Thursday, September 3, 2026

 

 

Teva's Immune Disorder Drug Meets Main Goal in Mid-Stage Trial

(9/2, Reuters) ...Teva Pharmaceutical Industries, said on Wednesday its experimental drug helped prevent gluten-related intestinal damage in adults with celiac disease, meeting the main goal of a mid-stage trial...A single injection of TEV-408 significantly reduced damage and inflammation in the small intestine compared with a placebo after eight weeks, Teva said... Full

 

Teva Moves Closer to a Drug for Celiac Disease With Positive Phase 2 Results

(9/2, Sophie Shulman, CTECH) ..."A strict gluten-free diet has long been the only option for people living with celiac disease. Yet, even with strict adherence to a gluten-free diet, many continue to experience symptoms, intestinal damage and a significant impact on their daily lives," said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. "These results underscore the potential to move beyond managing gluten exposure and address celiac disease at its biological source. They also strengthen our confidence in targeting the IL-15 pathway as an approach to reducing immune-driven intestinal damage."... Full

 

Teva's Anti-IL-15 Shows Positive Mid-Stage Results in Celiac Disease

(9/2, Matthew Dennis, FirstWord PHARMA) ...Speaking on a call with analysts Wednesday, Hughes surmised that the effects of TEV '408, which is designed for three-month dosing, might last longer than expected. "We do suppress these cells for a while after dosing… but the possibility exists that…since we're disease modifying, potentially that effect might last longer than we even anticipated."... Full

 

Teva Autoimmune Antibody Notches Ph. 2 Win in Celiac Disease

(9/2, Darren Incorvaia, Fierce Biotech) ...More dose-ranging and analysis of the phase 2 data are needed before a phase 3 follow-up can proceed, a Teva spokesperson told Fierce. "The celiac timeline remains subject to clinical results and regulatory alignment," the spokesperson said. "Celiac remains a priority and will progress as quickly as possible."... Full

 

Will Israel's Teva's New Celiac Medication Be the Best Thing Since Sliced Bread?

(9/2, Haaretz) ...In a call with Wall Street analysts, Teva CEO Richard Francis said the company has no intention of developing the drug with partners...In the next phase of the study, which is meant to provide sufficient data to the U.S. Food and Drug Administration (FDA) for approval, Teva expects it will need to give participants more gluten per day in a longer trial... Full

 

Teva Drug Rises to the Gluten Challenge, Stopping Intestinal Damage in Celiac Disease Trial

(9/2, Frank Vinluan, MedCity News) ...Teva said Wednesday that the results in celiac disease further validate the drug's potential to address many different immunological indications. For celiac disease alone, the company projects TEV '408 reaching $1.5 billion to $2 billion in peak sales, according to the presentation. Other potential indications include eosinophilic esophagitis, alopecia areata, and atopic dermatitis... Full

 

Teva Reports a Single-Shot Success in Celiac Disease, Heating the IL-15 Market

(9/2, Andrew Dunn, Endpoints News) ...In an analyst note, Evercore ISI analyst Umer Raffat said he's "reasonably comfortable" that Teva's readout isn't a chance finding but rather a signal of efficacy in celiac... Sub. Req'd

 

Teva's mAb Shows Benefit in Celiac Disease Study

(9/2, Abigail Beaney, Clinical Trials Arena) ...Jeffries analysts touted that TEV '408's Vh:Cd benefit was better than expected, with analysts estimating that the drug is likely to become a blockbuster for Teva. Meanwhile, Leerink analysts agreed that the data was well above the KOL-defined clinically meaningful floor... Full

 

 

BridgeBio's MFN Pact Exempts Orphan Products, Highlighting Deals' Bespoke Nature

(9/2, Cathy Kelly, Pink Sheet) ...The company is the first to publicly reveal a negotiated orphan drug exemption in an MFN deal. Most details of the agreements announced to date have remained confidential... Global Sub. Full

 

Medicare Spent Hundreds of Millions of Dollars on Ineligible Drugs, Audit Finds

(9/2, Rebecca Pifer Parduhn, Healthcare DIVE) ...Medicare Part D isn't supposed to pay for drugs that can be purchased without a prescription. But the government's current oversight isn't stopping that from happening, according to the HHS OIG audit... Full

 

