Tuesday, November 10, 2026

 

 

Teva Ukraine Appoints Former COO Sudak as General Manager

(11/9, Interfax-Ukraine) ...Dmytro Sudak, who previously served as chief operating officer of international pharmaceutical company Teva Ukraine, has been appointed its general manager. In his new role, Sudak will be responsible for the strategic development of the Ukrainian business and the implementation of the company's key priorities, the company said in a press release... Sub. Req'd

 

 

Trump's Plan to Lower Drug Prices in U.S. Is Leading to Fewer New Drugs in Europe

(11/9, Lizzy Lawrence, The Wall Street Journal) ...There has been a 27% drop in new drug releases across European countries over the last 17 months, compared with the same period before President Trump announced the plan, according to new data from market-research firm GlobalData. Meanwhile, drug approvals in Europe have held steady over that time period. "You have companies saying, 'Well maybe I won't enter the market there because it's just going to be used against me in the United States,'" said Ipsita Smolinski, director of health-policy research firm Capitol Street... Sub. Req'd

 

Health Brief: Exclusive | Dems Prepare Drug-Pricing Probe

(11/9, Megan R. Wilson, The Washington Post) ...Let the oversight begin. Top Democrats on congressional health committees are pressing drugmakers for the fine print on their most-favored-nation (MFN) deals with the Trump administration, according to a person directly familiar with the matter who spoke on the condition of anonymity to discuss sensitive details... Full

 

Trump's Drug Pricing Deals Force Tough Choices on Launches

(11/9, Maggie Fick, Endpoints News) ...In third-quarter earnings calls, executives at US and European pharmaceutical companies for the first time detailed some of the tangible ways they might protect their US prices, including delaying European launches, seeking favorable reference pricing from countries like Japan and even looking at private-pay options over government-negotiated rates. The comments signal to foreign governments that the threat of delayed drug launches is real, while also offering a glimpse into internal deliberations over where and when to introduce new medicines... Sub. Req'd

 

Wyden Open To Codifying Trump MFN Deals In Exchange For Expanding IRA Drug Negotiation

(11/9, Gabrielle Wanneh, Inside Health Policy) ...Senate Finance Committee ranking Democrat Ron Wyden (OR), the committee's likely next chair, told reporters Monday (Nov. 9) that negotiation is "on the table" for a potential agreement to codify the Trump administration's "most favored nation" agreements with drug companies in exchange for expanding the number of drugs that can be selected for Medicare price negotiations. But he said Democrats still need transparency from the Trump administration on what exactly the deals include... Sub. Req'd

 

Trump Administration To Reform 340B; Hospitals Warn Of Costly Burdens

(11/9, Joshua P. Cohen, Forbes) ...The Trump administration wants to reform 340B by making it "more accountable" in terms of how the discounts are used. Hospitals and clinics fear that this will impose inordinate financial and administrative burdens... Full

 

PCMA Launches New Campaign: "Big Pharma's War on Generics," Highlighting Drugmaker Patent Abuse

(11/9, PCMA) ...[PCMA] today launched a new seven-figure multi-channel advertising campaign designed to show how brand drug manufacturers use shady tactics to delay lower-cost generic and biosimilar competition from entering the market, all to keep prescription drug prices high for American patients. The campaign's introductory ad, "War on Generics," shows how Big Pharma deploys armies of lawyers to carry out patent abuse tactics to extend monopolies beyond their expiration date. Ending these practices has drawn bipartisan support in Congress... Full

 

Industry Braces For FDA User Fee Riders As Democrats Take Congress

(11/9, James Jarvis, Inside Health Policy) ...Although stakeholders largely expect the underlying commitments negotiated between FDA and industry to remain intact, several anticipate lawmakers could seek additional provisions addressing FDA staffing transparency, post-market drug safety oversight and longstanding regulatory barriers to generic and biosimilar competition... Sub. Req'd

 

Auchincloss Pitches Clinical Trial Bill As PDUFA Add-On

(11/9, Jessica Karins, Inside Health Policy) ...Rep. Jake Auchincloss (D-MA) wants his bipartisan Faster Clinical Trials Act to serve as the framework for policies riders attached to the upcoming reauthorization of the Prescription Drug User Fee Amendments and is making the pitch to new and returning lawmakers that his bill creates an infrastructure for science, he told Inside Health Policy in an interview. He expects a Senate counterpart bill to be introduced soon... Sub. Req'd

 

Watch: Where Do Our Generic Drugs Come From? We Dug to Find Out.

