Friday, November 13, 2026

 

 

Teva Targets Up to $7B in Innovative Drug Sales by 2030

(11/12, Anna Bratulic, FirstWord Pharma) ...Meanwhile, Teva is also advancing a pipeline that it hopes will extend growth beyond 2030, including TEV-'408, an IL-15-blocking antibody that is in Phase II for coeliac disease and is also in earlier-stage testing for vitiligo and alopecia... Full

 

 

Pharmas Should Stay Agile as Democrats Amp Up Scrutiny Over Trump's MFN Deals

(11/12, Donavyn Coffey, Fierce Pharma) ...The investigation into the opaque, high-profile deals, along with several of the Trump Administration's other pharma policies, are almost guaranteed to get "noisy" in the wake of the midterms, experts told Fierce. But the real-time implications for drugmakers and their strategies are less clear... Full

 

Democrats Plan Early Action on Tariffs, Health Insurance Costs

(11/12, Caitlin Reilly, Bloomberg) ...Representative Richard Neal, who is set to lead the powerful House committee with jurisdiction over tax, health and trade policy, said he and his Senate counterpart already have a coordinated the strategy to show "we heard what voters had to say."... Sub. Req'd

 

Florida Democrat Wants Health Panel Gavel on Energy and Commerce

(11/13, Victoria Knight and Erin Durkin, Bloomberg) ...Castor said her priorities as Health subcommittee chair would be pushing forward "anything to lower the cost and improve the quality, and stand up to the corruption that's costing everybody." That could include reviving the enhanced Affordable Care Act tax credits, which expired at the end of 2025... Sub. Req'd

 

GLOBE Goes to Court. American Innovation Is on Trial.

(11/12, Peter J. Pitts, RealClearHealth) ...CMS is implementing GLOBE through its Innovation Center, which Congress created to test new ways of paying for and delivering healthcare. That's a worthwhile mission. But testing a payment model is one thing. Using that authority to reshape pharmaceutical pricing policy by administrative fiat is quite another... Full

 

HHS Taps Cuban To Build Ibogaine Supply, Prep US Trials For PTSD

(11/12, James Jarvis, Inside Health Policy) ...HHS plans to commit up to $4.9 million to lay the groundwork for U.S. trials of ibogaine as a potential treatment for post-traumatic stress disorder, particularly in veterans, and will tap Mark Cuban's drug company to establish a domestic supply of the psychedelic drug while drawing on data from patients who have already received ibogaine at a clinic in Mexico to help design the studies... Sub. Req'd

 

Dubious Buys Raise Alarm Over Local Control of Opioid Cash

(11/12, Aneri Pattani, KFF Health News) ...Although there are some spending guidelines within the settlement agreements, there is considerable flexibility, a vacuum of leadership and oversight, and significant gaps in how the public can track the dollars... Full

 

FDA Seeks Input on Addressing Patient-Level Data Challenges for RWD/RWE

(11/12, Joanne S. Eglovitch, Regulatory Focus) ...First, FDA said it wants to know about the opportunities and challenges facing the pharmaceutical industry when it comes to the current requirement to submit patient-level data collected from RWD sources for submissions proposing the use of RWE. The agency also wants to know what solutions can improve industry practices for sharing patient-level RWD with the FDA... Full

 

Fed Up with the Healthcare Industry, this Red State Capped Insulin Prices for Patients

(11/13, Noam Levy, KFF Health News) ..."Typically, Republicans are more on the free-market side of things, Democrats are more supportive of intervening," said North Dakota state Sen. Sean Cleary, a Republican. "But in this case, I think there was broad-enough agreement that this market just wasn't functioning for folks." Cleary co-sponsored legislation last year to cap patients' insulin bills at $25 a month. North Dakota is one of 29 states that have enacted such measures... Full

 

How Biosimilars Could Lower Part D Costs for Seniors

(11/13, Sabrina McCrear and Juliana M. Reed, The Center for Biosimilars) ...Juliana M. Reed, MS, of the Biosimilars Forum says reference biologics outnumber biosimilars 2:1 in Medicare despite steep discounts... Full

 

 

Orzeyful's 'Lighter' DEA Schedule Paves Way for Takeda's First-in-Class Narcolepsy Launch

