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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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