Wednesday, August 27, 2025

White House Officials Link Pharma Tariffs with ‘Most Favored Nation' Pricing Program

(8/24, Max Bayer, Endpoints News) ...For the first time, top members of the administration publicly linked the Commerce Department's 232 investigation into pharmaceutical products — and tariffs that are expected to follow — with President Donald Trump's "most favored nation" plan to get drugmakers to reduce prices in the US. Commerce Secretary Howard Lutnick told the president that the combination of the 232 investigation and the most favored nation program, which is being led in part by HHS Secretary Robert F. Kennedy Jr., "really gives Bobby the tools to go execute your plan."... Sub. Req’d

RFK Jr. Says Negotiations to Lower Drug Prices Are at An Advanced Stage

(8/26, Dulan Lokuwithana, Seeking Alpha) ...During a cabinet meeting chaired by Trump at the White House on Tuesday, RFK Jr. stated that "we are deep into MFN negotiations with 14 companies," and Commerce Secretary Howard Lutnick has also joined the efforts. In response, Lutnick said that the MFN policy and an ongoing Section 232 national security investigation focused on the impact of pharma and related imports will provide the Trump administration with adequate tools to lower drug prices. "I'm supporting Bobby as he executes his plan," Lutnick added... Full

BOB: Congress Should Codify Most-Favored Nation Drug Pricing Initiative

(8/27, Daniel Bob, DV Journal) ...For MFN drug pricing to endure, Congress should codify it and provide a clear legal framework. Legislation should specify which drugs are included and set transparent criteria for reference countries; give HHS authority to penalize noncompliant manufacturers; require public disclosure of reference prices and savings realized; and align MFN pricing with efforts to close loopholes. Codification would reduce uncertainty, encourage long-term compliance and shield the policy from political reversal. Without it, MFN pricing risks becoming a short-lived negotiating tactic... Full

Right Ailment, Wrong Prescription

(8/26, John Murphy, The Washington Times) ...New generics languish on nonpreferred tiers for an average of three years, and plans often cover them for barely 50% of beneficiaries even after that point. Aligning incentives so plans embrace lower-cost options on Day 1 would save seniors long before any tariff idea clears litigation. Tariffs and MFN mandates miss the mark because global supply chains are complex and fragile. A tablet's active ingredient may be sourced in India, finished in Ireland and packaged in Illinois. Slapping a 200% duty on any link in that chain raises costs for every American patient... Full

Importing Foreign Price Controls Won't Lower Drug Prices

(8/27, Nicholas Armstrong, Washington Examiner) ...If these international price controls became the standard in the U.S., it would inhibit drug manufacturers from bringing new lifesaving drugs to patients. Developing a new drug can cost more than $2 billion and take between 10 to 15 years before it reaches the market. After all of that time and money, only 12% of drugs are approved for introduction by the Food and Drug Administration. Imposing price controls would make it harder for drug manufacturers to cover their costs of developing new drugs — leaving Americans without drugs in the future to treat cancer, Alzheimer's disease, and others... Full

Pharma's New Watchdog Group Seeks to Halt US Drug Price Cuts

(8/27, Nyah Phengsitthy and Kate Ackley, Bloomberg Law) ...The group, which includes Bristol Myers Squibb Co., AstraZeneca Plc, Merck & Co., and Eli Lilly & Co., is dubbed IRA Watchdog and seeks to share with lawmakers and the public the effects of the Inflation Reduction Act's negotiation program that allows the government to be in talks with manufacturers over certain drug prices. It's housed at DLA Piper, a law and lobbying firm. The main goal is to create analytical reports that could encourage the government to halt any plans to expand the program before fully understanding its current impact, according to the firm... Sub. Req’d

Rx Research Corner: Drug Companies Continue to Set High Prescription Drug Launch Prices

(8/26, PCMA) ...Big Pharma sets the price of the prescription drugs - and the price is the problem when it comes to Americans facing difficulty affording their prescription drugs... Full

Georgia Congressman Ramps Up Calls to Rein in ‘The Middleman' in Pharmaceutical Industry

(8/26, Maya Homan, Georgia Recorder) ...U.S. Rep. Buddy Carter, a pharmacist representing a coastal Georgia district, is renewing his push to increase regulation of pharmacy benefit managers as Congress' August recess draws to a close..."We can bring down prescription drug prices if we simply eliminate the middleman and have more transparency," Carter said... Full

PhRMA Loses Appeals Court Challenge to Oregon Drug Price Transparency Law

(8/26, Nicole DeFeudis, Endpoints News) ...The US Court of Appeals for the Ninth Circuit rejected PhRMA's claims that Oregon's Prescription Drug Price Transparency Act violates free speech under the First Amendment and the Fifth Amendment's takings clause.. PhRMA called the Ninth Circuit's decision "disappointing" in a statement to Endpoints News, and said it is "reviewing the decision and evaluating next steps."... Sub. Req’d

Oregon Drug Pricing Transparency Law Survives Constitutional Challenge, US Appeals Court Says

