Thursday, April 30, 2026

 

 

With Austedo at Helm, Teva's Impressive Innovative Drug Sales Signal Company's Successful Metamorphosis

(4/29, Fraiser Kansteiner, Fierce Pharma) ...[T]he company still topped Wall Street estimates in 2026's first quarter, buoyed by the impressive performance of branded drugs like Austedo, Uzedy and Ajovy. Meanwhile, with some seven additional potential readouts or regulatory decisions stemming from its innovative pipeline this year, it's not just about beating those industry watcher estimates, "but how we beat," Francis said in an interview with Fierce... Full

 

Teva Pharmaceuticals CEO on Acquiring Emalex Biosciences, Drug Portfolio

(4/29, CNBC) ...Teva Pharmaceuticals CEO Richard Francis joins 'Money Movers' to discuss the company's latest acquisition of Emalex Biosciences, their latest drug offerings, and more... Full

 

Teva Leans on Branded Drugs for Profit Beat as Generics Face Pressure

(4/29, Reuters) ...J.P.Morgan analyst Chris Schott said investor focus was increasingly shifting to Teva's branded portfolio, with core assets led by Austedo "growing nicely" and a series of pipeline updates expected later this year... Full

 

The Deal That Signals Teva Is Back

(4/30, Sophia Schulman, CTech) ...Eli Kalif, Teva's chief financial officer, said the company has not yet had the final word on acquisitions and may pursue one or two additional deals worth hundreds of millions of dollars in the near future. He also noted that the board has instructed management to explore a share buyback program, years after the company halted dividend payments. The scope of the program has not yet been determined... Full

 

Teva Surges As Its New Growth Strategy Hits A Key Inflection Point

(4/29, Allison Gatlin, Investor's Business Daily) ...Teva, which has a suite of treatments for movements and psychiatric conditions, is the "right owner" for a drug like this, Chief Executive Richard Francis told Investor's Business Daily. "When you put that in the hands of Teva, because of our neuroscience capability, our capability to (commercialize) products into the movement disorder space, into the neuropsych space, we've built up a great reputation the last three-and-a-half years," he said... Sub. Req'd

 

Teva Rises After Sales Top Estimates on Shift to Branded Drugs

(4/29, Jessica Nix, Bloomberg) ..."We've been in this area, we understand it," Teva Chief Executive Officer Richard Francis said in an interview. "It ticked all the boxes that we had for doing any type of deal." Teva plans apply for the treatment's approval with the Food and Drug Administration in the second half of the year, Francis said... Full

 

Investors Welcome Teva's First M&A Move in a Decade

(4/29, Elizabeth S. Eaton, FirstWord PHARMA) ..."This is a prime example of our Pivot to Growth strategy in action, advancing focused, capital-efficient agreements that expand our late-stage innovative pipeline and commercial portfolio," said Teva CEO Richard Francis. "With our deep neuroscience expertise, we are well-positioned to advance this first-in-class investigational compound."... Full

 

Teva 1Q Net Up, Backs 2026 Revenue View, to Buy Tourette Drug Maker

(4/29, Rob Curran, Dow Jones) ...The company expects the deal, which is subject to customary closing conditions, to close by the third quarter. Emalex expects to file for Food and Drug Administration approval of the Tourette treatment in the second half of the year... Sub. Req'd

 

Teva Inks $700M Emalex Buyout to Bag Near-Approval Tourette Drug

(4/29, Nick Paul Taylor, Fierce Biotech) ...On an earnings call Wednesday, CEO Richard Francis said Teva's sales, marketing, market access and patient services capabilities can drive uptake of the molecule. Francis cited Teva's handling of Austedo and Uzedy, neuroscience treatments that grew 41% and 62%, respectively, in the first quarter, as evidence that the company can expand the Tourette market once it launches ecopipam. The company will hire a small pediatric sales force for ecopipam, Francis said, but will also leverage its existing expertise in movement disorders and psychiatric conditions... Full

 

Mum's The Word On Teva's Tyvaso Strategy

(4/30, Dean Rudge, Generics Bulletin) ..."I think a license would give you sole source as a generic for [a] pretty extended period of time," he said, asking whether the delay reflected regulatory hurdles or a deliberate strategic choice. "Is it simply difficult to get a generic approval?" In response, Teva's CEO, Richard Francis, declined to elaborate, stating: "With regards to the generic pipeline, we don't talk about it for competitive reasons as well as legal and others."... Global Sub. Full

 

 

AstraZeneca CEO's Conservative MFN Model Excludes Reference Markets From Forecast

(4/29, Angus Liu, Fierce Pharma) ...As AstraZeneca braces for the impact of the U.S. "most favored nation" drug pricing policy, CEO Pascal Soriot suggests that a "very conservative" way to model the fallout would be removing the eight reference markets from future product forecasts. Soriot provided that method during AZ's first-quarter earnings call, stressing that it's only a "very conservative" approach that the British drugmaker doesn't think will actually materialize... Full

