Wednesday, August 20, 2025
U.S. Policy & Regulatory News
Ridgefield Pharma Firm Celebrates Cancer Drug Approval, Pledges to Work with Trump On Drug Pricing
(8/19, Liese Klein, CT Insider) ..."We are continuing to innovate and we are going to continue to find new innovative treatments to bring to the marketplace," said Brian Hilberdink, president of U.S. Human Pharma for the global firm. "A lot of that is being supported by the research and development that is being done right here in Ridgefield, Connecticut."...Last year, Boehringer capped out-of-pocket costs for inhalers and said it would lower some other product prices after a U.S. Senate committee launched an investigation. "We actually are trying to find and define an opportunity for a partnership with the government, as opposed to looking at it as an adversarial relationship," Hilberdink said... Full
Repatriating Drug Manufacturing, Lowering Drug Prices
(8/19, RealClearHealth) ...Several pharmaceutical companies have recently announced multi-billion dollar plans to reinvest in US manufacturing. Many others are determining whether manufacturing costs could be lowered in order to offer more competitive pricing in the US. At present, it's nearly impossible to do both at the same time, and companies must choose to either onshore manufacturing or lower the price of drugs. But here are three steps the Trump administration can take in order to achieve both objectives, while supporting US pharmaceutical companies and furthering American innovation... Full
Tariffs and MFN Policy Power a Broad, Confusing Pharma War
(8/20, Dan Samorodnitsky, BioSpace) ...Experts believe there are other more realistic and applicable policy avenues that the administration could pursue to more directly target pharma companies and drug prices. Brad Setser, a senior fellow at the Council on Foreign Relations, told BioSpace in an interview that a better, more realistic target would be to close the tax incentive for "roundtripping," the practice of pharma companies routing revenue from sales of products in the U.S. through internationally-based subsidiaries, essentially offshoring profits and avoiding U.S. corporate taxes. Removing that loophole would potentially reshore billions in lost tax revenue back to the U.S... Full
Trade-Offs Abound as Big Pharma Makes Direct-to-Consumer Transition
(8/19, Robert Barrie, Pharmaceutical Technology) ...Novo Nordisk is the latest drugmaker to slash the price of a blockbuster medicine via its online platform amid drug pricing reforms in the US, but analysis shows a smooth transition to direct-to-consumer (DTC) channels will be tricky...GlobalData's senior pharma strategic intelligence analyst Wafaa Hassan comments: "The [DTC] development, closely tied to the administration's ‘America First' healthcare agenda and its revived MFN pricing framework, marks a renewed phase of pressure on drugmakers to lower domestic prices while signalling alignment between the White House and the pharmaceutical industry."... Full
PCMA Supports the Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act
(8/19, PCMA) ..."We applaud Senators Dick Durbin (R-IL) and Bill Cassidy, M.D. (R-LA) for introducing the Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act to promote competition in the prescription drug market by limiting tactics used by some drug companies that delay the entrance of generic drugs through multiple late filled patents."... Full
GLP-1s, Cancer Care are Driving Higher Employer Health Care Costs in 2026
(8/20, Tara Bannow, STAT+) ...In its annual survey released Tuesday, 121 employers who cover 11.6 million people told the Business Group on Health they expect health care costs to spike by a median of 9% next year, a figure that's in line with other forecasts for employer-based health insurance. The Business Group on Health is a coalition of over 400 companies trying to lower the amounts they spend on employees' health care. Companies' strategies for managing the ballooning costs, several experts said, will likely skew toward more aggressive scrutiny of their health insurance carriers and other third-party vendors that help them manage costs, and finding alternatives, if necessary. The higher costs raise the prospect of higher insurance premiums and deductibles for workers, though Ellen Kelsay, CEO of the Business Group on Health, said companies will try to shield employees as much as they can... Sub. Req’d
