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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Katrine Bosley (AP Photo/Mark Lennihan)

For­mer Ed­i­tas CEO Ka­trine Bosley goes the VC route, join­ing ear­ly-stage in­vestor

More than three years after abruptly exiting Editas Medicine, Katrine Bosley is leaping to the venture capital side of things.

London-based early-stage investor Advent Life Sciences announced Thursday that Bosley is joining the firm as venture partner. It’s also adding two general partners to the team: Dominic Schmidt, formerly of Syncona, will be in the UK; and Satish Jindal, most recently the CEO of investment fund BioMotiv, will be based in Boston, just like Bosley.

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Serhat Gumrukçu, Enochian BioSciences co-founder (Seraph Research Institute)

LA biotech founder ar­rest­ed, charged in mur­der-for-hire scheme be­hind 2018 death

A biotech founder has been arrested and charged for his role in a murder-for-hire scheme that resulted in the death of a man in Vermont back in 2018.

Serhat Gumrukçu, the co-founder of Enochian BioSciences, was arrested in Los Angeles, where the company is based, according to the Department of Justice. He was charged alongside Berk Eratay of Las Vegas, and a third person, Jerry Banks of Colorado, was previously arrested for kidnapping and allegedly murdering the victim, Gregory Davis.

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Adam Russell, ARPA-H's incoming acting deputy director

NI­H's new, in­de­pen­dent break­through drug ac­cel­er­a­tor ARPA-H gets its first em­ploy­ee

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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