 

Oz Signals Codifying MFN Part Of Reconciliation Talks, Lawmakers Weigh Policy Concerns

(4/29, Sigi Ris, Gabrielle Wanneh, Inside Health Policy) ...CMS Administrator Mehmet Oz signaled Tuesday (April 28) that codifying most-favored nation drug pricing is part of the Trump administration's ongoing discussions with Congress on what to include in a GOP reconciliation bill. A key industry lobbyist also predicted the policy could emerge in reconciliation, citing new interest from House Budget Chair Jodey Arrington (R-TX) and other key Republicans, but said the details need to be worked out... Sub. Req'd

 

CMS Extends Application Deadlines for Medicaid Drug Pricing Model

(4/29, Sahil Pandey, Reuters) ...Drug makers will have until June 11 to apply for CMS' Medicaid model aimed at lowering Medicaid prescription drug prices, the Trump administration announced Wednesday (April 29), extending the application for a second time with the expressed goal of helping small- and medium-size drug makers. More time will give these drug makers more time to review participation information and prepare their application, CMS says... Full

 

A 2022 Law May Be Quietly Helping People Stay on Their Meds

(4/29, Joshua Cohen, Undark) ...In an email to Undark, one of the authors, Benjamin Rome, an assistant professor of medicine at Harvard Medical School, noted that he and his colleagues will soon publish a paper "demonstrating a massive increase in the use of brand-name drugs in Medicare" following imposition of the out-of-pocket maximum in 2024, on "the order of 20-30% higher" when compared to privately insured adults... Full

 

Oral Arguments Show SCOTUS May Return Key Skinny Labeling Case To Lower Courts

(4/29, Gabrielle Wanneh, Inside Health Policy) ...At oral arguments held Wednesday (April 29), Supreme Court justices appeared interested in providing an opinion on the merits of the case, but the suit was originally decided on a motion to dismiss by a Delaware district court back in 2022. Even though the Federal Circuit Court of Appeals reversed this dismissal in 2024, Wednesday's arguments indicated SCOTUS may consider sending the case back to the lower courts to decide on whether key aspects of Amarin's allegations against generic drug company Hikma hold up... Sub. Req'd

 

Why a Supreme Court Case on 'Skinny Labeling' Matters for Drug Costs

(4/29, Cecelia Smith-Schoenwalder, U.S. News & World Report) ...A ruling in favor of Amarin could increase the legal risk that comes with skinny labeling, potentially chilling the market and resulting in fewer generic drugs coming to consumers. Fewer generic drugs coming to market would mean higher prices for patients... Full

 

PBM Regulation May Bolster Big Three Market Position Versus Smaller Competitors

(4/29, Cathy Kelly, Pink Sheet) ...Regulations implementing the legislative reforms in the Consolidated Appropriations Act in January and from the Federal Trade Commission's settlement with Express Scripts in February could disadvantage smaller PBMs relative to the three market leaders, they said during a recent Drug Channels webinar... Global Sub. Full

 

Experts Push FDA To Revisit Evidence Standards To Spur Rx-OTC Switches

(4/29, James Jarvis, Inside Health Policy) ...At a Duke-Margolis Institute for Health Policy meeting convened under a cooperative agreement with FDA, researchers, industry representatives and former agency advisers said while the agency's new Additional Conditions for Nonprescription Use (ACNU) rule -- which took effect in 2025 and allows some drugs to be sold over the counter with additional safeguards such as a questionnaire or digital screening tool -- could help broaden access to a wider range of prescription drugs for consumers, its success may depend on whether FDA also modernizes how it evaluates consumer behavior, real-world use and the public health benefits of faster access... Sub. Req'd

 

US FDA's Makary Expects To Name Permanent CBER Director Within Weeks As Prasad Departs

(4/29, Pink Sheet) ...US Food and Drug Administration Commissioner Martin Makary expects to name a permanent director for the Center for Biologics Evaluation and Research in the coming weeks, as current Director Vinay Prasad will depart April 30. During an April 28 press conference on the real-time clinical trials pilot program, Makary said the search has attracted "terrific candidates," but no final decision has been made... Global Sub. Full

 

 

Pfizer Looks to Jump Start Elrexfio with Topline Win in Second-Line Myeloma

(4/29, Eric Sagonowsky, Fierce Pharma) ...In the phase 3 MagnetisMM-5 study, Elrexfio as a monotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus standard-of-care daratumumab, pomalidomide and dexamethasone (DPd), Pfizer said in a Wednesday press release. The open-label trial enrolled 497 patients with RRMM who had received at least one prior line of treatment, including lenalidomide and a proteasome inhibitor (PI)... Full

 

GSK's Blenrep Launch Brings BCMA-Targeted ADC Option to Relapsed Multiple Myeloma Patients in Korea

