Thursday, August 13, 2026

 

 

Prescription Drug Prices Record Sharpest Drop in More Than 60 Years

(8/13, Steve Thompson, Federica Cocco, Christopher Rowland, The Washington Post) ...While overall costs for medical services continued to rise, prices for medicinal drugs fell 2.7 percent over the 12 months ending in July, the largest annual drop on record, according to Bureau of Labor Statistics data released Wednesday...The White House took credit for the good news, saying President Donald Trump's efforts to slash drug prices were working. Some experts said a Biden-era policy that requires Medicare to negotiate prices for some popular prescription drugs is more likely to be driving down costs... Full

 

Apotex Sees Canadian Footprint as Shield Against Potential U.S. Generic Tariffs -- Market Talk

(8/12, Dow Jones) ...Executive Christine Batur says there is a "unique recognition of Canada as part of the solution," giving the company a "good potential advantage" over global rivals... Sub. Req'd

 

PhRMA Calls For Deal With Germany Similar To US-UK Drug Agreement

(8/12, Brett Fortnam, Inside Health Policy) ..."This agreement should eliminate the burden on U.S. commerce described in this submission by reducing the gap between what the United States and Germany spend on new medicines. Consistent with the U.S.-UK Arrangement on Pharmaceutical Pricing, the agreement should require Germany to achieve a minimum level of spending on innovative medicines based on its relative ability to pay. Specifically, the agreement should require Germany to spend the same share of its GDP on innovative medicines as the United States."... Sub. Req'd

 

The West Has Given China the Keys to the Medicine Cabinet

(8/12, Ara Darzi, Financial Times) ...China, meanwhile, is not standing still. It already dominates the manufacturing base, and after a decade of regulatory reform it now accounts for roughly a third of the world's new drug pipeline. The west could still out-innovate it. China is behind in first-in-class antibiotic discovery, an opening the US could exploit if it chose to. But the west has forgotten how to make, pay for and deploy what it invents... Sub. Req'd

 

Patients Benefit When Medicines Keep Improving

(8/12, Patrick Kilbride, RealClear Health) ...Simply put, activists misunderstand -- or are deliberately misrepresenting -- how the patent system works. And unfortunately, enough lawmakers have bought into these myths that they're considering several bills to weaken patent protections. If those bills become law, and companies can't protect their medical discoveries from premature copycatting, biotech firms will be far less likely to undertake the high-risk research that produces those breakthroughs. That would mean fewer new and improved medicines for the millions of Americans battling cancer and other severe diseases... Full

 

Drugmakers, Health Insurers Battle Over Coupons for High-Cost Medicine

(8/13, Tom Howell Jr., The Washington Times) ..."Copay accumulator programs are necessary because drug manufacturers' copay coupons, which are illegal in Medicare and Medicaid, are a marketing tool used by Big Pharma to steer patients toward a more expensive drug instead of an equally effective, more affordable generic option, which leads patients and employers to pay higher drug costs," said Greg Lopes, a spokesman for the Pharmaceutical Care Management Association, a major lobby for pharmacy benefit managers, or PBMs, which manage prescription drug benefits for insurers and employers... Full

 

US FDA Tweaks PDUFA Meeting Structure: Type D Expanded, INTERACT Limited

(8/12, Derrick Gingery, Pink Sheet) ...In new final guidance, the US [FDA] clarified that Type D meetings can be used to follow up on issues previously covered and attempted to better explain the purpose and timing of INTERACT sessions, a long-time point of confusion with sponsors... Global Sub. Full

 

GDUFA IV: Commitment Letter Outlines Key Changes to Program

(8/12, Joanne S. Eglovitch, Regulatory Focus) ..."The proposed enhancements for GDUFA IV address many of the top priorities identified by FDA, the regulated industry, and other stakeholders. These include proposed program enhancements to stabilize fee revenue, advance approvals in fewer review cycles, improve program efficiency, enhance processes around complex data issues, and provide mechanisms to facilitate onshoring of generic drug manufacturing," FDA wrote in the Federal Register notice... Full

 

After 10-Year Dispute, US FDA Grants Hearing On Lannett Generic Concerta Withdrawal