(8/26, Diana Novak Jones, Reuters) ...New state laws governing drug prices have spurred dozens of lawsuits from pharmaceutical companies and groups like PhRMA, who say drug companies aren't the only ones to blame for the high prices. In its lawsuit against the Oregon law, PhRMA had said the law infringed on pharmaceutical companies' free speech rights because it forced them to endorse the state's view that the companies are to blame for high drug prices and could require companies to share trade secrets... Full

Va. Backs Big Pharma Deals for AstraZeneca in Albemarle, Eli Lilly in Goochland

(8/26, Michael Martz, Richmond Times-Dispatch) ...Virginia lawmakers have approved two proposed economic development packages for advanced pharmaceutical manufacturing plants proposed by AstraZeneca in Albemarle County and Eli Lilly & Co. in Goochland County, according to multiple state sources...The proposed AstraZeneca and Eli Lilly sites in Virginia would be major new links in a pharmaceutical manufacturing corridor from the Shenandoah Valley, where Merck & Co. has operated a manufacturing plant for more than 75 years, to the Richmond and Petersburg area... Full

Industry Wants Clarity On Scope of ICH Stability Testing Guideline, Timing of Studies

(8/26, Joanne S. Eglovitch, Regulatory Focus) ...The new guideline is a major reworking of ICH's earlier guidelines. It consolidates the existing five stability guidelines into one document and addresses new topics such as stability considerations for advanced therapies, bracketing and matrixing, stability modeling, and stability considerations for reference materials and novel excipients... Full

Xbrane Sees Strategic Opening For US Ranibizumab After Sandoz Withdrawal

(8/27, Dean Rudge, Generics Bulletin) ...Xbrane Biopharma sees an opportunity in the US market following Sandoz's withdrawal of its Lucentis biosimilar, which it believes has created a "void" for its ranibizumab candidate, Lucamzi. Xbrane's CEO, Martin Åmark, has expressed cautious optimism regarding the approval process, which hinges on successful re-inspections of its contract manufacturers. The firm estimates that depending on Lucamzi's market share and pricing, annual profit-sharing could reach between SEK120m-SEK220m ($12.5m-$23m)... Global Sub. Full

Stada And Bio-Thera Add To Biosimilars Alliance With Tocilizumab

(8/26, Dave Wallace, Generics Bulletin) ...Stada has struck a deal with Bio-Thera Solutions to commercialize the Chinese developer's tocilizumab biosimilar rival to RoActemra in Europe. The agreement builds on an existing alliance between the two companies struck last year that covers Bio-Thera's golimumab version of Simponi. Bio-Thera's tocilizumab biosimilar was previously marketed in Europe by Biogen as Tofidence. Biogen's former biosimilars head Ian Henshaw recently took over leadership of Stada's Specialty division... Global Sub. Full

Bio-Thera's Biosimilar Referencing Stelara Approved in the EU

(8/26, Charlie Sternberg, Contract Pharma) ...The European Commission (EC) has approved Bio-Thera Solutions Inc.'s BAT2206 (ustekinumab), a biosimilar referencing Stelara, following a positive opinion from the EMA's CHMP on June 19, 2025. Gedeon Richter has the rights to market BAT2206 in Europe under the brand name USYMRO. BAT2206 is Bio-Thera's third EC-approved product... Full

LY01011, Biosimilar of Denosumab, Meets Primary End Point in Study

(8/26, Gillian McGovern, Pharmacy Times) ...Recent study findings published in the Journal of Bone Oncology show that LY01011 (Shandong Boan BioTechnology), a biosimilar to denosumab (Xgeva; Amgen), demonstrated equivalent efficacy and safety to its reference product when treating patients with bone metastases. Notably, no unexpected adverse events (AEs) were observed during the study's duration... Full

Canadian RWE Shows Comparable Outcomes Between Etanercept Biosimilars, Originator

(8/26, Skylar Jeremias, Center for Biosimilars) ...As the US continues to wait for etanercept biosimilars to be allowed entrance into the market,1 a new Canadian analysis using real-world evidence (RWE) found no meaningful differences in remission outcomes between individuals with rheumatoid arthritis (RA) initiating etanercept biosimilars and those starting the reference product... Full

‘It Validates Adalvo‘ – CEO Anil Okay Talks EQT Takeover

(8/26, Dave Wallace, Generics Bulletin) ...In the wake of a major transaction that saw private-equity firm EQT take control of Alvo group B2B business Adalvo, CEO Anil Okay talks to Generics Bulletin about what the deal means for Adalvo and how it is planning to expand in future..."Today, we are the only approved generic for a mirabegron product in Europe. We are the only generic for desmopressin in Europe. So all these products are sourced to these big clients," and "Adalvo has a lot of products where they are the only source." A key future trend, he said, would be "peptide technology – I will not call it just GLP-1." Adalvo had "more approved peptides than Teva, than Stada, than Zentiva," he suggested. "So we have very strong peptide capabilities, including GLP-1s. So this is a space for us and for the market is in huge growth."... Global Sub. Full