(11/9, video by Katie Nixdorf, reporting by Debbie Cenziper, Megan Rose and Brandon Roberts, ProPublica) ...To better understand how the FDA regulates the generic drug industry, Debbie Cenziper and Megan Rose interviewed current and former factory inspectors, tested medications in a lab and sued the federal government for critical documents... Full

 

Filthy Rooms, Bare Toes, Mislabeled Toxic Materials: Inside Factories Making Our Medicines

(11/9, Lisa Fletcher, Andrea Nejman and Nathan Aaron, KUTV) ...Newly obtained photos are mostly grayed out because the U.S. Food and Drug Administration doesn't want you to see the filthy, unsanitary conditions in which some of America's prescription drugs are being made. The new images are just the tip of the iceberg in a series of troubling new reports we've uncovered about the overseas factories making our drugs... Full

 

Regulatory Intelligence Requires Critical Thinking, Actionability to Be Valuable, Experts Say

(11/9, Ferdous Al-Faruque, Regulatory Focus) ...The experts, who spoke at the opening plenary of the RAPS Regulatory Intelligence Conference Europe, agreed that the purpose of regulatory intelligence to identify trends and ensure compliance with rapidly changing laws, and that its value comes from interpreting and acting upon that information... Full

 

Enterprises Say AI Regulation Won't Stop Corporate Innovation

(11/9, Belle Lin, The Wall Street Journal) ...Regulation around AI models could take any number of forms, especially as Democrats are likely to focus on the topic of safety , which had already become a bigger priority for lawmakers. Democrats at the national and state level may push for regulations that set guardrails for new AI models, which could include testing models before they are released publicly... Sub. Req'd

 

BIO Unveils Plan for US to Remain Biotech's 'Global Leader'

(11/10, Gwendolyn Wu, BioPharma DIVE) ...The "action plan" by the Biotechnology Innovation Organization unveiled Tuesday lays out seven priorities Congress and the Trump administration should act on to "ensure" the U.S. remains the sector's "global leader." Called "BioAdvance: Securing America's Biotech Century," it involves ways to speed up drug development, improve the nation's clinical trial infrastructure, attract investment and better support biomedical research... Full

 

Terror Suit Against Drugmakers Draws US Supreme Court Inquiry

(11/9, Greg Stohr, Bloomberg) ...The companies are seeking review of a ruling that let American terrorism victims sue the companies for allegedly paying millions of dollars in bribes to secure medical-supply contracts with the Iraqi Ministry of Health from 2004 to 2013. The victims say the money went to Jaysh al-Mahdi, a militant group that controlled the ministry. The lawsuit names units of AstraZeneca Plc, Roche Holding Ltd., GE HealthCare Technologies Inc., Johnson & Johnson, Pfizer Inc. and Viatris Inc. as defendants. The companies were sued by servicemembers and civilians who served in Iraq, as well as their families... Sub. Req'd

 

New Poll: Californians Prioritize Healthcare Affordability and Access

(11/9, The California Endowment) ...The poll reveals overwhelming support for specific policies that make healthcare more affordable and accountable: 93% support negotiating lower prescription drug prices... Full

 

 

J&J's Icotyde Pill Drives Biologic-Like Efficacy in Psoriatic Arthritis Despite High-Dose Miss

(11/9, Angus Liu, Fierce Pharma) ...Icotyde delivered "competitive joint efficacy, strong skin responses and a clean safety profile" in psoriatic arthritis patients who had not received a biologic drug, Jefferies analyst Roger Song, M.D., described in a Nov. 8 note about J&J's phase 3 data from the Iconic-PsA 1 trial... Full

 

Zura Scraps Hidradenitis Suppurativa Program After Phase 2 Miss, Sinking Stock

(11/9, Nick Paul Taylor, Fierce Biotech) ...The failed Tibushield trial compared two doses of tibulizumab, an antibody that inhibits IL-17A and BAFF, to placebo in 247 HS patients. At Week 16, the changes from baseline in the total abscess and inflammatory nodule (AN) count were 56% and 58.1% on 300 mg and 150 mg of tibulizumab, respectively. The placebo rate was 52.5%, causing the trial to miss its primary endpoint... Full

 

Valbenazine for Tardive Dyskinesia Tied to Less Antipsychotic Drop-Off

(11/9, Kristen Monaco, Medpage Today) ...Starting valbenazine (Ingrezza) to treat tardive dyskinesia might reduce antipsychotic discontinuation in patients newly diagnosed with the side effect, a retrospective cohort study of Medicare claims indicated... Sub. Req'd

 

 

Hikma Chief Cites Success In Stabilizing Generics And Injectables

(11/9, Dave Wallace, Generics Bulletin) ..."Branded is outperforming, profitability in Hikma Rx [generics business] is improving, and Injectables is stabilizing, well positioned for future growth," [Hikma CEO Said Darwazah] summarized, while "we have expanded our portfolio and pipeline through new launches and an increased investment in R&D." The apparent trade-off for this stability is sales growth, with both the Hikma Rx generics business and the injectables unit expected to see flat turnover this year... Global Sub. Full

 

