John Nkengasong, Africa CDC director (Andre Pain/AFP via Getty Images)

Covid-19 roundup: Africa CDC to seek vac­cine do­na­tion pause — re­port; New study sug­gests blood clots from As­traZeneca shot are very rare

The Africa CDC is re­port­ed­ly seek­ing a pause in vac­cine do­na­tions as lo­gis­ti­cal chal­lenges and hes­i­tan­cy be­gin to out­strip sup­ply is­sues.

John Nken­ga­song, the agency’s di­rec­tor, told Politi­co on Tues­day that coun­tries are bet­ter able to pro­vide shots for their cit­i­zens. But con­cerns over get­ting shots in­to arms have mount­ed in re­cent weeks, and the con­ti­nent’s CDC will ask for a do­na­tions pause un­til the third or fourth quar­ter this year.

Nken­ga­song rea­soned the vac­cines would ex­pire if oth­er coun­tries and CO­V­AX con­tin­ued the pace of its cur­rent ship­ments.

“It’s like buy­ing a whole bas­ket of foods and just to put it on your kitchen counter,” he told Politi­co. “If you can­not use any, it will rot. But if you do that in small­er pieces, then you still get to the end goal with the same amount of food on your kitchen ta­ble — but at least you don’t have any waste.”

Most of the con­ti­nent’s vac­cine hes­i­tan­cy comes from young in­di­vid­u­als who don’t see the virus as much of a threat, he added. In ad­di­tion, he list­ed the fol­low­ing lo­gis­ti­cal chal­lenges: African coun­tries still need to build up their cold-stor­age ca­pac­i­ties, make more sup­plies like sy­ringes and nee­dles avail­able, and fig­ure out where to store un­used shots.

Thus far, CO­V­AX says it has shipped more than 500 mil­lion Covid-19 vac­cine dos­es to low-in­come coun­tries, many of which are in Africa. The Africa CDC’s strat­e­gy al­so comes as Pres­i­dent Joe Biden aims to boost US vac­cine do­na­tions to oth­er coun­tries as the Omi­cron wave sub­sides state­side.

New study shows blood clot risk is ex­treme­ly low af­ter As­traZeneca shot 

A new study from the UK is delv­ing deep­er in­to side ef­fects from the As­traZeneca vac­cine, sug­gest­ing events of rare blood clots may be more un­com­mon than pre­vi­ous­ly thought.

Re­searchers found the clots on­ly ap­peared in one case per three mil­lion vac­ci­na­tions, and on­ly af­ter in­di­vid­u­als re­ceived their first dose, ac­cord­ing to a pa­per pub­lished in PLOS Med­i­cine. The study an­a­lyzed health records of 46 mil­lion Eng­lish adults be­tween De­cem­ber 2020 and March 2021 to draw its con­clu­sions.

The pa­per’s au­thors looked specif­i­cal­ly at in­tracra­nial ve­nous throm­bo­sis (ICVT) and throm­bo­cy­tope­nia, or clots that are some­times ac­com­pa­nied by low platelet counts. Some coun­tries sus­pend­ed roll­outs of the As­traZeneca vac­cine when these is­sues first arose in ear­ly 2021.

Tues­day’s study showed no risk of blood clots for those old­er than 70, with younger pop­u­la­tions see­ing high­er risk. For all pop­u­la­tions, the au­thors said the risk of blood clots “are like­ly to be out­weighed” by the shot’s ben­e­fits in pro­tect­ing against Covid-19 hos­pi­tal­iza­tion and death.

It’s the same side ef­fect that in­duced a dis­tri­b­u­tion pause in the US for the J&J vac­cine last April. Though ad­min­is­tra­tion re­sumed a few weeks lat­er fol­low­ing a re­view clear­ing the shot, the pause damp­ened vac­cine up­take at the time, par­tic­u­lar­ly for the J&J shot. As­traZeneca and J&J used the same tech­nol­o­gy in de­vel­op­ing their vac­cines — ade­n­ovi­ral vec­tors.

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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Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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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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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

(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.