Covid-19 roundup: Eu­ro­pean Com­mis­sion sues As­traZeneca over vac­cine sup­plies; South Africa re­sumes J&J vac­cine tri­al

The Eu­ro­pean Com­mis­sion said Mon­day that it’s tak­ing le­gal ac­tion against As­traZeneca for fail­ing to pro­vide a suf­fi­cient num­ber of vac­cine dos­es as out­lined in its con­tract.

As­traZeneca’s con­tract with the EU al­lowed for the pur­chase of 300 mil­lion dos­es, with an op­tion for 100 mil­lion more. But on­ly 30 mil­lion dos­es were de­liv­ered in the first quar­ter of 2021, ac­cord­ing to the AP, and the com­pa­ny says it can pro­vide 70 mil­lion in the sec­ond quar­ter, rather than the 180 mil­lion it had promised.

As­traZeneca said in a state­ment Mon­day that it is about to de­liv­er al­most 50 mil­lion dos­es to the EU by the end of April, “in line with our fore­cast. As­traZeneca has ful­ly com­plied with the Ad­vance Pur­chase Agree­ment with the Eu­ro­pean Com­mis­sion and will strong­ly de­fend it­self in court. We be­lieve any lit­i­ga­tion is with­out mer­it and we wel­come this op­por­tu­ni­ty to re­solve this dis­pute as soon as pos­si­ble.” — Zachary Bren­nan

South Africa re­sumes J&J vac­cine tri­al

As the US lifts its pause on the roll­out of John­son & John­son’s Covid-19 vac­cine, South Africa is al­so re­sum­ing a study that had been paused over con­cerns of rare blood clots, ac­cord­ing to Reuters

“It is much bet­ter to have the vac­cine than to avoid tak­ing it for fear of get­ting a blood clot,” Health Min­is­ter Zweli Mkhize said, per the out­let.

A con­cern­ing vari­ant emerged in South Africa months ago, which now has the high­est Covid-19 case count on the con­ti­nent. Ear­li­er this month, of­fi­cials halt­ed the roll­out of As­traZeneca and Ox­ford Uni­ver­si­ty’s vac­cine af­ter a study showed it didn’t pro­tect against mild-to-mod­er­ate cas­es caused by the B.1.351 vari­ant, which is now wide­spread in South Africa. The coun­try has since sold its re­main­ing dos­es of the jab to the African Union, Reuters re­port­ed.

Just less than two weeks ago, the US slammed the brakes on roll­out of J&J’s jab over con­cerns about rare but some­times fa­tal blood clots in women be­tween the ages of 18 and 49. But the FDA and CDC de­cid­ed on Fri­day that the vac­cine’s known and po­ten­tial ben­e­fits still out­weigh the risks.

The FDA has up­dat­ed the fact sheets for vac­cine re­cip­i­ents and providers to note the risk of blood clots and low lev­els of platelets, known as throm­bo­sis with throm­bo­cy­tope­nia syn­drome (TTS). The CDC said it has record­ed 15 cas­es of TTS, among about 8 mil­lion re­ceiv­ing the vac­cine. Among those cas­es are three deaths, sev­en peo­ple hos­pi­tal­ized, four of whom are in in­ten­sive care, and five peo­ple dis­charged.

South African au­thor­i­ties promised “in­ten­si­fied pre-vac­ci­na­tion as­sess­ment and post-vac­ci­na­tion mon­i­tor­ing” ac­cord­ing to Reuters. So far, 290,000 health­care work­ers have re­ceived the shot as part of the study, which seeks to en­roll 500,000 peo­ple, the news agency said. — Nicole De­Feud­is

Biden ad­min­is­tra­tion al­lows ex­port of raw vac­cine ma­te­ri­als to In­dia 

In an ef­fort to help In­dia through what’s shap­ing up to be the world’s worst Covid-19 surge yet, the Biden ad­min­is­tra­tion said it would par­tial­ly lift an em­bar­go on raw vac­cine ma­te­ri­als and send vi­tal sup­plies like test kits, ther­a­peu­tics and ven­ti­la­tors to the strug­gling coun­try.

In­dia has long held the world’s sec­ond-high­est Covid-19 case count, be­hind on­ly the US. How­ev­er, the coun­try re­port­ed 2,767 deaths in the last 24 hours, as op­posed to 868 in the US.

