Wednesday, August 19, 2026

 

 

Teva Scores Rare Partial Win in CMS Price Negotiation Appeal

(8/18, Kevin Dunleavy, Fierce Pharma) ...On Tuesday, however, Teva Pharmaceuticals gained a partial win as the U.S. Court of Appeals for Washington, D.C. sent (PDF) a previous ruling back to the District Court for further review. It concerns Teva's challenge to the requirement by the Centers for Medicare & Medicaid Services (CMS) that a generic drug be genuinely marketed before its brand-name reference product is excluded from negotiation... Full

 

Federal Appeals Court Revives Part of Teva's IRA Case as Austedo Price Cuts Loom

(8/19, Nicole DeFeudis, Endpoints News) ...The DC Circuit Court ruled on Tuesday that Teva's challenge to CMS using the "bona fide marketing" standard is "ripe for review." The decision gives Teva a second chance to argue that CMS is mistaken in its guidance on when a branded drug should be exempt from price negotiations due to generic competition. It's an incremental win for the pharma industry after a string of losses in its years-long battle against the Inflation Reduction Act. A Teva spokesperson said the company is "encouraged" by the decision... Sub. Req'd

 

D.C. Circuit Rejects Another Drug Negotiation Challenge In Teva Case

(8/18, Inside Health Policy) ...The court's ruling Tuesday (Aug. 18) also said CMS was justified in treating Teva's Austedo and Austedo XR as a single drug for the purposes of negotiation... Sub. Req'd

 

Lawsuit Paid And Patents Delisted Following Teva's QVAR Inhaler Generics Settlement

(8/18, Anabel Costa-Ferreira, Generics Bulletin) ...After an agreement filed at the end of last year, a Massachusetts federal judge has approved a $35m settlement over a class-action lawsuit over Teva allegedly illegally delaying generic competition for its QVAR (beclomethasone dipropionate HFA) asthma inhalers... Global Sub. Full

 

 

Donald Trump Says Deal Reached With Canada and Pauses Tariffs

(8/18, Ilya Gridneff, Financial Times) ...US trade representative Jamieson Greer said: "The deal will include comprehensive market access for all American goods, economic security commitments, digital trade alignment, and many important provisions that will continue to protect our market and American workers, along with our Canadian partners."... Sub. Req'd

 

Generic Drug Tariffs Could Backfire. There's A Better Way To Win

(8/18, Arthur L. Kellermann, Forbes) ...Before Trump's team formally implements his tariff threat, I hope they'll realize there is a surer, safer path to reducing America's dependence on foreign drugs of dubious quality. It's grounded in three principles that made our economy great: American ingenuity, informed consumers, and homegrown industries committed to ensuring our health and security... Full

 

The White House Declares 'Promises Made, Promises Kept' on Lowering Drug Prices. Nice Try

(8/18, Ed Silverman, STAT+) ...About six months after brand-name drugs lose patent protection, the BLS removes them from its calculations and replaces them with lower-cost generics, which cost 80% to 85% less, on average. This is a big drop in price. And numerous big-selling, brand-name drugs are losing patent protection this year. The upshot is that the CPI provides an incomplete picture... Sub. Req'd

 

DC Circuit Rejects Drugmaker's Bid for Medicare Discount Relief

(8/18, Lauren Clason, Bloomberg Law) ...Servier Pharmaceuticals LLC does not qualify for a special status allowing it to phase in Medicare patient discounts under the Inflation Reduction Act, a federal DC appeals court ruled. The decision from the US Court of Appeals for the DC Circuit affirmed the district court's decision, which ruled that the drugmaker only qualifies for one of two special designations under the law... Full

 

PhRMA Touts IQVIA Findings As Reason Not To Expand IRA Price Control Scope

(8/18, Gabrielle Wanneh, Inside Health Policy) ...An industry-sponsored analysis released by IQVIA this month shows 24% of all first attempts to fill a prescription for a drug with a new CMS-negotiated price that took effect this year were initially rejected by plan sponsors during the first quarter of 2026, roughly the same rate as before the new prices kicked in during 2025. According to the brand-name drug lobby, the results indicate CMS and Congress should address insurers' use of utilization management tools to deny coverage before considering expanding the scope of price controls within and beyond Medicare... Sub. Req'd

 

Let's Bring Drug Wholesalers Out of the Shadows

(8/18, Amanda Frost, RealClear Health) ...Despite their outsized influence, wholesalers face concerningly few guardrails and have barely been explored by Congress. We know far too little about their impact on pharmacy competition and generic drug pricing, including the relationships among pharmacy services administrative organizations (PSAOs) and independent pharmacies... Full

 

FDA Issues Draft Guidance Clarifying Differences Between ANDAs and 505(b)(2) Applications

