Tuesday, November 3, 2026

 

 

Teva Pharmaceutical Q3 Profit Gain Beats Estimates

(11/3, Steven Scheer, Reuters) ...Teva Pharmaceutical Industries, reported on Tuesday a higher-than-expected rise in third-quarter profit, helped by strong sales of a trio of its own drugs to offset declines in copycat medicines... Full

 

Teva 3Q Net Down, Lifts 2026 Rev View

(11/3, Rob Curran, Dow Jones) ...Teva, which has historically focused on generic drugs, is also trying to grow its brand-name business. Sales of its three brand-name products collectively grew 33% to $1.1 billion during the quarter... Sub. Req'd

 

Teva's Transformation Gains Momentum as Innovative Drug Sales Rise 33%

(11/3, Sophie Shulman, CTech) ...The performance prompted Teva to raise its full-year 2026 revenue forecasts for all three products. It now expects Austedo to generate $2.55 billion to $2.65 billion, compared with its previous forecast of $2.45 billion to $2.60 billion. The outlook for Ajovy was raised to $930 million to $960 million from $850 million to $870 million, while the forecast for Uzedy increased to $290 million to $310 million from $270 million to $290 million... Full

 

Teva Sees FY26 EPS $1.92-$2.11, Consensus $2.09

(11/3, The Fly) ...[CEO Richard] Francis added: "At the same time, we are continuously building the next phase of sustainable growth at Teva. The U.S. launch of WELTRUZA expands our schizophrenia franchise, while progress across ecopipam, anti-IL-15 and our broader late-stage pipeline supports our ambition to deliver at least five potential innovative launches over five years. Our return to investment grade and debt refinancing reflect our strengthened financial position."... Sub. Req'd

 

Teva Pharma (TEVA) Tops Q3 EPS by 14c

(11/3, StreetInsider.com) ...Teva Pharma reported Q3 EPS of $0.86, $0.14 better than the analyst estimate of $0.72. Revenue for the quarter came in at $4.4 billion versus the consensus estimate of $4.25 billion... Sub. Req'd

 

Teva Raises Uzedy Revenue Outlook to $290-310M After Q3 Sales Jump

(11/3, StreetInsider.com) ...UZEDY® is the first product commercialized using Medincell's BEPO® technology. Teva recently received FDA approval for WELTRUZA™, a once-monthly subcutaneous olanzapine long-acting injectable based on the same platform, with a U.S. launch underway. Both products are covered under the same worldwide licensing agreement between Medincell and Teva... Sub. Req'd

 

Teva Raises 2026 Outlook for AUSTEDO, AJOVY and UZEDY After Strong Q3 Growth

(11/3, Manshi Mamtora, CFA, Seeking Alpha) ...Non-GAAP gross margin expanded 345 basis points Y/Y to 58.7%, its highest quarterly level in a decade excluding the $500M duvakitug milestone payments received in Q4 2025... Full

 

Teva Pharmaceutical Industries Limited Q3 Income Declines

(11/3, RTTNews) ...The company's revenue for the period fell 1.9% to $4.395 billion from $4.480 billion last year... Full

 

Teva, Samsung Bioepis Enter Pact to Commercialize Infliximab-abda and Eticovo

(11/3, The Fly) ...Teva and Samsung Bioepis announced that they have entered into a license and commercialization agreement for two FDA-approved immunology biosimilars: infliximab-abda, a biosimilar to Remicade and Eticovo, a biosimilar to Enbrel... Sub. Req'd

 

Samsung Bioepis, Teva Partner on $420M U.S. Biosimilar Deal

(11/3, Park Su-hyeon, ChosunBiz) ...Under this agreement, Samsung Bioepis will oversee development, production, and supply of the two products, while Teva will handle U.S. sales. The contract size, up to 420 million dollars, corresponds to approximately 34% of Samsung Bioepis's consolidated sales last year... Full

 

Teva and Samsung Bioepis Commercialize Two FDA-Approved Biosimilars in the U.S.

