Trump signs bills to elim­i­nate phar­ma­cy ‘gag’ claus­es

Pres­i­dent Don­ald Trump on Wednes­day signed in­to law two bills that mean all phar­ma­cists are now al­lowed to in­form pa­tients of whether they can pur­chase med­i­cines for less mon­ey.

The so-called “gag claus­es” pre­vi­ous­ly re­strict­ed phar­ma­cists from in­form­ing pa­tients of what the new law calls “any dif­fer­en­tial be­tween the ne­go­ti­at­ed price of, or co­pay­ment or coin­sur­ance for, the drug or bi­o­log­i­cal to the en­rollee un­der the plan and a low­er price the in­di­vid­ual would pay for the drug or bi­o­log­i­cal if the en­rollee ob­tained the drug with­out us­ing any health in­sur­ance cov­er­age.”

The Pa­tient Right to Know Drug Prices Act is for com­mer­cial em­ploy­er-based and in­di­vid­ual poli­cies, while the Know the Low­est Price Act is for Medicare and Medicare Ad­van­tage ben­e­fi­cia­ries.

In ad­di­tion, the Pa­tient Right to Know Drug Prices Act al­so re­quires man­u­fac­tur­ers to re­port to the Fed­er­al Trade Com­mis­sion pay-for-de­lay agree­ments that could slow biosim­i­lars from en­ter­ing the mar­ket.

The Phar­ma­ceu­ti­cal Care Man­age­ment As­so­ci­a­tion (PC­MA), which rep­re­sents phar­ma­cy ben­e­fit man­agers, said it “strong­ly sup­ports” both laws.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Achiev­ing Dig­i­tal Trans­for­ma­tion: Un­lock­ing Cost Re­duc­tion, Clin­i­cal Ex­cel­lence & Pre­ci­sion Ther­a­peu­tics Man­u­fac­tur­ing

In the dynamic landscape of pharmaceutical and biotech industries, L7 Informatics is leading the charge in transforming traditional operations through digital innovation. With a firm focus on cost reduction, clinical improvements, reducing tech-transfer times, L7 Informatics is revolutionizing the way companies research, develop, and manufacture while also prioritizing the well-being of patients and providers thereby paving the way for a future where patients receive better treatments at lower costs.

Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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EMA rec­om­mends re­vok­ing au­tho­riza­tion of No­var­tis' sick­le cell drug

The European Medicines Agency’s committee for medicinal products for human use (CHMP) on Friday recommended revoking the marketing authorization for Novartis’ treatment for a painful complication related to sickle cell, after a recent study did not confirm its clinical benefit.

CHMP’s review looked at results of the STAND study, finding that Adakveo (crizanlizumab) did not reduce the number of painful crises leading to a healthcare visit, and patients treated with Adakveo had slightly more painful crises on average, with a subsequent healthcare visit, over the first year of treatment, compared with those on placebo.

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Teresa Bitetti, Takeda's president of the global oncology business unit

Take­da wins pri­or­i­ty re­view for $400M col­orec­tal can­cer drug, li­censed from Hutchmed in Jan­u­ary

Takeda and Hutchmed scored a priority review Thursday afternoon for a colorectal cancer drug, the companies announced.

The experimental drug in question is fruquintinib, previously approved in China in 2018 to treat metastatic colorectal cancer. Takeda and Hutchmed are aiming to bring fruquintinib to the US and other countries outside China in the same indication, and the FDA set its decision date for Nov. 30 of this year.

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Athena Countouriotis, Avenzo Therapeutics CEO (website via Nasdaq)

Ex-Turn­ing Point ex­ecs plan to have their next bet, Aven­zo, on the Nas­daq next sum­mer

The crew at Turning Point Therapeutics is back together for a new biotech that wants to acquire early-stage oncology assets and potentially form partnerships with China-based drug developers for ex-China rights as it eyes a speedy leap onto the Nasdaq around this time next year, according to CEO Athena Countouriotis.

After selling Turning Point to Bristol Myers Squibb, announced at the onset of last year’s ASCO confab, she and colleague Mohammad Hirmand founded Avenzo Therapeutics. The CEO and CMO already have approximately $200 million in seed financing from five big-name investors to evaluate which drugs to bring into its pipeline. That includes SR One, OrbiMed, Foresite Capital, Citadel’s Surveyor Capital and Lilly Asia Ventures.

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bench­Sci rais­es $70M Se­ries D for drug dis­cov­ery soft­ware; Zen­tal­is touts PhIb ovar­i­an can­cer da­ta

Canada’s BenchSci has raised $70 million in a Series D round designed to scale its AI drug discovery platform for scientists working in preclinical research.

The company boasts thousands of clients for its software, including 16 of the top 20 pharmaceutical companies. On the platform, researchers can get a digest of AI’s summary of medical, clinical and research data — helping them spot biological connections and choose among thousands of options with, say, a reagent or antibody.

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Fred Aslan, Artiva Biotherapeutics CEO

Arti­va boasts ear­ly NK cell ther­a­py re­sults, giv­ing life­line to part­ner Af­fimed

Artiva Biotherapeutics reported early data on its off-the-shelf NK cell therapy in combination with rituximab, suggesting the combo could shrink tumors in non-Hodgkin lymphoma patients who have already tried many other cancer therapies.

Four of six patients who received the combo therapy of AB-101 and rituximab saw their tumors shrink, and three of those six saw signs of cancer go away completely, according to an ASCO abstract released Thursday evening. Three of the patients who responded to treatment have had ongoing responses of five, seven and nine months.

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Marc Lajoie, Outpace Bio CEO

Out­pace Bio ex­pands cell ther­a­py R&D, nets re­search col­lab­o­ra­tions in Seat­tle

Outpace Bio, a Seattle-based biotech that aims to create cell therapies, has cemented its presence in the Emerald City with a new facility and a pair of local research partnerships with scientific leaders.

The biotech announced Tuesday that it secured a new facility in a 23,000-square-foot space in Seattle’s Dexter Yard to house the company’s R&D efforts. The company now has 53 employees and has grown from a platform company to a pipeline and platform company, both of which require growth and more space, according to Outpace CEO Marc Lajoie in an interview with Endpoints News.

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