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President Trump speaks at the White House during the Republican National Convention (Alex Brandon, AP Images)

Trump promis­es a safe, ef­fec­tive vac­cine for Covid-19 be­fore year’s end — 'or maybe even soon­er!' So where does that leave the FDA?

While FDA chief Stephen Hahn scrambled to make the difficult case that the FDA will stay on the straight and narrow scientific path in reviewing vaccines for wide public use against the pandemic, President Trump has laid down his own timeline and issued marching orders the agency will be hard pressed to ignore.

And he’s clearly leaving the door open to a snap OK ahead of the election.

On Thursday night, Trump used his national speech accepting the Republican nomination for a second term to promise the American people a “safe and effective” vaccine within 4 months.

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Stephen Hahn, AP

FDA com­mish Hahn spot­lights Oct 22 vac­cine ad­vi­so­ry meet­ing as the next big flash­point in the Covid-19 cam­paign

Mark October 22 on your calendars if you want to watch the next big controversy over the rapid-fire development of Covid-19 vaccines play out at the FDA.

Embattled FDA commissioner Stephen Hahn was back on Twitter Wednesday, offering assurances and spotlighting the virtual session being planned by the vaccine advisory board, and he’s clearly ready to lay out all the Covid-19 data available — 12 days ahead of the election.

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Moderna CEO Stéphane Bancel (AP Images)

The lead­ers in the race to de­vel­op a Covid-19 vac­cine say they could have piv­otal da­ta in Oc­to­ber — but Trump claims FDA is slow­ing re­cruit­ment

Late Friday night Moderna tweeted that their Phase III study had come close to the halfway mark in recruiting the 30,000 or so subjects needed for the pivotal test of their Covid-19 vaccine mRNA-1273.

So I thought it was a good time to catch up with CEO Stéphane Bancel on the timing of the readout, which is of intense interest around the world — and particularly in Washington DC, where the top regulators and scientists involved repeatedly insist they won’t tolerate any political interference in pushing a premature announcement of a win ahead of the election November 3rd.

Clockwise from left: Canaccord Genuity principal Michelle Gilson, Canaccord Genuity CSO Brian Mueller and BioMarin CSO Hank Fuchs (Canaccord Genuity webcast)

Bio­Marin CSO diss­es ri­vals for the he­mo­phil­ia A gene ther­a­py crown: Way be­hind, fac­ing big re­cruit­ment chal­lenges and at best a .6 on the gen-one scale

The leader in the race to a hemophilia A gene therapy does not like to be compared unfavorably to the competition. And when their top execs do the comparing, don’t look for any modesty — BioMarin, they say, owns the lead.

As Factor VIII expression wanes over time, quite a few analysts have raised questions about the kind of future BioMarin’s gene therapy — a supposed once-and-done treatment — faces if it stops working. But just 7 days away from their PDUFA date, with high odds of success, the top execs clearly feel that they are way out front, while promising their rivals will discover there’s a tough slog ahead trying to pursue trials where large numbers of patients are ineligible for new therapies.

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President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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President Trump speaks during an event to sign executive orders on lowering drug prices, July 24, 2020 (Alex Brandon/AP Images)

Trump’s ‘rad­i­cal’, ‘hor­ri­ble’ ex­ec­u­tive or­ders on drug pric­ing earn a C-suite back­lash this week — with one threat to do more over­seas

Once the pandemic erupted in the US, Big Pharma enjoyed a brief period of detente — if not actually warm relations — with the Trump administration.

After years of criticizing high drug prices and threatening legislation that would curb the industry’s pricing freedom, the president warmly encouraged the industry’s commitment to a pell mell race to new vaccines and drugs to fight Covid-19 — often at speeds that would have been considered impossible back in January. And it raised the possibility that biopharma could finally find a way to achieve some kind of popularity after years of public toxicity.

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Rick Gonzalez, AbbVie CEO (Pablo Martinez Monsivais/AP Images)

The phar­ma world's cham­pi­on patent wall builder is called out for their 'drip-feed' strat­e­gy to safe­guard the next megablock­buster fran­chise

By all accounts, AbbVie holds the title as a master builder of patent walls. Its work on Humira has been both legendary and extraordinarily controversial, encircling a cash cow that can be milked without any generic rivals butting in until 2023 — as new and better drugs come along to outperform the copycats to come.

And now a group of patient advocates at I-MAK say AbbVie is deep into building its second high security patent perimeter around Imbruvica — the next Humira in the AbbVie portfolio.

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Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Andrew Allen, Gritstone Oncology CEO

A neoanti­gen pi­o­neer says its tech is work­ing great. So what wrecked the share price?

Gritstone Oncology was one of the original neoantigen upstarts, raising cash and planning to disrupt the immuno-oncology field with a bold new approach to fighting cancer with a new brand of vaccines.

On Monday, the crew in charge ran out a full display of what they’ve been seeing in a Phase I study. And everything seems to be working perfectly with one big exception: It didn’t significantly shrink tumors, let alone eradicate them.

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