Covid-19 roundup: Trump ad­min­is­tra­tion prep­ping ex­ec or­der to re­duce re­liance on for­eign man­u­fac­tur­ing of 'essen­tial med­i­ci­nes'

Back when Pres­i­dent Trump was cham­pi­oning the po­ten­tial of the malar­ia drug hy­drox­y­chloro­quine, he con­vinced the In­di­an gov­ern­ment to re­lax its ex­port re­stric­tions to sup­ply the Unit­ed States. In­deed, most gener­ic ther­a­pies in the coun­try are man­u­fac­tured in In­dia and Chi­na — and now, as the coro­n­avirus pan­dem­ic puts this de­pen­dence in the spot­light, the Trump ad­min­is­tra­tion is re­port­ed­ly work­ing on mak­ing sure cer­tain es­sen­tial drugs are made at home.

Ac­cord­ing to a Bloomberg re­port, the ad­min­is­tra­tion is prepar­ing an ex­ec­u­tive or­der to that ef­fect.

“It is crit­i­cal that we re­duce our de­pen­dence on for­eign man­u­fac­tur­ers for es­sen­tial med­i­cines, med­ical coun­ter­mea­sures,” the nine-page draft said to “en­sure suf­fi­cient and re­li­able long-term do­mes­tic man­u­fac­tur­ing” in or­der to pre­vent short­ages when need­ed. (Con­t­a­m­i­na­tion con­cerns are, of course, an­oth­er per­ti­nent is­sue.)

The ex­ec­u­tive or­der, which is still in the draft stage, does not spec­i­fy the list of “es­sen­tial med­i­cines,” but gen­er­al­ly cov­ers drugs and de­vices used to re­spond to a pub­lic health emer­gency or bio­haz­ard at­tack. The or­der lim­its fed­er­al con­tracts for sup­plies to US man­u­fac­tur­ers and re­quires that pro­duc­tion be di­vid­ed among drug­mak­ers to en­sure price com­pe­ti­tion, the re­port said.

The or­der is un­der re­view at fed­er­al agen­cies in­clud­ing the Pen­ta­gon and the De­part­ment of Health and Hu­man Ser­vices and has not been signed off on by the pres­i­dent, it added. — Na­tal­ie Grover

Ac­cu­ra­cy of wide­ly used Ab­bott test caus­es FDA con­cern

Test, test, test, the WHO urged na­tions months ago as the coro­n­avirus cri­sis took on pan­dem­ic pro­por­tions. Test­ing, how­ev­er, has been fraught with in­ac­cu­ra­cies as sci­en­tists scram­bled to get their tests on to mar­kets swift­ly, and reg­u­la­tors grant­ed their bless­ings at an ac­cel­er­at­ed rate.

A rapid test from Ab­bott, pro­mot­ed by the Trump ad­min­is­tra­tion as a key com­po­nent to fight the US epi­dem­ic and is in­deed used for dai­ly test­ing in the White House, could be miss­ing near­ly half of pos­i­tive cas­es, ac­cord­ing to a re­cent study from re­searchers at New York Uni­ver­si­ty (al­though the da­ta has not yet been peer-re­viewed).

On Thurs­day, the FDA is­sued a state­ment cau­tion­ing the point-of-care test, which comes up with re­sults in min­utes, may re­turn false-neg­a­tive re­sults.

“The FDA is shar­ing ear­ly in­for­ma­tion avail­able about po­ten­tial in­ac­cu­rate re­sults in the spir­it of trans­paren­cy,” the agency not­ed, adding that it had re­ceived 15 ad­verse event re­ports about the de­vice that sug­gest­ed some users are re­ceiv­ing in­ac­cu­rate neg­a­tive re­sults.

Af­ter the NYU study da­ta were un­veiled, Ab­bott re­fut­ed the da­ta in a se­ries of tweets. The Ab­bott ID NOW test demon­strat­ed 91% sen­si­tiv­i­ty and 100% speci­fici­ty in a sep­a­rate study con­duct­ed in Wash­ing­ton state, the com­pa­ny said on Wednes­day on Twit­ter. — Na­tal­ie Grover

Analy­sis of com­pas­sion­ate use da­ta sug­gest con­va­les­cent plas­ma is safe for Covid-19

Late Thurs­day, a group of re­searchers sup­port­ed by BAR­DA re­port­ed that da­ta from 5,000 com­pas­sion­ate use cas­es con­firmed the safe­ty of this kind of treat­ment.

