Tuesday, August 18, 2026

 

 

Trump Administration Puts "America First" Twist on Drug Reviews

(8/18, Adriel Bettelheim, Axios) ...The FDA included financial incentives for sponsors in the agency's user fee agreement "to deliver on the Trump administration's commitment to bring drug development back to the United States," Department of Health and Human Services spokesperson Emily Hilliard said... Full

 

Drug Prices Have Declined Sharply, and Trump Is Taking Credit. The Reason Behind the Drop Is Complex

(8/18, Associated Press) ..."These policies are under development and have not affected payers in the index," [ Stacie Dusetzina, a professor of health policy at Vanderbilt University School of Medicine,] told The Associated Press in an email. "Ultimately, I believe that the change is likely to be more directly related to the IRA's policies and the Medicare drug price negotiation program than it is to current policies."... Full

 

Warren: WH May Be Pulling TrumpRx Savings Numbers From 'Thin Air'

(8/17, Jessica Karins, Inside Health Policy) ..."Absent this information, it is simply impossible to verify the accuracy of any claims of savings. The administration's claim is also questionable in light of a recent filing by TrumpRx partner GoodRx, which reveals that GoodRx views the impact of TrumpRx on its business to be minimal, saying that utilization of TrumpRx 'has not had a material impact on GoodRx's] business to date,'" Warren wrote, quoting the company's Securities and Exchange Commission filing this month... Sub. Req'd

 

Medicare Beneficiaries Are Paying More for Price-Negotiated Drugs, Survey Finds

(8/17, Denise Myshko, Managed Healthcare Executive) ...Almost half of Medicare Part D beneficiaries believe they are paying more this year for prescription drugs, including any of the first 10 selected drugs for price negotiations, according to a new survey by the law firm DLA Piper. Thirty percent of respondents also experienced access issues, including prior authorization requirements and drug availability concerns... Full

 

AHA Comments on CMS Medicare Drug Pricing and Benefit Programs Proposed Rule

(8/17, American Hospital Association) ...The AHA strongly supports CMS' efforts to implement the IRA's drug pricing provisions in a manner that lowers costs for Medicare beneficiaries and preserves access to needed therapies. As CMS continues to operationalize the MDPNP, it is critically important that the agency codify policies that are administratively feasible for hospitals and health systems most likely to be furnishing negotiation-eligible drugs to Medicare beneficiaries... Full

 

Drugmakers Voice Support of US Probe into Germany's Drug Pricing Plans

(8/17, Anna Brown, Endpoints News) ...AbbVie, Pfizer, Merck, Bristol Myers Squibb, Gilead, Eli Lilly and Regeneron all submitted comments to the US Trade Representative's probe into Germany..."It is critical that Germany not be allowed to continue unabated its unfair acts, practices and policies," an AbbVie representative wrote in a 1,699-page document submitted to the USTR, the most extensive out of the seven pharma companies... Sub. Req'd

 

Your Prescriptions Are About to Get More Expensive — Thanks to a Rule Nobody Asked For

(8/17, Iulia Lupse, Washington Examiner) ...Fewer PBMs means less competitive pressure in an industry whose entire value proposition is using aggregated bargaining power to negotiate discounts from drug manufacturers. PBM competition already lowers prescription drug spending by an estimated 40% to 50% compared with an unmanaged market. Weaken that competition, and the savings weaken with it... Full

 

US FDA Drug Repurposing Pathway Will Drive Research But Faces Many Challenges

(8/17, Sue Sutter, Pink Sheet) ...A forthcoming US [FDA] framework for repurposing off-patent, generic drugs could catalyze rare disease research but will need to address a host of challenges. Standards for effectiveness, how evidence supporting drug repurposing gets into the FDA's hands, and who reviews it are among the issues that must be addressed, experts said at a recent Reagan-Udall Foundation meeting... Global Sub. Full

 

US FDA Drug Inspections Return To Pre-Pandemic Levels; Domestic OIA Citations Exceed Global Average

(8/17, Grace Moser, Pink Sheet) ...FDA conducted 1,248 drug quality assurance inspections – which include surveillance and for-cause inspections – in FY 2025, nearly matching the pace of 1,308 inspections conducted in FY 2019. The 2025 level is a 28% increase compared to the number of inspections conducted in FY 2024 (972). The increase continues a trend of increases in inspection counts since the lows observed during the pandemic, according to the agency's FY 2025 Report on the State of Pharmaceutical Quality... Global Sub. Full

 

State Regulatory Overreach Is Bad Medicine for Growth

(8/17, Michael Busler, RealClearHealth) ...State-ordered PBM divestiture was always a blunt substitute for addressing specific conduct. Now it is also duplicative. Congress and the Trump administration have already taken major actions aimed squarely at the practices that prompted these state proposals. It is difficult to justify any additional regulation before identifying any unaddressed problems. Good policymaking measures the results of one set of reforms before imposing another... Full

