FDA approves Bristol Myers Squibb's Zenbexus, first CELMoD therapy for multiple myeloma
The accelerated approval of Zenbexus (iberdomide) marks the debut of a new class of protein-degrading medicines for relapsed/refractory multiple myeloma.
BioPharma Dive · +14 outlets
PTC Therapeutics wins bankruptcy auction for Sangamo's Fabry disease gene therapy with $211M bid
PTC outbid other buyers to acquire Sangamo's Fabry disease gene therapy program from bankruptcy, positioning for a potential market entry against existing treat
BioPharma Dive · +9 outlets
Taiho and Cullinan's zipalertinib hits phase 3 goal in EGFR exon20 lung cancer, setting up J&J competition
Positive data positions zipalertinib as a challenger to approved EGFR exon20-targeting drugs and triggers a $100M milestone for Cullinan.
BioPharma Dive · +5 outlets
FDA approves Bristol Myers Celgene-acquired 'milestone' myeloma drug
The approval validates the Celgene acquisition strategy and provides a new option for multiple myeloma patients.
biopharmadive.com · +10 outlets
Epic Systems under FTC investigation for alleged anticompetitive practices
Federal and state investigators are probing Epic's use of non-disclosure agreements and other business practices in the health IT market.
STAT · +13 outlets
InduPro raises $77M and begins first human trial of cancer drug
The Seattle biotech advances its pipeline with new funding and a first-in-human clinical trial for an undisclosed cancer therapy.
GeekWire · +3 outlets
Regeneron's gene therapy for genetic hearing loss gets accelerated FDA nod
The FDA granted accelerated designation for Regeneron's investigational gene therapy targeting a form of inherited deafness.
Stocktwits · +3 outlets
Data manipulation allegations wipe out EU approval for avacopan as FDA hearing approaches
Concerns over trial data integrity have derailed avacopan's EU approval and now threaten its standing with the FDA.
Tech Times · +2 outlets
Skye and Redx merge with $125M to advance fibrosis assets
The combined company aims to develop treatments for fibrotic diseases with the backing of a significant financing round.
Fierce Biotech · +3 outlets
FDA grants accelerated approval for Allogene's TALEN-edited lymphoma cell therapy
The FDA provided accelerated approval for Allogene's CRISPR-edited cell therapy targeting lymphoma.
CRISPR Medicine News · +1 outlets
Capricor shares spike as FDA signals willingness to review updated Duchenne cell therapy submission
The FDA's openness to review an updated filing for Capricor's Duchenne muscular dystrophy cell therapy boosted investor sentiment.
BioPharma Dive · +2 outlets
Alphamab seals $2.2B licensing deal with AI biotech
Chinese biotech Alphamab entered a major licensing agreement with an AI-driven drug discovery company.
thebambooworks.com
Soticlestat revived by Perceptive Advisors who argue FDA rejected trial design, not the drug
Perceptive Advisors is backing soticlestat, claiming the FDA's prior rejection was due to trial design flaws rather than the drug's merit.
Tech Times
Zealand sells rights to Takeda blood cancer drug for $100M
Zealand Pharma offloads rights to a hematologic cancer drug to Takeda, generating cash for its pipeline.
Fierce Biotech · +2 outlets
Eli Lilly targets booming black market for retatrutide
Lilly is taking action against unauthorized sales of its experimental obesity drug retatrutide.
STAT · +1 outlets
FDA clears Phase 3 trial of PhenoNet's inhaled PHENOGENE-1A for early Alzheimer's
PhenoNet received FDA go-ahead for a Phase 3 trial of its inhaled gene therapy candidate for early Alzheimer's disease.
BioSpace · +2 outlets
AbCellera's nonhormonal menopause drug shows early success
The biotech's experimental nonhormonal therapy for menopause symptoms demonstrated positive early clinical data.
Drug Discovery News · +4 outlets
PTC Therapeutics pauses phase 3 cancer therapy to focus on colorectal candidate
The company shifts resources to a colorectal cancer contender after halting work on its phase 3 program.
Fierce Biotech · +1 outlets