Lilly's retatrutide beats Ozempic on blood sugar and weight loss in phase 3 diabetes trial
The triple-G drug produced roughly double the weight loss of Novo Nordisk's Ozempic, though with higher rates of side effects and treatment discontinuations.
STAT · +13 outlets
Personalized mRNA melanoma vaccine cuts recurrence or death risk by 42% in phase 3 trial
The Moderna-Merck cancer vaccine results, presented at ESMO, were hailed as a major step for personalized cancer therapy, though overall survival benefit remain
Oncology News Central · +14 outlets
Genmab soars to record high as head and neck cancer bispecific succeeds in phase 3
Positive data for the antibody acquired in Genmab's $8 billion Merus deal sent shares up sharply, adding more than $7 billion in market value.
Biopharmadive · +5 outlets
LABOR DEPARTMENT FINALIZES PBM DISCLOSURE RULE REQUIRING FEE AND COMPENSATION DATA
Starting in 2027, pharmacy benefit managers must share fee and compensation details with self-funded employer clients; employers backed the rule while PBMs call
Biopharmadive · +11 outlets
FDA issues draft guidance to speed personalized 'plug and play' gene therapies for rare diseases
The framework, developed with CMS, offers an approval pathway for individualized gene editing therapies benefiting patient subsets with the same disease.
Biopharmadive · +10 outlets
FDA approves GSK's functional cure for hepatitis B
The approval marks a new treatment approach for chronic hepatitis B, a virus affecting hundreds of millions worldwide.
Drug Discovery News · +14 outlets
Iovance shares crash on surprise lung cancer trial result
The setback hit one of the top-performing biotech stocks, raising questions about the broader applicability of its tumor-infiltrating lymphocyte therapy.
Investor's Business Daily · +5 outlets
HHS to allow compounding pharmacies to make six unapproved peptides
RFK Jr.'s policy grants enforcement discretion for peptides that won a contested FDA advisory recommendation, over objections from FDA career scientists.
Biopharmadive · +13 outlets
Astellas to pay up to $1.34B for Melbourne startup's cancer candidate
The deal adds another cancer immunotherapy prospect to Astellas' pipeline as large pharma continues to buy into early-stage oncology assets.
BiotechDispatch · +1 outlets
Dren Bio raises $350M to push rare blood cancer therapy toward market
The funding supports late-stage development of the company's bispecific antibody program in rare blood cancers.
BioSpace · +1 outlets
Ferring to acquire fertility biotech Gameto for up to $1.38bn
The deal expands Ferring's fertility portfolio through Gameto's stem-cell-based reproductive medicine programs.
MedWatch · +4 outlets
FDA approves first-ever drug for a rare neurological disorder after 30 years
The approval ends a decades-long drought for patients with the condition and marks a milestone for rare disease drug development.
ScienceAlert · +14 outlets
Federal judge rejects new Medicaid 'frailty' definition for work requirements
The ruling found federal regulators exceeded their authority in narrowing medical exceptions to Medicaid work requirements.
STAT · +14 outlets
FDA approves Rasonque for previously treated advanced pancreatic cancer
The approval provides a new option for patients with advanced pancreatic cancer who have already received prior therapy.
Denkstrom · +13 outlets
Pancreatic cancer vaccine sparks immune responses in 99% of patients
Early trial results showed near-universal immune response, though clinical benefit has yet to be established.
ScienceAlert · +1 outlets
HHS green lights six peptides despite concerns from FDA scientists
The move gives a regulatory boost to the peptide craze embraced by RFK Jr. and the MAHA movement, despite limited evidence for many compounds.
STAT · +12 outlets
Vertex kidney disease drug scrutinized for infection risk ahead of FDA decision
The FDA is set to decide on the drug by Nov 30, with reviewers focused on infection risk in the lead-up to the decision.
STAT · +1 outlets
Flagship blends three biotech startups to form AI-aided drugmaker Etcelera
Etiome, Cellarity and Empress Therapeutics are being combined into one company claiming better prediction of how new medicines will perform in humans.
Biopharmadive · +1 outlets