(11/3, Choi Mun-hee, BusinessKorea) ...Under the terms of the agreement, Teva will obtain U.S. commercialization rights to etanercept-ykro at closing, while U.S. commercialization rights to infliximab-abda will transfer to Teva in Q3 2027... Full

 

Teva To Obtain U.S. Commercialization Rights For Two FDA-approved Immunology Biosimilars

(11/3, RTT News) ...Teva will pay Samsung Bioepis an upfront payment over the next 3 years. Samsung Bioepis may be eligible for additional launch and sales milestones payments. The companies will share profit from the commercialization of these products... Full

 

Teva to Discontinue Mid-Stage Neurodegenerative Disorder Study

(11/2, Reuters) ...The company was testing its experimental oral drug, emrusolmin, in adults with multiple system atrophy, a rare neurodegenerative disorder that causes people to lose coordination and balance or become slow and stiff....The drugmaker said the decision was based on the recommendation of an independent data monitoring committee based on a planned early analysis to assess whether the study was unlikely to succeed... Full

 

Teva Pharmaceutical Industries to Discontinue Phase 2 Study for Multiple System Atrophy Drug

(11/2, Kelly Cloonan, Dow Jones) ..."While we are disappointed by the outcome of this interim analysis for the Phase 2 study, we remain deeply committed to learning everything we can from these data," said Eric Hughes, executive vice president, global R&D and chief medical officer at Teva... Sub. Req'd

 

Teva Halts Mid-Stage Study of Neurodegenerative Drug Emrusolmin

(11/2, StreetInsider.com) ...The company added that no safety concerns were identified during the review... Sub. Req'd

 

Teva Ends Trial of One of Its Original Line-Up of Innovative Meds Over Futility

(11/2, James Waldron, Fierce Biotech) ..."We are deeply grateful to the patients, families, investigators and study teams who contributed their time and commitment to this research," [Eric] Hughes added. "Our hope is that the science and learnings can deepen our understanding of MSA and help us determine a path forward for emrusolmin."... Full

 

Teva Halts Phase II Emrusolmin Trial in Multiple System Atrophy After Interim Futility Analysis

(11/2, The Pharma Letter) ...The company will work with the study investigators to ensure the protocols are followed while the trial is discontinued, and said the decision concerns TOPAS-MSA only and does not represent a final decision on the broader emrusolmin program... Sub. Req'd

 

Teva Suffers Innovative Medicines Setback with Study Halt for Emrusolmin

(11/2, Matthew Dennis, FirstWord PHARMA) ...Historically a generics powerhouse, Teva has been expanding its innovative medicines portfolio in an effort to fuel its "Pivot to Growth" strategy. Recently, the company acquired BioXcel's neuroscience portfolio, while earlier in the year it purchased Emalex Biosciences... Full

 

Teva To Discontinue TOPAS-MSA Study In Adults With Multiple System Atrophy

(11/2, RTT News) ...Teva said the decision concerns TOPAS-MSA and does not represent a final decision on the broader emrusolmin program... Full

 

Teva Shares Slide After Drug Trial Discontinuation

(11/2, Luke Juricic, Investing.com) ...The company plans to conduct a comprehensive analysis of the TOPAS-MSA data and available data from the open-label extension study of emrusolmin in MSA... Full

 

Teva to Halt Phase II MSA Therapy Trial after Futility Analysis

(11/3, Srivani Venna, Clinical Trials Arena) ...Teva noted this was a predictive assessment rather than a final efficacy analysis. No safety concerns arose from the interim review... Full

 

Teva Drops Emrusolmin in Multiple System Atrophy Trial after Interim Futility Analysis

(11/2, Robert McTiernan, AllSci) ...TOPAS-MSA (NCT06568237) was a randomized, double-blind, placebo-controlled study designed to enroll approximately 350 participants receiving emrusolmin 300 mg or placebo for approximately 48 weeks, followed by a four-week follow-up period... Full

 

Teva's Pipeline in 2027: Can it Sustain its Transformation?

