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BioNTech will pay Shanghai-based Duality Biologics $170 million upfront for rights to two of its topoisomerase-1 inhibitor-based antibody drug conjugates.
Almost two years after its launch, eye-focused gene therapy start-up Vedere Bio II is closing its doors, company leaders announced through a LinkedIn post over the weekend.
Cytokinetics is discontinuing the Phase III COURAGE-ALS trial in amyotrophic lateral sclerosis after its candidate reldesemtiv failed a planned interim analysis, the company announced Friday.
HUTCHMED has completed the rolling submission of its New Drug Application to the FDA for fruquintinib, its candidate for refractor metastatic colorectal cancer.
With several recent milestones, Intellia Therapeutics is setting a solid foundation for gene editing in rare diseases with an eye toward broader patient populations.
Ravi B. Parikh discussed how new FDA guidance on accelerated approval for cancer drugs will affect the space.
Nearly eight months after leaving his post as head of R&D at Johnson & Johnson, Mathai Mammen has found a new job as CEO of cancer focused FogPharma.
GSK will help commercialize Brexafemme (ibrexafungerp), currently approved to treat vaginal yeast infections and vulvovaginal candidiasis (VVC).
BIIB080 successfully reduced tau pathology in patients with early-stage disease across all six brain regions analyzed.
Proximity bias, a term that describes how managers tend to favor those they see in person, may force remote and hybrid workers to work harder to keep up with their in-person counterparts.
The RSV race has lost one high-profile contender as Janssen announced it is discontinuing the Phase III EVERGREEN trial studying its RSV vaccine candidate.
A federal court sided in favor of Vanda Pharmaceuticals in its Freedom of Information Act case against the FDA regarding the CRL for its sleep drug label expansion.
In an earnings call Wednesday, bluebird bio revealed it is unlikely to meet its first-quarter goal to submit a Biologics License Application for sickle cell disease (SCD) gene therapy lovo-cel.
There have already been several big biotech licensing deals in Q1. See inside for some of this quarter’s biggest licensing deals — from the surprising and pivotal to the lucrative and consequential.
Citing reports of “alarming toxicity” among other accusations, short-seller Scorpion Capital will file a Citizen’s Petition with the FDA to have its approval of Wakix withdrawn.
Boston-based Covant Therapeutics gained $10 million upfront in a deal with Boehringer Ingelheim to chase after a cancer immunotherapy target, ADAR1.
Tuesday, Viking Therapeutics released Phase I results for its weight-loss candidate VK2735, which demonstrated a good safety and tolerability profile and resulted in significant weight reductions.
Intra-Cellular Therapies’ Caplyta met its primary endpoint in the Phase III Study 403 trial, easing the burden of depressive episodes in patients with major depressive disorder or bipolar depression.
Notch Therapeutics, Inc., a biotechnology company developing renewable, induced pluripotent stem cell (iPSC)-derived cell therapies for cancer, is pleased to announce Dr. Chris Bond has been promoted to Chief Scientific Officer.
Bristol Myers Squibb is expanding its strategic collaboration with German partner Evotec for eight more years to discover and develop treatments for neurodegenerative diseases.