ICER, West Health Band Together For Annual Watchdog Report On Drug Launch Prices

(9/2, Gabrielle Wanneh, Inside Health Policy) ...The report will cover launch pricing trends from 2022 through 2025 using an analysis of real-world pharmacy and medical claims data, payer coverage policies and patient surveys... Sub. Req'd

 

Updated US FDA Therapeutic Equivalence Guidance Allows Faster 505(b)(2) Rating Requests

(9/2, Manas Mishra, Pink Sheet) ...The Evaluation of Therapeutic Equivalence final guidance describes the FDA's approach to assigning therapeutic equivalence codes, including the Orange Book "A" rating that makes a product eligible for automatic substitution. The FDA issued a draft version in July 2022. Products classified as therapeutically equivalent can be expected to have the same clinical effect and safety profile as the prescribed product when administered under the conditions specified in labeling... Global Sub. Full

 

Analyzing The Federal Trade Commission's Pharmacy Benefit Manager Settlements

(9/2, Michael A. Carrier, Rachel Sachs, Health Affairs Forefront) ...In this article, we review the background of the lawsuits, introduce concerns about PBMs, and summarize the main provisions of the settlements. We explain why, despite the agency's promises, the settlements will not be fully effective at accomplishing their stated goals. We focus in particular on the settlements' neglect of the recent development of PBMs marketing their own drugs. We close by situating the settlements within broader PBM and drug pricing developments... Full

 

Senators Demand Federal Probe Linking Foreign Drug Makers To U.S. Recalls

(9/2, Danielle Shockey, Tampa Free Press) ...Chairman Rick Scott and Ranking Member Kirsten Gillibrand sent a formal letter to Acting Comptroller General Orice Brown on Wednesday, requesting that the Government Accountability Office (GAO) conduct a comprehensive review of the nation's overseas drug supply chain. In the letter, the lawmakers expressed concern over how much of the nation's medication supply now originates overseas... Full

 

Illinois Law to Lower Prescription Drug Prices Struck down

(9/2, Brian Weckerly, OurQC News) ...A federal judge has struck down an Illinois state law meant to bring prescription drug prices down. The Illinois Prescription Drug Affordability Act (House Bill 1697) was signed into law in July 2025 and took effect January 1... Full

 

New CSRxP Analysis: Big Pharma Spends Three Times More on Profits, Advertising and Overhead than R&D

(9/2, CSRxP) ..."Big Pharma routinely opposes bipartisan, market-based solutions that would effectively lower prescription drug prices for the American people by claiming they would undermine innovation, but the brand name pharmaceutical industry's own financial data tells a different story," said CSRxP executive director Lauren Aronson. "Brand name drug companies now dedicate three times more of each dollar of revenue to profits, advertising and overhead than to researching and developing new treatments for patients."... Full

 

 

uniQure Submits Long-Awaited US Filing for Huntington's Gene Therapy

(9/2, Anna Bratulic, FirstWord PHARMA) ...After a recent FDA reversal cleared the path for uniQure to use its existing clinical data, the company said Wednesday it submitted a marketing application for its Huntington's disease gene therapy ifezuntirgene inilparvovec (AMT-130). It is seeking accelerated approval, along with a priority review, and has also filed an application with UK regulators... Full

 

UniQure, After Setbacks, Seeks FDA Approval of Huntington's Gene Therapy

(9/2, Kristen Jensen, BioPharma DIVE) ..."Some regulatory risk remains, given the continued leadership changes at the FDA," William Blair analyst Sami Corwin wrote in a note to clients after Wednesday's announcement. Still, she and other analysts said they were encouraged that UniQure appears to be aligned with agency officials on how to run a confirmatory study — and that the trial won't require a sham surgery control... Full

 

 

Aspen Bets on Manufacturing Rebound, Obesity Drug Push for Growth

(9/2, Reuters) ...Commercial Pharmaceuticals, Aspen's largest unit, is expected to deliver mid-single-digit revenue and EBITDA growth, led by emerging markets growth and the start of a global rollout of its generic semaglutide, the active ingredient found in Novo Nordisk's blockbuster Ozempic. The rollout will initially rely on third-party manufacturers, including an existing arrangement with India's Dr Reddy's Laboratories for Canada and some other markets, [Aspen CEO Stephen] Saad said... Full

 