(11/12, Fraiser Kansteiner, Fierce Pharma) ...The medicine has now been tagged as Schedule IV—a category inclusive of drugs the DEA has determined to have a "low potential" for abuse and risk of dependence—and in turn clearing the "last hurdle" before rollout, analysts at Jefferies wrote in a note to clients Wednesday. The categorization also places the new-to-market Orzeyful "below the oxybates and well below stimulants" in terms of DEA scheduling hierarchy, the analyst team said... Full

 

 

Gedeon Richter Urges Countries To Recalibrate Biosimilar Tenders, Citing Supply Shortfalls

(11/13, Urte Fultinaviciute, Generics Bulletin) ..."There's no denying that we expected those price erosion rates to be significantly less problematic," Gedeon Richter's CEO Gábor Orbán said as he described the biosimilar pricing environment in Europe...Without naming the exact countries, the CEO said he does not "see how the biosimilar penetration, how biosimilar access will be solved in those places," but urged them to recalibrate their approach to tendering, pricing, contracting, and sourcing... Global Sub. Full

 

Viatris Looks Ahead To Pacira Benefits As Generics Slide In Q3

(11/12, Dave Wallace, Generics Bulletin) ...Generics sales in developed markets that grew by 2% to $1.03bn benefited from "strong growth in North America driven by estradiol patches and new product contributions, including octreotide," although this was "partially offset by anticipated negative impact of certain continued supply constraints in Europe."...Outside of developed markets, generics sales also saw a downturn in emerging markets where generics turnover was down by 37% to $93m, again "due to continued supply constraints." In Japan, Australia and New Zealand (JANZ) Viatris' generics sales were down by 2% to $144m, while in China the firm registered another $5m in generics sales... Global Sub. Full

 

Omalizumab Biosimilar CT-P39: Quality of Life Gains Precede CSU Control

(11/12, Chelsie Derman, HCP Live) ...Quality of life gains came before disease activity responses with omalizumab in chronic spontaneous urticaria (CSU), according to post hoc analyses of the omalizumab-igec (Omlyclo; CT-P39) phase 3 trial Celltrion USA will present at the American College of Allergy, Asthma and Immunology (ACAAI) 2026 Annual Scientific Meeting in Phoenix... Full

 

 

ANI Proposes Egetis Acquisition As It Continues To Bolster Its Identity As a Rare Disease Company

(11/12, Anabel Costa-Ferreira, Generics Bulletin) ...As ANI Pharmaceuticals heads to the end of 2026, it remains focused on executing its goals across the branded and generics space, building up its generics saleson the back of multiple launches while pushing its rare diseases business with the recent proposed $560m acquisition of Egetis Therapeutics set to bolster its portfolio... Global Sub. Full

 

New Antihypertensives Face Access Hurdles Competing Against Established Generics

(11/12, Cathy Kelly, Pink Sheet) ...The aldosterone synthase inhibitors represent the latest advance in hypertension treatment, but clinicians and payers worry insufficient data exists comparing them to existing treatments like spironolactone or eplerenone, which are available as generics... Global Sub. Full

 

Big Pharma's Race to Stop Alzheimer's Before it Starts

(11/13, Aanu Adeoye and Michael Peel, Financial Times) ...Now Roche has joined companies including Eli Lilly pushing into a new frontier of research — testing whether treatments can not only stave off cognitive decline but prevent symptoms from ever emerging in the first place... Sub. Req'd

 

Migraine Review: CGRP Drugs Effective but Not Disease-Modifying

(11/13, Bioengineer.org) ...The study, authored by Leah Mistry, Alexandre Mathy, and Anish Bahra, examines the journey from bench to bedside, detailing why certain mechanistic pathways have failed to yield effective drugs while others have borne fruit. It emphasizes the need to reframe clinical goals from simple symptom suppression to longer-term disease modification, addressing the impact of confounding comorbidities and moving towards a biopsychosocial model of pain management... Full

 

Cellular Atlas Created for the Basal Ganglia, a Key Brain Region

(11/12, Will Dunham, Reuters) ...The researchers mapped the cell types and cellular gene activity in the basal ganglia, an interconnected set of structures deep within the brain, in humans as well as in mice and in macaque and marmoset monkeys. Basal ganglia dysfunction is associated with conditions such as Parkinson's disease, Huntington's disease, schizophrenia, Tourette's syndrome, bipolar disorder, obsessive-compulsive disorder and addiction... Full

 

CVS Breakup Won't Satisfy Washington. It Could Still Work for Wall Street.

