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.”

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus -- chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

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Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

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Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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Game on: Re­gen­eron's BC­MA bis­pe­cif­ic makes clin­i­cal da­ta de­but, kick­ing off mul­ti­ple myelo­ma matchup with Bris­tol-My­ers

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.

Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff – although that’s only one level of a multi-step process.

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