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.

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Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

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But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

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Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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Faced with thou­sands of opi­oid law­suits, En­do says it will like­ly file for bank­rupt­cy 'im­mi­nent­ly'

Endo International will likely be the next pharma company to file for bankruptcy under a mountain of opioid lawsuits.

The Dublin, Ireland-based company revealed in its Q2 results on Tuesday that it’s in talks with first lien creditors, and that “these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.”

George Scangos, Vir CEO (BIO via YouTube)

Af­ter FDA re­vokes EUA for GSK-part­nered mAb, Vir changes its plans on Covid-19 treat­ments

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