Trump scolds phar­ma ex­ecs, de­mand­ing low­er prices, more US man­u­fac­tur­ing while promis­ing to slash FDA regs

Some of the top CEOs of the phar­ma in­dus­try got to­geth­er with Pres­i­dent Trump Tues­day morn­ing look­ing for com­mon ground. In­stead, they got an­oth­er lec­ture on drug pric­ing, a re­newed promise that the FDA will speed up new drug ap­provals with just a frac­tion of the old reg­u­la­tions in play, and as­sur­ances of an FDA pick wait­ing in the wings who will help put every­thing in or­der.

“We have to get the prices way down,” said Trump, flanked by Cel­gene CEO Bob Hug­in and Mer­ck CEO Ken Fra­zier. “The pric­ing has been as­tro­nom­i­cal for our coun­try.”

But there was a car­rot of­fered along with the stick, as Trump re­peat­ed­ly hit on his promise to slash drug reg­u­la­tions to help speed new drug ap­provals.

“We’re al­so go­ing to be stream­lin­ing the process,” he told the ex­ecs, “so that from your stand­point when you have a drug that you can ac­tu­al­ly get it ap­proved in­stead of wait­ing many, many years.”

“We’re go­ing to get the ap­proval process much faster,” he said. “We’re go­ing to be cut­ting reg­u­la­tions at a lev­el peo­ple have nev­er seen be­fore,” he added. Peo­ple can still be pro­tect­ed, he said, “but in­stead of 9,000 pages it can be 100 pages. And you don’t have to dou­ble up and quadru­ple up. We have com­pa­nies that have more peo­ple work­ing on reg­u­la­tions than they have work­ing at the com­pa­ny.”

To il­lus­trate his point, Trump came up with an anec­dote of a dy­ing pa­tient with just weeks to live, un­able to get an ex­per­i­men­tal ther­a­py. Those days, he vowed, are over. And he in­sist­ed that the com­pa­nies would be re­quired to do far more of their drug man­u­fac­tur­ing in­side the coun­try.

“You have to get your com­pa­nies back here,” he said, re­peat­ing a pledge to re­duce the reg­u­la­to­ry work­load need­ed to get a new plant ap­proved and in op­er­a­tion.

Trump signed a new ex­ec­u­tive or­der Mon­day or­der­ing that every gov­ern­ment agency would be re­quired to elim­i­nate two reg­u­la­tions on the books, for every one they want to add.

Said the pres­i­dent: “I’ll op­pose any­thing that makes it hard­er for small­er, younger com­pa­nies to take the risk of bring­ing a prod­uct to a vi­brant­ly com­pet­i­tive mar­ket. That in­cludes price fix­ing by the biggest dog in the mar­ket, Medicare, which is what’s hap­pen­ing. But we can in­crease com­pe­ti­tion and bid­ding wars big time.”

Trump al­so lev­eled a blast at the rest of the world, which have re­lied on high prices in the US to sub­si­dize their own dis­count­ed rates.

“We’re go­ing to end glob­al free­load­ing,” he pledged. “You’re go­ing to get your prod­ucts ei­ther ap­proved or not ap­proved, but its not go­ing to take 15 years,” he said, cit­ing av­er­age cost of drug de­vel­op­ment at $2.5 bil­lion. Both of those fig­ures are hot­ly de­bat­ed in bio­phar­ma, where poor R&D re­turns in Big Phar­ma have long in­flat­ed the cost and time it takes to get a new drug to mar­ket.

“We’re go­ing to be chang­ing a lot of the rules,” Trump not­ed about the FDA, adding that he has an FDA com­mis­sion­er who’s been picked out and will be named soon. He al­so seemed to ze­ro in on safe­ty as a key con­sid­er­a­tion of quick ap­provals, echo­ing a sug­ges­tion from Jim O’Neill, a Lib­er­tar­i­an close to Trump sup­port­er Pe­ter Thiel, who’s ad­vo­cat­ed ap­provals based on ev­i­dence of safe­ty alone. O’Neill is one of sev­er­al ru­mored can­di­dates for the top job at the FDA.

Along with Hug­in and Fra­zier, David Ricks at Eli Lil­ly, Joe Jimenez at No­var­tis and oth­ers joined the ses­sion.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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J&J’s Rem­i­cade — the poster child for how to block biosim­i­lars — fi­nal­ly set­tles Pfiz­er suit

Biosimilars have proven time and again (although mostly in Europe) that competition works to bring down the cost of a once-pricey biologic, and can even expand its use.

J&J’s Remicade, however, has always proven to be an outlier.

Back in 2016, Pfizer won FDA approval for its infliximab biosimilar, known as Inflectra, but when the launch foundered, the company sued J&J, claiming that the company’s plan to block biosimilar competition worked incredibly well. Pfizer even went on to win FDA approval for a second infliximab biosimilar in 2017, known as Ixifi, but decided to never launch it.

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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UP­DAT­ED: Pan­el of neu­ro­science ex­perts lays out the com­pli­ca­tions with us­ing Bio­gen's new Alzheimer's drug

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

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If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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