(8/12, Sue Sutter, Pink Sheet) ...The US [FDA] will finally hold a public hearing on the Center for Drug Evaluation and Research's proposed withdrawal of Lannett's generic version of the attention deficit hyperactivity disorder Concerta (methylphenidate), approximately 10 years after the company's predecessor first requested it... Global Sub. Full

 

Newsom Promotes Affordable Insulin, But California's Generic Label Is Off to a Slow Start

(8/13, Angela Hart, STAT+) ...Seven months after the launch of its own low-cost insulin brand, state health officials said California has distributed more than 120,000 five-pen packs of insulin glargine priced at $55 each, significantly less than the $89 to $411 that the state says most popular brand names charge before any retail markups or consumer discounts... Sub. Req'd

 

Senators: New Jersey Can Finish the Job on PBM Reform — Together

(8/12, David Wildstein, New Jersey Globe) ...We know these proposals will generate significant lobbying. Vertically integrated companies have spent years building business models around the very silos we need to unwind. They will argue that reform is too complicated, existing contracts already provide sufficient protection, affiliation creates efficiencies, and stronger duties will disrupt the market. Efficiency can't mean forcing patients into a company-owned pharmacy... Full

 

'Bureaucratic Inertia': Delaware Lawmaker Says State Board Should Pursue More Aggressive Reforms to Drive Down Employee Drug Prices

(8/13, Sarah Mueller, WHYY) ...The General Assembly unanimously passed a resolution in 2025, sponsored by state Sen. Ray Seigfried, D-Claymont, that required the State Employee Benefits Committee to examine ways to revamp how the state negotiates drug prices with pharmacy benefit managers, or PBMs, and report back...Seigfried, a former ChristianaCare executive, said the state could save tens of millions of dollars by addressing hidden costs built into the health care supply chain... Full

 

 

New Ingrezza Data Shows Improved Quality of Life and Daily Functioning in Tardive Dyskinesia

(8/12, Jessica Walters, Psychiatric Times) ...New study results show Ingrezza (valbenazine) for tardive dyskinesia (TD ) improved patient-reported quality of life and functionality, as well as movement severity.1 The phase 4 open-label KINECT-PRO study found improvement in TD symptoms and quality of life with Ingrezza, regardless of underlying psychiatric diagnosis or baseline movement severity... Full

 

Remepy Pockets $36M to Push Parkinson's Hybrid Drug Towards Phase III

(8/12, Olivia Roger, FirstWord PHARMA) ...Hybrid Drug developer Remepy has added $36 million to its coffers to advance its Parkinson's disease treatment into Phase III trials and extend its model of pairing prescription medicines with therapeutic software to other disease areas... Full

 

Daiichi Sankyo and AstraZeneca's Enhertu Plus Pertuzumab Approved in China for First-Line HER2+ Metastatic Breast Cancer

(8/12, OncoDaily) ...The approval by China's National Medical Products Administration (NMPA) is based on results from the phase 3 DESTINY-Breast09 trial. In the study, Daiichi Sankyo and AstraZeneca's Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% compared with taxane, trastuzumab and pertuzumab (THP), with a hazard ratio of 0.56 (95% CI, 0.44–0.71; p<0.00001)... Full

 

After Depression Study Win, Definium's Psychedelic Tablet Now Delivers in Anxiety

(8/12, Anna Bratulic, FirstWord PHARMA) ...The biotech said DT120, its orally disintegrating tablet (ODT) formulation of lysergide (LSD), met the primary and all key secondary endpoints in the Voyage study of adults with generalised anxiety disorder (GAD), giving the company its second positive Phase III readout in less than two months. The result follows DT120's June success in the Emerge study for major depressive disorder (MDD)... Full

 

 

ANI Targets 15-Plus Annual Generics Launches To Sustain Rare Disease Push

(8/13, Dean Rudge, Generics Bulletin) ...Generics revenues increased by 9.7% to $99.1m in the second quarter, supported by new launches, continued strength from an unnamed partnered generic introduced in the third quarter of last year, and what ANI described as "commercial and operational outperformance."... Global Sub. Full

 

New Study From CVS Caremark and Employee Benefit News Shows How Employers Rely on Their Pharmacy Benefit Manager to Create Sustainable Pharmacy Solutions

(8/12, CVS Health) ...The survey findings also illustrate that biosimilars represent one of the largest untapped opportunities for employers to reduce drug costs in the U.S. health care market, offering clinically equivalent therapies to improve affordability and enhance access without compromising safety or efficacy... Full

