Lisinopril

Starting Monday, TrumpRx.gov started to separately list common generic medications like lisinopril to lower high blood pressure and the ubiquitous diabetes drug metformin. With questions already swirling about the actual affordability impact of the government’s drug purchasing portal, TrumpRx, the White House is updating the platform to address a key gap in the medicines it lists, albeit with a number of caveats remaining. The expansion of TrumpRx.gov, announced by President Donald Trump on Monday, adds more than 600 generic medicines to the platform. The site allows patients to compare non-insurance prices for certain medications and links to other direct-to-consumer purchasing platforms, including online pharmacies and those operated by drug manufacturers. When the website launched near the top of the year, TrumpRx initially included only select branded pharmaceuticals that had been subject to price reductions under the Trump administration’s most favored nation agenda, which broadly seeks to align high U.S. drug prices with the lowest prices paid in certain high-income comparator nations. Now, the platform will separately list common generic medications like lisinopril to lower high blood pressure and the ubiquitous diabetes drug metformin, as well as the cholesterol medication atorvastatin and blood thinner clopidogrel, according to a White House fact sheet. The inclusion of copycat medicines on the government-run purchasing portal fills a significant gap that was left with TrumpRx’s debut earlier this year, with the FDA estimating that generic drugs make up some 9 out of 10 prescriptions filled in the U.S. As has been the case since the site’s launch, TrumpRx.gov won’t sell the generic medications to patients directly— instead, allowing them to “compare the best cash prices available to them at their local pharmacies,” plus weigh delivery options through various private pharmacy programs. The White House noted that it has integrated discounts offered through online medication channels like Amazon Pharmacy, GoodRx and Mark Cuban’s Cost Plus Drugs into the website, as well. While the update will include “some of the most popular and commonly-used everyday medications,” per the fact sheet, TrumpRx will omit controlled substances—which would include, for instance, stimulant-based ADHD medications—as well as those with FDA-mandated risk evaluation and mitigation strategies (REMS) and those “not commonly offered through direct-to-consumer channels.”TrumpRx forms a key pillar of the President’s drug pricing and broader pharmaceutical policy agenda, with Trump calling on 17 of the world’s biggest pharmas last year to embrace direct-to-consumer sales channels—among other price-lowering demands—in his most-favored-nation call to action.  Coupled with the cudgel of the second Trump administration’s pharmaceutical import tariffs, the White House has been able to extract pricing concessions and U.S. investment pledges from many of the industry’s most prominent drugmakers, including Novo Nordisk, Eli Lilly, Gilead, Roche and, most recently, Regeneron. Under those agreements, 17 Big Pharmas have also made pledges to register certain products at discounted prices through the TrumpRx portal, with Regeneron offering up its cholesterol-lowering drug Praluent in its case. Other branded medicines featured on the government site include Novo’s GLP-1 blockbusters Ozempic and Wegovy, fertility meds from Merck KGaA’s EMD Serono, AstraZeneca inhalers and Pfizer’s eczema ointment Eucrisa, to name just a few examples. Even before its launch, TrumpRx was the target of controversy, attracting scrutiny from Democratic Sens. Dick Durbin of Illinois, Peter Welch of Vermont and Elizabeth Warren of Massachusetts, who warned the HHS’ Office of Inspector General in January that the website could violate federal anti-kickback laws. Since then, the site’s true impact on the affordability of medicines for American patients has been further drawn into question.  In March, a report from The New York Times and German news organizations Süddeutsche Zeitung, NDR and WDR found that drug prices in Germany remained lower than many listed on TrumpRx in a side-by-side comparison. At the time, the report also flagged that while the TrumpRx price for Novo’s obesity med Wegovy was lower than Canada’s, it remained higher on the government site than that in seven other countries, including Germany, the U.K. and Japan. On Tuesday, Reuters separately reported that, based on its own comparison of publicly available prices, the costs recorded on TrumpRx are, in many instances, not lower than those paid in the U.K. 