NC Employers Look to Smaller PBMs Without "Shenanigans"
(8/20, Grace Vitaglione, North Carolina Health News) ...The newer, alternative PBMs aim to set themselves apart with promises of greater transparency and by passing 100 percent of the savings they achieve to their customers. These new entries into the market don't have the same incentive as large PBMs to steer patients to higher-cost drugs to maximize rebates, said Jon Rankin, CEO of the North Carolina Business Coalition on Health, an employer group advocating for improved health care delivery in the state. Smaller PBMs are more transparent and can focus on driving customers to lower-cost drugs that achieve the same outcomes, he said. Connor Rose, lobbyist for industry group Pharmaceutical Care Management Association, which represents PBMs, pushed back on claims that PBMs contribute to increasing prescription drug costs as "patently false." Without PBMs, Rose said, drug costs would increase... Full
US FDA Maintaining Approval Output Despite Losing Staff
(8/19, Derrick Gingery, Pink Sheet) ...Drug approval totals, one of the chief US Food and Drug Administration outputs for the pharmaceutical industry, still do not appear to have been affected by staffing cuts and massive departures. Data on new drug application, biologics license application and abbreviated new drug application approvals in 2025 by the FDA's Center for Drug Evaluation and Research indicates reviewers are maintaining or exceeding the recent trend... Global Sub. Full
Generics & Biosimilars News
Natco Pharma, Lupen Launch Bosentan Tablets in US With 180-Day Exclusivity
(8/20, The Hindu BusinessLine) ...Natco Pharma launched Bosentan tablets for oral suspension in the United States with Lupen as its marketing partner...Bosentan Tablets for Oral Suspension, 32 mg, are bioequivalent to Tracleer Tablets for Oral Suspension of Actelion Pharmaceuticals US, Inc... Full
Litigation, Launch, and Lower Costs: 3 Big Moves in the US Biosimilar Space
(8/19, Skylar Jeremias, The Center For Biosimilars) ...Discover the latest advancements in the biosimilar landscape, including the first patent lawsuit regarding a petuzumab biosimilar, a new ustekinumab biosimilar launch, and a new strategy for unbranded biosimilar access...MedImpact Holdings Inc. revealed its plan to provide access to an unbranded ustekinumab-aekn biosimilar, an interchangeable biosimilar to Stelara.4 This biosimilar would be available at a significantly lower cost than the reference product. Distributed by Anda, an affiliate of Teva Pharmaceuticals USA, the biosimilar would be directly purchasable by any licensed specialty pharmacy from MedImpact's preferred partner, Birdi... Full
Industry News
Several US Pharma Giants Stage Q2 Sales Turnaround After Subpar Results Earlier in Year
(8/19, Kevin Dunleavy, Fierce Pharma) ...It was difficult to determine whether the poor performance in the first quarter had anything to do with the angst felt by the industry over the tariff threats and price-cutting aspirations of President Donald Trump, along with the unsettling prospect of pharma adversary Robert F. Kennedy Jr. heading up the Department of Health and Human Services. Either way, the second quarter brought results that are more typical of the industry. Pfizer credited its rebound in large part to the timing of contractual arrangements for COVID products Comirnaty and Paxlovid, which posted year-over-year sales increases of 95% and 71%, respectively. Meanwhile, Regeneron overcame a continued slide for eye disease drug Eylea, which saw a 25% decline in U.S. sales, with another big boost from Dupixent, which was up 22%... Full
Aurobindo Pharma Shares Slump 5% as Co Clarifies On Zentiva Buyout News
(8/20, Amit Mudgill, Business Today) ...Aurobindo Pharma shares slipped 5 per cent in Wednesday's trade after the drug maker clarified on a 'potential' acquisition, saying the company regularly explores various strategic opportunities in the ordinary course of its business, including potential acquisitions and partnerships, to enhance long-term shareholder value. That said, no definitive decision has been made by the board of directors of the company in relation to the Zentiva transaction... Full
