Thursday, October 15, 2026
Top News
Teva Pharma (TEVA) PT Raised to $47 at Barclays
(10/15, StreetInsider.com) ...Barclays analyst Glen Santangelo raised the price target on Teva Pharma to $47.00 (from $42.00) while maintaining a Overweight rating... Sub. Req'd
Teva Price Target Raised to $47 from $42 at Barclays
(10/15, The Fly) ...Barclays analyst Glen Santangelo...keeps an Overweight rating on the shares as part of a Q3 earnings preview. While expectations are higher heading into the print, the results and Teva's pending inflection in the pipeline "will perpetuate momentum in shares," the analyst tells investors in a research note... Sub. Req'd
U.S. Policy & Regulatory News
CBP Delays Rule That Would Create Hurdles For Low-Cost Drug Imports
(10/14, Gabrielle Wanneh, Inside Health Policy) ...At issue is an interim final rule that was set to go into effect Oct. 22 that would have created new hurdles for importation of low-cost prescription drugs and other items. The delay allows those products to continue to be imported into the United States duty-free, tax-free and with minimal paperwork requirements until Jan. 20, 2027... Sub. Req'd
Competition Can't Wait: Policymakers Must Address Patent Abuse
(10/14, PCMA Blog) ..."Patent thickets, product hopping, litigation risks, and the lack of institutional coordination all contribute toward the high prices of prescription drugs in America. Bills introduced this Congress tackle these challenges with varying mechanisms, but the ultimate goal is the same: a robust market for lower-cost generics and biosimilars driven by competition rather than litigation and gamesmanship."... Full
Medicare Part D Plans Stabilizing But 2030 Premium Cliff Needs Attention, CMS' Brooks Says
(10/14, Cathy Kelly, Pink Sheet) ...The Centers for Medicare and Medicaid Services now feels comfortable about its decision to curtail the Part D premium stabilization demonstration for standalone Part D plans initiated by the Biden Administration, [CMS Center for Medicare Director David] Brooks said during the recent Association for Value-Based Cancer Care Summit... Global Sub. Full
Biosimilar Regulation Has Not Kept Up with the Science
(10/14, Justin Leventhal, RealClear Health) ...Interchangeability regulations are not the only barrier biosimilars face. FDA's naming rules make the system even more confusing... Full
Biosimilars Are Gaining Ground, but PBM Economics Still Shape Access
(10/14, Paul Pruitt, Future Healthcare Today) ...Organizations evaluating PBMs and biosimilar strategies should focus on the economic result across the entire prescription journey... Full
US FDA Generic Drugs Office Director Steps Down Amid 'Political Pressure,' Admin Burden
(10/14, Derrick Gingery, Sue Sutter, Maaisha Osman, Pink Sheet) ...Iilun Murphy has stepped down as director of the US Food and Drug Administration's Office of Generic Drugs and moved to a lesser role, in part because of growing political pressure and administrative burden at the agency. Multiple sources told the Pink Sheet Oct. 14 that Murphy will become associate director of regulatory science in OGD. Center for Drug Evaluation and Research Director Mike Davis said in an email to staff that Murphy is transitioning to the new role, where she will help advance the center's drug repurposing efforts... Global Sub. Full
Former FDA Officials Blast DOGE as 'One of The Biggest Disasters in American History'
(10/14, Chelsea Cirruzzo, STAT+) ..."DOGE will go down as one of the biggest disasters in American history," Robert Califf, former FDA commissioner under Presidents Obama and Biden, said during the STAT Summit...Califf's sharp tone was echoed by Scott Gottlieb, who served as commissioner for part of the first Trump administration, and Ned Sharpless, who was acting commissioner towards the end of the first Trump administration. Sharpless called the cuts "arbitrary" and said that the companies he works with as co-founder of Jupiter BioVentures often now find themselves in meetings with more junior and less experienced drug and medical device reviewers. "You lost a lot of institutional memory," Gottlieb added... Sub. Req'd
Maryland Will Likely Pass Law to Put Limits on Payments for 25 Drugs
(10/14, Scott Maucione, WYPR - 88.1) ...The bill allows the board to set limits on what the state will pay for drugs the federal government has already set a maximum fair price on. To date, the government has capped prices on what Medicare will pay for 25 drugs with its negotiated maximum fair price... Full
Innovative News
Celltrion to Spotlight Subcutaneous (SC) Infliximab (Remsima SC) and Broader IBD Portfolio at UEG Week 2026
(10/15, Celltrion) ...Celltrion will showcase its comprehensive infliximab portfolio, comprising Remsima™ intravenous (IV) and subcutaneous (SC) formulations, as well as the Remsima™ IV liquid formulation launched in Europe earlier this year.1 Additionally, the company will highlight its broader IBD portfolio, including SteQeyma™ (ustekinumab) and Yuflyma™ (adalimumab), reflecting its continued efforts to expand treatment options for patients with IBD... Full
Takeda's ORZEYFUL (oveporexton) Launches Simultaneously in Japan and China Giving Physicians First Access to Prescribe Novel Orexin Agonist to Patients with Narcolepsy Type 1
(10/15, Takeda) ...Takeda announced today that ORZEYFUL (oveporexton) is now available in Japan and China for the treatment of narcolepsy type 1 (NT1), providing first access to clinicians to prescribe treatment with the new class of medicine. ORZEYFUL is a first-in-class orexin receptor 2 (OX2R) agonist, in tablet form, designed to treat the underlying orexin deficiency associated with NT1... Full
PeDRA 2026: Nemolizumab Phase II Data Show Long-Term Symptom Relief for Children Aged 2 to 11 Years with Moderate-to-Severe Atopic Dermatitis
