President Donald Trump speaks during a meeting with restaurant industry executives about the coronavirus response, in the State Dining Room of the White House, Monday, May 18, 2020, in Washington. (Evan Vucci, AP Images)

Covid-19 roundup: Trump says he's been tak­ing hy­drox­y­chloro­quine for days; Mod­er­na rais­es $1.3B on the heels of ground­break­ing da­ta

A cou­ple of months af­ter he start­ed tout­ing hy­drox­y­chloro­quine as a po­ten­tial treat­ment for Covid-19 on thin ev­i­dence, Pres­i­dent Don­ald Trump re­vealed that he’s been tak­ing the an­ti-malar­ia drug for a lit­tle over a week.

Trump’s pub­lic pro­mo­tion of the drug — as well as his aides’ be­hind-the-scenes work to push for wider use — has been the cen­ter of a whistle­blow­er com­plaint in which Rick Bright, the for­mer chief of BAR­DA, al­leged he was oust­ed for re­sist­ing the pres­sure to en­dorse the un­proven ther­a­py and chloro­quine, a sim­i­lar com­pound.

The FDA pro­vid­ed the emer­gency use au­tho­riza­tion that paved the way for wider use in late March but lim­it­ed the man­date to the hos­pi­tal set­ting. With­in a month, it al­so is­sued a safe­ty warn­ing with­in a month, ad­vis­ing physi­cians to close­ly screen and mon­i­tor pa­tients to help mit­i­gate the risks of heart rhythm prob­lems.

At a press con­fer­ence on Mon­day, Trump at­tacked Bright, say­ing “there’s a lot of bad things com­ing out about him” and point­ing out that he had signed the ap­pli­ca­tion for the EUA, be­fore piv­ot­ing to prais­ing hy­droxy.

The pres­i­dent said he’s tak­ing hy­drox­y­chloro­quine as a pro­phy­lac­tic, a use that’s be­ing in­ves­ti­gat­ed among front­line health­care work­ers and oth­ers at high risk of get­ting ex­posed to the virus.

“I hap­pen to be tak­ing it. I hap­pen to be tak­ing it. I’m tak­ing it, hy­drox­y­chloro­quine. Right now, yeah. A cou­ple weeks ago I start­ed tak­ing it. Be­cause I think it’s good, I heard a lot of good sto­ries … I take a pill every day,” he said, adding: “I think peo­ple should be al­lowed to.”

When pressed, he cit­ed “a lot of pos­i­tive calls about it” as the source of his con­fi­dence that the drug would have a pre­ven­ta­tive ef­fect, even though he main­tains he’s not been ex­posed. Call­ing the neg­a­tive VA study a “very un­sci­en­tif­ic re­port,” he re­it­er­at­ed the pre­vi­ous line: “What have you got to lose?” — Am­ber Tong

Bol­stered by PhI up­date, Mod­er­na quick­ly snags $1.35B raise

The fron­trun­ner sta­tus in the race to de­vel­op a vac­cine against Covid-19 is prov­ing lu­cra­tive for Mod­er­na, which has raised $1.34 bil­lion in a pub­lic of­fer­ing.

The Cam­bridge, MA-based biotech pro­posed to sell and then quick­ly priced 17,600,000 shares at $76 a pop. While that would have marked a 15% pre­mi­um on the stock price Mon­day morn­ing, the re­lease of pre­lim­i­nary re­sults from the on­go­ing Phase I tri­al of its mR­NA SARS-CoV-2 vac­cine boost­ed it well be­yond that in­to the $80 ter­ri­to­ry.

From the pro­pos­al to the pric­ing, Mod­er­na took mere­ly hours to com­plete the ex­er­cise, il­lus­trat­ing the de­mand for its shares.

It’s not just in­vestors who are bet­ting on Mod­er­na. BAR­DA has in­ject­ed $483 mil­lion in­to the clin­i­cal and man­u­fac­tur­ing ops, in the hopes of get­ting the pro­duc­tion ca­pac­i­ty in place for a large-scale roll­out.  — Am­ber Tong

Ahead of pric­ing strat­e­gy un­veil­ing, Gilead re­port­ed­ly do­nates more dos­es of remde­sivir

As an­a­lysts’ an­tic­i­pa­tion con­tin­ues to build re­gard­ing how Gilead would price remde­sivir, the com­pa­ny has pledged to do­nate more dos­es of the an­tivi­ral.

The new do­na­tion would bring the to­tal vials for the fed­er­al gov­ern­ment from 607,000 to 940,000, STAT re­port­ed cit­ing the HHS. That means 30,000 to 55,000 more pa­tients could be treat­ed, de­pend­ing on how long their course of treat­ment is.

But Gilead won’t be of­fer­ing the drug — the on­ly treat­ment to have shown clin­i­cal ben­e­fit in a place­bo-con­trolled study and one that’s been au­tho­rized for emer­gency use — for free for­ev­er. SVB Leerink an­a­lyst Ge­of­frey Porges, who host­ed a vir­tu­al fire­side chat with Gilead CFO An­drew Dick­in­son and SVP of HIV & emerg­ing in­fec­tions Di­ana Brainard, had this to re­port:

The ini­tial do­nat­ed sup­ply of remde­sivir to the US and for­eign gov­ern­ments is ex­pect­ed to be de­plet­ed in June or Ju­ly, and Gilead an­tic­i­pates un­veil­ing a pric­ing strat­e­gy be­fore that oc­curs. The com­pa­ny in­tends to piv­ot to a com­mer­cial mod­el, and stat­ed that in­vestors should ex­pect remde­sivir prod­uct sales in H2.

Am­ber Tong

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.

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.

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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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.”

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.

In a sup­ply chain short­age workaround, Aus­trali­a's Vic­to­ria state aims to build its own mR­NA fa­cil­i­ty

As countries all around the world have experienced troubles with vaccine shortages, Australia’s Victoria state is developing its own mRNA manufacturing facility in an effort to up its number of vaccinated residents.

Victoria will spend $39 million to set up the facility, which could be the first in the southern hemisphere, Reuters reported. The mRNA technology is used in the Pfizer-BioNTech and Moderna vaccines, and has gotten more attention, as adenovirus-based vaccines from AstraZeneca and J&J have had reports of rare, but similar blood clots in some patients. There have been no reports of major side effects in either Moderna or Pfizer’s jab.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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