Clin­ton’s chief strate­gist urged tough drug stance that aimed straight for the "cost pain point”

Hillary Clin­ton, cred­it: Max Gold­berg

Last fall, Bernie Sanders, Hillary Clin­ton’s chief De­mo­c­ra­t­ic op­po­nent in the pri­maries, was get­ting promi­nent at­ten­tion for his at­tack on drug com­pa­nies. In the words of Joel Be­nen­son, Clin­ton’s chief strate­gist, Sanders’ mes­sage was: “drug com­pa­nies are screw­ing Amer­i­cans three ways to Sun­day and he’s go­ing to put an end to it.”

Be­nen­son, in an email from Sep­tem­ber 16, 2015 which was hacked by Wik­iLeaks, want­ed to do some­thing about it, aim­ing straight for the “cost pain point” felt by the Amer­i­can con­sumer. And he out­lined a num­ber of steps that could put Clin­ton ahead on the is­sue, tack­ling some of the holi­est cows on Big Phar­ma’s ranch­ing the process.

Why aren’t we call­ing for an end to tax de­duc­tions for di­rect to con­sumer ad­ver­tis­ing of pre­scrip­tion drugs and for sam­pling to docs? They are spend­ing hun­dreds of mil­lions to goad con­sumers in­to ask­ing for drugs from their doc­tors they shouldn’t get tax breaks for do­ing it.  (I would go fur­ther and con­sid­er ban­ning TV ad­ver­tis­ing to con­sumers,  (I know there may be 1st amend­ment rights; al­though we do ban cig­a­rette ads).

We have to make sure that what­ev­er our plans are here – they are sim­ple, di­gestible and ad­dress a re­al cost pain point with a clear so­lu­tion that fix­es it.  Things like cost shift­ing to em­ploy­ers/in­sur­ers seem less like bold so­lu­tions that will bend the cost curve down and ul­ti­mate­ly could leave us open to an easy at­tack from Sanders that “HRC’s plans aren’t bold, don’t change the sys­tem of cor­po­rate greed in health care and will end up mak­ing you pay more one way or an­oth­er while drug and in­sur­ance com­pa­nies con­tin­ue to make mass prof­its at your ex­pense. ”

Seems to me that our pro­pos­als have to be able to counter that.

Clin­ton made her po­si­tion on drug pric­ing a key is­sue dur­ing her cam­paign, which in­flict­ed con­sid­er­able dam­age on biotech share prices. As we re­port­ed ear­li­er, her tweets and state­ments on the is­sue had been care­ful­ly craft­ed by a team that was con­vinced that at­tack­ing phar­ma com­pa­nies was a sure-fire method for spurring sup­port.

Five days af­ter Be­nen­son sent his email, Clin­ton would mount a di­rect at­tack on Mar­tin Shkre­li, the volatile biotech ex­ec who had in­curred the wrath­ful at­ten­tion of a vi­ral on­line mob for his de­ci­sion to boost the price of Dara­prim by more than 5000%. And in the af­ter­math, Ann O’Leary, a se­nior pol­i­cy an­a­lyst on the Clin­ton team, would ex­ult: “FYI — We have start­ed the war on phar­ma!!”

(Shehla Shakoor con­tributed to this sto­ry.)

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.

Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

No­var­tis los­es biosim­i­lar ap­peal as court up­holds a 31-year mo­nop­oly by Am­gen's En­brel

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.