Tag Archives: 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 …

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 …

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 …

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 …

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 …

Packages of M&M’s milk chocolate candy are stacked at a Costco Wholesale store on July 12, 2025 in San Diego, California. Kevin Carter | Getty Images News | Getty Images Candy maker Mars said Wednesday it’s partnered with biotech company Pairwise to speed up the development of more resilient cocoa using CRISPR-based gene editing technology. The agreement gives the M&M’s …

Celcuity’s breast cancer combo hits goals, teeing up FDA filing  Fierce Biotech Celcuity Stock Triples on Positive Breast Cancer Treatment Study  Yahoo Finance Celcuity’s triple cancer drug combo beats AstraZeneca in halting cancer progression, shows study  Mint Celcuity posts Phase 3 win in breast cancer, setting up challenge to Novartis and Roche  Endpoints News Gedatolisib Triplet Boosts Progression-Free Survival in Breast Cancer  Curetoday Source link

William J. Rutter, Biotech Pioneer of Gene-Based Medicine, Dies at 97  The New York Times Source link

Replimune’s shares crater as FDA rejects melanoma drug  Fierce Biotech Replimune skin cancer therapy rejected by FDA, a sign of regulators’ hardened stance  statnews.com Replimune drug rejected by FDA; Omega raises $647M biotech fund  Yahoo Finance Replimmune Plummets Following FDA’s Surprise Rejection of Melanoma Treatment  BioSpace Replimune Stock Plummets 75% After FDA Rejects Application for Skin Cancer Treatment  Barron’s Source link

Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at drewqjoseph.45. The Food and Drug Administration on Monday named George Tidmarsh, a longtime biotech executive who has a background in oncology and pediatrics, as its top drug regulator. Tidmarsh, who will be the director for the FDA’s Center for Drug Evaluation and …