In a time of political uncertainty, it’s hard to say whether the rules will withstand expected legal challenges from the pharmaceutical industry or whether the incoming Biden administration will accept, amend or try to roll them back entirely.
In a separate development, the FDA on Thursday gave emergency authorization to use of another anti-inflammatory drug sold by Eli Lilly, baricitinib, to be used with remdesivir.
The action comes days after Pfizer Inc. and its German partner BioNTech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study.
Phase III trials are now accumulating the data needed to report results as a renewed surge of the pandemic hits countries around the world.
The announcement from Pfizer and its German partner BioNTech comes as the team is preparing within days to formally ask U.S. regulators to allow emergency use of the vaccine.
Moderna said its vaccine appears to be 94.5% effective, according to preliminary data from the company’s still-ongoing study.
Markets were already sharply higher on the U.S. election result when Pfizer said that research shows vaccine shots may be 90% effective at preventing COVID-19, indicating the company is on track this month to file an emergency-use application with U.S. regulators.
The coronavirus shots, made by Pfizer and its German partner BioNTech, are among 10 possible vaccine candidates in late-stage testing around the world—four of them so far in huge studies in the U.S.
The Biogen drug, known as aducanumab, does not cure or reverse Alzheimer’s, but it might modestly slow the rate of decline.
A startup that’s planning to launch a $60 million drug-manufacturing plant sees big growth in contract manufacturing.
The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days—from 15 days to 10 on average—in a large study led by the U.S. National Institutes of Health.
On Thursday, a federal advisory committee will debate whether the guidelines the FDA has set for vaccine developers are rigorous enough. Interest is so high, the FDA is airing the meeting on YouTube.
Purdue Pharma, the company that makes OxyContin, the powerful painkiller that experts say helped touch off an opioid epidemic, will plead guilty to counts including conspiracy to defraud the United States and violating federal anti-kickback laws, the officials said.
The new company, contract drug developer INCog Biopharma, plans to build a $60 million facility and hire up to 150 workers by the end of 2024.
The pause is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the United States.
A long-simmering dispute between Eli Lilly and Co. and safety-net hospitals across the nation over the price of prescription drugs has reached the boiling point.
Two of the world’s biggest vaccine makers, began testing their experimental COVID-19 shot in the first patients on Thursday and aim to start late-stage trials before year-end.
Lilly and partner Boehringer Ingelheim published results from a trial showing the drug cut the risk of cardiovascular hospitalizations or death by 25%, compared to placebo in heart failure patients.
Now that the company has closed its $6.9 billion acquisition of the German conglomerate’s animal-health division, it must now swiftly and carefully integrate the two sprawling companies in the midst of a pandemic.
The developers said they have the potential to manufacture up to 100 million vaccine doses by the end of this year and up to 1.3 billion doses by the end of 2021.