(10/15, Galderma) ...Galderma...today announced new phase II data showing that nemolizumab provided meaningful improvements in itch, sleep disturbance, and quality of life in children aged 2 to 11 years with moderate-to-severe atopic dermatitis, sustained through Week 52... Full
Merz Therapeutics Announces Completion of Recruitment in Two Phase III Trials Investigating XEOMIN® (incobotulinumtoxinA) for Migraine Prevention
(10/15, Merz Therapeutics) ...Merz Therapeutics...today announced the completion of patient recruitment in two global Phase III clinical trials, MINT-E (NCT07018700) and MINT-C (NCT07018713), evaluating the efficacy and safety of XEOMIN® (incobotulinumtoxinA) for the prevention of episodic and chronic migraine in adults. The trials recruited approximately 1800 adults across 109 study sites in North America and Europe... Full
Generics & Biosimilars News
Why Biosimilars Keep Losing Ground to Brand-Name Rivals: A Q&A with Christine Johnston
(10/14, Lauren Gordon, Managed Healthcare Executive) ...To understand what's behind that shift, Managed Healthcare Executive spoke with Christine Johnston, president and co-founder of Foundational Pharmacy Strategies, about the rebate incentives, formulary strategies and regulatory landscape shaping biosimilar access today... Full
Beyond the Base Case: Why Biosimilar Companies Need Two Forecasting Engines, Not One
(10/15, Predrag Tanasijevic, In Vivo) ...Organizations should strive for a unified decision framework, common governance, and a single version of truth. But the evidence suggests a single forecasting methodology across the asset's lifecycle compromises decision quality precisely where uncertainty is greatest... Full
Industry News
GLP-1s Took Eli Lilly To $1 Trillion. CEO Dave Ricks Is Betting Billions He Can Do It Again
(10/15, Amy Feldman, Forbes) ...Now, the trillion-dollar question for Lilly is how to build—or buy—a pipeline of drugs that can sustain its tremendous success..."It's the defining challenge," Ricks tells Forbes in an interview on the executive floor at Lilly's Indianapolis headquarters, where formal paintings of the company's 10 previous CEOs hang on the walls. "If we're finding we're not successful in doing that, then we should give the money back to shareholders and be smaller, but I'm not in that mode right now."... Full
Sanofi's New R&D Chief Says Western Pharma Shouldn't Ignore China's Role in Drug Pipelines
(10/14, Maggie Fick, Endpoints News) ...Paulo Fontoura, who joined the French company last month from AI-focused biotech Xaira Therapeutics, told Endpoints News he had been visiting China for more than a decade and witnessed its biotech industry's evolution. "It's probably hard for a global company to ignore the innovation coming in from the Chinese ecosystem, because there [are] so many things happening there," Fontoura said in an interview. "Does it change the mix of what we do? I think we should seriously consider that, honestly."...Western drugmakers can also "learn probably a thing or two about efficiency, timelines, costs" from China, Fontoura said... Sub. Req'd
Merck CEO Tells CNBC He Expects Breakthrough Cancer Vaccine Will Become Faster to Make
(10/14, Annika Kim Constantino, CNBC) ..."We are going to drive for improvement, but right now the focus really is, let's make sure we have the supply ready, we have the market ready to bring this important innovation to the market, and then we'll talk about how do we accelerate," [Merck CEO Rob Davis] told CNBC in an exclusive interview. "But I do think over time you're going to see that timeline shortened."... Full
AstraZeneca Strikes $40 Million AI Drug Discovery Deal with Insitro
(10/15, Patrick Wingrove, Reuters) ...Insitro will use its "Virtual Human" AI platform, which combines lab-grown cell models and machine learning, to identify causal disease biology and advance AstraZeneca-nominated targets from discovery to development-candidate stage. AstraZeneca will then run and fund future clinical trials... Full
Big Pharma Is Pouring Billions Into a New Class of 'Protein Degrader' Drugs
(10/15, Lizzy Lawrence, The Wall Street Journal) ...A new class of medications -- known as "protein degraders" -- are showing promise in going after a certain kind of hard-to-target protein in diseased cells. Most medicines on the market today work by latching onto the rough surface of a protein and blocking it from causing disease. But some proteins are so flat that they are hard to latch on to. These elusive, smooth proteins are involved in 85% of disease drivers that researchers have so far been unable to attack... Sub. Req'd
10 Crucial Trends Facing U.S. Drug Wholesalers in 2026 and Beyond
(10/14, Adam J. Fein, Ph.D., Drug Channels) ...But as I explain below, wholesalers continue to position themselves as essential intermediaries by expanding their role across the drug channel and strengthening their economic fundamentals... Full
Dr Reddy's Laboratories Stock in Focus as USFDA Completes Pre-Approval Inspection at FTO-9 Plant
(10/15, Business Today) ...Dr. Reddy's Laboratories Ltd shares will be in focus on Thursday morning after the company disclosed that the United States Food and Drug Administration (USFDA) completed a pre-approval inspection at its FTO-9 manufacturing facility in Visakhapatnam, Andhra Pradesh, and issued a Form 483 with three observations... Full
International News
Seven-Year UK Pharma Pricing Deal Takes Shape Amid Dispute Over Spending Targets
(10/14, Dean Rudge, Pink Sheet) ...The UK government and pharmaceutical industry have agreed that the successor to the VPAG, the current branded medicines pricing agreement, should run for seven years, setting the timeframe for a longer-term regime intended to support higher spending on innovative drugs while maintaining controls on National Health Service (NHS) costs... Global Sub. Full
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