→ The first drug­mak­er tipped to win ap­proval for a NASH ther­a­peu­tic is go­ing to have to wait three months longer. The FDA is now ex­pect­ed to make its fi­nal de­ci­sion on In­ter­cept Phar­ma­ceu­ti­cals‘ obeti­cholic acid by June 26. The de­lay was at­trib­uted to a ma­jor amend­ment — ad­di­tion­al in­for­ma­tion was pro­vid­ed by the com­pa­ny in re­sponse to FDA re­quests — as well as to ac­com­mo­date an ad­vi­so­ry com­mit­tee meet­ing, In­ter­cept said in a fil­ing on Fri­day. Last month, the FDA no­ti­fied the com­pa­ny it ten­ta­tive­ly in­tend­ed to hold the ad­comm on April 22 — so a de­lay to the March PDU­FA was in any case ex­pect­ed.

→ This week, the EMA’s safe­ty com­mit­tee rec­om­mend­ed sus­pend­ing the mar­ket­ing au­tho­riza­tion of Dan­ish drug­mak­er LEO Phar­ma‘s gel Pi­ca­to. Pa­tients should stop us­ing the ther­a­py — which is ap­proved to treat the skin con­di­tion ac­tinic ker­ato­sis — while the reg­u­la­tor in­ves­ti­gates the top­i­cal treat­ment’s links to skin can­cer, the agency said.

→ A Chi­nese fund has in­vest­ed AUS$45 mil­lion to al­low re­searchers from the Uni­ver­si­ty of Ade­laide, Uni­ver­si­ty of South Aus­tralia, state hos­pi­tals and oth­er in­sti­tu­tions to fo­cus on drug de­vel­op­ment and clin­i­cal di­ag­nos­tics. An Lu­Fan, ex­ec­u­tive di­rec­tor of D&R Phar­ma­ceu­ti­cals, heads the fund and is backed by pri­vate in­vestors based in Nan­jing, Chi­na.

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

GSK has landed a new first from UNICEF — the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”