Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, the alternatives are not particularly appetizing, yes? While you ponder the possibilities, we invite you to join us for a delightful cup or two of stimulation. Our choice today is pistachio creme. Remember that no prescription is required — so no co-pay or rebate negotiation is involved. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day, and please do stay in touch. Feedback, tips, and criticism are always appreciated. …
The U.S. Food and Drug Administration named Richard Pazdur, its longtime overseer of cancer therapies, as its top drug regulator, STAT notes. Pazdur replaces former Center for Drug Evaluation and Research Director George Tidmarsh, who left the agency earlier this month amid accusations of using his regulatory authority to advance a personal vendetta against a former business associate, as well as infighting with vaccine and biologics center director Vinay Prasad. Pazdur has worked at the FDA for 26 years, and founded the agency’s Oncology Center of Excellence. His appointment signals an effort to bring stability to a crucial part of the FDA that’s been wracked by declining morale and staff departures. He will be the third person to lead CDER since President Trump took office. “Up to this point, appointments (at FDA) have created significant uncertainty for patients and industry as decision-making has appeared often times bipolar,” Raymond James analyst Chris Meekins wrote in an investor note.
In one of the biggest cancer spending sprees in years, pharmaceutical giants are pouring billions into developing treatments linking old drugs together — with little proof they can help patients live longer, Bloomberg News explains. This is an industry gold rush based on a tantalizing prospect: a new class of treatments that might dethrone Merck’s Keytruda, an immunotherapy used in a range of cancers and one of the world’s best-selling medicines. The drugs are not based on a breakthrough discovery. Instead, they combine versions of Keytruda and Roche’s Avastin into a single drug. With the individual therapies, combinations have been tested repeatedly with limited success in prolonging lives. Nevertheless, drugmakers have piled in to gain rights to the treatments, known as PD-1/VEGF bispecific antibodies. Drug companies have collectively announced more than $6 billion in deals in the past year for the dual-acting drugs. And they are set to shell out even more money on clinical trials for thousands of patients.
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STAT Pharma: The science and business of new drug development
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