Cy­to­Dyn’s col­or­ful and in­fa­mous CEO may be gone, but the is­sues that be­gan fes­ter­ing dur­ing his long reign are very much here to stay.

The biotech dis­closed two FDA clin­i­cal holds on its lead drug, the CCR5 an­tag­o­nist leron­limab, af­ter mar­ket close on Wednes­day: a par­tial hold on the HIV pro­gram, and a full one on the Covid-19 pro­gram. As a re­sult, some pa­tients on HIV ex­ten­sion tri­als will have to be tran­si­tioned to oth­er ther­a­py op­tions, while Cy­to­Dyn would not be able to start new Covid-19 tri­als in the US.

While Cy­to­Dyn did not go in­to de­tail about the rea­sons for the holds, it’s not the first time reg­u­la­tors have rep­ri­mand­ed the com­pa­ny, a one-time pen­ny stock that cap­i­tal­ized on the pan­dem­ic and soared to record heights be­fore crash­ing back down.

Un­der for­mer CEO Nad­er Pourhas­san, Cy­to­Dyn be­came known for its ag­gres­sive — bor­der­ing on the reck­less — pro­mo­tion­al cam­paigns, pump­ing press re­lease af­ter press re­lease to tout the (un­sub­stan­ti­at­ed) po­ten­tial of leron­limab as a Covid-19 treat­ment. At the same time, Pourhas­san went on we­b­casts and record­ed videos to talk up the drug, un­de­terred even af­ter the FDA re­ject­ed a BLA for its use in HIV, its orig­i­nal in­di­ca­tion, and the drug failed a pair of Covid-19 stud­ies.

Any­thing, ac­cord­ing to the com­pa­ny at the time, could be pos­i­tive news, whether it’s start­ing a com­pas­sion­ate use pro­gram for leron­limab in the Philip­pines or win­ning a court fight against its clin­i­cal tri­al ser­vice provider.

In the wake of the Covid-19 flop (and sub­se­quent com­mu­ni­ca­tions from Cy­to­Dyn try­ing to spin the re­sults as pos­i­tive), the FDA is­sued a rare pub­lic re­buke, ex­plain­ing the tri­als failed on all end­points.

Ear­li­er this year, the agency’s Of­fice of Pre­scrip­tion Drug Pro­mo­tion sent an­oth­er harsh warn­ing for a pro­mo video in which Pourhas­san again made claims about leron­limab that were not backed up by da­ta.

It got so out of hand that both the SEC and the De­part­ment of Jus­tice de­cid­ed to in­ter­vene, is­su­ing sub­poe­nas to look in­to its pro­mo­tion and mar­ket­ing prac­tices.

In an at­tempt to re­deem it­self and ac­tu­al­ly up the chances of ap­proval and com­mer­cial­iza­tion, Cy­to­Dyn oust­ed Pourhas­san and put the CFO in charge as the board set up a search for a new chief.

The biotech said it is now in the process of eval­u­at­ing which pro­grams to pri­or­i­tize.

As part of that ef­fort, Cy­to­Dyn paused its Brazil Covid-19 tri­als pend­ing re­sults from a da­ta safe­ty mon­i­tor­ing com­mit­tee meet­ing and will re­con­sid­er the tim­ing of its HIV BLA re­sub­mis­sion.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Republicans have taken a stand against the pandemic era habit of lax work-from-home schedules. Now that they’ve wrestled control of the House majority, the FDA’s leadership is playing ball, sending many of the agency’s more than 18,000 employees back to their desks early next year.

Whether this exodus back to White Oak in Silver Spring, MD (many staff will still be allowed to work from home for multiple days per week) will mean more defections to industry and elsewhere remains to be seen.

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

The FDA is struggling to remove drugs from the marketplace that don’t show effectiveness in late stage trials, new JAMA analyses found, thanks to the persistent tension between speed and confidence in early clinical data.

Congress, regulated industry and patients have urged the FDA to shorten the amount of time that the market has to wait for drugs to become available that may help severe and prevalent diseases – and the FDA has listened, offering up a quick accelerated approval pathway that’s frequently used by new cancer drugs.

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.