FDA re­ports short­age of se­da­tion drug used for putting Covid-19 pa­tients on ven­ti­la­tors

The FDA on Thurs­day up­dat­ed its list of drugs in short­age to in­clude the se­da­tion drug mi­da­zo­lam, which along with oth­er seda­tives is be­ing used to treat COVID-19 pa­tients re­quir­ing me­chan­i­cal ven­ti­la­tion.

The up­dat­ed list­ings for five man­u­fac­tur­ers note an in­creased de­mand for mi­da­zo­lam and may just be the be­gin­ning of what’s to come for oth­er se­da­tion drugs too.

Michael Ganio

Michael Ganio, se­nior di­rec­tor of phar­ma­cy prac­tice and qual­i­ty at the Amer­i­can So­ci­ety for Health-Sys­tem Phar­ma­cists, told Fo­cus via email: “We have mul­ti­ple re­ports of in­creas­es in pur­chas­es and uti­liza­tion of seda­tives like mi­da­zo­lam, fen­tanyl, and propo­fol to treat COVID-19 pa­tients who re­quire me­chan­i­cal ven­ti­la­tion.”

Stat News’ Phar­malot re­port­ed on this in­creas­ing de­mand for seda­tives ear­li­er this week, not­ing there has been a 51% in­crease in de­mand so far this month for half a dozen dif­fer­ent seda­tives and anes­thet­ics.

“The amount of seda­tives saved from for elec­tive surg­eries is not enough to equal the in­creased use of seda­tives for me­chan­i­cal­ly ven­ti­lat­ed pa­tients, es­pe­cial­ly con­sid­er­ing the amount of seda­tives need­ed and the du­ra­tion these pa­tients are on ven­ti­la­tors,” Ganio added.

He al­so not­ed that hos­pi­tals na­tion­wide are prepar­ing for a surge in cas­es of COVID-19 and they are at­tempt­ing to ac­quire the sup­plies and med­ica­tions nec­es­sary to meet the needs of those pa­tients.

A Pfiz­er spokesper­son told Fo­cus via email: “We cur­rent­ly have am­ple sup­ply of sev­er­al pre­sen­ta­tions of Mi­da­zo­lam but are ex­pe­ri­enc­ing high de­mand for the prod­uct. As of to­day, Pfiz­er’s man­u­fac­tur­ing and dis­tri­b­u­tion net­work con­tin­ues to op­er­ate with­out sig­nif­i­cant dis­rup­tion. We’ve iden­ti­fied a list of med­i­cines that are crit­i­cal to treat­ing pa­tients with COVID-19 dur­ing this time. For many of these crit­i­cal med­i­cines, we have am­ple sup­ply. For some, the un­prece­dent­ed surge in de­mand for these prod­ucts is lim­it­ing our abil­i­ty to ful­ly sat­is­fy cus­tomer or­ders in the short-term. We are mak­ing every ef­fort to ad­vance the or­der­ing of ad­di­tion­al ma­te­ri­als, in­crease our pro­duc­tion of the most es­sen­tial prod­ucts, ex­pe­dite or­ders to cus­tomers, es­pe­cial­ly those in high-im­pact ar­eas, and al­lo­cate cus­tomer or­ders to en­sure the most ap­pro­pri­ate dis­tri­b­u­tion.”

In ad­di­tion to the seda­tives, the un­proven but po­ten­tial COVID-19 treat­ment hy­drox­y­chloro­quine sul­fate is al­so list­ed as cur­rent­ly in short­age. Last week, FDA al­so re­leased guid­ance on re­port­ing drug short­ages dur­ing the pan­dem­ic.

FDA Drug Short­age List

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What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

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.

Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Take­da scores a win for a rare type of lung can­cer, gear­ing up for a show­down with J&J

Four months after J&J’s infused drug Rybrevant scored the industry’s first win in a rare type of non-small cell lung cancer (NSCLC), Takeda is following up with an oral option for the small but desperate patient population.

The FDA granted an accelerated approval to Takeda’s oral TKI inhibitor Exkivity (mobocertinib) in metastatic NSCLC patients with EGFR exon 20 gene mutations who had previously undergone platinum-based chemotherapy, the company announced on Wednesday.

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