President Joe Biden recently signed an executive order to accelerate the development of novel COVID-19 therapies and improve access to care for all Americans.
First, Biden called on the HHS and...
Janet Woodcock will be stepping in as Acting FDA Commissioner while the Biden administration finalizes a nominee for the position.
Woodcock will replace Stephen M. Hahn, MD, after he resigned last...
AbbVie and Frontier Medicines recently announced a multi-year global strategic collaboration to discover, develop, and commercialize a pipeline of innovative novel drug therapies against...
The implementation of a COVID-19 vaccination program will contribute more to the success a vaccine than drug efficacy, according to a recent Health Affairs study.
The study’s findings could...
Boston Children’s Hospital and Deerfield Management Company recently announced a research collaboration aimed at advancing drug discovery and development to address rare and complex pediatric...
Regeneron Pharmaceuticals recently announced positive prospective results from an ongoing Phase 2/3 clinical trial evaluating its COVID-19 antibody cocktail.
The trial found that the cocktail,...
Roche and Atea Pharmaceuticals recently partnered to develop, manufacture, and distribute Atea’s investigational oral COVID-19 antiviral globally.
The oral treatment, AT-527, is a direct-acting...
HHS recently announced that American hospitals can go back to purchasing Gilead’s COVID-19 antiviral, Veklury (remdesivir), directly from the drug’s distributor starting.
Over the...
COVID-19 vaccines are being developed at a quick pace, but a broken supply chain could derail this momentum. A new report from PricewaterhouseCoopers (PwC), however, uncovered three steps drug...
New drugs and therapies must undergo a series of tests and studies in order to help the individuals who need a cure or treatment for their conditions. These clinical trials are key to ensuring safety...
From 2000 to 2019, composition and design of clinical trials changed substantially by sponsor type, suggested a need for increased funding for larger randomized trials , a JAMA Network Open study...
Discovering and developing a novel vaccine candidate is a lengthy process. Even after the vaccine is created and tested for safety, licensing and manufacturing draw out the process making it years before it is available to the general...
Pfizer recently announced a multi-year agreement with Gilead Sciences to manufacture and supply the company’s investigational COVID-19 treatment, remdesivir.
For more coronavirus updates, visit...
Roche recently announced that a Phase 3 study evaluating its lung cancer drug, Tecentriq, combined with chemotherapy, did not meet its primary endpoint for treatment of metastatic triple-negative...
A bipartisan multistate coalition recently called on HHS, the National Institutes of Health (NIH), and FDA urging them to use their authority to increase the availability of remdesivir.
For more...
President Trump recently signed an executive order to increase production of essential medical supplies in the US and cut down reliance on foreign producers.
The executive order signed Thursday...
FDA recently announced that it is requiring label changes for opioid pain medicines and medicines used to treat opioid use disorder (OUD).
Updated labels for the prescription drugs will need to say,...
Among FDA approval packages for novel therapeutic agents from 2011 and 2015, disagreements were common over new drug approvals, populations indicated, and the specific parameters of the approval,...
Twenty-four members of Congress demand increased oversight and transparency of Operation Warp Speed vaccine development program in an official letter to HHS Secretary Alex Azar.
In the letter, the...
Harvard University recently launched Vesigen Therapeutics, which will address the challenges of delivering RNAi, mRNA, and CRISPR technologies to intracellular targets in specific tissues of...
