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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Christophe Bourdon, Leo Pharma CEO

Leo Phar­ma looks 'be­yond the skin' in atopic der­mati­tis aware­ness cam­paign

As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.