TrumpRx welcomes 600 generic medicines BioMarin's $270M Inozyme bet faltersChinese firms Full-Life, Accro raise fresh capitalHansa out-licenses Idefirix in key ex-US marketsTrumpRx welcomes 600 generic medicines More than 600 generic products were added to the Trump administration's direct-to-consumer drug purchasing portal on Monday. The TrumpRx site initially launched in February with cash-pay coupons for about 40 brand-name drugs, many of which have cheaper generic alternatives.Now, the government-run website appears to segment branded products under a section labelled "Presidential deals," while the generic drugs — including cholesterol treatment atorvastatin, the blood thinner clopidogrel, blood pressure medication lisinopril and diabetes drug metformin — are listed under a "Standard prices" tab. By clicking on a generic product, patients can compare out-of-pocket costs at their local pharmacy with delivery options from private pharmacy companies like Mark Cuban's Cost Plus Drugs, Amazon Pharmacy and GoodRx. -Elizabeth EatonBioMarin's $270M Inozyme bet faltersA pivotal Phase III study of BioMarin Pharmaceutical's enzyme replacement therapy BMN 401 in children aged 1-12 with the rare genetic condition ENPP1 deficiency met only one of two co-primary endpoints. "We are actively evaluating these data to determine the appropriate next steps," said Greg Friberg, the firm's chief R&D officer.The ENERGY 3 trial showed that treatment with BMN 401 resulted in statistically significant increases in plasma inorganic pyrophosphate through week 52 compared to conventional therapy. However, the other main goal of improvement in Radiographic Global Impression of Change scores was missed, while there were no positive trends for secondary endpoints, including Rickets Severity Score and growth Z-score.BioMarin gained BMN 401 via last year's $270-million purchase of Inozyme Pharma, with the therapy at the centre of the deal.-Matt DennisChinese firms Full-Life, Accro raise fresh capitalTwo Chinese companies, radiotherapeutics firm Full-Life Technologies and clinical-stage biotech Accro Bioscience, respectively closed a $110-million series D and a $50-million series C.Full-Life will deploy the fresh funds to advance [225Ac]-FL-020, a radioligand therapy for prostate cancer, and [225Ac]-FL-261, a candidate targeting multiple solid tumours. The proceeds will also support 225Ac manufacturing at the company's Belgian facility to secure isotope supply ahead of clinical trials.The latest financing — led by Vivo Capital and joined by SK Biopharmaceuticals, Chengwei Capital, HSG, Junson Capital, Yunion, Plaisance, Sky9 Capital and TSG Capital — brings Full-Life's total funding since its 2021 inception to nearly $350 million. Meanwhile, Accro Bioscience's fundraise will help fund a Phase IIb trial of AC-101, a selective RIPK2 inhibitor targeting the NOD signalling pathway in moderate-to-severe ulcerative colitis. AC-101 previously cleared a Phase Ib/IIa proof-of-concept trial in Chinese patients. Accro's C round was fronted by OrbiMed, with participation from TCG Crossover, LAV, Cenova Capital, and existing backers Shenzhen Capital Group and Oriza Holdings.-Pavan KamatHansa out-licenses Idefirix in key ex-US marketsHansa Biopharma granted SERB Pharmaceuticals an exclusive licence to develop and commercialise Idefirix (imlifidase) across the EU, UK, Switzerland, Norway, Liechtenstein, Iceland, and Middle East and North Africa (MENA) regions in a deal worth up to €115 million ($134 million).Idefirix is conditionally approved in the EU for highly sensitised kidney transplant recipients; in the US, where it's supported by a separate pivotal trial, the desensitisation therapy is currently under FDA review with a target action date of December 19.Hansa will receive €110 million upfront and a further €5 million upon EMA acceptance of the full approval filing for Idefirix. SERB will take charge of an ongoing paediatric trial and long-term follow-up studies.-Pavan Kamat