President Trump listens to FDA Commissioner Stephen Hahn speaking at a press briefing on the Covid-19 pandemic with members of the Coronavirus Task Force at the White House in Washington on March 19, 2020. Photo by Yuri Gripas/Abaca/Sipa USA(Sipa via AP Images)

Drug­mak­er re­thinks its de­ci­sion to dou­ble price of a gener­ic af­ter Trump calls it a coro­n­avirus life­saver — re­ports

Af­ter Pres­i­dent Trump on Thurs­day im­plied a decades-old malar­ia drug was sanc­tioned by the FDA to fight the new coro­n­avirus, re­ports emerged that late last year the drug’s mak­er dou­bled the price of the com­pound, but has now re­stored the orig­i­nal price tag as the virus en­velops much of the globe.

Made by New Jer­sey-based Ris­ing Phar­ma­ceu­ti­cals — the drug, called chloro­quine phos­phate — saw a hike of rough­ly 98% to $7.66 for a 250 mg tablet, STAT and the Fi­nan­cial Times re­port­ed, cit­ing da­ta from re­search and pub­lish­ing firm El­se­vi­er.

As FDA com­mis­sion­er Stephen Hahn was forced to clar­i­fy that the drug was still be­ing eval­u­at­ed for use against coro­n­avirus on Thurs­day, the com­pa­ny sug­gest­ed the price hike came months ahead of the out­break snow­balled in­to a pan­dem­ic, and be­fore re­searchers be­gan to spec­u­late it might help in­fect­ed pa­tients.

The com­pa­ny — which in De­cem­ber agreed to pay a fine of more than $3 mil­lion af­ter be­ing charged with con­spir­ing to fix prices for a gener­ic hy­per­ten­sion drug — has re­vert­ed back to chloro­quine phos­phate’s orig­i­nal price set in 2015.

“As soon as we saw the in­crease in de­mand and the po­ten­tial that this was go­ing to be uti­lized in the way some folks are pro­ject­ing it to be, we re­scind­ed that price in­crease to the same price it has been on the mar­ket for since 2015,” an ex­ec­u­tive told the FT.

Al­though the drug is be­ing used as part of com­pas­sion­ate use pro­grams in some coun­tries, there is no de­fin­i­tive ev­i­dence sug­gest­ing it helps pa­tients in­fect­ed with the new coro­n­avirus, al­though even Tes­la founder Elon Musk — who has pre­vi­ous­ly sug­gest­ed the “dan­ger of pan­ic” still far ex­ceeds the dan­ger of coro­n­avirus — has tak­en no­tice of its promise.

The drug, now a gener­ic, is de­rived from the bark of the chin­chona tree and has been in use since World War II. It is un­der­stood to be gen­er­al­ly safe in mild-to-mod­er­ate cas­es, but can be tox­ic at high dos­es. Apart from its use against malar­ia, an ill­ness caused by a par­a­site and spread to hu­mans via mos­qui­to bites, the med­i­cine is al­so de­ployed for use in cer­tain au­toim­mune con­di­tions.

Ear­ly da­ta emerg­ing out of France, test­ing a less tox­ic de­riv­a­tive of chloro­quine — hy­drox­y­chloro­quine — on a few dozen pa­tients with Covid-19, sug­gest it may help curb the pe­ri­od that peo­ple with the dis­ease are in­fec­tious. Mean­while, Chi­na’s Min­istry of Sci­ence and Tech­nol­o­gy has al­so sug­gest­ed that chloro­quine phos­phate should be in­clud­ed in the stan­dard Covid-19 reg­i­men, af­ter show­ing promis­ing re­sults in tri­als across 10 hos­pi­tals.

On Thurs­day, Ger­man drug­mak­er Bay­er an­nounced in a press re­lease that it was do­nat­ing 3 mil­lion tablets of its ver­sion of chloro­quine phos­phate for use in US pa­tients.

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

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Covid-19 has roiled clin­i­cal tri­al plans around the world, rais­ing con­cerns over the in­dus­try’s fu­ture on new drug ap­provals

Over the past 4 months, a group of analysts at GlobalData tracked 322 biopharma companies — biotechs, pharmas, CROs and such — reporting on the trouble Covid-19 has caused for their clinical development plans.

Slightly more than half — 179 — are US operations, with about 1 in 4 scattered throughout Europe and in Canada. And the disruptions are clustered around mid-stage development, though a hefty number of late-stage derailments may well blunt the stream of approvals down the road.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”