Weekly FDA Drug Pipeline Calendar (Oct 31- Nov 4)

BioPharm Insight US wrote a column · Oct 31, 2022 23:58

Hello mooers, welcome to another week of the FDA calendar. Here are what happened last week and what's coming up this week.

Top Medical News of the Week

Merck Q3 earnings top Wall Street’s expectations

Merck stock surged within a buy zone Thursday after the pharma giant notched a third-quarter beat on particularly strong performances from Keytruda and Gardasil.

Revenue from blockbuster cancer drug Keytruda soared 20% during the quarter, leading a 15% jump for Gardasil, a human papillomavirus vaccine. The base business performed so well that $Merck & Co (MRK.US)$ raised its outlook for 2022. The guidance boost comes despite exchange-rate headwinds and a 22-cent hit to per-share earnings from a recent collaboration with $Moderna (MRNA.US)$ on a treatment for melanoma.

Omicron subvariants resistant to key antibody treatments are increasing every week in the U.S.

The subvariants BQ.1 and BQ.1.1 now represent 27% of infections in the U.S., a significant jump from the week prior when they made up about 16% of new cases.

President Joe Biden this week cautioned people with compromised immune system that they in particular are at risk this winter

FDA says two studies showing omicron boosters weren’t much better than old Covid shots were too small to come to any conclusions

Scientists at Columbia and Harvard, in two independent studies, found that the new Covid boosters don’t trigger a better response against omicron BA.5 than the old shots.

Dr. Peter Marks, head of the FDA’s vaccine division, said the new studies are small and subject to limitations. Data from larger well-controlled studies are coming soon, he added.