Vanessa Doctor, RN

Connect Biopharma Phase II trial on a potential drug for adults with moderate-to-severe ulcerative colitis may have failed to meet its primary endpoint, but the company isn’t giving up yet.
The FDA accepted Bayer’s supplemental New Drug Application for its proposed oral treatment for metastatic hormone-sensitive prostate cancer.
Spero is reducing a huge chunk of its staff to minimize expenses and reallocate resources toward more promising projects in anticipation of the FDA’s decision on its NDA for tebipenem HBr.
Hutchmed failed to secure FDA approval for its proposed drug for pancreatic cancer. The company will have to go through another trial if they want U.S. approval.
Notably, Qelbree is the first novel FDA approval of a novel non-stimulant treatment for ADHD in adults in 20 years.
Sio Gene has terminated its licensing deal with the UMass to develop and commercialize two gene therapy product candidates to focus on more potentially profitable projects.
BeiGene’s candidate drug tislelizumab for cancer succeeded in meeting the primary endpoint of overall survival in a global Phase III trial. Learn more about it here.
The U.S. Congress is calling for the coronavirus management plan to deliberate on the timeline for the approval and release of vaccines for children under 5 years old.
Protagonist Therapeutics’ Phase II study of an ulcerative colitis treatment failed to meet its primary endpoint at a higher dosage amount. Even so, the company remains optimistic about the drug’s future.
The first quarter hasn’t been kind to international biopharmaceutical firms. BioSpace takes a look at the fates of Saniona and Black Diamond below.
Scientists from the U.K. may have identified several more environmental causes for cancer after evaluating genetic data of over 12,000 cancer patients from the NHS files.
The FDA noted that the EUA application for Novavax’s COVID-19 shot may take a while to be resolved, citing an “incredibly complex review process.”
Coeptis Therapeutics is merging with special purpose acquisition company Bull Horn Holdings in a definitive deal worth around $175 million.
Two investigational drugs have been taking the spotlight recently from Revive and Ascletis as they share news regarding their potential treatment against COVID-19.
FDA
The U.S.Food and Drug Administration has granted Emergency Use Authorization to a breathalyzer that can detect COVID-19 within three minutes.