(4/29, Lee Han-so, Korea Biomedical Review) ...At a press conference held in Seoul on Wednesday, Professor Kim Jin-seok of the Division of Hematology at Severance Hospital said the entry of Blenrep was meaningful because many patients with multiple myeloma eventually relapse despite advances in first-line therapy... Full

 

Updated: AstraZeneca Cuts a Couple of Late-Stage Life-Cycle Trials After Disappointing Efficacy

(4/30, Elizabeth Cairns, Endpoints News) ...A Phase 3 trial of Breztri in the lung disease COPD met its primary endpoint by showing improved inhaling capacity during exercise versus placebo. But AstraZeneca disclosed that the trial missed statistical significance on its second primary objective, which assessed the drug versus dual therapy with an inhaled steroid and a long-acting beta-2 agonist on measures of hyperinflation... Sub. Req'd

 

 

A Tale Of Two Segments: Sandoz Biosimilars Sales Soar As Generics Dip

(4/29, Dave Wallace, Generics Bulletin) ...The differing trajectories of the generics and biosimilars businesses were brought into sharper focus late in the quarter when Sandoz announced in March that it would be focusing its biosimilar development, manufacturing and supply activities under a new dedicated business led by Armin Metzger... Global Sub. Full

 

AXS26: Biosimilars Could Slash Specialty Drug Spend 20% by 2029

(4/29, Gina Shaw, Specialty Pharmacy Continuum) ..."When has there ever been such an opportunity in the pharmacy benefits space to basically change the way the cost curve works?" Dr. Patel said. But getting there will require cooperation and innovation across the entire healthcare ecosystem, he stressed, from manufacturers and formulary designers to specialty pharmacies and patients... Full

 

Pfizer Reaches Settlement Agreements with Dexcel Pharma, Hikma Pharma & Cipla for Infringement of Patents Relating to Vyndamax

(4/30, Pharmabiz.com) ...Pfizer had previously anticipated a significant decline in US revenues for Vyndamax beginning in 2029 upon patent expiry. As a result of this settlement, revenues are now expected to remain relatively stable from 2028 through mid-2031... Full

 

 

Regeneron Beats Quarterly Results Estimates on Strong Dupixent Demand

(4/29, Puyaan Singh, Kunal Das, Reuters) ...Quarterly sales for Dupixent - the highest prescribed biologic by dermatologists and pulmonologists in the U.S. - recorded by Sanofi rose 33% to $4.88 billion, above analysts' estimates of $4.59 billion, according to LSEG data... Full

 

AstraZeneca Plans U.K. Investment as Cancer Drugs Lift Revenue

(4/30, Adrià Calatayud, The Wall Street Journal) ...AstraZeneca outlined plans to invest 300 million pounds ($405.5 million) in the U.K., after the drugmaker reported higher first-quarter earnings mainly thanks to growing sales of its cancer medicines... Sub. Req'd

 

Which Blockbuster is GSK Gunning for Next? CEO Miels Is Looking to Oncology

(4/30, James Waldron, Fierce Biotech) ...When it comes to GSK's new dealmaking strategy of trying to outdo established blockbusters, CEO Luke Miels has told Fierce that oncology may offer the most tempting targets...On this morning's first-quarter earnings call, Miels made clear that this strategy remains in place. But when pushed by Fierce on exactly what other blockbusters GSK now has in its sights, the CEO remained tight-lipped. "I'd love to be more granular, but unfortunately I can't," he told Fierce on a press call April 29... Full

 

GSK CEO Says Team Reorg Could Be in the Cards Pending Upcoming Phase 3 Readouts

(4/30, Ayisha Sharma, Endpoints News) ...GSK is expecting several key late-stage readouts this year and, if they do not succeed, the company could change its team structure, CEO Luke Miels said during its first-quarter earnings call with the media Wednesday... Sub. Req'd

 

Astellas's R&D Head Talks Strategy Ahead of Looming Patent Cliff

(4/29, Rowan Walrath, C&EN) ...Chief R&D officer Tadaaki Taniguchi tells C&EN that Astellas has concentrated its drug development engine in four focus areas: oncology, targeted protein degradation, genetic regulation, and blindness and regeneration. "This is our strength, from basic research to clinical research or even commercialization phase," Taniguchi says. "So this is a perfect fit for us to bring up more product to differentiate any other company that's working on this space."... Full

 

Biocon Shares Decline After USFDA Issues Form 483 with Five Observations for Bengaluru Unit

(4/30, Shloka Badkar, CNBC TV18) ...Biocon said the observations are procedural and do not pertain to data integrity or quality oversight. No repeat observations were noted, the exchange filing stated... Full

 

 

Iran War Squeezes India's Pharma Supply Chain

(4/29, Murali Krishnan, DW) ...At the heart of the strain on India's healthcare manufacturing sector is its reliance on imported active pharmaceutical ingredients (APIs), the core components of drugs, 60%-70% of which are sourced from China...For now, some drug prices have gone up, but only modestly. The larger increases are still seen in inputs and raw materials, which have not fully been passed on to consumers yet... Full

 

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