Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfiz­er and BioN­Tech said Fri­day that they’ve sub­mit­ted a bi­o­log­ics li­cense ap­pli­ca­tion to the FDA for full ap­proval of their mR­NA vac­cine for those over the age of 16.

Pe­ter Marks FDA

How long it will take the FDA to de­cide on the BLA will be set once it’s been for­mal­ly ac­cept­ed by the agency.

Pe­ter Marks, di­rec­tor of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, pre­vi­ous­ly told End­points News that the re­view of the BLA should take be­tween three and four months, but it may be even faster than that.

“In this case, since they’re al­ready un­der emer­gency use au­tho­riza­tion and the large bulk of ad­di­tion­al in­for­ma­tion com­ing in will be safe­ty da­ta and in­for­ma­tion on man­u­fac­tur­ing, we’re in­tend­ing to speed that re­view,” he said.

Pfiz­er and BioN­Tech are al­so await­ing im­mi­nent ap­proval for an ap­pli­ca­tion to ex­pand the cur­rent EUA for their vac­cine to in­clude in­di­vid­u­als 12 to 15 years of age. The com­pa­nies said Fri­day that they in­tend to sub­mit a sup­ple­men­tal BLA to sup­port li­cen­sure of the vac­cine in this age group once the re­quired da­ta six months af­ter the sec­ond vac­cine dose are avail­able.

Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Ger­many’s leader An­gela Merkel on Thurs­day an­nounced her op­po­si­tion to the Biden ad­min­is­tra­tion’s sur­prise de­ci­sion to back a World Trade Or­ga­ni­za­tion waiv­er that would sus­pend in­tel­lec­tu­al prop­er­ty around the Covid-19 vac­cines.

Merkel, ac­cord­ing to the Fi­nan­cial Times, said the pro­pos­al has “se­ri­ous im­pli­ca­tions,” not­ing that what’s lim­it­ing vac­cine sup­plies is not IP, as Mod­er­na CEO Stéphane Ban­cel al­so said Thurs­day, but pro­duc­tion ca­pa­bil­i­ties with high-qual­i­ty stan­dards.

“The pro­tec­tion of in­tel­lec­tu­al prop­er­ty is a source of in­no­va­tion and it must re­main so in the fu­ture,” she said. Ger­many or any oth­er coun­try that’s a mem­ber of the WTO has the pow­er to ve­to the waiv­er.

Rus­sia, France and Spain of­fered sup­port for the US pro­pos­al, while oth­er diplo­mats from Brazil and Chi­na said they would dis­cuss it un­der the WTO frame­work.

UK calls for those un­der 40 to not re­ceive the As­traZeneca vac­cine

The UK’s Joint Com­mit­tee on Vac­ci­na­tion and Im­mu­ni­sa­tion on Fri­day called to re­strict the use of the As­traZeneca Covid-19 vac­cine to on­ly those who are over 40 years old be­cause of con­cerns re­lat­ed to rare but po­ten­tial­ly fa­tal cas­es of blood clots with low platelets.

As of April 28, the UK’s drug reg­u­la­tor re­ceived 242 re­ports of blood clot­ting cas­es in peo­ple who al­so had low lev­els of platelets in the UK, fol­low­ing the use of the As­traZeneca vac­cine.

“These num­bers are very small com­pared to the mil­lions of peo­ple who have re­ceived the vac­cine. The over­all in­ci­dence of case re­ports of throm­boem­bol­ic events with low platelets af­ter first or un­known dos­es was 10.5 per mil­lion dos­es,” the JCVI said.

The com­mit­tee al­so not­ed that the ma­jor­i­ty of these rare events oc­curred af­ter the first dose, so, “Every­body who has al­ready had a first dose of the Ox­ford/As­traZeneca vac­cine should re­ceive a sec­ond dose of the same jab, ir­re­spec­tive of age, ex­cept for the very small num­ber of peo­ple who ex­pe­ri­enced blood clots with low platelet counts from their first vac­ci­na­tion.”

EMA starts rolling re­view of GSK, Vir mon­o­clon­al an­ti­body

The Eu­ro­pean Med­i­cines Agency on Fri­day kicked off a rolling re­view of Glax­o­SmithK­line and Vir’s Covid-19 mon­o­clon­al an­ti­body sotro­vimab.

The com­pa­nies said the de­ci­sion to start the rolling re­view is based on the in­ter­im analy­sis of ef­fi­ca­cy and safe­ty da­ta from a Phase III tri­al, which eval­u­at­ed sotro­vimab as monother­a­py for the ear­ly treat­ment of COVID-19 in 583 adults at high-risk of hos­pi­tal­iza­tion.