Un­til mon­o­clon­al an­ti­bod­ies against SARS-CoV-2 be­come wide­ly avail­able — and even the most ad­vanced can­di­dates are still mak­ing their way to the clin­ic — old-fash­ioned con­va­les­cent plas­ma re­mains the on­ly an­ti­body-based ther­a­py avail­able for Covid-19 pa­tients. The idea of har­vest­ing blood (and the myr­i­ad an­ti­bod­ies in it) from peo­ple who have re­cov­ered from a dis­ease dates back decades, but the re­searchers not­ed in a preprint post­ed on medRx­iv Thurs­day that it’s not yet been specif­i­cal­ly shown to be safe in Covid-19.

“The da­ta are re­as­sur­ing,” Ar­turo Casade­vall of Johns Hop­kins Uni­ver­si­ty, a co-au­thor, told the Wall Street Jour­nal. “Now we can fo­cus on find­ing out if it is ef­fec­tive.”

The pa­tients an­a­lyzed here have se­vere or even life-threat­en­ing coro­n­avirus in­fec­tions, with 66% in the in­ten­sive care unit. Se­ri­ous ad­verse events oc­curred in the first four hours af­ter trans­fu­sion for less than 1% of the pa­tients, in­clud­ing a mor­tal­i­ty rate of 0.3%.

“How­ev­er, on­ly 2 (of 36) SAEs were judged as def­i­nite­ly re­lat­ed to the con­va­les­cent plas­ma trans­fu­sion by the treat­ing physi­cian,” they wrote. “The sev­en-day mor­tal­i­ty rate was 14.9%.”

That num­ber “does not ap­pear ex­ces­sive” giv­en the dead­ly na­ture of Covid-19, they con­clud­ed. But it al­so can’t be con­strued as any in­di­ca­tion as to the ef­fi­ca­cy — as there was no con­trol arm. — Am­ber Tong

With 5 vac­cine can­di­dates in Phase II, Chi­na hints there’s more to come next month

Chi­na ex­pects to ap­prove more vac­cine can­di­dates for hu­man tri­als in June, adding to the cur­rent co­hort of five, a gov­ern­ment of­fi­cial said in a brief­ing on Fri­day.

Yix­in Zeng, vice min­is­ter of the Na­tion­al Health Com­mis­sion, not­ed that among the 2,000 peo­ple who have re­ceived ex­per­i­men­tal vac­cines in Phase II tri­als, no se­ri­ous side ef­fects have yet been re­port­ed.

Backed in some cas­es by mil­i­tary and state and bol­stered by ac­cel­er­at­ed reg­u­la­to­ry time­lines, the coun­try boasts of more vac­cines in de­vel­op­ment than any oth­er. CanSi­no Bi­o­log­ics was among the first to launch clin­i­cal stud­ies, rac­ing oth­er fron­trun­ning ef­forts at Mod­er­na and Ox­ford Uni­ver­si­ty, and has been in talks with re­searchers in Cana­da to con­duct large-scale test­ing there as the pan­dem­ic comes un­der con­trol in Chi­na. — Am­ber Tong

Dutch re­searchers ex­plor­ing phar­ma deals for broad­ly neu­tral­iz­ing an­ti­body can­di­date

Af­ter propos­ing a new neu­tral­iz­ing an­ti­body against Covid-19 in Na­ture Com­mu­ni­ca­tions ear­li­er this month, re­searchers from Nether­lands’ Utrecht Uni­ver­si­ty said they are in talks with ma­jor phar­ma­ceu­ti­cal man­u­fac­tur­ers to de­vel­op the po­ten­tial treat­ment.

“I think the most op­ti­mistic sce­nario is that we can reach the first pa­tients in about six months,” said vi­rol­o­gist and co-lead au­thor Berend-Jan Bosch at a press con­fer­ence, per Reuters.

The drug can­di­date, which ap­peared to neu­tral­ize both SARS-CoV-2 and the orig­i­nal SARS virus in vit­ro, was de­vel­oped in part­ner­ship with Eras­mus Med­ical Cen­tre and Har­bour Bio­med. — Am­ber Tong

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

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.