Top of the morning to you, and a fine one it is. A bright, shiny sun and clear blue skies are hovering over the Pharmalot campus, where the short person is sleeping in and the official mascot is bounding about in search of furry creatures. As for us, we are following our usual routine of brewing cups of stimulation — our choice today is maple bourbon — and foraging for items of interest. On that note, we are proud to present the latest line-up further down this screen. We hope your journey today is meaningful and productive and, of course, do keep in touch. Our inbox remains open 24 hours a day and we treasure your secrets and insights. Have a smashing day. …
A top U.S. Food and Drug Administration official says the agency needs to start using accelerated approval, a much-debated path commonly used for advancing cancer drugs, to advance gene therapies for rare diseases, STAT reports. In a speech at an industry conference, Marks largely focused on the rarest of diseases, those that affect fewer than 100 patients per year. But his remarks came as the FDA considers granting accelerated approval for a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy, a muscle-wasting disease that takes many patients’ lives in their 20s. This is the first time the agency will consider using an accelerated approval for gene therapy.
The pharmaceutical industry asked the Biden administration to extend generous tax breaks and subsidies contained in its $280 billion semiconductor support package to biotech companies as part of an effort to build up the sector in the U.S., The Financial Times reports. PhRMA, the main industry lobby group, asked the White House to offer companies an advance manufacturing tax credit of 25% to help offset the cost of building and expanding biomanufacturing plants, according to a submission to the U.S. Office of Science and Technology Policy. The industry wants lower taxes on manufacturing income for drugs produced in the U.S. and federal funding to cover the cost of loans.
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