A lit­tle more than two months af­ter the US halt­ed all ship­ments of Eli Lil­ly’s mon­o­clon­al an­ti­body com­bo for the treat­ment of Covid-19 on a na­tion­al ba­sis, the FDA has de­cid­ed that the use of the drug can re­sume across the coun­try.

“Based on the most cur­rent­ly avail­able da­ta, bam­lanivimab and ete­se­vimab are now au­tho­rized in all U.S. states, ter­ri­to­ries, and ju­ris­dic­tions,” the FDA said yes­ter­day, not­ing in a fact sheet that the com­bo re­tained ac­tiv­i­ty against the Delta vari­ant. The com­bo had pre­vi­ous­ly been pulled be­cause it strug­gled to work against the Be­ta and Gam­ma vari­ants, which are now no longer preva­lent in the US.

The FDA added:

Based on in vit­ro as­says that are used to as­sess the sus­cep­ti­bil­i­ty of vi­ral vari­ants to mon­o­clon­al an­ti­bod­ies, bam­lanivimab and ete­se­vimab, ad­min­is­tered to­geth­er, are ex­pect­ed to re­tain ac­tiv­i­ty against the Delta vari­ant (B.1.617.2), which is now the dom­i­nant vari­ant in the Unit­ed States. The in­crease in preva­lence of B.1.617.2 has been as­so­ci­at­ed with a con­comi­tant de­crease in the fre­quen­cy of iden­ti­fied vari­ants that are ex­pect­ed to be re­sis­tant to bam­lanivimab and ete­se­vimab.

Ship­ments of the com­bo treat­ment re­sumed in some states in late Au­gust, ac­cord­ing to Lil­ly, which praised the an­nounce­ment. The com­pa­ny stood to lose about $375 mil­lion in sales due to the pre­vi­ous pause, ac­cord­ing to one Wall Street an­a­lyst.

The news will al­so be wel­comed by in­fu­sion sites, which have pre­vi­ous­ly dealt with short­ages of oth­er mAbs to treat Covid-19, as an uptick of Delta cas­es con­tin­ues to rav­age the coun­try.

The fed­er­al gov­ern­ment has al­lo­cat­ed al­most 1 mil­lion cours­es of the var­i­ous mAb cock­tails through ear­ly March, ac­cord­ing to fed­er­al da­ta.

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

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.

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.