Thursday, August 7, 2025

Trump, Pharma Industry Discuss Boosting Medicine Spending Abroad to Cut US Prices, Sources Say

(8/7, Patrick Wingrove and Maggie Fick, Reuters) ...U.S. officials told drug companies it would support their international negotiations with governments if they adopt "most favored nation" pricing under which U.S. drug costs match the lower rates offered to other wealthy countries, the White House official said...The Trump administration has asked some companies for ideas on raising prices abroad, two of the sources said, describing multiple meetings over several months aimed at lowering U.S. prices without triggering cuts to research and development spending drugmakers insist would result. The White House official called the effort collaborative, saying both sides were seeking advice from each other... Full

Big Pharma in ‘Active Discussions' with Trump On Pricing

(8/6, Brenda Strohmaier, Euractiv) ..."We continue to observe high volatility," Bayer CEO Bill Anderson commented on the US trade policy, adding that it remains unclear whether ongoing investigations in the sector will lead to additional pharma tariffs. He also commented on Trump's announcement that tariffs on pharmaceuticals could reach 250% in the coming years, intended to push companies to relocate production to the US...German pharmaceutical company Boehringer Ingelheim issued a statement on Tuesday, striking a similarly constructive tone: "We will continue to work constructively with governments, regulatory authorities, and patient organizations to ensure that patients have access to affordable medicines and that medical innovation for life-saving treatments remains possible."... Full

Reed Slams Trump's Reckless Threat to Drastically Raise Rx Drug Prices On U.S. Consumers

(8/6, United States Senator for Rhode Island Jack Reed) ...President Trump told CNBC his pharmaceutical tariffs will roll out in phases: "We will be putting an initially small tariff on pharmaceuticals, but in one year, one and a half years maximum, it is going to go to 150 percent and then it is going to go to 250 percent because we want pharmaceuticals made in our country." U.S. Senator Jack Reed (D-RI) panned the reckless, ill-conceived threat as a massive price increase on consumers, highlighted President Trump's lack of strategy and refusal to use Rx drug price negotiating tools he already has, and pointed out that the timeline for standing up a new FDA-approved pharmaceutical manufacturing facility does not align with Trump's tariff threats... Full

US Chamber Loses Bid to Revive Lawsuit On Drug Price Talks

(8/6, Nyah Phengsitthy and Celine Castronuovo, Bloomberg Law) ...The order is another blow for business groups after various courts have ruled in favor of the government program that seeks to lower drug prices by allowing the Medicare agency and drugmakers to be in back-and-forth talks... Sub. Req’d

Sixth Circuit Judges Uphold Decision Over IRA Drug Price Negotiations in Government's Favor

(8/6, Nicole DeFeudis, Endpoints News) ...The lower court had ruled that the fourth plaintiff, the US Chamber of Commerce, "arguably has associational standing," but would have to file suit in a different court. Andrew Varcoe, deputy chief council for the US Chamber of Commerce Litigation Center, told Endpoints News that the chamber is "carefully reviewing the Sixth Circuit's ruling and considering next steps." "We respectfully disagree with the court's opinion that the Dayton Area, Ohio, and Michigan Chambers of Commerce have no interest in challenging price controls that have adverse impacts across the nation," Varcoe said... Sub. Req’d

Brian Anderson of Milliman Warns That Mandating PBM Transparency Could Backfire

(8/6, Peter Wehrwein, Briana Contreras, Managed Healthcare Executive) ...Brian Anderson, MBA, a principal and consulting actuary at Milliman, is one of this year's winners of Managed Healthcare Executive's inaugural PBMI Innovator Award. The honor recognizes leaders who are reshaping the pharmacy benefits space in innovative and meaningful ways. Anderson, who works closely with large clients and PBMs, believes transparency is essential-but sees risks in how it's being pursued... Full

Republicans Gear Up to Fight Insurers On Pharmacy Benefit System

(8/7, Erin Durkin, Bloomberg Law) ...Often referred to as "middlemen" on Capitol Hill, pharmacy benefit managers administer drug benefits for health insurers and large employers. Increasingly, PBMs are getting their share of the blame for practices that lawmakers allege pad their profits and, as a result, drive up health costs. And according to Rep. Buddy Carter (R-Ga.), who is sponsoring a fresh round of legislative reforms, the insurance lobby won't cede those changes without a fight... Sub. Req’d

