THE VILLAGES, FLORIDA — President Donald Trump speaks during an event today in central Florida, where he signed an executive order calling for further privatizing of Medicare. (Photo — Joe Raedle/Getty)

Phar­ma to blame for im­peach­ment woes? Yep, Pres­i­dent Trump just sug­gest­ed that about Amer­i­ca's least fa­vorite in­dus­try

Pres­i­dent Don­ald Trump sug­gest­ed to­day with­out ev­i­dence that the phar­ma­ceu­ti­cal in­dus­try is be­hind the new im­peach­ment in­quiry from House De­moc­rats.

“I would be very sur­prised if the hoax didn’t come a lit­tle bit from the peo­ple that we’re tak­ing on… I wouldn’t be sur­prised if it was from some of these in­dus­tries that we take on, like phar­ma,” Trump said. He was speak­ing in cen­tral Flori­da at an of­fi­cial White House event on Medicare. HHS sec­re­tary Alex Azar, a for­mer pres­i­dent of the US di­vi­sion of Eli Lil­ly, was in at­ten­dance.

The ac­cu­sa­tions come on the heels of an in­dus­try rep­u­ta­tion poll from Pew last month that rates the phar­ma­ceu­ti­cal in­dus­try dead last among Amer­i­cans, even a full 21% low­er than the health­care in­dus­try. Trump rode in­to the pres­i­den­cy at­tack­ing in­sti­tu­tions that had lost pub­lic trust –  the Wash­ing­ton “swamp”, the “crooked” news me­dia — and phar­ma is an easy tar­get.

News that phar­ma is in-ca­hoots with De­moc­rats to oust a pres­i­dent may come as a sur­prise to those with­in the in­dus­try, as lob­by­ists and top play­ers came out force­ful­ly against Nan­cy Pelosi’s new far-reach­ing bill to al­low the fed­er­al gov­ern­ment to ne­go­ti­ate prices for Medicare’s most ex­pen­sive drugs. The in­dus­try has sim­i­lar­ly tak­en aim at price-reg­u­lat­ing pro­pos­als from Trump and top De­mo­c­ra­t­ic pres­i­den­tial can­di­dates.

The pres­i­dent al­so waxed lyri­cal about a num­ber of is­sues per­ti­nent to bio­phar­ma watch­ers.

Af­ter win­ning some ap­plause for a line about gener­ic drug ap­provals, he claimed any­time he sees peo­ple from the FDA he prods them to go faster.

He then piv­ot­ed to right-to-try, giv­ing an en­tire­ly false ren­di­tion of what the law ac­tu­al­ly cov­ers (com­pas­sion­ate use for pa­tients with a life-threat­en­ing con­di­tion who have ex­haust­ed oth­er op­tions and are seek­ing a drug that has passed Phase I but not been FDA ap­proved) and claimed “mir­a­cles are hap­pen­ing.” It’s a line he of­ten us­es al­though the first pa­tient to take ad­van­tage of the May 2018 law was on­ly dosed this year.

Next he turned to his ju­di­cial­ly-blocked reg­u­la­tion to force drug com­pa­nies to dis­close prices in com­mer­cials, say­ing they were “al­most” there.

Trump al­so had a few lines on drug im­por­ta­tion, telling Flori­da’s Re­pub­li­can gov­er­nor Ron De­San­tis, who was in at­ten­dance, that he will be able to “ne­go­ti­ate til his heart’s con­tent,” and will be able to go to Cana­da and Eu­ro­pean coun­tries to find low­er prices, “and I have a feel­ing that when that hap­pens, the drug com­pa­nies are just go­ing to drop their prices, I think. Now they’re very smart, they may go the oth­er way. And when they do, don’t blame me.”

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

A day af­ter Mod­er­na vac­cine re­sults, ru­mors swirl of pend­ing As­traZeneca da­ta

A day after Moderna and the NIH published much-anticipated data from their Phase I Covid-19 vaccine trial, attention is turning to AstraZeneca which, according to a UK report, is expected to publish its own early data tomorrow.

ITV’s Robert Peston reported that AstraZeneca will publish the Phase I data in The Lancet. 

AstraZeneca and Moderna represent the two most ambitious Covid-19 vaccine efforts, having set the quickest timelines for approval (though they were recently joined in that regard by the Pfizer-BioNTech partnership) and some of the loftiest goals in total doses. Yet there is even less known about AstraZeneca’s vaccine’s effect on humans than there was about Moderna’s before yesterday. Although, in a controversial move, Moderna released some statistics from its Phase I in May, AstraZeneca has yet to say anything about what it saw in its Phase I trial — a move consistent with the scientific convention to withhold data until it can be published in a peer-reviewed journal.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

‘Plan­ning to vac­ci­nate every­one in the US,’ Mod­er­na out­lines ef­forts to sup­ply their Covid-19 vac­cine as man­u­fac­tur­ing ramps up ahead of PhI­II

Twelve days from the planned start of their Phase III pivotal trial, the executive crew at Moderna has set up the manufacturing base needed to begin production of the first 500,000 doses of their Covid-19 vaccine with plans to feed it into a global supply chain. But the initial batches will likely be ready in the US first, where company CEO Stéphane Bancel plans to be able to vaccinate everyone.

“We have started making commercial product at-risk, and will continue to do so every day and every week of the month,” Bancel told analysts during their morning call on the Phase I data just published in the New England Journal of Medicine.

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Covid-19 roundup: Vac­cine by end of 2020? Ken Fra­zier warns hype do­ing 'grave dis­ser­vice'

When it comes to setting expectations about a Covid-19 vaccine, Ken Frazier does not mince words.

Over a month after first casting doubts on the aggressive 12- to 18-month timeframe championed by the US government and his biopharma peers, the Merck CEO again cautioned against any hype around a quick vaccine approval.

In a wide-ranging interview with Harvard Business School professor Tsedal Neeley that touched other big topics such as race, Frazier emphasized that vaccines take a long time to develop. He would know: Out of the seven new vaccines introduced around the world in the past 25 years, four came from Merck.

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Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)

A top an­a­lyst turns the spot­light on Mod­er­na, fu­el­ing a fast-and-fu­ri­ous Street race over the fu­ture of mR­NA

Bioregnum Opinion Column by John Carroll

Four months ago, one of the favorite talking points on the biopharma social media wave length was whether Moderna shares $MRNA were priced right or were wildly inflated.

After all, said the naysayers, the company had never actually pushed a treatment to an approval. Did messenger RNA really work, coding cells to make a drug or a vaccine? And how about all that chatter about how ‘secretive’ they are, or were?

Now, as CEO Stéphane Bancel and the top execs push the company to the forefront of a frantic race to develop the first vaccine to fight against the reignited wildfire spread of Covid-19, all those questions have been magnified — along with the stock price.

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Ludwig Hantson, Alexion CEO

Why pay $4B for a steady di­et of dis­ap­point­ment? Porges turns thumbs down on Alex­ion’s M&A strat­e­gy, of­fers some point­ers

When Alexion announced recently that it was paying $1.4 billion to bag Portola and its underperforming Factor Xa inhibitor reversal agent, you could hear the head-scratching going on around virtual Wall Street.

Why was Alexion going down the discount lane for new products? And why something like this? Analysts have been urging Alexion to get serious about M&A for years if it was serious about diversifying the company beyond Soliris and its successor drug. But this wasn’t the kind of heavy-impact deal they were looking for.

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