FDA warns on safe­ty threat posed by 2 drugs ini­tial­ly backed by Trump for Covid-19 — fol­low­ing an emer­gency use au­tho­riza­tion

Two of Pres­i­dent Trump’s ini­tial top picks as near-term ther­a­peu­tic reme­dies for Covid-19 are the sub­ject of an FDA safe­ty warn­ing to­day.

The agency is­sued an alert on Fri­day on hy­drox­y­chloro­quine and chloro­quine for “se­ri­ous and po­ten­tial­ly life-threat­en­ing heart rhythm prob­lems, that have been re­port­ed with their use for the treat­ment or pre­ven­tion of COVID-19.”

Trump, whose most re­cent mus­ings on Covid-19 fo­cused on the use of dis­in­fec­tants (dan­ger­ous) and light (?) to stop the virus, ear­li­er made re­peat­ed sup­port­ive com­ments re­gard­ing chloro­quine and hy­drox­y­chloro­quine, which he has cit­ed as a pow­er­ful drug that could be a po­ten­tial “game chang­er” and which couldn’t hurt any­one who tried it.

Rick Bright

Both drugs are used for malar­ia and have be­come hard to find in the wake of Trump’s en­dorse­ment.

The FDA hasn’t ful­ly ap­proved the drugs for Covid-19, but they did pro­vide emer­gency use au­tho­riza­tion as the pres­i­dent ex­tolled the ther­a­pies in his dai­ly press con­fer­ences. More re­cent­ly, press re­ports in­di­cate that the pres­i­dent has be­gun to back away from these drugs, but he re­mains fixed on find­ing some­thing handy to fight the pan­dem­ic.

Just this week, Rick Bright says he was oust­ed from BAR­DA for re­fus­ing to back hy­droxy, say­ing he had re­sist­ed in­vest­ing in ther­a­pies “that lack sci­en­tif­ic mer­it.”

Bio­phar­ma ex­perts, mean­while, are fo­cused on de­vel­op­ing ad­vanced drugs for the new virus, find­ing new ones or go­ing af­ter a vac­cine. The main ar­gu­ment in the in­dus­try isn’t what’s need­ed, but how long it’s go­ing to take.

“While clin­i­cal tri­als are on­go­ing to de­ter­mine the safe­ty and ef­fec­tive­ness of these drugs for COVID-19, there are known side ef­fects of these med­ica­tions that should be con­sid­ered,” of­fered new FDA com­mis­sion­er Stephen Hahn. “We en­cour­age health care pro­fes­sion­als mak­ing in­di­vid­ual pa­tient de­ci­sions close­ly screen and mon­i­tor those pa­tients to help mit­i­gate these risks. The FDA will con­tin­ue to mon­i­tor and in­ves­ti­gate these po­ten­tial risks and will com­mu­ni­cate pub­licly when more in­for­ma­tion is avail­able.”

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

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Why re­mote drug man­u­fac­tur­ing eval­u­a­tions won't re­al­ly re­duce FDA's back­log of in­spec­tions

For the first several months of the pandemic last spring, the FDA continued to plow through its user fee-enabled work on new drug and biologic applications, meeting nearly all of its goal dates.

But by last fall and into the winter, complete response letters and other delays began arriving in companies’ mailboxes as the agency struggled to catch up to a growing backlog of both domestic and foreign drug manufacturing inspections.

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House Committee on Oversight and Reform Chairwoman Carolyn Maloney (Getty Images)

House De­moc­rats call on Emer­gent ex­ecs to tes­ti­fy on qual­i­ty is­sues next month

The House Oversight Committee is investigating Covid-19 vaccine producer Emergent BioSolutions, which secured a $628 million US government contract to make AstraZeneca and J&J vaccines despite “a long, documented history” of quality control issues, Democrats said in a letter to the contract manufacturer’s executives.

Emergent’s Baltimore plant, which was shuttered on Monday by FDA, has been embroiled in controversy after being forced to destroy millions of AstraZeneca and J&J doses due to an ingredient mix-up and possible contamination.

Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.