FDA names 9 first recipients of 1- to 2-month priority review vouchers Fierce Biotech FDA unveils drugs to receive expedited review in support of ‘national priorities’ AP News FDA announces first nine recipients of priority drug review vouchers | STAT statnews.com FDA unveils nine drugs getting streamlined reviews Axios US FDA announces recipients of national priority vouchers Reuters Source link
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Biotech Startup Claims It’s Getting Closer to ‘Resurrecting’ the Extinct Dodo
A version of the dodo bird (Raphus cucullatus) could make a return someday soon. Colossal Biosciences announced this week several milestones in its quest to bring the extinct species back to life. On Wednesday, the Dallas-based company reported that its researchers at the Avian Genetics Group have successfully grown pigeon primordial germ cells (PGCs) in the lab, a scientific first. …
Read More »Novartis assembles 2nd molecular glue deal with Monte Rosa, this one worth up to $5.7B – Fierce Biotech
Novartis assembles 2nd molecular glue deal with Monte Rosa, this one worth up to $5.7B Fierce Biotech Monte Rosa Therapeutics Announces Collaboration with Novartis for Degraders to Treat Immune-mediated Diseases GlobeNewswire Novartis signs up to $5.7 billion licensing deal with Monte Rosa Therapeutics Yahoo Finance Updated: Novartis extends deal spree with $120M for Monte Rosa’s immune degraders Endpoints News Novartis dives deeper into protein …
Read More »Eli Lilly reconsiders UK biotech incubator, pauses buildout – Fierce Biotech
Eli Lilly reconsiders UK biotech incubator, pauses buildout Fierce Biotech US urged UK to offer better drug pricing deal to pharma companies Financial Times Lilly’s UK Gateway Labs plans are up in the air in latest blow to region’s biopharma industry Endpoints News Eli Lilly joins big pharma fallout over drug prices The Observer Ministers scramble to gag drug giants amid fears of Trump …
Read More »Trump admin mulls 'severe restrictions' on US pharmas licensing Chinese meds: NYT – Fierce Biotech
Trump admin mulls ‘severe restrictions’ on US pharmas licensing Chinese meds: NYT Fierce Biotech U.S. Drugmakers Warn White House of Chaos as Trump Weighs Curbs on China The New York Times China Drugmaker Stocks Drop on Report of Potential Trump Curbs Bloomberg.com Rumored Trump Move Rattles China-Based Biotech Stocks Investor’s Business Daily Hong Kong stocks slip from 4-year high amid fears of US sanctions …
Read More »FDA moves to publish drug rejection letters in real time, releases new batch including Replimune's high-profile snub – Fierce Biotech
FDA moves to publish drug rejection letters in real time, releases new batch including Replimune’s high-profile snub Fierce Biotech FDA Drops Another Cache of Heavily Redacted Rejection Letters, Promises Future ‘Real-Time’ Access BioSpace In a first, FDA publishes complete response letters for ongoing drug applications Endpoints News MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-assisted Therapy Yahoo Finance In major …
Read More »NCI axes funding for pediatric brain cancer trial consortium, shifts focus to broader oncology group – Fierce Biotech
NCI axes funding for pediatric brain cancer trial consortium, shifts focus to broader oncology group Fierce Biotech A major childhood brain cancer network is ending statnews.com Pratiti Bandopadhayay: Urgent Need to Sustain Funding for Pediatric Brain Tumor Trials Oncodaily HHS winds down pediatric brain tumor pact after 26 years, prioritizing other childhood cancer work Endpoints News Parvati Tiwari: Advocates Express Alarm Over NCI’s Decision …
Read More »CSL to lay off up to 15% of workforce, cut R&D costs and spin out vaccine unit – Fierce Biotech
CSL to lay off up to 15% of workforce, cut R&D costs and spin out vaccine unit Fierce Biotech CSL to Spin Off Seqirus, Cut Up to 15% of Staff in Sweeping Restructure – WSJ The Wall Street Journal CSL Shares Slump as Disappointing Profit Eclipses Spinoff Bloomberg.com CSL shares dive as biotech firm flags more than 3,000 job cuts — as it …
Read More »Biotech Startup Tahoe Therapeutics Raised $30 Million To Build AI Models Of Living Cells
Tahoe cofounders (L-R): Kevin Shokat, Nima Alidoust, Johnny Yu and Hani Goodarzi Tahoe Therapeutics One of the holy grails of biology is digitally simulating a living cell. If researchers can use computers to more accurately understand how new medicines would react in the body, that could give them greater confidence when they’re tested on animals and humans. But while large …
Read More »IO Biotech Melanoma Drug Shows 19.4-Month PFS in Phase 3 Trial Despite Statistical Miss
IO Biotech (NASDAQ: IOBT) announced topline results from its pivotal Phase 3 trial of Cylembio® plus KEYTRUDA® for first-line advanced melanoma treatment. While the combination showed clinical improvement in progression-free survival (19.4 months vs. 11.0 months), it narrowly missed statistical significance with HR=0.77 (p=0.056). Notable findings include a profound effect in PD-L1 …
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