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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

New Charles River Laboratories High Quality (HQ) Plasmid DNA Centre of Excellence at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. (Charles River)

Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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