→ For­mer HHS Sec­re­tary Tom­my Thomp­son is ex­pand­ing his biotech re­sume. Thomp­son has signed as a board mem­ber at New York-based Tyme Tech­nolo­gies, which is work­ing on a pipeline of can­cer ther­a­pies. Thomp­son is al­so chair­man of Ther­a­peu­tic­sMD, which re­cent­ly won a re­ver­sal of the FDA’s de­ci­sion to re­ject its lead ther­a­py and per­mit a full re­view of its mar­ket­ing ap­pli­ca­tion.

→ Medi­gene AG has gained a reg­u­la­to­ry green light to be­gin the first Phase I/II study of its TCR-mod­i­fied T cell ther­a­py MDG1011. “With our spe­cif­ic study de­sign, we are able to eval­u­ate our T cell ther­a­py si­mul­ta­ne­ous­ly in var­i­ous dis­eases and to gen­er­ate da­ta in three hema­to­log­i­cal in­di­ca­tions in par­al­lel,” said Kai Pinck­er­nell, the CMO at Medi­gene.

→ Bloomberg re­ports that J&J is scout­ing for po­ten­tial buy­ers of its ster­il­iza­tion prod­ucts di­vi­sion, which could be worth up to $2 bil­lion.

Biohaven is at risk of making a habit of disappointing its investors. 

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.