Pfiz­er preps a laun­dry list of drug price hikes for the New Year — let the po­lit­i­cal fire­works be­gin

Pfiz­er is billing this as a re­strained and com­plete­ly rea­son­able move, but the phar­ma gi­ant has just thrown down a gaunt­let beg­ging Pres­i­dent Don­ald Trump to pick it up.

Bioreg­num Opin­ion Col­umn by John Car­roll

On Fri­day af­ter­noon the phar­ma gi­ant $PFE put out a state­ment say­ing that it’s hold­ing the price line on 90% of its drug port­fo­lio come the New Year. But 41 of its drugs have been picked for a price hike on Jan­u­ary 15, av­er­ag­ing 5%. And one of those drugs, which Pfiz­er said has just been ap­proved for 2 new in­di­ca­tions af­ter ex­ten­sive R&D work, is in line for a 9% hike.

Two years ago, that news would have been greet­ed as a sign of re­mark­able mod­er­a­tion. But for ear­ly 2019, af­ter Trump has re­peat­ed­ly ex­co­ri­at­ed the ma­jors for “get­ting away with mur­der” on drug prices, it’s like­ly go­ing to be seen as a call to leg­isla­tive arms.

Just be­fore the elec­tions Trump sug­gest­ed that Medicare Part B move to im­port over­seas drug prices, hop­ing to per­suade com­pa­nies to mus­cle sin­gle pay­er sys­tems to pay more while low­er­ing the cost of ther­a­pies in the US. Ear­li­er, Trump al­so made a high pro­file call to Pfiz­er CEO Ian Read — one of the most re­sis­tant to rein­ing in price hikes — per­suad­ing him to put a planned slate of price in­creas­es on the back burn­er, at least through the end of the year. Oth­er big play­ers al­so quick­ly fol­lowed suit, though Pfiz­er re­cent­ly in­di­cat­ed that they were mov­ing back to busi­ness as usu­al come 2019.

Pfiz­er is al­so promis­ing that con­sumers shouldn’t feel much fi­nan­cial heat. Their state­ment:

These list price in­creas­es are ex­pect­ed to be off­set by high­er re­bates and dis­counts paid to In­sur­ance Com­pa­nies and Phar­ma­cy Ben­e­fit Man­agers and the net ef­fect on rev­enue growth in the U.S. in 2019 is ex­pect­ed to be ze­ro. Giv­en the high­er re­bates and dis­counts, we ex­pect that the health­care sys­tem will share those ben­e­fits with pa­tients so they do not ex­pe­ri­ence high­er costs for their med­i­cines. In 2018 the net im­pact of price in­creas­es on rev­enue growth is pro­ject­ed to be a neg­a­tive 1 per­cent in the U.S com­pared with 2017.

That’s un­like­ly to sat­is­fy the cur­rent res­i­dent in the White House, who is like­ly to view the move as a per­son­al provo­ca­tion.

The Dems, who may wind up as the strangest bed­fel­lows of the Trump ad­min­is­tra­tion on this is­sue, seem to see some op­por­tu­ni­ties here as well.

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.

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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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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Af­ter near­ly a year of de­bate, the Covid-19 vac­cine chal­lenge tri­als are of­fi­cial­ly com­ing

After nearly a year of public advocacy and often rancorous ethical debate, human challenge trials for Covid-19 vaccines are getting off the ground in London.

The UK government’s Covid-19 Vaccine Taskforce and the contract research firm Open Orphan announced today £10 million ($13 million) plan to test experimental Covid-19 vaccines in volunteers whintentionally exposed to the novel coronavirus. The studies, which won’t launch until early 2021, come after 9 months of debate over whether such studies were safe and would actually hasten vaccine development, and they follow a long history of researchers using challenge models to study other respiratory viruses, including flu and the coronaviruses that cause the common cold.

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Derek Chalmers, Cara Ther

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

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Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Gilead feels the heat as close al­ly Gala­pa­gos re­ports a big set­back on one of their top ex­per­i­men­tal drugs

The bad news keeps stacking up at Galapagos — which quite likely just lost control of a billion-dollar deal — and by extension their close partners at Gilead.

The biotech $GLPG reported after the bell Thursday that GLPG1972, one of their top development programs, flat failed a mid-stage study for osteoarthritis, flunking the primary and all secondary endpoints.

Testing 3 different doses of their drug, which relies on ADAMTS-5 inhibition, investigators concluded that none of them triggered a statistically significant response — as measured by cartilage thickness.

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IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.

News brief­ing: Ab­b­Vie and Roche's Ven­clex­ta scores an­oth­er FDA OK; Im­muno­Gen nabs Chi­na deal with $40M cash

AbbVie and Roche’s Venclexta has gotten a new FDA thumbs up.

The pair announced Monday that regulators have approved the drug in combination with azacitidine or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in adults who are 75 or older or those who can’t undergo intensive chemotherapy. This follows the drug’s accelerated approval in 2018 and positive data from two Phase III confirmatory trials.