→ 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.

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.