They Said It! U.S. Senate Experts Highlight Bipartisan, Market-Based Solutions to Hold Big Pharma Accountable for Patent Abuse, Boost Competition to Lower Drug Prices

(8/6, CSRxP) ...In case you missed it, the Federal Trade Commission (FTC) and Department of Justice (DOJ) held a listening session on Monday with policy and legal experts representing the offices of U.S. Senators John Cornyn (R-TX), Mike Lee (R-UT) and Chuck Grassley (R-IA), to discuss lowering prescription drug prices in the U.S. by fostering greater competition. The panel highlighted several bipartisan, market-based solutions that would help bring more affordable alternatives, like generics and biosimilars, to the market more quickly... Full

US Appeals Court Reinstates Drug-Price Conspiracy Lawsuit Against Sanofi, Rival Pharma Companies

(8/6, Mike Scarcella, Reuters) ...Drugmakers Sanofi, Eli Lilly, Novo Nordisk and AstraZeneca must face a lawsuit from two health centers accusing them of conspiring to restrict drug discounts offered to community pharmacies that contract with providers serving low-income patients...A Sanofi spokesperson in a statement said the company was reviewing the opinion and considering its next steps. In a statement, Novo Nordisk called the allegations meritless, and said it "will continue to vigorously defend against these claims." Lilly in a statement said it "strongly disagrees with today's decision to allow this meritless complaint to proceed."... Full

Novo Nordisk, Sanofi, Lilly to Face Renewed Fight Over Alleged 340B Price Fixing

(8/6, Nicole DeFeudis, Endpoints News) ...The plaintiffs alleged that "by acting together, Defendants safeguarded themselves against competition in the lucrative diabetes medication markets," and accused the companies of violating state and federal antitrust laws...The US Court of Appeals for the Second Circuit disagreed on Wednesday. It said the group of plaintiffs "plausibly alleges that Defendants acted similarly enough in substance by restricting Section 340B Drug Discount pricing and raising prices in the market of certain popular diabetes medication over the course of months." The judges noted that the policy changes were also similar in timing... Sub. Req’d

RAAP Policy Study Release Solving for Access and Affordability: PDABs are Not the Answer

(8/6, Rare Access Action Project) ..."RAAP is excited to release our study on PDABs. While the talking points sound good, theory has not matched reality and the implementation of PDABs has revealed difficulties in achieving its lofty goals and has led to concerns about unintended consequences. A quick legislative win creating a PDAB can, overall, mean little to the state or its residents because the healthcare system is incredibly complex, and savings may prove illusive. New Hampshire, for example, enacted a PDAB in 2020 and repealed it in 2025," said Michael Eging, Executive Director of RAAP... Full

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

(8/6, Derrick Gingery, Pink Sheet) ...Hiring remains constrained by Trump Administration directives, but without the extra user fee funding, the FDA could have more trouble meeting its increasing workload. The agency also did not provide its current staffing level and the estimated level needed to meet its drug and biosimilar user fee program needs in fiscal year 2026, which further complicates the issue... Global Sub. Full

Hobbs Signs Order for Statewide Prescription Drug Discount Program

(8/6, Caitlin Sievers, AZ Mirror) ...Arizona is joining with five other states to offer residents discounts on prescription drugs, Gov. Katie Hobbs announced Wednesday morning. The ArrayRX discount card program won't be available to Arizonans until early 2026, but Christian Slater, a spokesman for the governor, told the Arizona Mirror that the executive order Hobbs signed Wednesday morning instructing the Department of Health Services to join the program was a crucial first step in the process... Full

FDA Approves Expanded Indication for Teva's Ajovy in Pediatric Patients with Episodic Migraine

(8/6, Don Tracy, PharmExec.com) ...Ajovy becomes first FDA-approved calcitonin gene-related peptide migraine prevention for pediatric patients: New indication allows use in children aged six to 17 years with episodic migraine weighing at least 99 lbs. Phase III SPACE trial shows significant efficacy: Ajovy reduced monthly migraine and headache days and achieved a 50% responder rate in nearly half of pediatric patients... Full