 

 

AstraZeneca Suffers Another Setback as it Halts Volrustomig Lung Cancer Trial

(8/17, Reuters) ...The latest decision followed a recommendation from an independent data monitoring committee, which found AstraZeneca's volrustomig drug, when combined with chemotherapy, was unlikely to help patients live longer or keep their disease from worsening compared with rival Merck's blockbuster immunotherapy Keytruda plus chemotherapy... Full

 

Tagrisso, Orpathys Combo Leads Dual Success for AstraZeneca in Lung Cancer Trials

(8/17, Matthew Dennis, FirstWord PHARMA) ...According to top-line results from SAFFRON, Tagrisso plus Orpathys demonstrated a statistically significant and clinically meaningful improvement on the primary endpoint of progression-free survival (PFS) and key secondary goal of overall survival (OS), versus chemotherapy. The findings are expected to be presented at an upcoming medical meeting and shared with global regulatory authorities... Full

 

Slate Uses Fulcrum to Vault onto Nasdaq with $245m Financing for Migraine Trials

(8/17, Nick Paul Taylor, Fierce Biotech) ...North Carolina-based Slate emerged in February with $130 million in series A funding and a pipeline led by a migraine candidate licensed from China's DartsBio Pharmaceuticals. The drug candidate, SLTE-1009, is a monoclonal antibody that binds PACAP and VIP. Drugmakers including Lundbeck and Eli Lilly have tested anti-PACAP antibodies in humans, although the latter failed a trial and stopped development... Full

 

Argenx Jumps on Phase 3 Data for Blockbuster Vyvgart

(8/17, Delilah Alvarado, BioPharma DIVE) ...The Dutch biopharmaceutical company said Monday an under-the-skin injection version of Vyvgart, called Vyvgart Hytrulo, met its primary endpoint in a late-stage combined study of people with myositis, a rare autoimmune disease that attacks the muscles and has limited treatments... Full

 

Lilly Inks $370M Ion Channel-Focused Deal with OmniAb

(8/17, Elizabeth S. Eaton, FirstWord PHARMA) ...The licensing agreement covers a new ion channel programme with an undisclosed target and modality, though it's likely to be antibody-based given OmniAb specialises in antibody discovery... Full

 

 

4 New Drugs in Shortage

(8/17, Ella Jeffries, Becker's Hospital Review) ...Diclofenac sodium tablet, delayed release: Teva Pharmaceuticals discontinued six presentations of the musculoskeletal drug, in 50-milligram and 75-milligram strengths, Aug. 13, citing a business decision... Full

 

Sandoz Strikes $322M Biosimilars Deal With Shanghai Henlius

(8/17, Kevin Dunleavy, Fierce Pharma) ...In a note to investors, analysts from Jefferies said that they "expect further in-licensing activity at Sandoz to fill an upcoming industry pipeline void." Jefferies called the Repatha biosimilar "an attractive late-decade biosimilar opportunity." The analysts also pointed out that Erbitux lost its patent protection a decade ago but that there are still no biosimilars on the market because of the complexity of the compound has "deterred competitors."... Full

 

Expectations Vs. Reality: Formycon Faces Muted Stelara Biosimilar Momentum

(8/18, Urte Fultinaviciute, Generics Bulletin) ..."We had expected stronger momentum and thus better performance in H1," said chief financial officer Enno Spillner during the firm's earnings call. The firm's management did not disclose the market share that Otulfi captured in the countries where it has been launched or the reasons for the muted performance. In its earnings press release, Formycon pointed to a "challenging and price-sensitive market environment during the reporting period."... Global Sub. Full

 

Coherus Oncology Announces Special Dividend of Biosimilar Contingent Value Rights

(8/17, Coherus Oncology) ...Coherus...today announced a special dividend of contingent value rights (each, a "CVR" and collectively, the "CVRs"), which will be distributed on a pro rata basis to stockholders of record of the Company's common stock as of 5:00 p.m., New York City time, on September 30, 2026... Full

 

US Humira Sales Overwhelmed by Biosimilar Competition

(8/17, Stanton Mehr, Biosimilars Review & Report) ...Although the numbers are hard to come by, it seems apparent that adalimumab biosimilar sales have pounded the reference product Humira into submission through the second quarter of 2026. AbbVie announced Humana net revenues of only $425,000,000 for the second quarter, another massive drop of 47% versus the same quarter of last year... Full

 

