Elizabeth Warren and Amy Klobuchar, AP Images

War­ren and Klobuchar say they can low­er drug prices with­out Con­gress’ help

On Tues­day, two De­moc­rats run­ning for pres­i­dent promised to do — each by her­self — what Wash­ing­ton has so far proven un­able to do: low­er the prices of pre­scrip­tion drugs.

Speak­ing dur­ing the last De­mo­c­ra­t­ic de­bate be­fore the Iowa cau­cus on Feb. 3, Sen. Eliz­a­beth War­ren of Mass­a­chu­setts and Sen. Amy Klobuchar of Min­neso­ta said, if elect­ed pres­i­dent, they would each act im­me­di­ate­ly to di­rect­ly re­duce the cost of cer­tain drugs.

Their de­c­la­ra­tions, com­ing from two sen­a­tors who have spon­sored their own bills to con­trol sky­rock­et­ing drug prices, stood out af­ter Con­gress spent last year de­bat­ing the prob­lem — and failed to pass sig­nif­i­cant leg­is­la­tion to fix it.

“We need to get as much help to peo­ple as we can, as soon as pos­si­ble,” War­ren said.

While they did not elab­o­rate on which pres­i­den­tial pow­ers they would use, War­ren and Klobuchar said the pres­i­dent al­ready has the le­gal au­thor­i­ty to rein in drug prices. (Klobuchar ac­tu­al­ly has a list of 137 things that she could do with­out Con­gres­sion­al ac­tion that in­clude but are not lim­it­ed to ac­tion on drug pric­ing.)

A 2019 poll from the Kaiser Fam­i­ly Foun­da­tion found that, due to cost, about 29% of Amer­i­cans had not tak­en a pre­scrip­tion as di­rect­ed in the pre­vi­ous year.

Hav­ing pro­posed leg­is­la­tion that would em­pow­er the fed­er­al gov­ern­ment to man­u­fac­ture drugs it­self, War­ren said she would act to low­er the price of in­sulin and drugs that treat HIV/AIDS.

Her cam­paign emailed re­porters a list of oth­er tar­get­ed drugs, in­clud­ing the EpiPen; Hu­mi­ra, the top-sell­ing rheuma­toid arthri­tis drug whose mak­er has been crit­i­cized for abus­ing patents to sti­fle com­pe­ti­tion; and Nalox­one, a drug that re­vers­es the ef­fects of opi­oid over­dose.

Klobuchar and for­mer May­or Pe­te Buttigieg of South Bend, IN, al­so en­dorsed em­pow­er­ing Medicare to ne­go­ti­ate low­er prices with drug­mak­ers — the pro­pos­al at the heart of the drug plan un­veiled last year by Speak­er Nan­cy Pelosi and oth­er House De­mo­c­ra­t­ic lead­ers.

How­ev­er, that idea is deeply un­pop­u­lar with con­gres­sion­al Re­pub­li­cans, who de­scribe it as gov­ern­ment in­ter­fer­ence in the free mar­ket. While the bill passed the House in De­cem­ber, Sen. Mitch Mc­Connell of Ken­tucky, the Re­pub­li­can leader, has said he will not al­low it to get a vote in the Sen­ate, killing its chances, at least for now.

Klobuchar said the re­al prob­lem is the num­ber of phar­ma­ceu­ti­cal lob­by­ists on Capi­tol Hill — two to every mem­ber of Con­gress, she said. Poli­ti­Fact rat­ed this claim Most­ly True last year.

“How do we ac­tu­al­ly break the cor­po­rate stran­gle­hold on our gov­ern­ment so we can get any of these things passed?” said Tom Stey­er, a busi­ness­man who was one of the six De­mo­c­ra­t­ic can­di­dates to qual­i­fy for the de­bate.

The de­bate, which took place in Des Moines less than three weeks be­fore vot­ing be­gins, gave for­mer Vice Pres­i­dent Joe Biden and Sen. Bernie Sanders of Ver­mont an­oth­er op­por­tu­ni­ty to spar over the cost of “Medicare for All,” al­beit on­ly briefly.

Elab­o­rat­ing on how he would pay for his sin­gle-pay­er over­haul of the na­tion’s health care sys­tem, Sanders said it would in­volve a 4% in­come tax, ex­empt­ing the first $29,000 of a tax­pay­er’s in­come to ease the bur­den on the “av­er­age fam­i­ly in Amer­i­ca.”

“Now is the time to take on the greed and cor­rup­tion of the health care in­dus­try, of the drug com­pa­nies, and fi­nal­ly pro­vide health care to all through a Medicare for All sin­gle-pay­er pro­gram,” Sanders said. “It won’t be easy. It’s what we have to do.”

“You can do it with­out Medicare for All,” Biden said. “You can get to the same place.”

Af­ter six de­bates spent pars­ing the de­tails of Medicare for All, though, War­ren ref­er­enced what comes next: a gen­er­al elec­tion dur­ing which the De­mo­c­ra­t­ic nom­i­nee will run against Pres­i­dent Don­ald Trump, a Re­pub­li­can who wants to re­peal the Af­ford­able Care Act.

War­ren said she would push her plan to ex­pand cov­er­age through a sin­gle-pay­er sys­tem — but al­so that she would de­fend the Af­ford­able Care Act.

“I’ll take our side of the ar­gu­ment any day,” she said. “We’re go­ing to beat him on this.”

The eighth de­bate is sched­uled for Feb. 8, the first of three De­mo­c­ra­t­ic de­bates next month.

This sto­ry was orig­i­nal­ly pub­lished by Kaiser Health News, a na­tion­al health pol­i­cy news ser­vice. It is an ed­i­to­ri­al­ly in­de­pen­dent pro­gram of the Hen­ry J. Kaiser Fam­i­ly Foun­da­tion which is not af­fil­i­at­ed with Kaiser Per­ma­nente. Writ­ten by Em­marie Huet­te­man: ehuet­te­man@kff.org

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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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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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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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.