Wednesday, July 15, 2026

 

 

Hawley Walks Out of Patent Hearing After Clashing With Tillis

(7/14, Nino Paoli, Bloomberg Law) ...Nearly two hours of civility between advocates for and critics of the legislation was disrupted when Hawley targeted pharmaceutical companies during his time to query the panel of four experts, which drew Tillis' ire. "Don't you think we can find a way to protect our patent system, which I'm all for doing, provided that it's not gamed any further by the pharma companies to keep prices high?" Hawley asked Dr. Debra G.B. Leonard, a professor and chair at the University of Vermont College of Medicine... Full

 

Editorial: Trump Wants More Tariffs. The Public Feedback Is Revealing.

(7/14, The Washington Post) ...Just because the administration is using a law that courts have held to allow unilateral imposition of tariffs does not change the economic facts. Tariffs are taxes on Americans that hurt many of the U.S. manufacturers that Trump says he is trying to help... Full

 

Cheaper Medicines Exist - Middlemen Are Keeping Them Out of Reach

(7/15, Robert Zirkelbach, The Hill) ...That gatekeeping role gives them enormous leverage to negotiate lower prices from manufacturers and, in theory, pass those savings on to patients. But in practice, they use that leverage to design formularies that maximize their own profits - not patient savings - leaving Americans to face higher out-of-pocket costs. This is particularly evident when it comes to lower-cost generics and biosimilars. pharmacy benefit managers routinely block access to these affordable medicines in favor of more expensive drugs that often carry larger rebates and discounts, or hidden fees, that they can retain... Full

 

Could GENEROUS MFN Model Help Advance Medicaid Coverage For Cell, Gene Therapy?

(7/14, Cathy Kelly, Pink Sheet) ...The initial version of the model does not appear focused on cell and gene therapies, but the principles involved could apply to the innovative treatments eventually... Global Sub. Full

 

Sales From Controversial U.S. Drug Discount Program Rose to $100 Billion Last Year

(7/14, Ed Silverman, STAT+) ...The data mark a steady rise in sales under the 340B program, which requires drugmakers to offer discounts that are typically estimated to be 25% to 50% - but could be higher - off all outpatient drugs to hospitals and clinics that primarily serve lower-income patients...In general, drugmakers argue that hospitals abuse the program and divert payments to other uses, such as fueling consolidation of health care systems that, in some cases, favor wealthy communities. As a result, the pharmaceutical and hospital industries have squared off over pricing, billing, and claims data... Sub. Req'd

 

House Democrats Want GAO Study Of US FDA User Fee Spending On Layoffs

(7/14, Derrick Gingery, Pink Sheet) ...Rep. Frank Pallone, D-NJ, the ranking member of the House Energy and Commerce Committee, requested the Government Accountability Office analyze the impact of the staffing cuts on the user fee programs because of concerns the dollars were mismanaged... Global Sub. Full

 

Vanda Fights to Sway Court to Keep Suit Over FDA's Drug Reviews

(7/14, Nyah Phengsitthy, Bloomberg Law) ...Vanda Pharmaceuticals Inc. sought to convince a federal court Tuesday that it still has authority over its challenge against the FDA's structure for signing off on drug reviews, even after it petitioned a higher court to review the issue... Full

 

FDA Plans to Release More Drug Rejection Letters as Controversial Policy Resumes

(7/15, Darren Incorvaia, Fierce Biotech) ...A spokesperson for the Department of Health and Human Services told Fierce last week that the policy to release complete response letters (CRLs) in real-time had been temporarily suspended in April, the first time the pause was confirmed. Mere days later, the agency dropped a new batch of 14 CRLs, raising questions about the policy's status. "FDA will continue to proactively publish appropriately redacted CRLs, building on the batch released on July 10," the spokesperson told Fierce today... Full

 

CVS Caremark Announces Agreement with FTC To Further Advance Industry-Leading Approaches to Transparency and Affordability