Re­sults of the in­ter­im analy­sis demon­strat­ed an 85% (p=0.002) re­duc­tion in hos­pi­tal­iza­tions over 24 hours or deaths in those re­ceiv­ing sotro­vimab com­pared to place­bo, which was the pri­ma­ry end­point of the tri­al.

An emer­gency use ap­pli­ca­tion for sotro­vimab has al­so been sub­mit­ted to the US FDA and Health Cana­da.

Eu­ro­pean Com­mis­sion lays out strat­e­gy for de­vel­op­ing more ther­a­peu­tics

The Eu­ro­pean Com­mis­sion on Thurs­day said it would es­tab­lish a “ther­a­peu­tics in­no­va­tion boost­er” by Ju­ly to ush­er the most promis­ing Covid-19 ther­a­peu­tics from pre­clin­i­cal re­search to mar­ket au­tho­riza­tion.

By June, the com­mis­sion will cre­ate a port­fo­lio of 10 po­ten­tial Covid-19 drugs and win­now that port­fo­lio down to the best five.

“It will or­gan­ise match­mak­ing events for in­dus­tri­al ac­tors in­volved in ther­a­peu­tics to en­sure enough pro­duc­tion ca­pac­i­ty and swift man­u­fac­tur­ing. New au­tho­ri­sa­tions, rolling re­views and joint pro­cure­ment con­tracts will be up and run­ning be­fore the end of the year,” the com­mis­sion said.

By Oc­to­ber, the com­mis­sion said it hopes to have at least three new ther­a­peu­tics to mar­ket, and pos­si­bly two more by the end of 2021, with the de­vel­op­ment of flex­i­ble reg­u­la­to­ry ap­proach­es to speed­ing up the as­sess­ment of drugs that are promis­ing and safe.

CMS in­creas­es pay­ments for mon­o­clon­al an­ti­bod­ies to in­cen­tivize home in­fu­sions

The US Cen­ters for Medicare & Med­ic­aid Ser­vices are up­ping their pay­ments for the ad­min­is­tra­tion of Covid-19 mon­o­clon­al an­ti­bod­ies from $310 to $450 for most health care set­tings, or $750 when mon­o­clon­al an­ti­bod­ies are ad­min­is­tered in a ben­e­fi­cia­ry’s home, in­clud­ing tem­po­rary lodg­ings like ho­tels, cruise ships or home­less shel­ters.

“These high­er na­tion­al av­er­age pay­ment rates re­flect ad­di­tion­al in­for­ma­tion pro­vid­ed to CMS about the costs of pro­vid­ing these ser­vices in a safe and time­ly man­ner, such as clin­i­cal staff and per­son­al pro­tec­tive equip­ment,” the cen­ters said.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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75M vac­cine dos­es wast­ed: FDA spells out Emer­gent fa­cil­i­ty de­fi­cien­cies at length in new memo

The FDA is offering a fuller account of what went wrong at Emergent BioSolutions’ Covid-19 manufacturing facility in Baltimore, where the cross contamination of J&J and AstraZeneca vaccines led to the discarding of about 75 million vaccine doses.

CBER director Peter Marks released a memo on Saturday with new specifics, making clear up front that no vaccine manufactured at this plant has been distributed for use in the US yet.

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UP­DAT­ED: Long-await­ed No­vavax PhI­II re­sults show 90.3% over­all ef­fi­ca­cy, with 100% ef­fec­tive­ness against mod­er­ate and se­vere Covid-19

After several months of delays and setbacks, the small Maryland biotech Novavax has finally completed its North American Phase III trial for its Covid-19 vaccine. And though they say the topline results are positive, it remains to be seen how much uptake there will be in the US given the waning numbers of cases, rising vaccination rates and a surplus of already-authorized vaccines.

Overall efficacy in the study hit 90.3% across nearly 30,000 patients in the US and Mexico, Novavax said, with a total of 77 cases observed. In the placebo arm, researchers saw 63 cases of Covid-19 compared to 14 in the vaccine group. Participants were randomized into the vaccine arm 2 to 1, and Novavax said it collected its data between Jan. 25 and April 30.

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Covid-19 roundup: Re­al world da­ta sug­gest As­traZeneca vac­cine ef­fec­tive against Delta, Al­pha vari­ants; No­vavax hails pos­i­tive study on coro­n­avirus, flu shots com­bo

AstraZeneca’s Covid-19 vaccine, which has been authorized for use in the EU and Japan among many countries but not yet the US, has proved effective against the Delta variant, the company announced on Tuesday.

Real world data from Public Health England showed that the vaccine conferred high levels of protection against the variant that originated in India, as its 2 doses demonstrated 92% efficacy against hospitalization due to this variant. For the Alpha variant, which originated in the UK, the vaccine spurred a 86% reduction in hospitalization, with no deaths reported.