(8/18, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration (FDA) has updated its seven-year-old guidance to clarify the differences among abbreviated approval pathways and the data it will accept for these applications. These pathways include the traditional Abbreviated New Drug Application (ANDA) process under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the 505(b)(2) pathway... Full

 

US FDA's Hands-On Repurposing Efforts Show Why A Formal Pathway Is Needed

(8/18, Sue Sutter, Pink Sheet) ...The agency finally has begun leveraging its authorities under the MODERN Labeling Act, issuing requests for labeling updates to generics of two reference listed drugs for the first time since the law was enacted in 2020... Global Sub. Full

 

Study Highlights Difficulty of Measuring Non-Clinical Factors That Could Influence FDA Drug Approval Decisions

(8/18, Jeff Craven, Regulatory Focus) ...FDA also appears to be susceptible to external political and stakeholder pressure, with several included papers noting that factors such as media attention, disease salience, and advocacy group wealth led to faster approval times. One author suggested that FDA "makes decisions not only to follow science or law but to maintain legitimacy among multiple audiences: Congress, industry, media, and the public."... Full

 

Trump To Nominate White House Advisor Overton As FDA Commissioner

(8/18, Maaisha Osman, Nielsen Hobbs, Pink Sheet) ...President Trump plans to nominate Heidi Overton, deputy director of the White House Domestic Policy Council, as the next US [FDA] commissioner, a source familiar with the decision told the Pink Sheet, filling a vacancy that has left the agency without permanent leadership since May... Global Sub. Full

 

 

Personalized Cancer Vaccine from Moderna, Merck Shows Promise in First Late-Stage Melanoma Trial

(8/19, Annika Kim Constantino, CNBC) ...The mRNA-based shot in combination with Merck's immunotherapy Keytruda met key goals in the phase three trial in more than 1,100 patients with higher-risk or advanced melanoma whose detectable cancer had been completely removed through surgery...The combination regimen met the main study goal of significantly extending the time patients lived without their melanoma returning, compared with Keytruda alone. The treatment also reduced the risk of the cancer spreading to distant parts of the body... Full

 

 

DC Circuit Partially Rejects Vanda's Fight of Generic Sleep Drug

(8/18, Nyah Phengsitthy, Bloomberg) ...The company couldn't convince the US Court of Appeals for the District of Columbia Circuit to fully reverse a lower court order that ruled the Food and Drug Administration lawfully approved a generic version of Hetlioz created by Teva Pharmaceuticals Inc. Vanda alleged the agency acted arbitrarily and capriciously when it allowed the generic to omit both the braille lettering and the associated pharmacy instructions... Sub. Req'd

 

Sandoz's Generics-Biosimilars Split Reaches US Leadership

(8/19, Dean Rudge, Generics Bulletin) ...Sandoz has reinforced its increasingly distinct approach to generics and biosimilars by installing separate leaders for the two businesses in the US, appointing Thomas Occhipinti as head of biosimilars while elevating long-serving executive Sébastien Ménard to lead generics... Global Sub. Full

 

China's Booster Shot for Drug Innovation

(8/18, Wang Xiaoyu, China Daily) ...Worldwide, the volume of early-stage drug development nearly doubled from 2015 to 2024, while the traditional United States-led model is giving way to a two-hub system centered on both the US and China, according to a study headed by health policy experts at Georgetown University in Washington... Sub. Req'd

 

 

The Key to Pharma M&A: Never Shopping Hungry - Heard on the Street

(8/19, David Wainer, Dow Jones Newswires) ...The better move is to make frequent, smaller trips to the store. In pharma terms, that means making a steady stream of small to medium-size bets rather than one gigantic deal... Sub. Req'd

 

Big Pharma Hunts for Weight-Loss Drugs Without Nasty Side Effects

(8/19, Aanu Adeoye, Financial Times) ...Pharma groups are now working to develop therapies that can deliver similar weight loss while addressing many of the concerns with the current market leaders... Sub. Req'd

 

 

The Israeli-Founded AI Company Decoding the Human Immune System

(8/18, Candice Krieger, Jewish News) ...AstraZeneca, Pfizer, Teva and Boehringer Ingelheim are among the global pharmaceutical companies partnering with Israeli-founded Immunai to improve how new medicines are discovered and developed... Full

 

 

GBMA Pushes For PBS Pricing Reform To Stave Off Australian Shortages

(8/18, Dean Rudge, Generics Bulletin) ...The association is seeking PBS floor-price reform, targeted indexation and more proportionate minimum stockholding requirements to support continued multi-supplier competition... Global Sub. Full

 

Japan Policies Position Pharma As Key Industry. But Can They Ensure Value?

(8/19, Lisa Takagi, Pink Sheet) ...Recent major new macroeconomic policies from the Japanese government suggest a willingness to support innovation in the biopharma industry, along with patient access to novel drugs, while driving increased use of AI in precision healthcare... Global Sub. Full

 

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