(7/14, CVS Caremark multimedia) ...The agreement eliminates the need for ongoing litigation and investigations and allows CVS Caremark to remain focused on delivering more value for American consumers and employers, lowering prescription drug costs, increasing transparency, and helping customers deliver affordable health care to the people they serve... Full

 

Toledo Lawmaker's Bill Would Cap Medical Prices During Emergencies

(7/14, Josh Croup, WTVG) ...State Rep. Michele Grim, D-Toledo, recently introduced the Medical Shortage Protection Act. The bill would cap price increases at 10% above pre-shortage levels and apply during official emergencies and declared shortages... Full

 

 

Draig Nets $65m to Advance Depression Drug Aimed at Rebuilding Synapses

(7/14, Ayisha Sharma, Endpoints News) ...Draig will use the Series B in part to advance its lead asset, known as DT-101, through ongoing Phase 2 development and into potential Phase 3 for major depressive disorder (MDD). The candidate is intended to modulate a receptor called AMPA, which helps regulate how neurons fire signals and communicate with each other, according to the company... Sub. Req'd

 

Avere Makes Debut via NextCure Reverse Merger, Oral IL-23 Drug from Hansoh

(7/14, Matthew Dennis, FirstWord PHARMA) ..."The combination of the strong clinical data from Hansoh's Phase Ib psoriasis study, the capital raised through this financing from a world-class investor syndicate, and immediate access to the public markets positions us to be highly competitive in the emerging oral IL-23 market," said Andrew Cheng, CEO of Avere... Full

 

Celcuity Gets FDA Nod for First-in-Class Breast Cancer Drug

(7/15, Phil Taylor, pharmaphorum) ...The US regulator has cleared gedatolisib under the Revtorpyk brand name as a second-line or later treatment for HR-positive, HER2-negative locally advanced or metastatic breast cancer without PIK3CA mutation, as a triple therapy with Pfizer's CDK4/6 inhibitor Ibrance (palbociclib) and aromatase inhibitor fulvestrant or dual therapy with fulvestrant... Full

 

An Experimental Alzheimer's Drug Shows Promise Targeting a Different Brain Protein, New Study Shows

(7/15, Lauran Neergaard, Associated Press) ...The new findings suggest Biogen's diranersen did more than lower tau levels. The study of about 400 people found signs that it also slowed cognitive decline, in one small subset enough to be comparable to amyloid therapy, according to results presented at the Alzheimer's Association International Conference in London. Biogen is planning a larger study to try to prove the drug's benefit... Full

 

 

Actavis Fails To Escape Key Generics Collusion Claims

(7/15, Dean Rudge, Generics Bulletin) ...Teva's Actavis must continue to face most of the product-specific claims against it in US states' sprawling generics price-fixing case, after a federal judge in Connecticut found that witness testimony, call records and market conduct could allow a jury to infer collusion involving a string of dermatology products... Global Sub. Full

 

Sun Pharma Gets Go-Ahead to Sell Generic Semaglutide in South Africa

(7/15, The Hindu Businessline) ...Sun Pharmaceutical Industries has received the green signal from the South African Health Products Regulatory Authority (SAHPRA) to manufacture and market a generic version of semaglutide injection in South Africa for the treatment of adults with inadequately controlled type 2 diabetes mellitus, the company said. The Mumbai-based drugmaker expects to launch the product shortly... Full

 

Celltrion Wins Korea Approval to Start Phase 1 Trial of Tremfya Biosimilar

(7/15, Park Su-hyeon, ChosunBiz) ...Celltrion said on the 15th that it received approval from the Ministery of Food and Drug Safety for a phase 1 clinical trial plan (IND) for the Tremfya biosimilar "CT-P68."... Full

 

Celltrion Ends European Keytruda Biosimilar Trial

(7/15, Choi Mun-hee, BusinessKorea) ...Celltrion has terminated the European Phase 3 clinical trial of 'CT-P51,' a biosimilar candidate for the immunotherapy drug 'Keytruda (ingredient name pembrolizumab),' early and voluntarily withdrawn its clinical trial plan. This is not a halt in development or a clinical failure, but an adjustment of its approval strategy in response to changes in the global regulatory environment, and clinical trials in countries outside of Europe will continue as scheduled... Full