Top Pharma Companies Work to Launch First Weight-Loss Pill
(8/19, Bhanvi Satija, Mrinalika Roy and Padmanabhan Ananthan, Reuters) ...Makers of weight-loss drugs are expected to rake in more than $150 billion in revenue by the early 2030s, thanks to the ever-growing popularity of Eli Lilly's Zepbound and Novo Nordisk's Wegovy. The GLP-1 drugs sold by both companies are weekly injections, although several drugmakers are racing to develop an oral medicine or pill that might prove to be as effective as the injectables. Pills are easier to manufacture and could also avoid some of the supply issues that were initially seen with Novo and Lilly's drugs. Here are some companies developing oral obesity drugs in the hopes of making their mark in a lucrative market... Full
Lilly's Direct-To-Consumer Portal Implicated In Texas Anti-Kickback Suit
(8/19, Cathy Kelly, Pink Sheet) ...Texas anti-kickback lawsuit against Lilly suggests the LillyDirect program also involves provider inducements promoting prescribing of its drugs. The lawsuit targets free nurse and reimbursement support programs that Lilly offers prescribers. The relator in the case brought similar anti-kickback charges against Lilly for such program in 2017 but the US government declined to participate in the action and it was ultimately dismissed by an appeals court... Global Sub. Full
Mark Cuban's Cost Plus Prices Often Higher Than Insurers' On Neurologic Medications
(8/19, Allison Bell, BenefitsPRO) ...For U.S. patients with migraine headaches, epilepsy and Parkinson's disease, getting prescription drugs through an ordinary commercial health insurance plan is often cheaper than buying them through the Mark Cuban Cost Plus Drug Company, a team of neurologists reports. Dr. Hussain Lalani, a neurologist at Brigham and Women's Hospital in Boston, and five colleagues measured the performance of Mark Cuban's pharmacy by shopping there for 79 generic drugs frequently used to treat neurologic conditions... Full
How the American Pharma Industry Became the ‘Bad Guys'
(8/20, Annalee Armstrong, BioSpace) ..."It's really hard to understand why the steel industry might be deemed not only a necessary industry but a gem in the sort of industrial firmament of the United States. But somehow, the pharmaceutical industry are just a bunch of bad guys," Michael Abrams, a managing partner at Numerof & Associates, told BioSpace in a recent interview...Rubin said pharma leaders have been participating in good faith as drug pricing policy comes up, agreeing to certain regulations like the Affordable Care Act and even the IRA. But the industry has asked for a revision to the IRA to scrap the pill penalty to incentivize innovation, and that wish has not yet been granted, despite Trump indicating support for the idea... Full
International News
Irish Pharma Exports to the US Decrease After Months of Stockpiling
(8/19, Anna Brown, Endpoints News) ...Exports of chemical products from Ireland to the US, which include pharma goods, dropped in June to the lowest they've been in a year, following months of drug stockpiling by pharma companies. Ireland exports of chemicals to the US decreased to €3.2 billion ($3.7 billion) in June, compared to the €9.4 billion ($11 billion) reported in May, according to Friday data from Ireland's Central Statistics Office. The decrease follows months of increased pharma imports into the US. In particular, companies rushed to stockpile their US drug inventories in March to cushion any short-term tariff impact... Sub. Req’d
Canada Approves Ozempic to Cut Risk of Kidney Failure, Heart-Related Deaths
(8/19, Mariam Sunny, Shinjini Ganguli and Patrick Wingrove, Reuters) ...Canada has approved Novo Nordisk's diabetes drug, Ozempic, to cut chronic kidney disease progression and reduce the risk of kidney failure and heart-related deaths in type-2 diabetes patients, the company said Tuesday...Novo said Tuesday's approval from Health Canada was backed by late-stage trial data that showed a 1 milligram dose of Ozempic cut the risk of kidney-related death and major cardiac events by 24%... Full
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