Tuesday, August 25, 2026

 

 

Days After Teva, DC Court Shoots Down Merck's Longstanding Case Against IRA

(8/24, Gabrielle Wanneh, Inside Health Policy) ...The court's decision came just days after the D.C. Circuit Court of Appeals shot down a similar challenge against drug price negotiation from Teva Pharmaceuticals, which was initially filed with the D.C. district court in 2025 and also rejected at that level... Sub. Req'd

 

Trump's 50% Tariff on Many Canada Imports in Effect as Talks Stall

(8/24, Phil Neuffer, MedTech Dive) ..."In recent weeks, we made important progress toward improving Canada's position as having the best deal in the world with the U.S. However, that progress has not been enough to meet our objectives for Canadians," Canada Prime Minister Mark Carney said in a statement Friday. "As a result, this evening, I have decided to suspend trade negotiations with the U.S. and have directed Canada's negotiators to return to Ottawa." Carney said he made the decision due to "last-minute changes" the U.S. proposed that "were unfair, uneconomic, and called into question the reliability of any deal." Meanwhile, the U.S. blamed Canada for the breakdown... Full

 

The Impact of Pharmaceutical Tariffs and Pricing Risks on Biopharmaceuticals

(8/24, Morningstar) ...Morningstar's latest report analyzes a representative basket of 5 large US and 5 large European drugmakers to estimate the effects of pharmaceutical tariffs on imported drugs into the US, the impact to the global supply chain to relocate manufacturing to the US, and the revived push for US drug prices to be lowered to most-favored-nation (MFN) prices... Full

 

Merck, AZ Lawsuits Against Medicare Price Negotiations Swatted down

(8/24, Kevin Dunleavy, Fierce Pharma) ...Last week, Teva got a rare partial win against the IRA as the federal appeals court in Washington sent (PDF) a previous ruling back to District Court for further review. It concerned Teva's challenge to the requirements by CMS that a generic drug be genuinely marketed before its brand-name reference product is excluded from negotiation...That Teva lawsuit was similar to the AZ challenge rejected last week by Judge Matthew Maddox... Full

 

The Medicare GLP-1 Discount Has One Big Catch: Some Sick Patients Don't Qualify

(8/25, Jackie Fortier, KFF Health News) ...But buried in the fine print is a distinction that's tripping up patients...The $50 price under Bridge applies only to people using the drug solely for weight loss. Anyone who has a qualifying medical condition that the Food and Drug Administration has approved GLP-1s to treat, such as Type 2 diabetes or moderate to severe obstructive sleep apnea, is instead routed back to their Medicare Part D prescription drug plan, which can require copays of hundreds of dollars a month for GLP-1s... Full

 

The Frontier for Cancer Cures Continues to Expand

(8/24, John Tamny, RealClearMarkets) ...The attempt by the Trump administration to associate MFN with lower drug prices is wrongheaded on its best day, and dangerous on its worst...Inexpensive drugs cannot be decreed, rather they're an effect... Full

 

Therapeutic Equivalence: FDA Finalizes Guidance on TE Evaluations

(8/24, Joanne S. Eglovitch, Regulatory Focus) ...FDA states that the guidance primarily applies to ANDAs submitted under Section 505(j) of the Federal Food, Drug, and Cosmetic (FD&C) Act. Sponsors of these products must show that the proposed generic product is the same as the RLD with respect to the active ingredient, conditions of use, route of administration, dosage form, strength, and labeling and that the drug is bioequivalent to the RLD... Full

 

BsUFA 2027 Fee Invoices on the Way!

(8/24, Bob Pollock, The Lachman Blog) ...FDA announced that BsUFA fee invoices were mailed on August 21, 2026 and should be coming to you soon... Full

 

OPM Data Show Continued Drop In FDA, HHS Staffing

(8/24, Jessica Karins, Inside Health Policy) ...Office of Personnel Management data posted online last week show FDA has seen a net loss of 743 employees in the first three quarters of fiscal 2026. It lost a net 3,879 employees the previous fiscal year, amid widespread HHS reductions in force, but continuing losses at the agency reflect persistent low staff morale following the RIFs and major turnovers in FDA leadership... Sub. Req'd

 

California Sending Free Inhalers to All Public Schools

(8/24, Zachary Stieber, Santa Clarita Valley Signal) ...Private schools can purchase inhalers at a discounted rate of $9.50 per inhaler and $93.75 for 25 single-use inhalers. That is up to 80% less for inhalers and 35% off the 25-pack... Full

 

 