 

Apotex Challenges Sandoz's Infuvite With US Launch Of Generic Multivitamin Injections

(7/14, Urte Fultinaviciute, Generics Bulletin) ...Apotex will be enjoying being the only generic competitor to Sandoz and Baxter's Infuvite multivitamin solution on the US market. The Canadian firm has launched the hospital product in four configurations: injections for adult and pediatric patients in single-dose or bulk packages. The market entry triggered 180-day market exclusivity for the adult bulk and pediatric single-dose presentations, as they were granted a competitive generic therapy designation... Global Sub. Full

 

 

J&J Bumps Up Guidance as 2Q Sales Rise

(7/15, Kelly Cloonan, The Wall Street Journal) ...The drug and medical-device maker said Wednesday it now expects adjusted earnings per share between $11.60 to $11.75 for 2026, compared with the guidance it gave in April for a range of $11.45 to $11.65. J&J now expects full-year sales of $100.8 billion to $101.4 billion, compared with its prior projection of $100.3 billion to $101.3 billion... Sub. Req'd

 

Chris Boshoff Pfizer's AI Strategy for the Future of Drug Development

(7/14, OncoDaily) ...What's happening now isn't incremental. The convergence of foundation models, autonomous agents, and decades of accumulated data from biological research is creating something genuinely new - a scientific infrastructure that learns continuously, reasons across domains simultaneously, and gets better with every experiment, every patient, every decision. At Pfizer, we're building toward exactly this... Full

 

A Drug Start-Up Powered By A.I. Raises $400 Million

(7/15, Michael J. de la Merced, The New York Times) ...A fast-growing player in that industry, Chai Discovery, plans to announce on Tuesday that it has raised $400 million in new funding that values the company at $3.8 billion... Sub. Req'd

 

Insilico Medicine and Bora Pharmaceuticals Announce Strategic Alliance for AI-Driven Drug Discovery and Development

(7/14, Insilico Medicine and Bora Pharmaceuticals) ...By linking AI-enabled discovery with automation-driven development, manufacturing, and quality execution, Insilico and Bora aim to pioneer a next-generation drug innovation model that connects novel molecule design with the capabilities required to develop, manufacture, and deliver medicines to patients with unmet medical needs... Full

 

Amazon Pharmacy, eNavvi Partner to Provide Clinicians, Patients With Medication Pricing, Home Delivery Options

(7/14, Sandra Levy, Drug Store News) ...Amazon Pharmacy and eNavvi, a digital prescription platform, is collaborating to provide clinicians with real-time medication pricing, availability and nationwide home delivery options directly through eNavvi's seamless e-prescribing workflow. The integration is designed to support medication adherence and increase access, especially for patients in pharmacy deserts... Full

 

Insurance Denials for Brand-Name Drugs Climbed Sharply Over Six Years, Study Finds

(7/14, Mark Huffman, Consumer Affairs) ...Insurance denials for first-time prescriptions of brand-name drugs with no generic alternative jumped 67% between 2018 and 2024, according to a new study published in JAMA. Nearly half of patients whose prescriptions were initially denied never filled either the prescribed medication or a similar drug within 90 days, raising concerns about delayed or foregone treatment... Full

 

 

Pharma Industry Slams New Health Reforms In Germany That 'Undermine' Innovation And Investment

(7/14, Francesca Bruce, Pink Sheet) ...The new law fails to take into account US trade and pricing policies, said Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations. This includes most favored nation (MFN) policies aimed at tying US drug prices to those in markets with lower prices, tariffs on drug imports coming into the US from the EU, and an investigation into German pricing policies by the US Trade Representative. These policies are "highly likely to exacerbate this difficult situation," Moll said. "The legislation worsens the economic conditions for innovative medicines at a time when Germany should be strengthening its attractiveness for investment, research and production."... Global Sub. Full

 

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