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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.