Par Health Q4 Spin-Off Lined Up As Mallinckrodt, Endo Conclude $6.7Bn Merger

(8/27, Dean Rudge, Generics Bulletin) ...Mallinckrodt and Endo have cemented plans for the spin-off of their combined generics and sterile injectables business, Par Health, scheduled for the fourth quarter of 2025. Par Health is set to be an independent firm with a comprehensive product range, including a significant controlled substances franchise and strong manufacturing infrastructure. Mallinckrodt anticipates net sales for Par Health in 2025 to reach between $1.72bn and $1.75bn... Global Sub. Full

Top Pharma Companies Work to Launch First Weight-Loss Pill

(8/26, Bhanvi Satija, Mrinalika Roy, Padmanabhan Ananthan and Mariam Sunny, Reuters) ...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

Eversana, Waltz Health to Merge and Form Combined Pharmaceutical Pricing Platform

(8/26, Paige Minemyer, Fierce Healthcare) ...The deal will bring together Waltz's proprietary drug marketplaces and direct-to-payer model with Eversana's global pharmaceutical commercialization platform. In tandem, the two platforms will be well positioned to tackle the misaligned incentives in the drug supply chain and close gaps for patients, the companies said. The combination will be especially critical in driving down the cost of pricey specialty pharmacy products, including GLP-1s, according to an announcement. Financial terms of the deal were not disclosed... Full

UK Drug Pricing Scheme Talks Collapse: Industry Braces For Another Year Of High Rebates

(8/26, Eliza Slawther, Pink Sheet) ...The UK industry for branded drugs and the government have failed to agree on a new method for setting rebate rates under the Voluntary Scheme for Branded Medicines, Pricing, Access and Growth (VPAG). As a result, next year's clawbacks will continue to be calculated using the current framework...A spokesperson for the ABPI explained to the Pink Sheet that this could impact the pharmaceutical industry because next year's VPAG rebates will be set using the same methodology as has been used this year. This means that drug companies could once again face a high rebate rate... Sub. Req’d

EMA Learns Hard Lessons From US-Inspired Streamlining Pilot

(8/26, Vibha Sharma, Pink Sheet) ...The European Medicines Agency's attempt to adopt a US-style "assessment aid" approach, where sponsors pre-fill regulatory templates, has not delivered the expected benefits in the EU, with feedback indicating it increases work for companies without significantly helping assessors. There are significant differences between the information required by the EMA in its assessment reports and the FDA's assessment aid, with the EMA asking for a much higher level of detail and strictly factual, interpretation-free data, making the process more labor-intensive for marketing authorization applicants. The EMA's final report on the pilot, expected in Q1 2026, will include recommendations for the CHMP, which will decide the future direction of the initiative... Global Sub. Full

US Tariff Hike On India: Industries Facing the Heat and Those Exempt

(8/27, CNBC TV-18) ...The 25% additional tariffs threatened by US President Donald Trump on Indian imports in to the US, have taken effect from 9:31 am Wednesday (August 27). These tariffs has put many Indian export sectors under heavy pressure...On the other hand, some sectors remain partially shielded. Pharmaceuticals have avoided direct tariffs for now, though risks remain. Electronics, petroleum products, steel, and select niche categories like books and plastics have been exempted or spared heavy duties... Full

US Pharma Tariffs Unlikely to Hit Indian Drugmakers Materially: Ind-Ra

(8/26, Sanket Koul, Business Standard) ...Any potential tariffs on pharmaceutical imports into the United States (US) are unlikely to impact the credit profiles of Indian pharma companies except for a short-term pricing blip, according to a report by India Ratings and Research (Ind-Ra). The report stated that the US generics market contributes around 35 per cent to the total revenue of the leading Indian pharma companies. However, this proportion has been steadily declining over the past few years due to price erosion and its impact on margins and returns... Full

Trump's Tariffs On India: What Forced the US Govt to Leave Indian Pharma Out of the 50% Tax Bracket? EXPLAINED

(8/27, Dhanya Nagasundaram, Mint) ...According to Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance, the Indian pharmaceutical industry has been "excluded" from the US's immediate tariff enforcement, as generic medications are "crucial" for maintaining affordable healthcare in the US, as reported by ANI. The sector is currently under review as part of the Section 232 investigation. Generic medications are vital for affordable healthcare in the US and generally operate on very narrow profit margins. Ensuring their steady availability is essential for patient treatment. Further, Sandeep Pandey, Co-founder at Basav Capital, explained that India's portion of pharmaceutical imports to the US is roughly 6%, indicating a significant reliance of the American Medicare system on India... Full

China NHSA Releases Preliminary Innovative Drug List For First Time

(8/27, Xu Hu, Pink Sheet) ...China's NHSA has released for the first time a preliminary list of innovative drugs covered by commercial insurance, along with preliminary annual revisions to the National Reimbursement Drug List (NRDL) under the basic national medical insurance scheme. No antibody-drug conjugates were on the preliminary list of innovative products, meaning no new ADCs will be priced higher than commercial insurance can potentially offer, if other newly approved ADCs also enter the finalized NRDL later this year. For products on both preliminary lists, under new rules analysts expect companies to balance price cuts usually imposed under the NRDL with type of insurance coverage to determine optimum strategy... Global Sub. Full

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