Natco Rules Out Semaglutide Filings In Canada And Brazil

(9/3, Dean Rudge, Generics Bulletin) ...Asked during Natco's first-quarter 2027 financial earnings call about the status of applications in Canada and Brazil, vice-chairman and chief executive officer Rajeev Nannapaneni said directly that the Indian firm was "not filing" for semaglutide... Global Sub. Full

 

Samsung Bioepis Gains Marketing Approval in Japan for 130mg Intravenous Infusion of Ustekinumab Biosimilar

(9/3, BioSpectrum Asia) ...South Korea-based Samsung Bioepis has announced the marketing approval of Ustekinumab BS Intravenous Infusion 130mg, a biosimilar referencing Stelara (ustekinumab), indicated for an induction therapy for moderate-to-severe active Crohn's disease where other treatments are ineffective. This is a second product to be approved in Japan under partnership with Nipro Corporation... Full

 

Cabometyx Patent Win Keeps MSN Generic At Bay Until 2030

(9/3, Dean Rudge, Generics Bulletin) ...Exelixis said the decision meant the earliest MSN could be permitted to commercially launch its proposed generic was January 15, 2030, subject to any further appeals or regulatory exclusivity. The three patents are subject to terminal disclaimers tying their terms to US patent 8,877,776, which expires in 2030... Global Sub. Full

 

Off-Patent, On Record: A Story Of Patients Fighting For Accessible Cystic Fibrosis Treatment How A Buyer's Club And A Generic Company Gave Hope For Families Across The World

(9/2, Urte Fultinaviciute, Generics Bullein) ...Generics Bulletin's senior reporter Urte Fultinaviciute is joined by Wilna Lottering and her son Josh from South Africa, as well as Gayle Pledger, a cystic fibrosis campaigner, who share their journey of navigating the patent system to find a generic cystic fibrosis drug... Sub. Req'd

 

 

Autoimmune CAR-T Faces Tough Questions After Novartis, Bristol Myers Study Halts

(9/2, Jonathan Gardner, BioPharma DIVE) ...Shares in companies like Kyverna, Cabaletta Bio, Allogene Therapeutics, CRISPR Therapeutics and Fate Therapeutics — all of which are investing in autoimmune cell therapy in one way or another — dropped abruptly before recovering. Since then, Wall Street analysts have begun assessing the impact of Novartis and Bristol Myers' findings, and multiple developers have tried to assure investors their prospective treatments are different. The results "have raised some investor questions regarding the broader [autoimmune cell therapy] landscape," wrote Leerink Partners analyst Thomas Smith... Full

 

Owkin Lands Third Major Pharma Partner in AI Deal with Boehringer Ingelheim

(9/2, Marta Rybczynski, FirstWord PHARMA) ...Under the collaboration, Owkin will generate new multimodal immunology data for the German drugmaker. Financial terms were undisclosed... Full

 

AI Speeds Drug Ideas But Creates Costly Testing Bottlenecks

(9/3, Sonja Wind, Bloomberg) ...The technology makes it possible to generate thousands of potential drug candidates in a fraction of the time, but those ideas still need to be tested. If companies can't weed out the bad ones quickly enough, the flood of possibilities risks creating a costly traffic jam. That's why pharmaceutical companies increasingly need to get better at killing bad ideas early... Sub. Req'd

 

Inside the Scramble for HRT — as Perimenopausal Women Get Creative amid Estrogen Patch Shortage

(9/3, Karen Fischer, The New York Post) ...With no clear end to the shortage in sight — experts estimate it could last several more months to several more years — some women are going to surprising lengths to manage their symptoms, from rationing to trading to flying to other countries... Full

 

Another Severe Chemo Shortage Hits: Why Is the US Still So Vulnerable?

(9/3, David Brzostowicki, Medscape) ...With ifosfamide in limited supply, some hospitals have been turning to drug-conservation strategies to reduce waste, such as rounding down doses or splitting vials, and, in some cases, making more consequential decisions about who gets the drug and who doesn't... Sub. Req'd

 

 

PIC/S Uses Look-And-Learn Visits To Build Pharmacovigilance Inspection Consistency

(9/2, Vibha Sharma, Pink Sheet) ...The joint visit program (JVP), launched by the pharmacovigilance expert circle under the international Pharmaceutical Inspection Co-operation Scheme (PIC/S), aims to promote greater consistency in pharmacovigilance inspections by enabling inspectors to compare approaches and learn from one another's procedures... Global Sub. Full

 

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