The de­ci­sion by the FDA on Wednes­day to re­verse course and re­view Mod­er­na's flu vac­cine ap­pli­ca­tion was the re­sult of a meet­ing Tues­day be­tween an un­usu­al group of se­nior FDA lead­ers and Mod­er­na, with the FDA lead­ers walk­ing back their boss’ over­rul­ing, ac­cord­ing to two sources fa­mil­iar with the meet­ing.

The re­ver­sal was not based on pre­vi­ous da­ta or the new sub­mis­sion, ac­cord­ing to an FDA se­nior leader with di­rect knowl­edge of Mod­er­na's ap­pli­ca­tion. In the meet­ing, three se­nior lead­ers in the agen­cy's Of­fice of Vac­cines Re­search and Re­view, in­clud­ing the of­fice di­rec­tor David Kaslow, walked back their refuse-to-file (RTF) let­ter sent last week. CBER Di­rec­tor Vinay Prasad had over­ruled Kaslow and re­view staff in mak­ing the de­ci­sion to is­sue the let­ter.

No­var­tis will pay $100 mil­lion in up­front and pre-IND mile­stone pay­ments to tap in­to a macro­cyclic pep­tide plat­form from Un­nat­ur­al Prod­ucts, a deal that could lead to new car­dio­vas­cu­lar dis­ease med­i­cines.

The move al­lows the Swiss phar­ma gi­ant to delve in­to a niche but grow­ing area of drug R&D that seeks to com­bine the pre­ci­sion and po­ten­cy of bi­o­log­ics with the eas­i­er-to-use de­liv­ery of oral med­i­cines.

The progress of macro­cyclic chem­istry is "open­ing en­tire­ly new av­enues in drug dis­cov­ery," said Mune­to Mo­gi, head of glob­al dis­cov­ery chem­istry at No­var­tis Bio­med­ical Re­search. Those ad­vances en­able tar­get en­gage­ment "at a dose and with a phar­ma­co­log­i­cal ver­sa­til­i­ty not pos­si­ble with many oth­er ap­proach­es," he added in a Wednes­day press re­lease.

Sen­sei Bio­ther­a­peu­tics has bought the can­cer me­tab­o­lism start­up Faeth Ther­a­peu­tics in an all-stock deal that has the hall­marks of a re­verse merg­er, and raised $200 mil­lion as part of a pri­vate place­ment, the com­pa­ny an­nounced Wednes­day morn­ing.

The deal aims to take Faeth pub­lic as it heads in­to a key read­out of an en­dome­tri­al can­cer treat­ment at the end of the year, while giv­ing Sen­sei — a com­pa­ny pre­vi­ous­ly with lit­tle funds and a murky fu­ture — an­oth­er shot at life.

“It is es­sen­tial­ly an IPO,” said Faeth CEO Anand Parikh, who will be­come chief op­er­at­ing of­fi­cer at Sen­sei. “The Sen­sei team and as­sets and struc­ture gives us the abil­i­ty to be a pub­lic com­pa­ny.”

🤝 Lil­ly's Zep­bound plus Taltz com­bo: The com­pa­ny said the drugs, when tak­en to­geth­er, helped 27.1% of pa­tients with plaque pso­ri­a­sis and obe­si­ty (or who were over­weight) achieve full skin clear­ance and at least 10% weight loss. Among those who took on­ly Taltz, 5.8% reached the same lev­el of skin clear­ance and weight loss. The dif­fer­ence was sta­tis­ti­cal­ly sig­nif­i­cant, and re­searchers mea­sured the changes af­ter 36 weeks. — Max Gel­man 

🎺 No­var­tis trum­pets Phase 3 Rhap­si­do da­ta: In pa­tients with cer­tain forms of chron­ic hives called chron­ic in­ducible ur­ticaria — where skin breaks out in re­sponse to spe­cif­ic stim­uli — Rhap­si­do reached "sig­nif­i­cant­ly high­er com­plete re­sponse rates ver­sus place­bo" af­ter 12 weeks, No­var­tis said. The com­pa­ny did not re­veal spe­cif­ic da­ta, but said the re­sponse rates were achieved in pa­tients whose hives are caused by rub­bing the skin, as well as cold and hot tem­per­a­tures. Rhap­si­do was pre­vi­ous­ly ap­proved to treat chron­ic spon­ta­neous ur­ticaria, or hives that oc­cur with­out any stim­uli, last year. — Max Gel­man