Merck, Moderna prepare FDA filing for personalized mRNA melanoma vaccine after Phase 3 results
The personalized cancer vaccine paired with Keytruda is a leading test of mRNA-based oncology and would be a major franchise for both companies.
Medical Daily · +13 outlets
Roche signs deal worth up to $15B with China's Hansoh for antibody-drug conjugate portfolio
The pact underscores Western pharma's deepening reliance on Chinese biotech for pipeline assets and includes a $400 million upfront payment.
Biopharmadive · +12 outlets
Disc Medicine's rare disease drug hits Phase 3 goal, reviving FDA approval hopes after rejection
The clean Phase 3 sweep for the light-sensitivity disease treatment sent shares to their best day since 2022 and sets up a re-engagement with regulators.
Biopharmadive · +8 outlets
Clene submits NDA seeking accelerated FDA approval for oral ALS drug
An accelerated approval filing would offer a new oral option in ALS, a field with few effective treatments.
NeurologyLive · +4 outlets
Moderna stock jumps as mRNA melanoma vaccine data looms; BMS, Pfizer also advance
Investor attention is concentrated on the Merck-Moderna cancer vaccine readout, a key catalyst for the mRNA sector.
24/7 Wall St. · +4 outlets
ICER finds most new drugs too costly at launch; net prices rose 35% from 2022 to 2025
The analysis adds pressure on drugmakers over launch pricing as the median net price reached $257,000 last year.
Biopharmadive · +14 outlets
FDA advisers narrowly vote to add 6 peptides to a drug compounding list
The vote bears on access to compounded versions of popular peptides, including knockoff diet drugs.
PBS · +6 outlets
Bipartisan lawmakers urge FDA to close peptide loophole used to import knockoff retatrutide
The push targets imports of copycat versions of Eli Lilly's investigational obesity drug.
STAT
Novartis pauses midstage Fabhalta trial in lupus nephritis, citing factors unrelated to efficacy and safety
The hold affects expansion of a key drug into a new indication, though Novartis says efficacy and safety are not at issue.
Fierce Pharma · +1 outlets
Gilead's oral IBD drug eliminates symptoms in mid-stage trial
Positive Phase 2 results give Gilead a potential entrant in the competitive inflammatory bowel disease market.
STAT · +2 outlets
China proposes restrictions on foreign acquisitions of critical biopharma technologies
The move reflects Beijing's aim to retain control of its rapidly growing drug development industry.
STAT · +8 outlets
GSK wins FDA approval for rectal cancer drug Jemperli in a subtype where most patients avoided surgery
The accelerated approval expands use of the immunotherapy into a subset of rectal cancer, following a high-profile case of a patient whose tumor disappeared.
Medical Daily · +7 outlets
Merck KGaA to buy Silence Therapeutics for $1.3B in RNAi bet
The deal adds a Phase 2 blood disorder medicine that could compete with a Takeda drug.
Biopharmadive · +11 outlets
Nouscom raises €120 million Series D to advance cancer immunotherapy into trials
The oversubscribed round backs off-the-shelf cancer vaccines, including data in Lynch syndrome carriers at ESMO.
EU-Startups · +8 outlets
Dana-Farber, Beth Israel to begin construction of $1.68 billion cancer hospital in Boston
The project intensifies competition with Mass General Brigham in the Boston cancer care market.
STAT · +6 outlets
Rapport's epilepsy drug RAP-219 hits main goal in bipolar trial
A narrow win in a mid-stage study opens a potential billion-dollar market opportunity for the biotech.
Biopharmadive · +9 outlets
BioNTech to present first ROSETTA Lung 107 Phase 2 data for pumitamig plus docetaxel at ESMO 2026
The late-stage oncology data will be a key test of BioNTech's pipeline beyond its COVID vaccine business.
Quiver Quantitative
AbbVie's next-gen Crohn's disease combo beats Skyrizi in Phase 2 trial
The result supports AbbVie's effort to extend its immunology franchise with newer combinations.
Fierce Biotech