Johnson & Johnson recently announced that it paused dosing participants in the Phase 3 ENSEMBLE trial evaluating its COVID-19 vaccine after a study participant experienced an unexplained...
Regeneron Pharmaceuticals recently announced that its COVID-19 antibody cocktail reduced viral load and alleviated symptoms in non-hospitalized coronavirus patients in a Phase 1/2/3 clinical...
FDA recently issued guidance to provide recommendations for vaccine sponsors regarding the data and information that would support an emergency use authorization (EUA) for a COVID-19 vaccine.
Chief...
HHS recently announced that the CDC will provide $200 million to 64 jurisdictions for COVID-19 vaccine preparedness.
CDC will award the funding from the Coronavirus Aid, Relief, and...
FDA recently proposed updates to its regulations to clarify the types of evidence the agency considers when determining the “intended use” of FDA-regulated products.
The proposed...
FDA recently announced that GSK Consumer Healthcare voluntarily recalled two lots of Children’s Robitussin and one lot of Children’s Dimetapp due to the inclusion of incorrect dosing...
A coalition of 51 attorney generals from around the US recently filed an antitrust complaint alleging that over two dozen drug manufacturers inflated the price of generic drugs illegally.
The...
AbbVie recently announced new Phase 3 clinical trial data, showing that RINVOQ (upadacitinib) was effective in adult patients with moderate to severe active rheumatoid arthritis.
SELECT-CHOICE, a...
FDA recently issued guidance to the Institutional Review Board (IRBs) regarding expanded access requests for COVID-19 investigational drugs, including expanded access for individual patients.
For more...
A recent COVID-19 clinical trial found that higher dosages of 2 chloroquine diphosphate should not be recommended for critically ill coronavirus patients because of its potential safety...
Bristol Myers Squibb and Exelixis Inc recently announced that CheckMate- 9ER, a pivotal Phase 3 clinical trial evaluating two drugs, showed positive results against untreated kidney cancer...
FDA recently announced that it issued a guidance for industry, investigators, and institutional review boards conducting clinical trials during the COVID-19 pandemic.
For more coronavirus updates,...
With COVID-19 continuously spreading throughout the US, the FDA took two major actions to address the virus and enhance its ongoing commitment to the public, according to a recent press release.
For...
The US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling false coronavirus (COVID-19) drugs, vaccines, and other products,...
Insys Therapeutics founder and former CEO, John Kapoor, was sentenced to 66 months in federal prison on January 23 for his role in the drugmaker’s alleged opioid kickback scheme.
The case was...
A Health Affairs blog post on Tuesday made the argument to invest in vaccine infrastructure and education to “turn the tide” on vaccine-preventable diseases, breaking it down by problem...
Reliance on just a select few pharmaceutical companies to carry the fight against the growing public health threat that is antimicrobial resistance could be what is holding back real...
As the Food and Drug Administration looks to reorganize its Office of New Drugs (OND) this year, drugmakers and industry trade groups have recommendations to inform OND’s...
The US Senate has voted to confirm Stephen Hahn, MD, the former chief medical executive for MD Anderson Cancer Center in Texas, as the new commissioner for the Food and Drug Administration (FDA).
In a...
As data becomes readily available and digital tools present opportunities to optimize patient and consumer relationships, pharmaceutical companies will tap the technologies necessary to boost their...