(11/3, Jules Adam, Labiotech) ...Teva has already demonstrated that its innovative medicines can drive revenue growth. The next question is whether it can build a sufficiently broad portfolio to make that growth less dependent on Austedo... Full

 

 

Bayer CEO Says Company Is 'Working On' MFN in the US

(11/3, Ayisha Sharma, Endpoints News) ...Bayer CEO Bill Anderson said the drugmaker is "working on" a most favored nation agreement, signaling that it is in talks with President Donald Trump's administration. The German drugmaker was not part of previous rounds of drug pricing agreements in the US. Tuesday's comment appears to be the first time that Bayer spelled out that it is in MFN talks, as most of its large pharma peers have already secured drug pricing agreements... Sub. Req'd

 

States Can't Confirm the Drug Price Savings Trump Keeps Touting

(11/2, Paige Huffman, The Washington Sun) ...As details roll out, state health agencies told The Washington Sun they still lack information on how much they can actually cut down on drug spending, and drug pricing analysts say the administration's savings projections for these models are misleading... Full

 

States Take Center Stage in the Drug Pricing Fight

(11/2, Michael Christel, Scott LaGanga, Pharmaceutical Executive) ...In this episode of the Pharmaceutical Executive podcast, Scott LaGanga, executive vice president of state advocacy at the Parmaceutical Research and Manufacturers of America (PhRMA), shares why he believes state lawmakers are now at the leading edge of health policy advancement, moving faster than federal pursuits in such areas as pharmacy benefit manager (PBM) reform, 340B pricing transparency, and patient affordability... Full

 

If Trump Gets Europe to Pay More for Drugs, More New Medicines Could Follow — Eventually

(11/2, Brian Buntz, Drug Discovery & Development) ..."We went way down and they went a little bit up," he said of U.S. and foreign prices. He also described the pressure behind the negotiations: "If they didn't agree, we were going to use tariffs to make sure they did it." Those were Trump's claims about the agreements. The research question is how much they change drugmakers' expected worldwide revenue, and what that change buys in additional medicines... Full

 

Generic Drug Industry Pushes For Earlier FDA Calls On 180-Day Forfeiture

(11/2, Maaisha Osman, Pink Sheet) ...Teva Pharmaceuticals VP and Chief Regulatory Counsel Brian McCormick said the FDA historically has made forfeiture decisions only when a subsequent applicant requests final approval because that is when the agency needs the answer. However, that timepoint can be years after the ANDA first-filer began paying for litigation, manufacturing and launch preparation. McCormick called the FDA's current approach "myopic," saying the first-filer is making "million-dollar investment decisions year after year after year" based on whether it holds exclusivity... Global Sub. Full

 

PhRMA to USTR: Use Trade Policy to Defend American Innovation

(11/2, Brian Picone, PhRMA Blog) ...Across the globe, high-income countries impose harmful government price controls that undervalue innovative medicines developed and produced in the United States. These policies allow other countries to benefit from U.S.-led research and development without paying their fair share for the resulting innovations – leaving America to shoulder a disproportionate share of the cost... Full

 

PhRMA Plays Both Sides of the Aisle in Midterm Election Spending

(11/3, Victoria Knight, Bloomberg Government) ...Pharmaceutical Research and Manufacturers of America spent at least $130,000 on congressional Republicans and their leadership political action committees in the first three quarters of 2026 this far, per the latest Federal Election Commission data. Congressional Democrats and their leadership PACs, meanwhile, received at least $107,500... Sub. Req'd

 

U.S. District Court: CMS Wrongly Sought Negotiation Of AbbVie's Botox

(11/2, Lauren Brensel, Inside Health Policy) ...In his 21-page ruling, U.S. District Judge Carl John Nichols agreed with AbbVie that Botox qualifies for the plasma product exemption because one of the three components in the product, human serum albumin (HSA), is a protein obtained from human blood plasma. Nichols refuted the government's assertion that HSA isn't the active ingredient in Botox, meaning it doesn't qualify for the exemption, suggesting Congress should've been more specific in drafting the statute....Nichols repeatedly referenced a recent ruling from a Teva Pharmaceuticals' lawsuit to refute CMS' argument that a judicial review is unconstitutional... Sub. Req'd

