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.

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 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.

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 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.

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.