Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in Au­gust, as ne­go­ti­a­tions on a pric­ing deal with Pres­i­dent Trump reached a boil­ing point, PhRMA pres­i­dent Stephen Ubl sent an email up­date to the 34 bio­phar­ma chiefs that sit on his board. He wrote that if the in­dus­try did not agree to pay for a $100 “cash card” sent to se­niors be­fore No­vem­ber, White House chief of staff Mark Mead­ows was go­ing to tell the news me­dia Big Phar­ma was re­fus­ing to “share the sav­ings” with the el­der­ly — and that all of the blame for failed drug pric­ing ne­go­ti­a­tions would lie square­ly on the in­dus­try.

Drug­mak­ers were on the brink of a deal. Typ­i­cal­ly un­palat­able items like Medicare co-pay­ments and $150 bil­lion in out-of-pock­et con­sumer costs were re­port­ed­ly ad­dressed. Yet it was the cash card de­mand by Mead­ows — Trump’s fourth chief-of-staff — that doomed the deal on a Sep­tem­ber 2 phone call be­tween Ubl and the PhRMA board. These de­tails were re­port­ed by the New York Times late on Fri­day, just as the na­tion was gripped with the news of Ruth Bad­er Gins­burg’s death.

Priscil­la Van­derVeer, the new vice pres­i­dent of pub­lic af­fairs at PhRMA, told the Times: “We could not agree to the ad­min­is­tra­tion’s plan to is­sue one-time sav­ings cards right be­fore a pres­i­den­tial elec­tion.”

The ne­go­ti­a­tions were tak­ing place at a time Trump was threat­en­ing to, and even­tu­al­ly did, un­veil a set of four ex­ec­u­tive or­ders aimed at re­duc­ing drug pric­ing. The most con­tro­ver­sial or­der, which seeks to tie some drug prices at lev­els paid in oth­er coun­tries — and of which the le­gal­i­ty is sure to be chal­lenged, was is­sued af­ter ne­go­ti­a­tions with PhRMA col­lapsed.

“Pres­i­dent Trump signed four ex­ec­u­tive or­ders ear­li­er this sum­mer. How­ev­er, he did not re­lease the fi­nal ex­ec­u­tive or­der on ‘most-fa­vored na­tion’ drug pric­ing, giv­ing drug com­pa­nies a month to come up with a coun­ter­pro­pos­al. Ne­go­ti­a­tions did not pro­duce an ac­cept­able al­ter­na­tive, so the pres­i­dent is mov­ing for­ward,” said Judd Deere, a Trump spokesper­son.

Cit­ing four sources fa­mil­iar with the mat­ter, the Times re­ports the com­pa­nies were will­ing, though re­luc­tant, to spend the mon­ey on co-pay as­sis­tance. But there was a “broad con­sen­sus” on PhRMA’s board that it was out of line to is­sue $100 cash cards so close to the elec­tion.

The PhRMA board con­sists of 34 mem­bers, cur­rent­ly chaired by BMS’ Gio­van­ni Caforio.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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Un­fazed by PhII miss, Roche ush­ers Prothena's Parkin­son's drug in­to late-stage tri­al — a $60M move

Prothena’s prasinezumab may not have met the primary endpoint in Phase II, but its partners at Roche are seeing enough to move it into a late-stage trial for Parkinson’s disease.

The Phase IIb will build on the Phase II PASADENA study, adding a subgroup of early Parkinson’s patients on stable levodopa therapy to the population.

It’s a significant milestone for a $600 million deal that dates back to 2013, as dosing of the first patient — expected next year — will trigger a $60 million milestone payment to Prothena.

Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.

RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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