The U.S. Food and Drug Administration reviewed several drugs under Priority Review ahead of their PDUFA target action dates scheduled during the week of March 8th, 2020.
Oncology is one of the most exciting areas in healthcare, as novel therapies continue to emerge that move forward our molecular understanding of the disease and offer effective treatment advances. This Q&A explores oncology innovation with Kantar’s Stephanie Hawthorne, Vice President of Oncology and Specialty Therapeutics.
The bladder cancer drug Padcev, which was approved by the U.S. Food and Drug Administration in December, secured Breakthrough Therapy designation for the treatment of patients with another type of bladder cancer.
Clarivate Analytics pegged 11 drugs set to enter the market during 2020 as potential blockbusters by 2024
San Diego-based Sorrento Therapeutics rejected a non-binding acquisition proposal from a private equity firm, saying that the offer “significantly undervalues Sorrento and is not in the best interest of the company’s stockholders.”
AstraZeneca announced that the company’s Brilinta (ticagrelor) hit the primary endpoint in the Phase III THALES trial in stroke.
The U.S. FDA granted Orphan Drug Designation for OBI Pharma Inc.’s first-in-class antibody drug conjugate (ADC) OBI-999 for the treatment of pancreatic cancer.
The U.S. FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu for adults with unresectable or metastatic HER2-positive breast cancer who have had two or more previous anti-HER2-based treatments in the metastatic setting.
Seattle Genetics is looking for a quicker path to resolution with Daiichi Sankyo over antibody drug conjugate technology that both companies claim ownership of.
Tokyo-based Daiichi Sankyo’s ESAX-DN Phase III trial of esaxerenone met the primary endpoint in diabetic nephropathy.