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.

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.