Thursday, May 29, 2025

Teva Reaffirms 'Pivot to Growth' Strategy with Launch of Acceleration Phase

(5/29, The Fly) ...The event, led by President and CEO Richard Francis and members of Teva's executive management team, will outline the company's strategy, progress and roadmap to deliver sustained shareholder value through 2030 and beyond...Teva has completed Phase 1 of the Strategy: Return to Growth, delivering: 9 consecutive quarters of growth - fueled by strong momentum from key innovative growth drivers. More than $2.3B in revenue in 2024 from Teva's innovative portfolio: AUSTEDO, AJOVY, and UZEDY. Returning the generics business to growth with +5% in revenues across regions, and top 3 global portfolio with potential for five product launches by 2027... Full

Teva Reaffirms 2027 Financial Targets

(5/29, RTT News) ...Teva Pharmaceutical Industries Ltd. reaffirmed 2027 financial targets, including 30% operating profit margin, driven by growth and transformation programs...Richard Francis, Teva's President and CEO, said: "Now, we are accelerating our growth into a leading biopharma company with a strong innovative medicines franchise and a powerhouse generics and biosimilars portfolio."... Full

Teva Wins New Buy at Truist Ahead of Innovation & Strategy Day

(5/28, Seeking Alpha) ...Analyst Les Sulewski issued a $25 per share target on the Israeli firm, urging investors to "accumulate" its stock, which she said is trading 25% lower than its recent peak. "Teva's dual focus on cultivating its high-margin brands while strengthening generics continues to de-risk topline and margin profile," Bloomberg reported, quoting Sulewski. "We look forward to hearing the next chapter for growth outlined in the company's upcoming Innovation and Strategy Day on May 29, when we anticipate management to introduce an updated 5-year outlook, both figurative and thematic."... Full

Big Pharma Likely to Endure Trump's Tariff, Pricing Pressures, But Threats to Generics Persist: S&P

(5/28, Fraiser Kansteiner, Fierce Pharma) ..."Since price points of generic drugs are much lower, margins thinner, and competition fiercer than that of branded drugs, some generic companies, especially those reliant on China, may find certain drugs unprofitable," the analysts warned. While this would weigh heavily on standard generic pharma companies, it could present an opportunity for bigger copycat drugmakers, such as Teva and Amneal, to scoop up some of the competition from those without U.S. production capacity, the S&P team added... Full

FDA Fast-Tracks Teva's Coeliac Disease Treatment

(5/28, Phil Taylor, Pharmaphorum) ...The only available treatment for a patient with coeliac disease is a strict gluten-free diet, which is often not enough on its own to curb symptoms. Now, the FDA has said it will carry out a speedy review of a Teva medicine that it hopes can change that. The US regulator has awarded fast-track status for TEV-53408, an anti-IL-15 antibody currently in a phase 2a trial as an add-on to a restricted diet for the disorder, which could lead to a more rapid review and allow it to be brought to market sooner... Full

Anti-Interleukin-15 Antibody Fast Tracked for Celiac Disease

(5/28, Diana Ernst, Rph, MPR) ..."The FDA's decision to grant Fast Track designation for TEV-53408, an investigational anti-IL-15 antibody therapy, reflects the promising nature of the treatment and the urgent unmet need of people living with celiac disease," said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva... Full

After Dasatinib Apotex Debuts US Tasigna Competition

(5/28, Dave Wallace, Generics Bulletin) ...Italy's Abiogen Pharma has struck a deal with Spanish biosimilars developer mAbxience for rights to an undisclosed biosimilar in Italy. While mAbxience will hold the marketing authorization for the product, Abiogen will manage commercialization and marketing activities. The firms said the partnership will benefit from Abiogen's "strong presence and commercial capabilities in the Italian market."... Global Sub. Full

Krka Looks To Kick On In India And China

(5/28, Dean Rudge, Generics Bulletin) ...Krka has highlighted the progress of its joint venture in India with Laurus Labs. The company is set to build a new production facility after acquiring land. In China, Krka is also working to enhance its market footprint through its joint enterprise with Ningbo Menovo Pharmaceutical. Overall, Krka's sales climbed 8% to €521.3m in Q1, with significant contributions from prescription pharmaceuticals especially in Eastern Europe... Global Sub. Full

Abiogen And mAbxience Join Forces In Italy

(5/28, Dave Wallace, Generics Bulletin) ...Italy's Abiogen Pharma has struck a deal with Spanish biosimilars developer mAbxience for rights to an undisclosed biosimilar in Italy. While mAbxience will hold the marketing authorization for the product, Abiogen will manage commercialization and marketing activities. The firms said the partnership will benefit from Abiogen's "strong presence and commercial capabilities in the Italian market."... Global Sub. Full

