Covid-19 roundup: US buys more of the on­ly an­ti­body that works against Omi­cron; BioN­Tech taps AI to de­tect new vari­ants faster

Glax­o­SmithK­line and Vir’s mon­o­clon­al an­ti­body sotro­vimab is still the on­ly mAb treat­ment that works against the Omi­cron vari­ant, and the US on Tues­day boost­ed its sup­ply again.

This lat­est deal, the fi­nan­cial de­tails of which were not im­me­di­ate­ly dis­closed, will bring 600,000 ad­di­tion­al dos­es to the US, ready for dis­tri­b­u­tion this quar­ter. GSK and Vir pre­vi­ous­ly land­ed two pri­or pro­cure­ment deals that amount­ed to about $1 bil­lion in sotro­vimab sold. GSK said it’s now signed agree­ments for ship­ping 1.7 mil­lion dos­es of sotro­vimab world­wide.

So far, the US has dis­trib­uted about 385,000 dos­es of sotro­vimab, which is less than half of the num­ber of dos­es of Re­gen­eron and Eli Lil­ly mAbs dis­trib­uted so far. And while the US has paused and then restart­ed its dis­tri­b­u­tion of the Re­gen­eron and Lil­ly prod­ucts, nei­ther of those work against Omi­cron.

BioN­Tech part­ners with Lon­don AI de­vel­op­er to hunt Covid vari­ants

BioN­Tech said Tues­day it’s work­ing with Lon­don-based AI de­vel­op­er In­staDeep to come up with a new com­pu­ta­tion­al method that an­a­lyzes se­quenc­ing da­ta and pre­dicts high-risk vari­ants of SARS-CoV-2.

The ear­ly warn­ing sys­tem com­bines struc­tur­al mod­el­ing of the SARS-CoV-2 spike pro­tein and AI al­go­rithms to flag po­ten­tial­ly high-risk vari­ants en­tered in­to SARS-CoV-2 se­quence da­ta repos­i­to­ries “with­in less than a day,” based on met­rics scor­ing their fit­ness (e.g. ACE2 and vari­ant Spike pro­tein in­ter­ac­tion) as well as their im­mune es­cape prop­er­ties, the com­pa­nies said.

Dur­ing a tri­al pe­ri­od of the sys­tem, it iden­ti­fied >90% of WHO-des­ig­nat­ed vari­ants two months faster than oth­er in­ter­na­tion­al ex­perts, the part­ners claimed.

“More than 10,000 nov­el vari­ant se­quences are cur­rent­ly dis­cov­ered every week and hu­man ex­perts sim­ply can­not cope with com­plex da­ta at this scale,” Karim Be­guir, co-founder and CEO of In­staDeep, said in a state­ment.

Mod­er­na vac­cine per­forms bet­ter than Pfiz­er against in­fec­tion, hos­pi­tal­iza­tion, new VA re­al-world da­ta study shows

A new re­al-world study fund­ed by the De­part­ment of Vet­er­ans Af­fairs re­veals that com­pared to those who re­ceived Pfiz­er’s Covid-19 vac­cine, Mod­er­na vac­cine re­cip­i­ents had a sig­nif­i­cant­ly low­er risk of SARS-CoV-2 in­fec­tion and re­lat­ed hos­pi­tal­iza­tions across all age groups, co­mor­bid­i­ty-bur­den cat­e­gories and race.

Au­thors of the study, pub­lished as a pre-print last week, not­ed dif­fer­ences be­tween Mod­er­na’s mR­NA-1273 vac­cine and Pfiz­er’s BNT162b2 “in risk of in­fec­tion or hos­pi­tal­iza­tion were pro­gres­sive­ly greater when the fol­low-up pe­ri­od was longer.”

The study eval­u­at­ed more than 900,000 vac­cine re­cip­i­ents, fol­lowed for a mean of 192 days, dur­ing which there were al­most 17,000 in­fec­tions, more than 3,500 hos­pi­tal­iza­tions and 381 deaths.

While few­er pa­tients who re­ceived Mod­er­na’s vac­cine died com­pared with Pfiz­er (168 ver­sus 213), the re­searchers said this dif­fer­ence was not sta­tis­ti­cal­ly sig­nif­i­cant (aHR 0.808, 95% CI 0.592-1.103).

Pfiz­er preps to launch Omi­cron-tar­get­ed vac­cine in March

Pfiz­er CEO Al­bert Bourla told CN­BC yes­ter­day his com­pa­ny is ready­ing the launch of an Omi­cron-spe­cif­ic vac­cine in March, and ramp­ing up man­u­fac­tur­ing now.

“The hope is that we will achieve some­thing that will have way, way bet­ter pro­tec­tion par­tic­u­lar­ly against in­fec­tions, be­cause the pro­tec­tion against the hos­pi­tal­iza­tions and the se­vere dis­ease — it is rea­son­able right now, with the cur­rent vac­cines as long as you are hav­ing let’s say the third dose,” Bourla said.

In ad­di­tion, the com­pa­ny is plan­ning for hu­man tri­als of the Omi­cron-tar­get­ed vac­cine to be­gin by the end of the month, ac­cord­ing to Busi­ness In­sid­er.

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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