Sam Chun Dang Ends Eylea Patent Fights With Global Settlements

(8/18, Park Su-hyeon, Chosun Biz) ...Sam Chun Dang Pharm said on the 18th that it signed a global settlement agreement with U.S.-based Regeneron Pharmaceuticals and Bayer Consumer Care regarding "SCD411," a biosimilar of the macular degeneration treatment "Eylea."... Full

 

Meloxicam Price Spike Leads UK Increases In July

(8/17, Dave Wallace, Generics Bulletin) ...Topping the table were meloxicam 15mg tablets in packs of 30, which saw a 428% average price increase to £3.75 ($5.08), based on the latest figures from market researcher WaveData. In second place was the same molecule in a 7.5mg strength, with a somewhat less steep 280% average increase to £2.09... Global Sub. Full

 

 

Biotech's Reverse Merger Renaissance Poised to Continue

(8/17, Kyle LaHucik, Endpoints News) ...Reverse mergers have been around for years, and their intrigue ebbs and flows. But 2026 has been a particularly lively period. The current renaissance has involved 17 drug developers so far in 2026, which almost equals this year's 19 biotech IPOs. It's the most active year since 2018, according to Raymond James bankers... Sub. Req'd

 

Celltrion Set to Ramp Up Pharmacy Biz in France With Gifrer Acquisition

(8/18, Nam Hyun-woo, The Korea Times) ...The company said the Gifrer's pharmacy network has strategic value because it fills the gap in Celltrion's direct sales network, allowing prescriptions initiated at hospitals to be linked to dispensing, administration and repeat purchases... Full

 

 

The Medicines Patent Pool Is Improving Access to Essential Medication Where It's Most Needed, But Does it Make Economic Sense?

(8/17, Bruno Bersaevel, Etienne Billette de Villemeur and Vianney Dequiedt, The Conversation) ...Expanding the MPP's activities to biotherapeutics aims to improve access to medicines for people in LMICs suffering from other forms of cancer. However, the complexity of biotherapeutic production processes creates more opportunities for patenting than the manufacturing of smaller chemical molecules, resulting in a larger number of patents... Full

 

Big Pharma Warns Germany's Attempts to Curb Drug Prices Will Backfire

(8/18, Florian Muller and Aanu Adeoye, Financial Times) ...Europe's biggest drugmakers have warned that Germany's attempts to curb healthcare costs will undermine one of the country's few remaining globally competitive industries and cede further ground to the US and China...[D]drugmakers say any savings from the measures will be modest and come at the cost of weaker investment and innovation, threatening a sector that is home to some of the world's largest pharmaceutical companies including Bayer, Stada and BioNTech... Sub. Req'd

 

Germany Must Reform Drug Pricing or Risk Losing Pharma Investment, Industry Warns

(8/17, Francesca Bruce, Pink Sheet) ...The German government should introduce reforms to allow for greater confidential drug pricing, and lobby for the abolition of international reference pricing, according to Pharma Deutschland, which represents pharmaceutical manufacturers in Germany. The recommendations are included in a wider strategy paper that Pharma Deutschland published on Aug. 14, ahead of the government's forthcoming pharmaceutical strategy, which is expected in the autumn... Global Sub. Full

 

Are Biosimilars, Price Masking The Answer To Europe's Problems Amid US MFN Policy?

(8/18, Vibha Ravi, Pink Sheet) ...As major European markets struggle with their "overall drug spends," they are "not making enough products available for unmet needs for patients…..we are starting to see in countries like France, that they are really doubling down on biosimilars," said Indian drug maker Lupin's CEO, Vinita Gupta, during the company's Q1 FY27 earnings call recently... Global Sub. Full

 

EXCLUSIVE: U.S. Policy Compelling Some Drug Companies to Stall Medicine Rollouts in Canada

(8/17, Cristina Howorun, CityNews) ...According to a survey of 31 pharmaceutical and life sciences companies by EY (formerly Ernst & Young), 16 medicine launches in Canada have been cancelled directly because of MFN pricing, and another 32 drugs have seen their rollouts delayed because of the policy... Full

 

Pharma Sector Must Move From Cost Competitiveness to Innovation: Experts

(8/18, PTI) ...Pushpa Vijayaraghavan, Director, Healthcare and Lifesciences Advisory, Sathguru Management Consultants, said India would have to progress simultaneously across generics, APIs, biologics, biosimilars and innovation. "We have to preserve our generics base, move faster on API backward integration, build scale in biologics and biosimilars, and invest far more seriously in innovation," she said... Full

 

Medicines UK Joins IGBA

(8/17, IGBA) ...IGBA, the International Generic and Biosimilar medicines Association, representing global manufacturers of generic and biosimilar medicines, announced today that Medicines UK has joined IGBA as a new Associate Member... Full

 

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