(11/13, David Wainer, The Wall Street Journal) ...There is a simpler financial logic, too. Investors value store chains and managed care operators very differently. Once apart, each can be judged, and run, on its own terms... Sub. Req'd

 

Bristol Myers Research Chief to Depart in 'Evolution' of Company's Structure

(11/12, Kristin Jensen, BioPharma DIVE) ...Bristol Myers Squibb is combining its research and development departments, elevating Cristian Massacesi to the new job of head of R&D and saying goodbye to Chief Research Officer Robert Plenge, who came to the company with its $74 billion acquisition of Celgene... Full

 

AI Models from Google, Anthropic and More Lean on Recommending Promoted Drugs: Study

(11/12, Ben Adams, Fierce Pharma) ...In their report, published Nov. 11 on The Lancet Digital Health, the team found that when the AI models were given a doctor-written clinical case, preceded by an ad for a drug, "the ad could shift which treatment the AI recommended, making it more likely to select the advertised drug," according to a release on the study... Full

 

GLP-1 Users Skip Doses, Stretch Supply Amid Cost Pressures

(11/12, Madison Muller, Bloomberg) ...The drugs have transformed treatment for obesity and diabetes, but high prices, limited insurance coverage and previous shortages have complicated access... Sub. Req'd

 

Novo Nordisk Taps DJ Khaled for Wegovy Campaign

(11/12, Thorvardur de Shong, Chain Drug Review) ...Through the campaign, Khaled will share details of his weight-loss journey, including his diet, exercise routine, and his decision to seek medical treatment. The initiative builds on his participation in Novo Nordisk's Wegovy commercial, which aired during the 2026 Super Bowl... Full

 

Exclusive- Pfizer to Stop Selling Premarin Hormone Therapy in Canada

(11/12, Mrinalika Roy, Reuters) ...Premarin vaginal cream, used to treat symptoms of menopause, has been in shortage in Canada since June and no further batches will be supplied, Pfizer Canada confirmed to Reuters on Thursday... Full

 

Estrogen Shortage Spreads From Patches to Injections and Vaginal Creams as Women Face Refill Gaps and Coverage Hurdles

(11/12, Cole Mercer, Medical Daily) ...Kevin Schipper, a director at the consulting firm ProPharma, told Reuters the pattern does not appear to reflect a broad raw-material shortage, though supply-chain problems could still play a role. He said the new shortages may partly reflect women switching from hard-to-find patches to other products. That suggests relief depends on manufacturers adding capacity across several forms at once... Full

 

 

Israel Has a Lot Riding on Nvidia, Whose CEO Just Resigned

(11/13, Benjamin Cohen, Forward) ...In the second quarter of 2026 alone, Nvidia's Israeli operation booked $17.5 billion in sales, nearly a fifth of the company's worldwide revenue and more than four times the sales of Teva Pharmaceuticals, the multinational Israeli drugmaker. Analysts credit Nvidia with largely driving a 13% jump in Israeli tax revenue, and its workforce there has roughly doubled since Oct. 7, 2023... Full

 

 

Companies Seek Right To Be Consulted Before EU Requires Drug Repurposing

(11/12, Dean Rudge, Pink Sheet) ...Drugmakers want EU regulators to consult them before deciding to change a medicine's label based on evidence from a third party, warning that the bloc's new pharmaceutical legislation does not expressly require this. EFPIA, which represents Europe's research-based drug industry, told the Pink Sheet that the lack of a clear requirement for prior consultation was its main concern with the new repurposing power... Global Sub. Full

 

The Connected Regulatory Future in Latin America: Data, Innovation, Reliance & Patient Access

(11/12, Pharma Boardroom) ...In this article, first published in DIA Global Forum's November 2026 edition, authors from Roche, AbbVie, Thermo Fisher Scientific, Nuvara and DIA draw on discussions at the DIA Latin America Annual Meeting 2026 in Mexico City... Full

 

Goa's Bid for a Bigger Role in Global Pharma

(11/12, Neha Aathavale, Express Pharma) ...India has built its pharma strength on two formidable foundations: the ability to manufacture at scale and the capacity to reach markets across the world. In recent years, however, it has become increasingly clear that scale alone cannot determine how far the industry can go. The challenge is to keep pace with the shifts while moving beyond volume to create greater value... Full

 

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