Orforglipron

Listen to the article 5 min This audio is auto-generated. Please let us know if you have feedback. Today, a brief rundown of news involving Crinetics and the Food and Drug Administration, as well as updates from Eli Lilly, Biogen and Gossamer Bio that you may have missed.Crinetics on Thursday won clearance from U.S. regulators to begin selling a new drug for the rare hormonal disorder acromegaly. Called Palsonify and, previously paltusotine, the drug is the first once-daily oral therapy for the condition and cleared for adults who aren't eligible for corrective surgery or haven't adequately responded to it. Palsonify is “poised to challenge the Goliaths of pharma,“ among them Novartis and Pfizer, with a “broad label and an attractive [annual] $290,000 list price,“ wrote Leerink Partners' Joseph Schwartz, who is predicting $375 million in peak yearly sales in the U.S. and Europe. Ben FidlerThe federal government this week announced multiple new initiatives designed to foster gene therapy research. The Food and Drug Administration on Wednesday published draft guidance outlining accelerated approval pathways, post-approval requirements and new clinical trial designs. And on Thursday, the Advanced Research Projects Agency debuted two programs aiming to speed development and assist with manufacturing, so the complex medicines are less costly to produce. Ben FidlerBristol Myers Squibb will begin selling its psoriasis drug Sotyktu online at a discounted price, the company said Thursday. Starting in January, Bristol Myers will offer Sotyktu at a cost more than 80% lower than its current list price for people who are uninsured, underinsured or pay for the medicine out of pocket. The initiative is part of a growing trend among pharmaceutical companies to provide products directly to consumers while bypassing traditional drug distribution channels. Bristol Myers started offering its heart drug Eliquis online at a reduced price this month. Ben FidlerEli Lilly announced the location of the second of the four new U.S. manufacturing plants it intends to build, a factory in Houston that will make the active ingredients for several small molecule drugs, including its experimental obesity medicine orforglipron. Lilly will pour $6.5 billion into the factory, which it says will employ 4,000 peopleduring constructionand 615 at the plant once it is operational in five years. Earlier this month, the company said it will locate another plant near Richmond, Virginia,as part of a promise to spend $50 billion on domestic manufacturing. Details regarding the two other factories will be announced this year. Jonathan GardnerThe FDA rejected a high-dose version of Biogens spinal muscular atrophy drug Spinraza. Study results last year showed that the newer form of Biogens drug appeared to slow neurodegeneration faster than the marketed treatment and, according to Biogen, the agency didnt cite any deficiencies with its clinical data. Instead, the FDA requested an update to certain technical information in the portion of its application dealing with manufacturing. Biogen intends to respond and update its application promptly, but its unclear whether the resubmission will be a Class 1 or Class 2 filing, each of which have different review timelines, wrote William Blair analyst Myles Minter. Ben FidlerGossamer Bio secured an option to acquire privately held pulmonary arterial hypertension drug developer Respira Therapeutics, the companies said Thursday. The deal provides Respira with funding to develop its lead candidate, an inhaled drug called RT234, for up to two years as the companies advance development. Respira completed a Phase 2b studyearlier this year.Gossamer issued 2.5 million shares of common stock upon signing the deal, and would add another 1.5 million if it exercises the acquisition option. Last year, Gossamer sold rights to its own PAH drug, seralutinib,to Italy-based Chiesi Farmaceutici. Gwendolyn WuAn experimental drug Harmony Bioscienceshas been developing for Fragile X syndrome failed a late-stage trial. In a Wednesday announcement, the company said its drug, ZYN002, failed to meet its main goal of improving social avoidance because of a higher than expected placebo response rate. Harmony acquired ZYN002, a topical, synthetic cannabidiol, in a 2023 buyout of Zynerba Pharmaceuticals. The compound previously failed studies in epilepsy and osteoarthritis-related knee pain. Gwendolyn Wu '

iStock, Tamer Soliman In an interview with German-language outlet Neue Zuercher Zeitung , Novartis CEO Vas Narasimhan said the company is exploring ways to remove or minimize the drug price gap between the U.S. and its other markets in similarly developed countries. Novartis is exploring options to lower the prices of its medicines in the U.S., according to CEO Vas Narasimhan. This push from the company comes amidst President Donald Trump’s campaign to lower drug costs in the country. Narasimhan made the comments in an interview with German-language news outlet Neue Zuercher Zeitung , according to reporting from Bloomberg News on Saturday. Despite a potential price cut for its products, Narasimhan remains confident that Novartis will be able to deliver on its sales forecasts. “We’re working with the [U.S.] government to find constructive solutions so Americans pay less for their medicines,” Narasimhan said, adding that Novartis’ profits will continue to “grow faster than revenue.” The pharma doesn’t yet see the need to adjust its full-year guidance. “No matter what happens, under current U.S. law, any changes should be manageable,” the CEO said. Novartis is also currently looking at ways that it could remove or minimize the pharmaceutical price gap between the U.S. and other similarly developed countries, he added. Since taking office in January, Trump has made lowering drug costs a cornerstone of his policy push. In May, he signed an executive order on Most Favored Nation drug pricing, which seeks to lower drug pricing in the U.S. to the same level as in other economically comparable countries. Since executive orders lack legislative power, in late July, Trump directly appealed to the CEOs of 17 Big Pharma companies to comply with the policy “within the next 60 days.” Novartis is among these companies, alongside Bristol Myers Squibb, AbbVie, Gilead, Merck, Novo Nordisk and more. “If you refuse to step up, we will deploy every tool in our arsenal to protect American families from continued drug pricing practices,” Trump wrote in a letter to the heads of these companies. Also in July, the FDA announced it was looking at the possibility of leveraging its recently launched Commissioner’s Priority Review program to incentivize companies to lower drug prices. The voucher aims to shorten drug reviews to 1–2 months for companies that align with certain U.S. national priorities. When the agency opened its pilot program later that month, it named “increasing affordability” as one of these priorities. The voucher, it said at the time, could be given to a company “that lowers the U.S. price of a drug or drugs consistent with Most Favored Nation pricing.” Last week, Wall Street analysts speculated, according to Reuters, that Eli Lilly’s orforglipron could qualify for one of these vouchers, “as it treats a high-burden chronic condition and can be priced at parity.”