Departing FDA Head Defends Agency’s Record, Looks Warily Ahead
Speaking with Stat ahead of his exit, Robert Califf expressed concern about the potential for brain drain in government. Other news is on promising drugs for lung cancer patients, the upcoming J.P. Morgan Healthcare Conference, and more.
Stat:
FDA's Califf Sees Gains In Drug Approvals And Food Regulation — And Trouble Ahead
In a wide-ranging interview, Robert Califf, the departing commissioner of the Food and Drug Administration, defended the FDA’s record under his leadership, praised the progress that has been made in changing the way the agency regulates food, and worried about the impact of the coming Trump administration. (Herper, 1/8)
More pharmaceutical news —
Stat:
Johnson & Johnson Says Drug Extended Survival In Lung Cancer
The standard option for many patients with non-small cell lung cancer today is AstraZeneca’s targeted therapy Tagrisso. A year and a half ago, data showed this drug could provide patients with what Yale Cancer Center deputy director Roy Herbst at the time called an “extraordinary” 51% reduction in the risk of death. Now, scientists at Johnson & Johnson think they have a drug combination that can take survival for these patients even further. (Chen, 1/7)
The New York Times:
Drug Company To Share Revenues With Indigenous People Who Donated Their Genes
Variant Bio, a small biotech company based in Seattle, is using genetic information from Indigenous people to develop drugs for obesity and diabetes. (Borrell, 1/7)
Reuters:
China's WuXi Biologics To Sell Irish Vaccine Facility To Merck As US Curbs Loom
China's WuXi Biologics said on Monday it will sell its vaccine facility in Ireland to U.S. drugmaker Merck & Co for about $500 million, ahead of potential U.S. legislation that would restrict business for Chinese biotech companies. The U.S. House of Representatives passed the Biosecure Act in September, which would ban federal contracts with targeted firms and their business partners. (S K, 1/6)
Stat:
JPM Conference 2025: Will Patent Cliff Spur Big Pharma Deals?
Next week brings the return of the J.P. Morgan Healthcare Conference, and with it another fabled opportunity for companies in the industry to court possible mergers, acquisitions, and licensing deals. This year, there will be even greater pressure to make a good match, as the pharmaceutical industry, which drives more than $1 trillion in economic activity and thousands of jobs, faces one of the largest patent cliffs in recent history. Between now and 2033, the patents on dozens of brand-name medications will expire, allowing generic drugmakers to begin selling cheaper versions. (DeAngelis and Feuerstein, 1/8)
