When Beth Hogan, a metasta­t­ic pan­cre­at­ic can­cer pa­tient, showed up for her in­fu­sion at Yale’s Smilow Can­cer Hos­pi­tal in New Haven, CT on Oct. 11, she said she was in­formed that day that she would not be re­ceiv­ing Bris­tol My­ers Squibb’s Abrax­ane, part of her com­bo treat­ment, be­cause of a short­age.

“I was told we don’t know when you can have it,” she told End­points News via email, adding that she doesn’t ex­pect to re­ceive any Abrax­ane this com­ing Mon­day at her treat­ment ap­point­ment ei­ther, and she doesn’t know when things will change.

Since Feb­ru­ary, Hogan has been in­fused with a com­bo of Abrax­ane and Gemzar, she said, which “has been a mir­a­cle for me,” not­ing two suc­ces­sive scans with no can­cer pro­gres­sion. “There has been no dis­cus­sion of an al­ter­na­tive. I think they are wait­ing to see if it re­solves it­self. But I was told that some­thing needs to hap­pen — that they don’t want to go be­yond a month with­out it,” she added.

Sev­er­al oth­er can­cer pa­tients reached out to End­points ask­ing about why they haven’t been able to get their Abrax­ane in­fu­sions. The FDA’s web­site lists man­u­fac­tur­ing de­lays but says lit­tle on when more is com­ing. Two can­cer doc­tors al­so con­firmed that Abrax­ane is re­place­able with the gener­ic form of pa­cli­tax­el, al­though one not­ed that Abrax­ane’s for­mu­la­tion is bet­ter tol­er­at­ed, but it’s “not a life or death dif­fer­ence.”

Bris­tol My­ers said it would pro­vide a fuller up­date in mid-No­vem­ber, and con­firmed that it’s pri­or­i­tiz­ing al­lo­ca­tions of the drug glob­al­ly to min­i­mize dis­rup­tions.

Abrax­ane brought in $1.2 bil­lion in sales for BMS in 2020, and $610 mil­lion in the first six months of 2021.

“A BMS fa­cil­i­ty that man­u­fac­tures Abrax­ane must com­plete ad­di­tion­al test­ing be­fore man­u­fac­ture and re­lease of ad­di­tion­al sup­ply, to en­sure prod­uct qual­i­ty and safe­ty. We have pri­or­i­tized re­sources to mon­i­tor and rem­e­dy this sit­u­a­tion,” a BMS spokesper­son said in an emailed state­ment. “There is no im­pact to the qual­i­ty of Abrax­ane cur­rent­ly on the mar­ket.”

But those man­u­fac­tur­ing is­sues have been lin­ger­ing for more than a year and a half af­ter Chi­nese of­fi­cials or­dered BeiGene to stop sell­ing Abrax­ane in the wake of an alarm­ing in­spec­tion, though the man­u­fac­tur­ing is­sues at the root of Chi­na’s im­port sus­pen­sion re­main un­re­solved. BeiGene dis­closed in an SEC fil­ing ear­li­er this month that BMS-Cel­gene is try­ing to end its agree­ment with the com­pa­ny as it can­not man­u­fac­ture the drug in Chi­na or the US.

While BeiGene looks to mend its re­la­tion­ship with BMS, Chi­na’s drug reg­u­la­tors at the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion no longer al­low cer­tain man­u­fac­tur­ing of Abrax­ane from a site in Mel­rose Park, IL, which was hit with an FDA warn­ing let­ter more than a decade ago. An­oth­er man­u­fac­tur­ing fa­cil­i­ty in Phoenix be­came the pri­ma­ry fa­cil­i­ty for Abrax­ane, ac­cord­ing to BeiGene’s fil­ing. BMS’ Cel­gene ini­tial­ly ac­quired those sites as part of its $2.9 bil­lion buy­out of Abrax­is.

“In Ju­ly 2021, me­dia fill test­ing at that [Phoenix] fa­cil­i­ty re­vealed a fail­ure. Fol­low­ing a root cause in­ves­ti­ga­tion, cor­rec­tive and pre­ven­ta­tive ac­tions were im­ple­ment­ed, but test­ing re­sult­ed in the re­jec­tion of ad­di­tion­al vials. Cel­gene is con­tin­u­ing to cor­rect the un­der­ly­ing is­sue, but all man­u­fac­tur­ing pro­duc­tion ac­tiv­i­ties with re­spect to Abrax­ane have ceased at the Phoenix fa­cil­i­ty for the time be­ing and the U.S. Food and Drug Ad­min­is­tra­tion has been no­ti­fied,” ac­cord­ing to a no­tice from BMS to BeiGene.

The an­nounce­ment of the short­age comes on the heels of the FDA deny­ing a pe­ti­tion by Bris­tol My­ers to stall gener­ic ver­sions of Abrax­ane. BMS set­tled with Te­va’s Ac­tavis, al­low­ing at least one Abrax­ane gener­ic to en­ter the mar­ket on March 31, 2022.

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.”

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

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.