Covid-19 roundup: Sup­ply chain short­ages lead to half the Mod­er­na dos­es de­liv­ered to Cana­da; J&J shots paused out of con­cern clots would be in­ap­pro­pri­ate­ly treat­ed — re­port

The num­ber of dos­es of Mod­er­na’s vac­cine ex­pect­ed to be de­liv­ered to Cana­da by the end of April has near­ly been cut in half, ac­cord­ing to the coun­try’s pro­cure­ment min­is­ter Ani­ta Anand.

Be­tween 1 mil­lion and 2 mil­lion dos­es of the 12.3 mil­lion ex­pect­ed to be de­liv­ered in time for the sec­ond quar­ter will be de­layed un­til the third, as Mod­er­na said Fri­day that ship­ments to Cana­da and the UK are be­hind sched­ule af­ter a sup­ply chain short­age will de­lay de­liv­er­ies.

De­liv­er­ies to the EU and Switzer­land are on sched­ule, the com­pa­ny said.

These com­pli­ca­tions have short­ened the vac­cine sup­ply in Eu­rope, as side ef­fects linked to J&J and As­traZeneca’s vac­cines have led the UK to ad­vise preg­nant women to get ei­ther Mod­er­na or Pfiz­er’s shot. — Josh Sul­li­van

J&J shots paused out of con­cern clots would be in­ap­pro­pri­ate­ly treat­ed re­port

A week af­ter the CDC and FDA joint­ly de­cid­ed to pause the roll­out of John­son & John­son’s Covid-19 vac­cine due to re­ports of blood clots, we’re get­ting a clos­er look at why.

Un­named sources told the Wall Street Jour­nal that health au­thor­i­ties rec­om­mend­ed sus­pend­ing the shots out of con­cern that doc­tors would im­prop­er­ly treat the con­di­tion. The CDC has ad­vised against us­ing he­parin, which is nor­mal­ly used for blood clots, but could be dan­ger­ous in this set­ting.

Sources told the WSJ that 4 of 6 women who de­vel­oped the clots af­ter be­ing vac­ci­nat­ed with J&J’s jab were treat­ed with the an­ti­co­ag­u­lant, which may have wors­ened their con­di­tion. While the clots haven’t of­fi­cial­ly been linked to the vac­cine, of­fi­cials are be­com­ing more per­suad­ed that the cas­es are re­lat­ed, ac­cord­ing to the WSJ.

The CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices held off last week on de­cid­ing whether or not to rec­om­mend lift­ing the pause, af­ter many of the com­mit­tee mem­bers said they want­ed to wait for more da­ta. They’re now sched­uled to meet again on Fri­day, to dis­cuss whether to con­tin­ue the roll­out with a warn­ing, lim­it the use of the vac­cine, or slam the brakes on the jabs al­to­geth­er.

On “Meet the Press” on Sun­day, An­tho­ny Fau­ci told NBC’s Chuck Todd that he ex­pects to know more by then.

“I think by Fri­day we’ll know which way we’re go­ing on this. Hope­ful­ly we’ll get back on track,” he said.

One of the op­tions on the ta­ble is lim­it­ing the vac­cine’s use to old­er peo­ple, as the blood clots oc­curred in younger women. —Nicole De­Feud­is

Italy throws sup­port in­to do­mes­tic mR­NA vac­cine pro­duc­tion

Af­ter sup­port for the ade­n­ovirus-based J&J and As­traZeneca Covid-19 vac­cines have wa­vered due to re­ports of safe­ty con­cerns, Italy has held talks with man­u­fac­tur­ers about pro­duc­ing more mR­NA-based vac­cines do­mes­ti­cal­ly, ac­cord­ing to the Fi­nan­cial Times.

Mod­er­na, No­var­tis and Ital­ian drug­mak­er Re­i­Thera have been in talks with the cap­i­tal in Rome about pro­duc­ing Cure­Vac’s vac­cine. All of the par­ties in­volved have de­clined to com­ment, the FT re­port­ed.

Faith in the ade­n­ovirus-based vac­cines has fal­tered af­ter a re­cent de­ci­sion in the US to tem­porar­i­ly halt ad­min­is­ter­ing the J&J vac­cine af­ter 6 re­ports of blood clots in pa­tients. Pre­vi­ous­ly, some Eu­ro­pean coun­tries have put a hold on the use of the As­traZeneca shot af­ter the EMA found a very rare link be­tween the vac­cine and sim­i­lar blood clots.

There was no in­di­ca­tion that the Ital­ian-made dos­es would be sole­ly for the peo­ple of Italy, but rather, all of Eu­rope, the FT re­port­ed. — Josh Sul­li­van

Rus­sia RDIF reach­es man­u­fac­tur­ing agree­ment for Sput­nik V

A Chi­nese drug­mak­er has reached an agree­ment with Rus­sia’s RDIF sov­er­eign wealth fund to pro­duce more than 100 mil­lion dos­es of the Sput­nik V vac­cine.

Reuters re­port­ed that the two sides have com­mit­ted to a long-term part­ner­ship, though fi­nan­cial terms or the length of that deal were not dis­closed. Last week, Ger­man Health Min­is­ter Jens Spahn said that the coun­try will en­ter pre­lim­i­nary ne­go­ti­a­tions with Rus­sia for the use of Sput­nik V, but on­ly af­ter the EMA has giv­en it au­tho­riza­tion.

The Fi­nan­cial Times re­port­ed that the EMA is in­ves­ti­gat­ing whether the vac­cine meets good clin­i­cal prac­tice (GCP) stan­dards, af­ter con­cerns that tri­als weren’t run eth­i­cal­ly. — Josh Sul­li­van

Amidst con­cerns sur­round­ing oth­er vac­cines, the EU ups its Pfiz­er vac­cine dos­es

An­oth­er 100 mil­lion dos­es of the Pfiz­er-BioN­Tech Covid-19 vac­cine are head­ed to the EU, Bloomberg has re­port­ed.

The op­tion ex­er­cised rais­es its or­der to 600 mil­lion dos­es, as part of an agree­ment signed in Feb­ru­ary. Last week, the two com­pa­nies agreed to up ship­ments to the EU by 25% this quar­ter. That brought an­oth­er 50 mil­lion dos­es to the coun­try that had orig­i­nal­ly been sched­uled to be de­liv­ered in the fourth quar­ter. — Josh Sul­li­van

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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