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.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.