 

After Hikma: A Transatlantic View Of Skinny Labels And Pharma Strategy

(11/3, Carla J. Baumel, Ellen K. Levish, Kai Rüting, and Sarah Taylor, Life Science Leader) ...Generics preparing for launch should assess not only the label, but also prescribing and dispensing practices, market conditions, reimbursement arrangements and any other practical measures available to discourage use for the patented indication. Brand companies, conversely, should seek evidence of positive encouragement of substantial patented-indication use, and conduct that makes such use attributable to the generic supplier... Full

 

GRx+Biosims 2026 – Some Tidbits from Day 1 of the Conference

(11/2, Bob Pollock, The Lachman Blog) ...We heard from John Brooks, JD, the Deputy Administrator and Director Medicare, from CMS, who participated in a fireside chat and discussed the how the CMS' role interplayed with the goal to get generics and biosimilars better positioned in drug product selection for Federal programs... Full

 

Trust But Verify, Verify, Verify

(11/3, AAM Blog) ...[W]hile increased AI capabilities present the promise of efficiency in analyzing and synthesizing data, that efficiency can't come at the expense of rigor, quality, and patient safety. That was the backdrop for Monday's well-attended learning track on AI and automation moderated by Biocon Biologics' Craig Kiester on the first day of GRx+Biosims 2026. Three FDA offices and two industry leaders delivered the same message: AI can do the reading and analysis, but people make the decisions and humans remain accountable... Full

 

 

FDA Grants uniQure's Huntington's Gene Therapy Priority Review, Teeing Up 'Defining Milestone'

(11/3, Maria Russo, Fierce Biotech) ...Despite a tumultuous recent run with the FDA, uniQure believes that an approval by May 1, 2027, would be a "defining milestone." In accepting the filing, the FDA stated that they tentatively plan to discuss it at an advisory committee meeting, uniQure said in its Nov. 2 release... Full

 

AbbVie's $757M Migraine Deal with Chinese Company Comes to Light

(11/2, Anna Bratulic, FirstWord PHARMA) ...In what appears to be the first public disclosure about the deal, Brise said it has "already achieved several near-term milestones," but didn't specify what they were nor any payments tied to them. The targets, mechanisms of action or development timelines weren't disclosed either... Full

 

Institute for Clinical and Economic Review Publishes Final Evidence Report on Treatment for Parkinson's Disease

(11/3, ICER) ...Currently available evidence indicates that tavapadon provides some relief from key symptoms. Benefits from tavapadon appear to be similar to those of older, generic drugs, however, and discontinuation from tavapadon due to adverse events was relatively high... Full

 

Lower Dose of Tiziana's MS Drug Reduces Neuroinflammation, While Higher Dose Struggles

(11/2, James Waldron, Fierce Biotech) ...The London- and Boston-based biotech evaluated the anti-CD3 monoclonal antibody, called foralumab, in the mid-stage Inform-MS trial of 48 patients with non-active secondary progressive MS. Participants received either 50 µg or 100 µg doses of intranasal foralumab or placebo over 12 weeks... Full

 

 

PanGen Seeks European Partners for EPO Biosimilar, CDMO Business

(11/3, Kim Ji-hye, Korea Biomedical Review) ...PanGen Biotech, a subsidiary of Huons Group, plans to seek European partners for its erythropoietin (EPO) biosimilar and contract development and manufacturing organization (CDMO) business at BIO-Europe 2026 in Cologne, Germany, from Nov. 9 to 11. The company said Tuesday it aims to expand beyond emerging markets, where it has gained experience in regulatory approvals and sales, into Europe... Full

 

US Approves Cheap Generic of Breakthrough HIV Shot for Poorer Countries

(11/2, Issam Ahmed, AFP) ...The tentative approval was announced by Dr. Reddy's Laboratories, the Indian maker of the generic version of lenacapavir, and by Unitaid, a global health initiative. The generic will be available for $40 per person per year in 120 countries, under a pricing agreement announced in September 2025 between Unitaid, the African health research institute Wits RHI, and the Clinton Health Access Initiative (CHAI) and Dr. Reddy's... Full

