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The U.S. Food and Drug Administration granted Emergency Use Authorization to Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) for high-risk adults and pediatric patients 12 years and older to treat COVID-19.
With all eyes on a new year, life sciences companies and organizations are making last-minute appointments to strengthen their leadership teams and board with these Movers & Shakers.
Takeda hoped that its experimental therapy could become the first FDA-approved treatment for EoE. However, the FDA wants the company to initiate another clinical study with TAK-721.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
The company aims to use the $100 million investment to support biotechnology firms involved in treating mental diseases and longevity projects.
Aduhelm was approved by the U.S. FDA for its ability to clear beta-amyloid. Researchers at Emory investigated the use of an FDA-approved ADHD medication on patients with mild Alzheimer’s symptoms and found it appeared to reduce levels of tau.
The new Phase III study will include an enhanced version of the Viaskin Peanut patch, approximately 50% larger than the patch initially rejected by the FDA.
Allakos reported mixed results on two clinical trials, the Phase II ENIGMA 2 and Phase II/III KRYPTOS trials of lirentelimab.
Dr. Charles Lieber was convicted Tuesday by a federal jury after being found guilty of lying to the U.S. government about his questionable ties with the People’s Republic of China.
Novartis believes Gyroscope’s investigational Phase II gene therapy for geographic atrophy has the potential to become the first therapy that demonstrates sustained efficacy for GA patients.
Ten studies are halted completely. Oral formulations of the drug will continue. Gilead stated that it is confident about the future of the drug’s potential and is working to resolve the vial quality problem.
These biotech companies made the nice list, earning them far more than a lump of coal.
Pioneers of synthetic biology have rallied together under the development of Senti Biosciences Inc, co-founded and led by Timothy Lu, associate professor of biological engineering, electrical engineering, and computer science at the Massachusetts Institute of Technology.
Amgen said the expansion would bring 150 construction jobs to the area.
Under the terms of the deal, Sanofi is paying Amunix $1 billion up front and up to $225 million in various development milestone payments.
In the last week, Omicron is credited for 73% of new COVID-19 infections and is accounted for 12.6% of positive cases, making it the most rapidly spreading variant the country has seen yet.
Pfizer has paused screening and dosing of a Phase Ib study of its experimental gene therapy treatment for Duchenne muscular dystrophy following the unexpected death of a patient.
The FDA placed bluebird bio’s clinical trial for its candidate sickle cell disease (SCD) treatment on partial hold for participants under 18 years old.
The government charged Chicago-based Daniel V.T. Catenacci, a medical school professor who served as the lead investigator of the company’s cancer drug bemarituzumab.
After last week’s avalanche of clinical trial news associated with the American Society of Hematology Annual Meeting, there are far fewer announcements, but some companies are getting their news out ahead of the holidays.