The Puma Biotechnology story is far from over
After a long and contentious saga, Puma Biotechnology won FDA approval for its much-debated breast cancer therapy. But there’s still plenty yet to unfold before we learn whether the company is sitting on a major success.
Puma’s drug, neratinib, is meant to prevent the recurrence of breast cancer in women who have already taken Roche’s Herceptin. In clinical trials, it managed to do that better than placebo, but not without troubling rates of serious diarrhea, stoking concerns that Puma will struggle to convince oncologists to prescribe its drug. (Also no one knows how much it's going to cost.)
The Puma story is a tidy distillation of life under today’s (arguably) laxer FDA. If agency standards are more liberal, the gatekeepers to blockbuster sales become payers, physicians, and, in some cases, patients. Where approval was once the effective end of the story, it is now more of an entr'acte.
Are we 'due' for a successful Alzheimer's drug?
Yes, according to a canned statement from the head of the nonprofit UsAgainstAlzheimer’s — who, pointing to a bevy therapies in the pipeline, said the field, “marred by decades of failures and under-investment, is due for big victories.”
Unfortunately, Alzheimer’s drugs are not baseball players, and that’s not how clinical trials work. But it is true that you can’t succeed if you don’t try, and, as UsAgainstAlzheimer’s points out, a lot of people are trying nowadays.
The group highlights 35 drugs that will have pivotal data in the next five years, led by Axovant Sciences’ intepirdine, which will read out in September. It is perhaps unwise to apply a batting average to future trials — the industry is .000 since 2003, after all — but we’re at least going to see a lot of hypothesis tested in the near future.
The real victims of pharma's M&A slump: bankers
With biopharma dealmaking far below the record heights of 2015, executives are dithering, analysts are saber-rattling, and financial middlemen are in pain.
"I have a few people I've worked with in the past that are investment bankers, and they moan about the tough times they're going through," Shire CEO Flemming Ornskov told Business Insider.
That's because the fees that once flowed from each top-of-the-market deal have stemmed to a trickle. And, as Ornskov notes, that's unlikely to change as long as President Trump's tax plan remains a mystery. Though it is possible that we'll soon get details on that plan — and an actual bill, even — since it looks like Congress is pretty much done with health care.
Meet the man who refuses to give up on a vaccine for heroin addiction
Chemist Kim Janda has been through the hype cycle of drug development. More than 20 years ago, his work was heralded as a "breakthrough" poised to shake up treatment for drug addiction, but decades of patchy funding and clinical difficulty have hampered his efforts.
Now, as the opioid epidemic claims lives and grabs headlines, Janda is pushing forward with plans to develop a vaccine he believes could make a meaningful difference for heroin addicts.
Read more on STAT Plus.
- The art of the deal? Why a money-back guarantee for drugs is a bad idea. (STAT)
- A close look at Boehringer Ingelheim, the family-owned firm taking on pharma giants. (Bloomberg)
- Merck got a $6 million grant to build an IT hub in Austin. (Statesman)
- FDA’s Scott Gottlieb is fielding a new team of recruiters to start scouting top talent. (Endpoints)