BioSpace looks at the 10 biggest drug approvals of 2021, headlined by Biogen’s Aduhelm (aducanumab) for Alzheimer’s disease and Pfizer and BioNTech’s COVID-19 vaccine Comirnaty.
Bristol Myers Squibb’s rheumatoid arthritis drug Orencia won marketing clearance as the first medicine approved for the prevention of moderate-to-severe acute graft versus host disease (aGvHD) in patients 2 years of age and older who have received unrelated donor hematopoietic stem cell transplantation.
The U.S. Food and Drug Administration approved Merck’s blockbuster checkpoint inhibitor Keytruda (pembrolizumab) for adjuvant treatment of renal cell carcinoma (RCC) patients at intermediate-high or high risk of recurrence after nephrectomy or following nephrectomy and resection of metastatic lesions.
AbbVie’s Allergan announced that VUITY, the company’s unique treatment for presbyopia, received approval from the U.S. Food and Drug Administration as the first eye drop to be approved for the condition.
The U.S. Food and Drug Administration greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.
The U.S. Food and Drug Administration approved Eli Lilly’s Verzenio (abemaciclib) for a specific type of early breast cancer that is at high risk of recurrence after surgery.
Mirum Pharmaceuticals Inc. said on Sept. 29 the company’s drug became the first U.S. approved therapy for treating itching in patients with a rare liver disorder called Alagille syndrome (ALGS).
Incyte announced Sept. 22 that the Food and Drug Administration approved the company’s Jakafi (ruxolitinib) to treat chronic graft-versus-host disease, one day after the U.S. regulator gave the green light to the cream Opzelura (ruxolinitib) for the short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis.
The U.S. Food and Drug Administration on Sept. 21 approved Incyte Corp.’s cream Opzelura for treating the inflammatory skin condition atopic dermatitis, commonly called eczema, in adolescents and adults with boxed warnings.
Dr. Bethany Valente, founder and managing partner of Tempo7 LLC, discusses the challenges that biotech and pharma-based businesses face as they work to create more efficient development time frames for product, therapy, or drug development. Dr. Valente says open innovation helps in resolving some of these challenges.
