Current medical news and unique business news for anyone who cares about the healthcare industry.
A high standard for ‘me too’ drugs. A new suggestion would make it harder for me-too drugs, particularly when there’s a generic version, to win FDA approval. The new article in the Journal of the American Medical Association says too many drugs make decisions by doctors and patients unnecessarily complex and diverts research and development away from finding new solutions.
Let the Food and Drug Administration review the first me-too drugs in usual way. Typically that would mean clinical trials comparing them to a placebo or studies that show they’re no worse than existing medicines.
But once a generic becomes available, new drugs in the class would have to show they are superior to existing medicines to win the FDA’s OK.
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Sanofi buys Genzyme for $20.1 billion. Via The Associated Press: “Genzyme would give Sanofi a new platform for growing its biotech business, let it expand into the growing – and lucrative – market for drugs for rare diseases, increase its U.S. presence and give it more experimental drugs in mid- and late-stage testing.” The all-cash deal includes additional payments tied to the success of certain drugs.
Streamlined flu vaccine. The new vaccine takes the influenza virus in cultures of animal cells rather than chicken eggs. It will cut six months off the development process and counter flu-shot shortages.
(Unintentional) medical humor. Here’s one of the winners of this year’s Dizzy Awards honoring bad writing from top medical publications: ““After three hours in the emergency department, the rectal temperature was 37.3 °C.…” (hat tip Notes from Dr. RW)
Hey pharma, think long term! Few drug companies are looking beyond the expiration of key patents and into future years. That’s driven in part by an overwhelming negative view of healthcare reform that hits the “trifecta for what analysts don’t want to see in a quarterly report:” lower gross margins, higher expenses and a higher effective tax rate.