FDA Approves Fremanezumab as First Anti-CGRP Drug for Prevention of Pediatric Episodic Migraine

(8/6, Ashley Gallagher, Drug Topics) ..."Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood," Chris Fox, executive vice president, US commercial and innovative franchise lead and head of global marketing business at Teva, said in a news release. "With this FDA approval, Ajovy now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition."... Full

Fremanezumab-Vfrm Approved by FDA for Preventative Treatment of Episodic Migraine in Children, Adolescents

(8/6, Gillian McGovern, Pharmacy Times) ..."Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood," Chris Fox, executive vice president, US commercial and innovative franchise lead, and head of global marketing business at Teva, said in a news release. "With this FDA approval, [fremanezumab] now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition."... Full

Sandoz Streamlines More Trials As First-Half Biosimilars Sales Hit $1.5Bn

(8/7, Dave Wallace, Generics Bulletin) ...Sandoz is streamlining its clinical trial programs for multiple biosimilars, as regulators around the world move away from requiring comparative efficacy studies as standard. Biosimilars continue to loom large in Sandoz's strategy, helping to drive growth in the first half of 2025 and underpinning several key investments and deals. Generics remain a "cornerstone" of Sandoz's business, however, with the firm looking towards GLP-1 competition in certain territories from next year... Global Sub. Full

Celltrion's Avtozma IV Formulation Gains FDA Approval for CRS Treatment

(8/7, Heo Ji-yoon, ChosunBiz) ...With this approval, the AVTOZMAIV formulation has obtained approval for the full label of indications acquired in the U.S., similar to the original drug. It can be used for rheumatoid arthritis, giant cell arteritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, coronavirus disease, and CRS. The principle is to inhibit the interleukin (IL)-6 protein involved in causing inflammation, thereby reducing inflammation. Celltrion plans to launch AVTOZMAin markets worldwide, including the U.S., in the second half of this year... Full

Intas Pharmaceuticals and Accord BioPharma Become One of the Largest Global Suppliers of Pegfilgrastim with Acquisition of UDENYCA®

(8/7, Intas Pharmaceuticals and Accord) ...UDENYCA, a biosimilar to Neulasta® (pegfilgrastim), significantly expands Intas and Accord's FDA-approved biosimilar portfolio and accelerates their strategic growth in the global biosimilar market. Accord is already a pegfilgrastim market leader in Europe—having been the first to commercialize a biosimilar pegfilgrastim and the only company to launch an autoinjector— has maintained its leadership despite intense competition. This acquisition further strengthens the company's presence and impact in both the U.S. and international biosimilar landscapes... Full

Richter Eyes More Drug Licensing Deals to Sidestep Trump Tariffs

(8/6, Andras Gergely, Bloomberg) ...Richter generated $622 million last year in royalties from its licensing deal with Abbvie, which markets its blockbuster anti-psychotic drug as Vraylar in the US. That income stream won't be subject to tariffs and is a model Richter wants to pursue with more local US partners in key areas such as women's health, Chief Executive Officer Gabor Orban told reporters Wednesday. "We supply the active ingredient to AbbVie and they make and package the product," Orban said after Richter reported second-quarter results. "We would like to go further in that direction, whereby our next molecules will also be produced in the same way, so that it is made in America for American patients."... Sub. Req’d

As US Tariffs Loom, Lupin Looks at Measures to Mitigate Impact

(8/6, PT Jyothi Datta, The Hindu BusinessLine) ...As the global pharmaceutical industry awaits a tariff announcement from US President Donald Trump, Indian drugmaker Lupin's management said it was looking at a mix of measures including tech-transfer to its US plants to mitigate the impact. It is hard to predict where the outcome of the Section 232 investigation would land, said Vinita Gupta, Lupin Chief Executive Officer, outlining the company's strategies, against the backdrop of impending US tariffs... Full

