The FDA on Wednes­day an­nounced that Eli Lil­ly’s Covid-19 drug bebtelovimab is no longer au­tho­rized to treat Covid-19 be­cause of the ris­ing num­bers of two new sub­vari­ants that the drug does not work against.

The Cen­ters for Dis­ease Con­trol and Pre­ven­tion last week pub­lished new es­ti­mates that the com­bined pro­por­tion of Covid-19 cas­es caused by the Omi­cron sub­vari­ants BQ.1 and BQ.1.1 are greater than 57% na­tion­al­ly, and al­ready above 50% in all in­di­vid­ual re­gions but one.

The US gov­ern­ment rec­om­mends all bebtelovimab sup­plies be re­tained by states in the event that vari­ants sus­cep­ti­ble to the treat­ment, which are still cur­rent­ly cir­cu­lat­ing at low­er preva­lence, be­come more preva­lent in the fu­ture.

Lil­ly said in a state­ment that both the com­pa­ny and the FDA

agree that it is not med­ical­ly ap­pro­pri­ate, at this time, to treat high-risk pa­tients with mild-to-mod­er­ate COVID-19 with bebtelovimab in the US. Based on pseudovirus da­ta, Lil­ly can con­firm that bebtelovimab does not re­tain neu­tral­iza­tion ac­tiv­i­ty against the BQ.1 and BQ.1.1 vari­ants, most like­ly due to an aminoacid K444T sub­sti­tu­tion. Lil­ly will pause all dis­tri­b­u­tion of bebtelovimab. Any un­used bebtelovimab may be kept dur­ing the pause.

But bebtelovimab isn’t the first Covid-19 treat­ment to lose its ef­fi­ca­cy due to new vari­ants. Last Jan­u­ary, two mon­o­clon­al an­ti­body com­bos from Eli Lil­ly and Re­gen­eron had their au­tho­riza­tions halt­ed and ship­ments ceased be­cause HHS said they are “high­ly un­like­ly” to work against Omi­cron.

And un­like with Lil­ly’s for­mer mAb bam­lanivimab, which had its EUA re­voked in April 2021, FDA opt­ed to re­vise, rather than re­voke, these three mAb EUAs.

Avail­able Covid-19 ther­a­pies in the US in­clude Pfiz­er’s Paxlovid, Mer­ck’s Lagevrio and Gilead’s Vek­lury.

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.