Avera Joins Civica to Help Minimize Risk of Drug Shortages

(5/28, Civica) ...Civica, a nonprofit pharmaceutical company created to prevent and mitigate drug shortages, announced today that Avera, a leading nonprofit healthcare provider in the Upper Midwest United States, has joined the company in helping protect patients from the impact of drug shortages of essential generic sterile injectable medicines... Full

How Ozempic's Maker Lost Its Grip on the Obesity Market It Created

(5/28, Peter Loftus and Noemie Bisserbe, The Wall Street Journal) ...A Novo Nordisk spokeswoman said the company remains the global-volume market leader in GLP-1 drugs, serving nearly two-thirds of patients taking them for diabetes and obesity. Some investors and industry watchers say Novo Nordisk's troubles stem from a cautious, reactive approach starting when the market first burst onto the scene, in contrast with a faster, more aggressive tack in production and marketing by Lilly... Sub. Req’d

Here's How Much GLP-1 Prescriptions for Obesity and Weight Management Have Grown Since 2019

(5/28, Paige Minemyer, Fierce Healthcare) ...The number of people prescribed GLP-1 drugs for weight management has skyrocketed over the past five years, according to new data from FAIR Health. The report found that just over 2% of adults in the U.S. took a GLP-1 to treat obesity or overweight in 2024, up from just 0.3% in 2019. This is a relative increase of 586.7%, according to the analysts... Full

Cancer Drugs Cost More Than Ever. They Often Don't Extend Lives

(5/28, Robert Langreth, Tanaz Meghjani and Rachael Dottle, Bloomberg) ...Some drugs are game-changers, especially new immune therapies that teach the body itself how to destroy cancer cells. But the downside of approving so many drugs with so few hurdles is now clear: Many don't prolong life at all, or do so only modestly, with problematic side effects. Indeed, fewer than half of the cancer drugs approved since 2000 that Bloomberg News reviewed based on their FDA labels have ever been shown to extend patient survival for any of their approved uses. Even fewer have been shown to improve cancer-related symptoms or quality of life. In the past decade alone, drugmakers have made more than $50 billion on cancer drugs that so far have demonstrated no survival benefit, Bloomberg's analysis shows... Full

Trump's ‘Liberation Day' Tariffs Halted by Court of International Trade

(5/28, David J. Lynch, Cat Zakrzewski, The Washington Post) ...A specialized federal court in New York on Wednesday ruled that most of President Donald Trump's tariffs — including those on Chinese goods — are illegal, upending negotiations with more than a dozen nations and creating fresh uncertainty for countless American businesses that depend upon foreign suppliers...Wednesday's ruling also applies to other tariffs that the president imposed on Mexico and Canada, citing an emergency over illegal migration and drug trafficking, and China for its alleged role in facilitating production of the opioid fentanyl... Sub. Req’d

Novo Nordisk ‘Strongly' Urges Against Pharma Tariffs as Comments Flood In

(5/28, Anna Brown, Endpoints News) ...Novo Nordisk warned the US government not to impose pharma-specific tariffs, but instead to tax illegal importers of semaglutide, as comments for the Department of Commerce's investigation into the sector start to roll in. Novo highlighted in its comment, made public on Wednesday, that all of its semaglutide, the API used to make its blockbuster GLP-1 drugs, is imported from Denmark...AbbVie, Amgen, Viatris and Pfizer are also among those with publicly available comments, warning tariffs could lead to drug shortages and higher costs. Pfizer emphasized that "tariffs are exceedingly likely to be counterproductive."... Sub. Req’d

From Autos to Pharma, CEOs Navigate Tariff Impacts

(5/28, Kathryn Dill and Annie Gasparro, The Wall Street Journal) ...GSK CEO Emma Walmsley said it's preparing for potential new U.S. tariffs on its medicines, and that she thinks GSK can successfully navigate through these significant costs. "It will take some actions, but I think we have that in hand, and we'll just respond as the data comes through," she said... Sub. Req’d

Trump's Pro-Patient, Anti-Big Pharma Pricing Plan Can Benefit All

(5/29, Rep. Jesse Petrea, The Atlanta Journal-Constitution) ...More than 70% of generic drugs used in the U.S. are manufactured overseas. The result has been chronic shortages, national security vulnerabilities and economic risk. We must restore American control of our medical supply chain, create jobs, and ensure a stable, affordable supply of essential medications. All these efforts underscore a critical truth: The current monopoly system on pharmaceutical drugs has cost the United States dearly... Sub. Req’d

Cassidy Argues Allowing Drug Companies to Profit Helps Medical Industry Discover New Cures

(5/28, Elaine Mallon, The Washington Examiner) ...Bill Cassidy (R-LA) argued in an interview released Wednesday that drug companies must be allowed to make a profit to make innovations on medical treatments and cures...However, Cassidy, who supports lowering the costs of prescription drugs, said that drug companies must be profitable to seek innovative treatments... Full

Baldwin, Colleagues Introduce Legislation to Expand Medicare Drug Price Negotiation and Lower Costs for Americans