Hikma Outlook Cut for Unit's Margins Clouds Confidence in Overall Forecasts

(8/7, Unnamalai L, Reuters) ...Hikma still expects 2025 core operating profit of $730 million to $770 million and revenue growth of 4% to 6%, including the impact of current tariffs...I think we'll be sitting in a better position than a lot of our peers," CEO Riad Mishlawi told Reuters. About 70% of Hikma's U.S. sales come from products made in the country, which makes up more than half of its total revenues. "The most important takeaway is that Hikma is well placed vis a vis tariffs and is making good progress in R&D," Panmure Liberum analysts said... Full

Viatris: Q2 Earnings Snapshot

(8/7, Associated Press) ...Viatris Inc on Thursday reported a loss of $4.6 million in its second quarter. The Canonsburg, Pennsylvania-based company said it had a loss of less than 1 cent on a per-share basis. Earnings, adjusted for amortization costs and non-recurring costs, came to 62 cents per share... Full

Eli Lilly Raises Full-Year Profit Forecast On Weight Loss Drug Strength

(8/7, Bhanvi Satija and Patrick Wingrove, Reuters) ...Eli Lilly raised its full-year profit forecast on Thursday, betting on surging demand for its blockbuster weight-loss drug, Zepbound, as it targets new markets and looks to grab more share from Novo Nordisk's Wegovy. However, shares of the U.S. drugmaker fell about 12% in premarket trading after it reported data from its oral weight loss drug, orforglipron, earlier in the day... Full

Novo's Outgoing CEO Prepares to Hand Off Business as Sales Threats From Lilly, GLP-1 Compounders Persist

(8/6, Fraiser Kansteiner, Fierce Pharma) ...Despite being first to market with its landmark GLP-1 drugs for diabetes and obesity, Ozempic and Wegovy, Novo has swiftly lost ground to its chief metabolic medicine rival Eli Lilly and the Indianapolis pharma's counterpart medicines Mounjaro and Zepbound. Separately, as both Novo and Lilly struggled to meet demand during the initial launches of their products, a booming GLP-1 compounding industry has sprung up in the U.S... Full

Merck KGaA Is Looking Into Direct Distribution to U.S. Patients

(8/7, Ludwig Burger, Reuters) ...German drugmaker Merck KGaA on Thursday joined peers in saying it was considering distribution models that serve U.S. patients directly if the government goes ahead with plans to slash drug prices to align with lower levels in other countries..."Direct-to-patient sales is an option in our plans if MFN is implemented," CEO Belen Garijo said in a media call after the release of quarterly results. "There is a significant cost burden associated (with) the distribution of medicines in the U.S., so anything that we can do to alleviate the burden to the patient is something that we will contemplate," she added... Full

Glenmark Pharmaceuticals' USA Arm Reaches $37.75 Million Settlement in US Antitrust Lawsuit

(8/7, Jomy Jos Pullokaran, CNBC TV-18) ...Glenmark Pharmaceuticals Ltd on Wednesday (August 7) said its subsidiary Glenmark Pharmaceuticals Inc., USA, has agreed to a $37.75 million settlement in connection with antitrust litigation in the United States. The lawsuits, consolidated in the Eastern District of Pennsylvania, involve allegations of price-fixing, market allocation, and other anticompetitive conduct in the generic drug industry... Full

Australia Worried by Trump Threat to Raise U.S. Pharma Tariffs to 250%

(8/7, Christine Chen, Reuters) ...Mark Butler said the plan would be a blow to producers such as CSL (CSL.AX), Australia's largest biotech company. "And that is why we are working so hard to press the case for the continuation of free trade," he told reporters...Butler said the national programme, which subsidises a wide range of prescription medicines for Australians, would not be changed to appease American companies and escape the threatened tariffs. "To the extent that this is motivated by big pharma companies seeking to lobby the U.S. administration to water down the protections of our PBS, it's simply not up for negotiation under our government," he said... Full

Trump Pharma Fight Could Embroil PBS

(8/6, Jennifer Hewett, Australian Financial Review) ...The US president's determination to change this "unfair" system may yet embroil Australia's pharmaceutical benefits scheme in another brawl, no matter how much the Albanese government insists the PBS is off limits. Big pharma will certainly argue that any trade-off for lower prices in the US must involve higher prices elsewhere to compensate. Trump may well agree. But the main reason for America's high drug prices has more to do with the perverse incentives of fragmented US domestic policy than the supposed perfidy of foreign governments... Full

