Gottlieb rebuts Science report on plummeting FDA inspections; Libtayo wins EMA and NICE endorsement
→ The journal Science on Tuesday published a report that concluded the FDA’s compliance and enforcement actions have plummeted since Donald Trump took office, using data compiled from the agency’s own public records.
In response, Scott Gottlieb — who recently exited the agency as Trump’s first FDA commissioner — defended his record. “We were pretty aggressive,” he wrote to Science. “I don’t think you can paint us with a political narrative—that just because we were a Republican administration, somehow we must have ratcheted down enforcement activity. We didn’t.” Gottlieb, much like the majority of former FDA commissioners that preceded him, has joined the industry he once regulated. Last week, he accepted a position on Pfizer‘s $PFE board of directors, sparking a storm of criticism after taking the fastest route between commissioner and big pharma seen in the agency’s history.
→ Less than a year after securing FDA approval for their PD-1, Libtayo, as a treatment for cutaneous squamous cell carcinoma (CSCC) partners Sanofi $SNY and Regeneron $REGN on Monday announced the European regulator had also endorsed the drug for the skin cancer population. The UK’s cost-effectiveness watchdog, NICE, quickly also backed its use on Tuesday. In a world where checkpoint inhibitors are a dime a dozen, Regeneron’s George Yancopoulos has emphasized that PD-1 therapies offer a much more potent mechanism to unleash an immune attack — which has been underscored by the duopoly of the PD-1’s Keytruda and Opdivo — as well as recent setbacks with other PD-L1 drugs.
→ Puma Biotechnologies $PBYI, which in June 2018 convinced the EMA to change its mind and back its breast cancer drug neratinib, is looking to expand the use of the drug in the United States. Sold as Nerlynx, the FDA approved the drug in 2017, despite side-effect concerns, to prevent the return of breast cancer after therapy including Roche’s Herceptin. Now, Puma is seeking US approval to use the drug in combination with the chemotherapy capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments.
→ Amicus Therapeutics $FOLD, which recently expanded its gene therapy collaboration with the University of Pennsylvania, has entered into a strategic manufacturing agreement with Catalent Biologics.