We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has called out Endo International, maker of Vasostrict, saying the agency plans to ask the Federal Trade Commission (FTC) to investigate Endo for “anticompetitive business practices” after the company pressed FDA to block generics of its best-selling drug. Read More
In another huge blow to Biogen’s controversial Alzheimer’s blockbuster, the European Medicines Agency (EMA) has declined to approve Aduhelm (aducanumab), saying the data don’t support a strong clinical benefit and studies did not show that the medicine was sufficiently safe. Read More
A federal judge has overturned a $4.5 billion settlement that protected members of the Sackler family, owners of Purdue Pharma, the maker of OxyContin. Read More
“Epidemiological tracking shows a steep trajectory of new infections, indicating Omicron’s rapid spread but so far with a flatter trajectory of hospital admissions,” said Andrew Noach, Discovery Health’s CEO. Read More
Preliminary results indicate that a Sanofi/GSK booster increased neutralizing antibodies by up to 43-fold, regardless of which vaccines participants originally received. Read More
The FDA announced that it will loosen longstanding restrictions on mifepristone, known as the abortion pill, making it easier to get just as the Supreme Court seems poised to curtail abortion access nationwide and many states are tightening restrictions on abortions. Read More
The FDA offered advice on designing a visual inspection program to ensure injectable drugs are free of visible particulates in a new draft guidance released yesterday, noting that automated inspections may be more reliable than visual inspections by humans. Read More
There are almost 800 drugs for rare diseases either in clinical trials or awaiting review by the FDA, according to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA). Read More
AstraZeneca’s COVID-19 vaccine becomes completely ineffective against the Omicron variant by 15 weeks, according to real-world British data released yesterday. Read More