As the fairness of orphan drug exclusivities is debated in Congress, the U.S. Food and Drug Administration granted Orphan Drug designations to Editas Medicine and Neurocrine Biosciences.
Weeks after Imara announced plans to discontinue the development of tovinontrinein for sickle cell disease, beta-thalassemia and heart failure indications, the company culled 83 percent of its workforce.
The U.S. FDA rejected Cambridge, Massachusetts-based Akebia Therapeutics’ New Drug Application (NDA) for vadadustat, a therapeutic for anemia due to chronic kidney disease (CKD).
Merck announced that the company will lay off 170 people from Cambridge, Massachusetts-based Acceleron Pharma, which was acquired during November 2021 for about $11.5 billion.
Biosimilar development continues to advance for the U.S. market in anticipation of becoming an alternative to a brand drug with similar safety and efficacy.
Sanofi and partner Swedish Orphan Biovitrum shared positive topline results from their ongoing Phase III trial on a candidate drug for patients diagnosed with severe hemophilia A.
Shares of bluebird bio fell in trading on March 7 after the company revealed its dire financial straits.
A late-stage study of Gilead Sciences’ antibody-drug conjugate Trodelvy shows promise in slowing disease progression in some of the most common forms of breast cancer.
The U.S. Food and Drug Administration approved CTI BioPharma Corp.’s drug for treating adult patients with a type of bone marrow cancer who also have low blood platelet count.
Three companies – Intellia Therapeutics, Editas Medicine and uniQure – are each anticipating a bright 2022 as the promises of gene therapy continue to be realized.