Upsher-Smith Launches Generic Copaxone

(8/24, Sandra Levy, Drug Store News) ...Upsher-Smith, a subsidiary of Bora Pharmaceuticals, is introducing glatiramer acetate injection in 20 mg/ml and 40 mg/ml strengths. The medication is the generic of Teva's Copaxone... Full

 

Biocon Arm Gets Japan Nod for Cancer Drug Pegfilgrastim Biosimilar

(8/25, PTI) ...Sandoz KK will exclusively promote, sell, and distribute the product in Japan, it added... Full

 

Aeon Bolsters Botox Biosimilar Package With Expanded Data

(8/24, Dave Wallace, Generics Bulletin) ...The expanded results increase coverage of the active botulinum neurotoxin primary sequence "from approximately 93% to 98%, with 100% amino acid identity across all regions analyzed," Aeon said, demonstrating "preservation of the critical disulfide bond architecture required for toxin activation" by identifying the same C430-C454 bond connecting the light and heavy chains in both products across all tested lots... Global Sub. Full

 

Celltrion Boosts Europe Push With 300 mg OMLYCLO Launch

(8/25, Heo Ji-yoon, Chosun Biz) ...Celltrion said on the 25th that it launched high-dose OMLYCLO (ingredient name Omalizumab), a treatment for chronic spontaneous urticaria and allergic asthma, in major European countries including Germany, the United Kingdom, and France. At the end of last year, it released OMLYCLO 75 mg and 150 mg in Europe, and it has now added 300 mg to broaden the lineup... Full

 

Amneal Builds End-to-End Biosimilars Capacity in the U.S.

(8/24, Chain Drug Review) ...The acquisition adds a 100,000-square-foot research and development and manufacturing facility in Chicago and gives Amneal two facilities totaling more than 150,000 square feet in New Jersey... Full

 

Nonmedical Adalimumab Biosimilar Switch Maintains Disease Control in Pediatric IBD

(8/24, Pearl Steinzor, The Center for Biosimilars) ..."Adalimumab biosimilars are as safe and effective compared to the originator. Adult patients with inflammatory bowel disease (IBD) who switched to a biosimilar have comparable outcomes, but pediatric data are limited," wrote the researchers of the study... Full

 

 

US FDA Expands Approval for J&J's Drug for Rare Blood Disorder

(8/24, Kunal Das, Padmanabhan Ananthan, Reuters) ...The approval makes Imaavy the first treatment cleared for warm autoimmune hemolytic anemia, or wAIHA, and covers patients aged 12 and older who are currently or were previously treated with steroids... Full

 

Eli Lilly Launches Foundayo Weight-Loss Pill in U.K.

(8/24, Dominic Chopping, The Wall Street Journal) ...The drug is available from Monday of this week, initially through private prescription, as Lilly continues to work with the healthcare spending watchdog over its assessment for potential coverage across England's state National Health Service, it said... Sub. Req'd

 

Lexicon Pharma Earns $10 Million Milestone Payment from Novo Nordisk

(8/24, Dean Seal, The Wall Street Journal) ...The biopharmaceutical company on Monday said that it has achieved a patient dosing milestone in the continuing phase 1 program for LX9851, a treatment being developed for obesity and associated metabolic disorders... Sub. Req'd

 

 

Sweden Suffers Two-Pronged Attack On Availability Of Generic And Innovative Drugs

(8/24, Francesca Bruce, Pink Sheet) ...The availability of all medicine types in Sweden is under threat from two fronts - the EU urban wastewater treatment directive (UWWTD) and the US most favored nation (MFN) drug pricing policy, according to Bengt Mattson, from Lif, the Swedish R&D-based pharmaceutical industry association. While the UWWTD is more likely to hit generic medicines, MFN will affect newer, innovative products, warned Lif's sustainability director in an interview with the Pink Sheet. "Together they really hit the full pharmaceutical market," he said... Global Sub. Full

 

Sweden's Push to Produce Its Own Antibiotics Comes With a Catch

(8/25, Daria Sukharchuk, Euractiv) ...Sweden can strengthen domestic antibiotic production but cannot achieve full self-sufficiency without securing active ingredients, state-owned drugmaker APL's CEO Erik Haeffler told Euractiv in an interview...Euractiv examined whether the factory has made Sweden more self-sufficient in generic medicines and better equipped to tackle the EU's drug shortages..."From a preparedness perspective, it's good to have a European supply chain," said Haeffler, pointing to the EU's efforts to strengthen domestic production and supply resilience through the Critical Medicines Act... Full

 

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