 

Lupin Receives US FDA Approval for Amifampridine Tablets

(11/3, Pharmabiz.com) ...Amifampridine tablets, 10 mg, bioequivalent to the reference listed drug (RLD), Firdapse tablets, 10 mg, of Catalyst Pharmaceuticals, Inc., for the indication in the approved labelling. Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity... Full

 

Japan's Shionogi Transfers Generic Drug Business to Zhejiang Gaozhi Pharma in China

(11/3, Biospectrum Asia) ...Shionogi has announced that Shionogi China, a Shionogi group company in China, has entered into a share transfer agreement with Zhejiang Gaozhi Pharmaceutical Technology Co., regarding the transfer of shares in Shenzhen Liancheng Pharmaceutical Co. and Nanjing Chang'ao Pharmaceutical Co., which operate Shionogi's generic drug business in China... Full

 

 

Pfizer Raises 2026 Forecasts on Strong Demand for Eliquis, Cancer Drugs

(11/2, Christy Santhosh and Mariam Sunny, Reuters) ...The U.S. drugmaker expects annual sales of $62 billion to $64.0 billion, up from the prior forecast of $60.5 billion to $62.5 billion. On an adjusted basis, the company expects an earnings per share of $2.95 to $3.05 this year, compared with previous forecast of $2.80 to $3.00 per share... Full

 

Amneal Pharmaceuticals (AMRX) Tops Q3 EPS by 3c; Offers Guidance

(11/3, StreetInsider.com) ...Amneal Pharmaceuticals reported Q3 EPS of $0.26, $0.03 better than the analyst estimate of $0.23. Revenue for the quarter came in at $862.68 million versus the consensus estimate of $812.11 million... Sub. Req'd

 

Sun Expects Organon Acquisition Closure In Q4, India Gains Offset Lenalidomide Slide In Q2

(11/2, Vibha Ravi, Generics Bulletin) ...Sun Pharma saw its Q2FY27 US formulation sales decline with falling lenalidomide sales, but the Organon acquisition closure in the fourth quarter, new product launches and continued India business growth are expected to lend support in the second half... Global Sub. Full

 

Neurocrine Biosciences Reports Third-Quarter 2026 Financial Results

(11/2, Neurocrine Biosciences) ...'This continued growth reinforces the strength of our strategy and expands our capacity to invest in innovation, advance our pipeline and build an enduring biopharmaceutical company. Looking ahead to 2027, we see meaningful opportunities for continued growth across INGREZZA, CRENESSITY (crinecerfont) and VYKAT (diazoxide choline) XR, alongside multiple important clinical milestones, including Phase 3 readouts for osavampator in major depressive disorder and direclidine in schizophrenia.'... Full

 

Lonza to Buy Five US Sites from Merck KgaA

(11/3, Danny Callaghan, Reuters) ...The deal will bring the number of Lonza's US sites to nine, and expand its cell and gene therapy capabilities, while Germany's Merck continues its shift towards a concentrated life science portfolio. The deal is valued in a range of low- to mid-triple-digit million Swiss francs, the companies said, and is expected to close in the middle of next year... Full

 

 

Switzerland Faces Pressure From US Drug Pricing Policy

(11/3, Nora Meuli, Swissinfo.ch) ...Pharma firms are responding by pushing other countries to accept higher prices. A new study by researchers at the federal technology institute ETH Zurich and the University of Zurich concludes that if Switzerland and other countries give in to this pressure, Swiss households could face additional annual costs amounting to hundreds of millions of francs... Full

 

Global eCTD v4.0 Rollout Advances With New Swiss, US Moves

(11/2, Neena Brizmohun, Pink Sheet) ...Switzerland plans to start making it voluntary to use eCTD v4.0 in 2027, and mandatory in 2030, according to the country's drug regulator, Swissmedic, and data from the ICH... Global Sub. Full

 

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