Re­call re­port: Zy­dus re­calls her­pes drug af­ter crys­tal­liza­tion com­plaints; Alem­bic pulls low blood pres­sure drug for in­cor­rect la­bel­ing

It’s been a rel­a­tive­ly qui­et start to the year in terms of drug re­calls, but the FDA hit two gener­ics mak­ers late last week for man­u­fac­tur­ing is­sues.

First, Zy­dus Phar­ma­ceu­ti­cals re­called a her­pes and shin­gles drug Thurs­day af­ter com­plaints of crys­tal­liza­tion in vials.

The ad­min­is­tra­tion of crys­tal­lized acy­clovir sodi­um in­jec­tion could cause in­flam­ma­tion of the vein or blood clots, an in­crease in stroke and heart at­tack and de­creased liv­er or kid­ney func­tion, ac­cord­ing to the FDA. Zy­dus hasn’t re­ceived any re­ports of neg­a­tive re­ac­tions con­nect­ed to the crys­tal­liza­tion.

The drug is pack­aged in sin­gle-dose glass vials, and dis­trib­uted across the US by Car­di­nal Health, Amerisource­Ber­gen Drug Cor­po­ra­tion and Mor­ris & Dick­son Com­pa­ny. The re­call in­cludes four lot num­bers: L000155, L000156, L000126 and L000127. Two of those lots are 20-mL vials and the oth­er two are 10-mL vials. Three of the lots were set to ex­pire in De­cem­ber 2021, and one in Jan­u­ary 2022.

Zy­dus has no­ti­fied dis­trib­u­tors and cus­tomers by email, and FedEx overnight couri­er ser­vice has arranged for the re­turn of all the re­tailed prod­ucts.

In 2019, an FDA in­spec­tor is­sued a warn­ing let­ter to the drug­mak­er af­ter man­u­fac­tur­ing is­sues were un­cov­ered at its Moraiya, In­dia plant.

In­dia-based Alem­bic Phar­ma­ceu­ti­cals al­so re­called one lot of its telmis­artin tablets due to in­cor­rect la­bel­ing. A mar­ket com­plaint said that in at least one in­stance, the low blood-pres­sure drug was la­beled as a 30-count of 20-mil­ligram tablets, but ac­tu­al­ly con­tained a 30 count of 40-mil­ligram strength..

That puts con­sumers of the drug at risk for low blood pres­sure, kid­ney dam­age or life-threat­en­ing el­e­va­tion of potas­si­um, the FDA said. The af­fect­ed lot is num­ber 1905005661 and ex­pires in March 2022.

The telmis­artin tablets are the third drug to be re­called this year due to mis­la­bel­ing. In Jan­u­ary, Meitheal Phar­ma­ceu­ti­cals re­called a lot of cisatracuri­um be­sy­late in­jec­tion af­ter a re­port that a por­tion was mis­la­beled as Phenyle­phrine Hy­drochlo­ride In­jec­tion, USP 100mg per 10mL. Ear­li­er this month, Bryant Ranch Prepack re­called four lots — 47 bot­tles — of the blood pres­sure drug spirono­lac­tone af­ter a re­port that bot­tles la­beled as 50-mil­ligram con­tained tablets that were ac­tu­al­ly 25-mil­ligram, and bot­tles la­beled as 25-mil­ligram con­tained 50-mil­ligram tablets.

Two male en­hance­ment sup­ple­ments were al­so re­called last week. Pre­mierZen and Im­pe­r­i­al were found to have un­de­clared silde­nafil and tadalafil, which could low­er blood pres­sure to dan­ger­ous lev­els.

On De­cem­ber 17, the FDA is­sued a press re­lease that warned con­sumers to avoid cer­tain prod­ucts found on Ama­zon, eBay and oth­er re­tail­ers due to hid­den and po­ten­tial­ly dan­ger­ous drug in­gre­di­ents.

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.

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.

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.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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Chi­nese biotech Ever­est signs $550M+ li­cens­ing deal for BTK in­hibitors on heels of Covid-19 pact

Everest Medicines is on a roll with two licensing deals in one week.

The Shanghai-based biotech has paid Sinovent and SinoMab $12 million upfront for the rights to a BTK inhibitor for renal diseases, the company announced Thursday. The deal comes just days after Everest came away with rights to a Covid-19 vaccine in China, Taiwan, Singapore, Thailand and Indonesia.

Everest will pay Sinovent and SinoMab up to $549 million in milestone payments and royalties. The agreement includes tech transfer of Sinovent and SinoMab’s manufacturing process for the candidate, named XNW1011.