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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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Sim­mer­ing feud be­tween blue­bird and a ri­val con­tin­ues with al­le­ga­tions of patent fraud

Bluebird bio was hit with a patent infringement lawsuit last week from a Chicago-based biotech it has had an ongoing beef with calling for $2 billion to help cure the “irreparable harm” caused by alleged willful infringement.

Bluebird bio is facing a lawsuit from Errant Gene Therapeutics for violating patent law in two instances, the company says.

The suit alleges that bluebird infringed the rights of EGT’s recombinant vectors used in the gene therapy treatment of rare diseases such as sickle cell disease and beta thalassemia for its drugs Zynteglo and LentiGlobin. EGT has an exclusive license from the Memorial Sloan Kettering Cancer Center to patents titled “vector encoding human global gene and use thereof in treatment of Hemoglobinopathies.”

Sanofi, Re­gen­eron gear up for new Dupix­ent fil­ing af­ter clear­ing sec­ond PhI­II for eosinophilic esophagi­tis

This fall’s harvest is proving fruitful for Dupixent.

Days after touting a clean Phase III sweep in prurigo nodularis, Sanofi and Regeneron report that their blockbuster anti-inflammatory drug has passed another Phase III test with flying colors, paving the way for regulatory filings in 2022.

It’s the second trial where Dupixent has proven effective against eosinophilic esophagitis, meeting the co-primary endpoints by spurring significant improvements in both clinical and histologic disease measures.

Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

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