its…
Muvon Therapeutics has linked its cell therapy to a 60% drop in stress incontinence episode frequency in a small phase 2 trial, leading the biotech to pitch the candidate as a way to reduce reliance
Weeks after being named the…
Weeks after being named the nation’s top drug regulator, Richard Pazdur, M.D., has taken steps to retire as head of the FDA’s Center for Drug Evaluation and Research at the end of this month.
The FDA has released a plan to…
The FDA has released a plan to stop or reduce the use of primates for testing the safety of certain monoclonal antibodies, the latest expansion of the regulator’s efforts to eliminate animal testing in drug
Almost exactly one year ago, Janux…
Almost exactly one year ago, Janux Therapeutics unveiled early data for its investigational T-cell engager that wowed investors and analysts alike. But the biotech’s newest update has failed to garner the same investor enthusiasm, with
Tiziana Life Sciences has pointed…
Tiziana Life Sciences has pointed to increased Big Pharma interest in the IL-6 pathway as justification for its decision to spin out its own candidate into a separate company.
Imvax has shrugged off the failure…
Imvax has shrugged off the failure of its phase 2b brain cancer trial to hit its primary endpoint, reporting evidence of improved overall survival and making a beeline for the FDA.
The European Union has launched a…
The European Union has launched a new funding initiative to support healthcare startups across the continent. The EU’s investment arm, the European Investment Bank (EIB), is teaming up with Italian conglomerate Angelini Industries to funnel
The companies will jointly develop…
The companies will jointly develop and commercialize Tessera's TSRA-196, a near-clinic candidate for alpha-1 antitrypsin deficiency (AATD) that uses Tessera's gene writing technique.
Akebia Therapeutics has struck a…
Akebia Therapeutics has struck a deal for Q32 Bio’s deprioritized complement inhibitor ADX-097, paying $7 million upfront for an asset that forms the centerpiece of its new rare kidney disease pipeline.
A phase 3 trial of Belite Bio’s…
A phase 3 trial of Belite Bio’s tinlarebant in adolescents with a rare genetic eye disease has met its primary endpoint, encouraging the biotech to add the U.S. to the list of countries where it
French vaccine maker Valneva is…
French vaccine maker Valneva is closing down a site that houses both operational and R&D work, impacting 30 employee roles.
Artificial intelligence is booming…
Artificial intelligence is booming across biopharma, with deployed tech taking aim at the industry’s biggest challenges: the significant risk of failure, high costs and long development timelines.
The FDA has delayed a decision on…
The FDA has delayed a decision on Ascendis Pharma’s dwarfism drug candidate TransCon CNP, pushing back the deadline by three months to buy time to review recently submitted information.
A federal commission is warning…
A federal commission is warning that the U.S. is losing its innovative edge, arguing that the nation needs to “reimagine the federal science enterprise” by streamlining funding and incorporating AI into processes.