Tristan Manalac

Tristan Manalac

Senior Staff Writer

Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has more than eight years of experience writing about medicine, biotech and science. Being formally trained in molecular biology, he once dreamed of collecting degrees and starting his own lab. But these days, he finds his greatest joy in a bottle of beer and a beautiful sentence. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.

Merck and Nectin Therapeutics announced a research collaboration agreement to study the safety and efficacy of Nectin’s investigational antibody in locally advanced and metastatic solid tumors.
Astellas named a new president and CEO and announced additional changes to its leadership structure in an effort to accelerate growth and chart its long-term business trajectory.
The FDA placed 4D Molecular Therapeutics’ gene therapy program, 4D-310, on clinical hold, the company announced Thursday.
Sanofi is discontinuing its Phase III study of tolebrutinib, an investigational BTK inhibitor for myasthenia gravis.
Magenta Therapeutics is cutting about 84% of its workforce after a patient’s death halted a Phase I/II trial in acute myeloid leukemia.
FDA
Wednesday, the FDA approved GSK’s daprodustat, now to be marketed as Jesduvroq, for the treatment of anemia due to chronic kidney disease in adult patients.
Roche is dropping its investigational AKT inhibitor ipatasertib, which was being assessed in a Phase III trial for castration-resistant prostate cancer, as well as several other candidates.
GSK has dropped two assets, an investigational celiac disease therapeutic and a Staphylococcus aureus vaccine hopeful, from its pipeline.
The FDA asked Taysha Gene Therapies to dose more patients in a double-blinded, placebo-controlled trial before submitting a BLA for its giant axonal neuropathy candidate.
Amgen is implementing organizational changes including laying off approximately 300 team members, confirmed Monday.
The FDA granted Eli Lilly’s Jaypirca accelerated approval for the treatment of adults with relapsed or refractory mantle cell lymphoma.
FDA
The FDA approved Merck’s Keytruda for the treatment of stage IB, II or IIIA non-small cell lung cancer after resection or platinum-based chemotherapy.
Phase I/II data showed AC Immune’s anti-amyloid-beta vaccine candidate could safely elicit an antibody response in patients with Alzheimer’s disease. Now, it will expand to Down Syndrome patients.
Following the death of a patient, Magenta Therapeutics placed a hold on Phase I/II dose-escalation trial of its acute myeloid leukemia therapy.
Merck posted a rare defeat Wednesday for its blockbuster Keytruda (pembrolizumab) in prostate cancer while simultaneously announcing a victory in biliary tract cancer.