Ei­sai will elim­i­nate 91 af­ter it out-li­censed a seizure drug.

An Ei­sai spokesper­son told End­points News that the change-up is tied to Fy­compa, a seizure treat­ment that Flori­da rare dis­ease biotech Cat­a­lyst Phar­ma­ceu­ti­cals agreed to pay $160 mil­lion to Ei­sai in ex­change for com­mer­cial rights back in De­cem­ber. The job cuts were orig­i­nal­ly flagged in a New Jer­sey state WARN no­tice.

The spokesper­son said that Cat­a­lyst in­di­cat­ed in­ter­est in re­tain­ing up to 40 em­ploy­ees who work on Fy­compa. Those who qual­i­fy will have an op­por­tu­ni­ty to in­ter­view with Cat­a­lyst.

Em­ploy­ees who meet cer­tain el­i­gi­bil­i­ty cri­te­ria are en­cour­aged to look at oth­er op­por­tu­ni­ties with­in the com­pa­ny, Ei­sai said. — Paul Schloess­er

Mer­ck touts Keytru­da re­sults in first-line en­dome­tri­al can­cer pa­tients

Mer­ck’s Keytru­da has notched a win in a new sub­group of en­dome­tri­al can­cer pa­tients; the com­pa­ny an­nounced one day af­ter re­veal­ing that the megablock­buster on­col­o­gy drug brought in $20.9 bil­lion last year.

When giv­en Keytru­da in com­bi­na­tion with chemother­a­py as a first-line treat­ment, a group of late-stage en­dome­tri­al can­cer pa­tients saw a “sig­nif­i­cant and clin­i­cal­ly mean­ing­ful im­prove­ment” in pro­gres­sion-free sur­vival, ac­cord­ing to an in­ter­im analy­sis of a Phase III study spon­sored by the Na­tion­al Can­cer In­sti­tute. The study in­clud­ed stage 3 or 4 or re­cur­rent pa­tients whose can­cer was ei­ther mis­match re­pair de­fi­cient (dMMR, the most com­mon cause of hered­i­tary en­dome­tri­al can­cer), or mis­match re­pair pro­fi­cient (pMMR).

Keytru­da was ad­min­is­tered along with chemother­a­py and then con­tin­ued as a sin­gle agent every six weeks for up to 14 cy­cles, ac­cord­ing to the com­pa­ny. Mer­ck’s sav­ing the full re­sults for an up­com­ing med­ical meet­ing and will dis­cuss the da­ta with reg­u­la­tors.

The news comes a day af­ter Mer­ck CEO Rob Davis tout­ed $20.9 bil­lion in 2022 Keytru­da sales and spelled out plans for “push­ing the bound­aries of what pem­bro can do.” He men­tioned nine on­go­ing tri­als dur­ing the earn­ings call, in­clud­ing five stud­ies in Phase III, for Keytru­da (pem­brolizum­ab) in com­bi­na­tion with oth­er im­muno-on­col­o­gy drugs. — Nicole De­Feud­is

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.