What hap­pens when you pull a re­quest to pull your drug from the mar­ket?

On­copep­tides is try­ing to find out, re­veal­ing late Fri­day that it has con­tact­ed the FDA and re­scind­ed a let­ter it sent back in Oc­to­ber, re­quest­ing vol­un­tary with­draw­al of the NDA of its mul­ti­ple myelo­ma drug, Pepax­to, in the US — the on­ly place where it’s ap­proved.

The Stock­holm-based biotech trig­gered a ma­jor melt­down with the an­nounce­ment back in Oc­to­ber, as the with­draw­al would force it to close its US and EU busi­ness units and en­act sig­nif­i­cant lay­offs.

No de­tails were giv­en for the sud­den change of mind. From a short, cryp­tic state­ment:

Fur­ther re­view and analy­ses of the het­eroge­nous Over­all Sur­vival da­ta from the phase 3 OCEAN study and oth­er rel­e­vant tri­als have led the Com­pa­ny to re­con­sid­er its pre­vi­ous vol­un­tary with­draw­al re­quest.

At the time, it seemed like On­copep­tides had lit­tle choice; Pepax­to, or mel­pha­lan flufe­namide, first won ac­cel­er­at­ed ap­proval in ear­ly 2021 as a treat­ment for re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma. But then in Ju­ly, in­ves­ti­ga­tors re­port­ed that the drug had failed the over­all sur­vival end­point in a con­fir­ma­to­ry study that pit it against Bris­tol My­ers Squibb’s Po­m­a­lyst — in fact, the risk of death was high­er for pa­tients on the Pepax­to arm.

The FDA quick­ly fol­lowed up with an alert to pa­tients and health­care providers about the safe­ty con­cern, and con­vened an ad­comm to weigh in.

But On­copep­tides stopped that dis­cus­sion from hap­pen­ing by pulling the drug days be­fore the pan­el of out­side ex­perts were set to meet.

Hav­ing stopped the mar­ket­ing of Pepax­to in the US, the com­pa­ny says it has no plans to restart “at this time.” What it will do, though, is ini­ti­ate a di­a­logue with the FDA to re­view the new da­ta.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

As Neulasta sales slip, Amgen has yet another biosimilar to look out for: Amneal Pharmaceuticals and Kashiv Biosciences’ Flynetra.

Flynetra became the fifth approved biosimilar to Neulasta on Friday, snagging a win in neutropenia, a condition common among chemotherapy patients where neutrophils, a type of white blood cell that fights infection, are too low.

As of last summer, the list price of Neulasta was more than $6,400 per dose. It’s designed to be taken in a single dose per chemotherapy cycle. Amneal declined to reveal how much it intends to charge for Flynetra in an email to Endpoints News.