FDA Grants Tentative Approval for First Generic Lenacapavir

(11/9, Brian Nowosielski, Drug Topics) ...The FDA has provided tentative approval for the generic version of Gilead's lenacapavir, an injectable treatment for HIV prevention, according to a release. The generic formulation was granted to Dr. Reddy's Laboratories and it comes just over a year following the original medication's approval... Full

 

 

Respiratory Today, Oncology Tomorrow: Glenmark Lines Up Its Next Chapter

(11/10, Vibha Ravi, Generics Bulletin) ...Glenmark is counting on Ryaltris (olopatadine, mometasone furoate) nasal spray launches in 10 more markets following Brazil, steady gains for its US fluticasone respiratory franchise, and the launch of its first oncology drug, licensed from Jiangsu Hansoh Pharma, by the end of FY27 to drive near-term growth...Glenmark's generic fluticasone propionate 44mcg inhalation aerosol, referencing GSK's Flovent HFA, introduced in the US in March with 180-day competitive generic therapy (CGT) exclusivity, continues to scale... Global Sub. Full

 

CVS Break-Up Shows How M&A-First Strategy Is Not the Healthiest Option

(11/10, Financial Times) ...The break-up is, on the face of it, an admission that previous attempts to beautify the group through M&A haven't worked...[T]he unpopularity of Big Healthcare has led to a backlash among both competition regulators and US states, which would like to separate drug stores from pharmacy benefit managers that oversee drug delivery to patients... Sub. Req'd

 

FDA Warns of Vision Loss Risk Linked to Popular GLP-1 Drugs Like Wegovy, Zepbound

(11/10, Elsa Ohlen, CNBC) ...The FDA is requiring the makers of all GLP-1 medications to add a warning about the potential increased risk of NAION associated with use of these medications, it said... Full

 

Johnson & Johnson is Backing a Psychedelic-Inspired Depression Startup in a $100 Million Round

(11/9, Cris Tolomia, Quartz) ...Johnson & Johnson $JNJ +2.13% led a $100 million Series C financing in Delix Therapeutics, a Bedford, Massachusetts, developer of psychedelic-inspired depression treatments, the company said on Monday. J&J invested through its venture capital arm, Johnson & Johnson Innovation – JJDC... Full

 

 

After Raising $100 Million, Israeli Medical Device Maker Art Medical Turns to Court for Help

(11/10, Lital Dobrovitzky, CTech) ...The company holds approximately 100 registered patents and has distribution agreements with Teva and Italian company MOSS. Its products have been used at leading hospitals in Israel and abroad, including Beilinson and Hadassah... Full

 

 

EU Risks 'Completely Screwing Up' Pharma Sandboxes, Academic Warns

(11/9, Dean Rudge, Pink Sheet) ...The EU could "completely screw it up" by adopting an overly bureaucratic approach that limits opportunities to challenge established regulatory rules and practices, said Stephen Gilbert, professor of medical device regulatory science at the Dresden University of Technology, in Germany... Global Sub. Full

 

Recruitment To Industry Trials Falls For Fifth Year In UK Despite Faster Approvals

(11/9, Vibha Sharma, Pink Sheet) ...Enrollment in commercial contract trials in the National Health Service fell for the fifth consecutive year in 2025/26, to 17,618 participants from 19,507 the year before, according to the annual clinical trials report published by the Association of the British Pharmaceutical Industry (ABPI) on Nov. 5...The downward trend in recruitment to industry trials is not being driven by a lack of "willingness of the public to participate in research," the ABPI contended... Global Sub. Full

 

China's Burgeoning Novel Medicines Success Presents Opportunity for Europe

(11/10, Annabel Kartal Allen, Pharmaceutical Technology) ..."I see China as being a catalyst for the Europeans," said Jeremy Levin, executive chair of Ovid Therapeutics, in a panel session on day one. "It's making us all wake up; if we stay where we are and don't do anything, and we don't develop more quickly, protect our intellectual property and speed up access to clinical studies, we will be run off the road by the fantastic skills and competences in China," he warned... Full

 

Korea Streamlines Review Of Digital Convergence Combos

(11/9, Ryner Lai, Pink Sheet) ..."Through the one-stop integrated review system for digital convergence medicines, we aim to help Korean products enter new markets and gain a first-mover advantage," explained Kang Seok-yeon, director of the National Institute of Food and Drug Safety Evaluation. "We will continue to issue guidance to accelerate their commercialization, including a Guideline on Clinical Trial Design for Digital Convergence Medicines, which we plan to publish by the end of this year."... Global Sub. Full

 

Japan Nudged to Probe Wide Gaps in Biosimilar Uptake

(11/6, Pharma Japan) ...Japan should investigate why biosimilar uptake varies so widely across products, a health ministry panel member urged on November 5, as new government data showed that only two of 20 biologic ingredients with biosimilar alternatives had achieved replacement rates of over 80%... Full

 

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