UK Medicines Shortages Inquiry Eyes Full Reshoring of Drug Manufacturing

(8/6, Neena Brizmohun, Pink Sheet) ...A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline...The inquiry comes amid efforts to tackle medicines shortages in the EU, where lawmakers are fast-tracking a new Critical Medicines Act that will aim to boost the bloc's competitiveness and manufacturing capacity, and reduce its overreliance on imports from Asia... Global Sub. Full

England: Pharma Firms To Benefit From Parallel HTA And Regulatory Pathway

(8/6, Eliza Slawther, Pink Sheet) ...The UK has initiated a joint information sharing agreement between its drug regulator and health technology assessment (HTA) body, aiming to expedite patient access to new medications by three to six months. This parallel review process will enable simultaneous reimbursement and regulatory decisions, potentially benefiting pharmaceutical companies with faster access. The pathway is set to launch by April 2026, and the government anticipates a 25% reduction in administrative costs for participating companies, fostering a more efficient regulatory environment... Global Sub. Full

Sweden Backs EU-Wide Patent Reform to Support Drug Innovation

(8/7, Monica Kleja, Euractiv) ...Hoping to support pharmaceutical innovation and competitiveness, Stockholm is advocating for a Unitary Patent System..."A unitary SPC would be an important piece of the puzzle to finalise the Unitary Patent System and a reform that would boost innovation and competitiveness", Louise Petrelius, a senior advisor at the Swedish Ministry of Justice, told Euractiv. She explains that the system is expected to streamline the extension of patent protection for both medicinal and plant protection products (e.g. pesticides) in the EU by introducing a single, unified procedure across participating member states... Full

Speeding Up Drug Approval Timelines a Priority, Health Minister Says

(8/6, Chris Hannay, The Globe and Mail) ...The federal government is committed to speeding up drug approval timelines as part of Prime Minister Mark Carney's drive to improve efficiency and cut red tape, Health Minister Marjorie Michel said in an interview. The Globe and Mail reported this week on new data that showed Health Canada is increasingly failing to review generic drug applications within its 180-day target, meaning cheaper pharmaceuticals are taking longer to get to market. That is on top of Canada's historically slow timelines for all drugs, which rank among the longest in developed countries... Full

Trump's Tariff Threats: Indian Pharma is Ready with a Multi-Pronged Defence Strategy

(8/7, Viswanath Pilla, Moneycontrol) ...The industry is not taking chances while drug formulations and active pharmaceutical ingredients (APIs) remain exempt from the latest 25 percent additional tariff hike under the ongoing Section 232 investigation. "The recent executive order by the US Administration excludes the pharmaceutical sector from immediate tariff imposition," said Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance. "Generic medicines are important for affordable healthcare in the US and typically operate on razor-thin margins," he said... Full

Indian Pharma On Alert as US Mulls Higher Drug Tariffs

(8/7, The Economic Times) ...Sources in the pharma industry said the same situation may prevail but they said there is an air of uncertainty given the frequent changes in the structure, prompting drug makers to look at mitigation strategies. Over its first quarter earnings call with investors on Wednesday, Lupin CEO Vinita Gupta said, "It is hard to predict where this (tariff) lands". But she added the company has considered price flexibility to offset the impact of tariffs... Full

Executive Order by US Administration Excludes Pharma Sector From Immediate Tariff Imposition

(8/7, ANI) ...The Indian pharmaceutical sector has been "excluded" from the immediate US tariff imposition, as generic medicines are "important" for affordable healthcare in the United States, said Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance, on Wednesday. This comes after US President Donald Trump imposed an additional 25 per cent tariff on India over the continued purchase of Russian oil... Full

India's PLI Scheme Transforms Pharma Industry from Policy to Practice: Vikram Aditya Sehgal

(8/7, Nandita Vijayasimha, Pharmabiz.com) ...Vikram Aditya Sehgal, director - finance, Centrient India said that the world has long recognized our country as the 'pharmacy of the world', providing over 20% of global generic drugs. However, this strength hides a significant weakness. Indian pharma imports nearly 70% of bulk drugs and API from China, which creates major supply chain dependency. The PLI scheme addresses this by promoting local production of essential raw materials through financial support and stable policies... Full

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