 

 

Apotex Reports $38M Net Loss in First Quarter After Going Public in June

(8/12, The Canadian Press) ...Apotex Health Corp. says it had a net loss of $38.3 million in its first quarter as its revenue fell from the same period last year. The pharmaceutical company says the result compared with a profit of $362.7 million in last year's first quarter... Full

 

Biopharma Saw a Q2 Sales Boom Led by Lilly, Sanofi, Regeneron and Astellas

(8/12, Kevin Dunleavy, Fierce Pharma) ...The revenue boom was even more pronounced when comparing figures between the first and second quarters. Of the top 25 drugmakers, more than half (13) realized double-digit sequential gains and only one, Daiichi Sankyo, saw a decline, at 2%... Full

 

Boulevard Starts Up with $65M to Pursue Targeted Autoimmune Drugs

(8/12, Gwendolyn Wu, BioPharma DIVE) ...One of those medicines is already in early testing. Called BLVD-101, that drug is a so-called bispecific antibody aimed at a pair of targets known to drive the progressive kidney condition IgA nephropathy... Full

 

Novo Nordisk CEO Defends Lawsuit Against Eli Lilly: 'Competition Has to Be Fair'

(8/12, Alexa LoMonaco, CNBC) ..."I am a big fan of competition. I think competition has to be fierce, but I also think competition has to be fair," [Novo Nordisk CEO Mike Doustdar] said on CNBC's "Mad Money."..."I believe that patients deserve to know the full truth together with their physicians before they make a choice of what product to take."... Full

 

Eli Lilly Cracks Down on Illicit Weight Loss Drug Trade with US Lawsuits

(8/13, Annabel Kartal Allen, Pharmaceutical Technology) ...As part of these efforts, Lilly has filed six lawsuits directed at US-based entities selling retatrutide products – including medical spas, compounding pharmacies and online sellers, which the Indiana-based pharma giant claims are advertising products for "research use only". Lilly refutes this claim, alleging that the companies intend for them to be used in humans... Full

 

ICER Says AZ's New Hypertension Drug Too Expensive

(8/13, Phil Taylor, PharmaPhorum) ...In a preliminary evidence report (PDF), ICER concludes that Baxfendy (baxdrostat), which was approved by the FDA in May and has a wholesale acquisition cost of around $900 for a 30-day supply, has not delivered sufficient improvements over older generic drugs to justify its higher cost... Full

 

Fresenius Pulls One Batch of Actemra Biosim Over Glass Particle Concerns

(8/12, Fraiser Kansteiner, Fierce Pharma) ...As of Aug. 12, Fresenius Kabi had not received any adverse event reports tied to the recall, a company spokesperson confirmed to Fierce... Full

 

 

ICH Finalizes Guideline To Harmonize Additional-Strength Biowaivers

(8/13, Dean Rudge, Generics Bulletin) ...Adopted as a final ICH guideline at Step 4, M13B sets out recommendations for obtaining bioequivalence study waivers for one or more additional strengths where in vivo pharmacokinetic BE, or efficacy and safety, has already been demonstrated for at least one strength. The guideline applies both during product development and after approval... Global Sub. Full

 

Paper-Based And Focused: Canada Moves To Cut Pharmacovigilance Inspection Burden

(8/12, Vibha Sharma, Pink Sheet) ...While focused inspections have already been incorporated into Health Canada's inspection framework, the paper based assessments, which allow compliance verification using recent foreign inspection reports or consultant audit reports, are expected to be rolled out in fall 2026... Global Sub. Full

 

Will Trump's Proposed Drug Tariffs End India's Reign as 'Pharmacy of the World'?

(8/12, Biman Mukherji, South China Morning Post) ...Vivek Mishra, deputy director of the Strategic Studies Programme at the Observer Research Foundation, said the move implied that Indian pharmaceutical companies would need to set up bases in the US and that many supply chains could be disrupted. "Some smaller Indian companies may have to shut down," he said, noting that the tariff burden would add significantly to increased freight costs due to the US-Iran conflict. However, he said some uncertainty remained about the timing of the move because the policy initiative could face headwinds from lawmakers, as it was bound to push up US prices of generic medicines... Full

 

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