FDA

Ocugen Inc. said on May 23 the U.S. drug regulator has lifted the clinical hold on a mid-to-late stage trial of the COVID-19 vaccine being developed by the company’s Indian partner Bharat Biotech.

FDA sign

The U.S. Food and Drug Administration issued a partial clinical hold for Foghorn Therapeutics’ Phase I clinical study, investigating the safety and efficacy of FHD-286 in patients with relapsed and/or refractory acute myelodysplastic leukemia (AML) and myelodysplastic syndromes (MDS). The hold follows a serious adverse event in which a study participant died after developing possible differentiation syndrome.

FDA

LogicBio Therapeutics was granted the green light to continue dosing participants in the company’s Phase I/II Sunrise trial investigating the safety of LB-001 in patients with methylmalonic acidemia (MMA), characterized by methylmalonyl-CoA mutase (MMUT) gene mutations.

Pfizer Inc. said on April 28 the company would open the first U.S. trial sites for its experimental gene therapy for a muscle-wasting disorder, after the Food and Drug Administration lifted the regulatory agency’s hold on a late-stage study.

Merck

Merck & Co. said on December 13 the U.S. Food and Drug Administration placed clinical holds on trials testing the company’s HIV drug islatravir.

Shares of bluebird bio climbed in trading after the company announced on March 10 that analyses demonstrate the lentiviral vector BB305 was unlikely to be the cause of acute myeloid leukemia (AML) reported in an early-stage clinical study of LentiGlobin for sickle cell disease.

Neoleukin was benched by the FDA with a clinical hold for the biopharma company’s lead cancer immunotherapy candidate.  

Cellectis announced that the U.S. Food and Drug Administration placed a clinical hold on the company’s MELANI-01 trial of UCARTCS1A for relapsed or refractory multiple myeloma (MM).

Shares in Solid Biosciences Inc. plunged 71 percent after a clinical trial testing the company’s gene therapy for a muscle-wasting disorder was halted for the second time in less than two years.

Bayer halted trials testing the experimental uterine fibroids treatment vilaprisan, which the company previously expected to generate peak annual sales of more than 1 billion euros ($1.1 billion), citing the risk of side effects.