On Thurs­day, the coun­try record­ed 314,000 new in­fec­tions — the world’s high­est ever sin­gle-day jump, ac­cord­ing to the Wall Street Jour­nal. And cas­es have on­ly gone up since.

Emi­ly Horne, a spokes­woman for the Na­tion­al Se­cu­ri­ty Coun­cil, said in a state­ment that the US has iden­ti­fied sources of raw ma­te­r­i­al to be used for the man­u­fac­tur­ing of Co­v­ishield, In­dia’s ver­sion of the As­traZeneca/Ox­ford vac­cine. It has promised to send ther­a­peu­tics, rapid di­ag­nos­tic test kits, ven­ti­la­tors and per­son­al pro­tec­tive equip­ment, and fund an ex­pan­sion at vac­cine man­u­fac­tur­er BioE that would en­able it to pro­duce at least a bil­lion dos­es by the end of 2022. Plus, the ad­min­is­tra­tion is send­ing a team of pub­lic health ad­vi­sors from the CDC.

“Just as In­dia sent as­sis­tance to the Unit­ed States as our hos­pi­tals were strained ear­ly in the pan­dem­ic, the Unit­ed States is de­ter­mined to help In­dia in its time of need,” Horne said in the email state­ment.

Un­til now, the Biden ad­min­is­tra­tion has avoid­ed lift­ing an em­bar­go on raw vac­cine ma­te­ri­als, ac­cord­ing to the New York Times. Just last week, State De­part­ment spokesman Ned Price told re­porters the coun­try is “first and fore­most is en­gaged in an am­bi­tious and ef­fec­tive and, so far, suc­cess­ful ef­fort to vac­ci­nate the Amer­i­can peo­ple.”

De­spite lift­ing the em­bar­go, the ad­min­is­tra­tion has blocked re­quests made by In­dia and South Africa for a tem­po­rary waiv­er to an in­tel­lec­tu­al prop­er­ty agree­ment that would pave the way for gener­ic ver­sions of vac­cines and treat­ments, the Times re­port­ed. — Nicole De­Feud­is

South Ko­rea pres­i­dent to meet with No­vavax about ac­cel­er­at­ed ap­proval of vac­cine — re­port

South Ko­rea pres­i­dent Moon Jae-in is re­port­ed­ly in talks with No­vavax CEO Stan­ley Er­ck about ex­pand­ing pro­duc­tion of the drug­mak­er’s Covid-19 vac­cine — and po­ten­tial­ly ap­prov­ing it ear­li­er.

The pres­i­dent will meet with Er­ck face-to-face to “ex­change opin­ions on the ex­pan­sion of the vac­cine pro­duc­tion part­ner­ship with No­vavax and dis­cuss ways to ad­vance the adop­tion, in­clud­ing an ear­li­er reg­u­la­to­ry ap­proval,” spokesper­son Park Kyung-mee said, per the Ko­rea Her­ald.

The vac­cine sub­sidiary of Ko­rea’s SK Group ex­pand­ed on its orig­i­nal man­u­fac­tur­ing pact with No­vavax back in Feb­ru­ary, giv­ing it a li­cense to man­u­fac­ture and com­mer­cial­ize NVX-CoV2373. SK con­cur­rent­ly struck an agree­ment to sup­ply the Ko­re­an gov­ern­ment with 40 mil­lion dos­es of the vac­cine. — Nicole De­Feud­is

*A pre­vi­ous ver­sion of this ar­ti­cle in­cor­rect­ly stat­ed that there is a surge of Covid-19 cas­es in South Africa. A cor­rec­tion has been made to re­flect that the coun­try is not cur­rent­ly in a surge, but has the high­est case count on the con­ti­nent. 

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.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Covid-19 roundup: HHS may strug­gle to ab­sorb Op­er­a­tion Warp Speed; Eu­rope has no plans for a fourth vac­cine dose

Operation Warp Speed, perhaps the greatest achievement of the former Trump administration, promptly delivered Covid-19 vaccine supplies nationwide when they became available, thanks to collaborations between HHS and the Department of Defense, while helping to fund and aid the manufacture of billions of doses.

But since the Biden administration took over a year ago, acting FDA commissioner Janet Woodcock transitioned out of her role as the therapeutics lead in Warp Speed, which has been converted into a new operation without the fancy name (now known as the “HHS-DOD COVID-19 Countermeasures Acceleration Group”), and as of the start of 2022, the Department of Defense is no longer helping HHS on the program.

Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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