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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Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

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.