Europe – Regulatory, industry panels address EU GMP Annex 1 implementation
Pharmaceutical manufacturers in the EU may have to approach the manufacturing of sterile drugs a little differently under the EU’s Annex 1 covering good...
UK – Sanofi Pasteur COVID-19 vaccine authorised by MHRA
VidPrevtyn Beta, the COVID-19 vaccine developed by Sanofi, has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
It becomes the seventh COVID-19...
International – mRNA revolutionized the race for a Covid-19 vaccine. Could cancer be next?
The unprecedented success of messenger RNA vaccines against the coronavirus is raising hopes that the technology could lead to new and better vaccines against...
UK – AstraZeneca’s Lynparza recommended by NICE for breast and prostate cancer
The anti-cancer medicine will now be routinely available for adults with HER2-negative, high-risk early breast cancer who have inherited faults in their BRCA1 or...
USA – FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults
Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment...
USA – Convergence: Psychedelic drug development is ‘hot,’ but proceed with caution
Psychedelic drug development is receiving more attention lately as these treatments offer the potential for needed therapeutic alternatives for various mental health conditions, yet...
USA – FDA issues long-awaited LDT final rule
After years of jostling with industry, failed legislative efforts, and some false starts, the US Food and Drug Administration (FDA) has unveiled its plan...
