BioNTech's mRNA cancer vaccine BNT113 misses primary endpoint in head and neck cancer trial
The Phase 2/3 miss raises doubts about mRNA cancer vaccine approaches and weighed on BioNTech shares.
BioPharm International · +14 outlets
Verastem's KRAS G12D inhibitor shows robust early response in pancreatic cancer study
Early data could make Verastem competitive in the crowded KRAS inhibitor field, where a rival drug struggled.
STAT · +14 outlets
FDA approves new weight loss drug
The approval adds another entrant to the fast-growing obesity treatment market.
BusinessWorld Online · +14 outlets
Merck and Moderna outline plans to pair Keytruda with personalized mRNA cancer vaccines
Executives said there is a lot of exploring to do after initial melanoma vaccine success, and Moderna shares rallied on the news.
STAT · +6 outlets
Arrowhead RNAi drug crosses into brain and hints at Alzheimer's benefit in first-of-its-kind study
A subcutaneously administered RNA interference medicine reduced levels of a protein implicated in the disease.
Biopharmadive · +5 outlets
FDA launches rare disease framework initiative to modernize small-cohort trial design
A revamped regulatory approach may reduce guesswork for investors weighing rare disease drug approvals.
Biopharmadive · +5 outlets
Former FDA commissioners Califf, Gottlieb and Sharpless criticize HHS leadership and DOGE cuts
The former chiefs said the staff exodus robbed the FDA of institutional knowledge that will take years to restore.
STAT
Trump administration advances plan to let specialty pharmacies produce peptides
The largely unregulated peptide injections are favored by HHS secretary Robert F. Kennedy Jr.
STAT · +2 outlets
AI drug discovery specialist Iambic banks $150M in IPO
The listing adds to a wave of young biotechs using AI to accelerate research.
Biopharmadive · +4 outlets
Kenya reports second Ebola case as Congo outbreak death toll exceeds 4,000
Authorities have struggled to contain the outbreak in Congo amid thousands of confirmed cases.
STAT · +14 outlets
Ultragenyx raises $413M selling rare disease priority review vouchers
The company monetized vouchers won from recent gene therapy approvals to fund pipeline expansion.
MedCity News · +3 outlets
Pig kidneys frozen for a year successfully rewarmed and shown to work again
Scientists hope to replicate the cryopreservation findings with human organs.
MIT Technology Review · +5 outlets
Legend Biotech wins FDA clearance for IND of in vivo CD19/CD20 CAR-T therapy LB2501
The in vivo CAR-T approach aims to generate immune cells inside the body rather than through ex vivo engineering.
The Manila Times · +6 outlets
CVS to pay $315M to settle opioid prescribing allegations
Prosecutors said the company filled unnecessary prescriptions that fueled the opioid epidemic.
Biopharmadive · +14 outlets
Zydus moves closer to US market as FDA accepts Keytruda biosimilar application
The acceptance advances a biosimilar challenge to Merck's blockbuster immunotherapy.
The Economic Times · +1 outlets
ImmunityBio wins FDA clearance for Anktiva expansion in bladder cancer
The expansion follows a period of regulatory whiplash for the company.
Fierce Pharma · +14 outlets
FDA adcomm members' ties to industry under scrutiny in new research
Nearly 40% of FDA advisory meetings over a 20-year period included patient or consumer reps with active industry ties.
STAT
Armed Cell Therapeutics revives Galapagos CAR-T research after rebrand to Lakefront
The Belgian startup, chaired by former Galapagos CEO Paul Stoffels, assumes control of divested cell therapies.
Biopharmadive · +1 outlets