(5/28, U.S. Senator Tammy Baldwin) ..."No Wisconsinite should be forced to forgo the medication they need to stay healthy because of cost," said Senator Baldwin. "This bill will build on the progress we've made to give more Americans some breathing room - cracking down on greedy drug companies and helping ensure no Wisconsinite has to choose between affording their medication and putting food on the table."... Full

Immuno-Oncology Stars Keytruda, Opdivo Likely To Come Into IRA Crosshairs

(5/28, Annalee Armstrong, BioSpace) ...Immuno-oncology stalwarts Keytruda and Opdivo are likely to targeted in the Inflation Reduction Act's next round of price negotiations, as the program expands from focusing solely Medicare Part D to also include Part B drugs, according to a new report from Leerink Partners...The drugs with the most Medicare revenue exposure flagged by Leerink are Merck's Keytruda and Bristol Myers Squibb's Opdivo, as well as Gilead's HIV-antiretroviral Biktarvy. For the first two, the companies are gearing up to lose exclusivity in 2028 anyway, whereas Gilead still enjoys patent protection through 2033... Full

Former FDA Commissioner: ‘Cost-Cutting' May Undo One of Trump's Best Drug Pricing Achievements

(5/28, Scott Gotlieb, STAT) ...President Trump has long celebrated the groundbreaking innovations produced by American drugmakers...Among the most effective pro-market, pro-competition drug policies from President Trump's first term were initiatives to swiftly bring generic medicines to market once valid patents on their branded alternatives expired. These substantial accomplishments risk being severely undermined, if not completely reversed, should the targeted dismantling of this critical generic drug policy team be allowed to endure... Full

Telehealth Companies Use ‘Loophole' To Continue GLP-1 Sales

(5/28, Cara Smith, Inside Health Policy) ...An FDA expert told Inside Health Policy if the agency continues to allow mass compounding through a loophole meant to serve individual patients, telehealth companies are likely to use the same method to sell other drugs directly to patients -- dodging FDA oversight... Sub. Req’d

PBM Investigation, Enforcement Action ‘Critical Priorities' At FTC, Chair Says

(5/28, Cathy Kelly, Pink Sheet) ...The FTC's investigation of potential anticompetitive actions by pharmacy benefit managers and its administrative lawsuit against the top three PBMs are "critical priorities" for the commission, Chair Andrew Ferguson told a House subcommittee. A planned 10% staff reduction and President Trump's dismissal of the two Democratic panel members will not impact the commission's commitment to PBM initiatives, Ferguson said. Congress is moving ahead with relatively modest PBM reforms in the budget reconciliation process... Global Sub. Full

US FDA Meeting Drought Ends … With A Vengeance

(5/28, Michael McCaughan, Pink Sheet) ...The FDA held almost as many meetings the week before Memorial Day as in the months since President Trump's inauguration. An event on talc and the announcement of the new COVID-19 vaccine framework are examples of FDA Commissioner Martin Makary's nontraditional communications approach. Subsequent weeks likely will not be as busy, but the freeze on FDA meetings appears to have ended... Global Sub. Full

RFK Jr. Slams Medical Journals, Floats In-House Publishing Plan

(5/28, Jason Gale, Bloomberg Law) ...US Health and Human Services Secretary Robert F. Kennedy Jr. said he may bar government scientists from publishing in top medical journals, accusing publications like The New England Journal of Medicine of being "corrupt" and beholden to pharmaceutical companies. "We're probably going to stop publishing in the Lancet, New England Journal of Medicine, JAMA and those other journals because they're all corrupt," Kennedy said on "The Ultimate Human" podcast with wellness influencer and biohacker Gary Brecka...Scientists from the National Institutes of Health will be blocked from reporting their research in certain publications "unless these journals change dramatically," Kennedy said, adding that his department would instead create its own journals for each of its institutes that could "become the preeminent journals."... Sub. Req’d

Trump DOJ Urges High Court to Skip Oklahoma Drug Pricing Law

(5/28, Lauren Clason, Bloomberg Law) ...The US Supreme Court should deny review of Oklahoma's law targeting pharmacy benefit managers because the state's argument that a lower court's decision violated high court precedent is "unsound," the Trump administration said Tuesday. The case would test how far states can go in regulating pharmacy benefit managers—which handle prescription drugs for insurance plans—without violating the Employee Retirement Income Security Act... Sub. Req’d

R.I.'s Health Care System is in a State of ‘Spectacular Failure,' Attorney General Says

(5/28, Christopher Gavin, The Boston Globe) ...Rhode Island Attorney General Peter Neronha on Wednesday unveiled a large slate of actions developed by his office — from legislative proposals to a lawsuit targeting pharmacy benefit managers and a call for a new health policy agency — that he said are urgently needed to correct and stabilize the state's failing health care system... Sub. Req’d

NY Bill Would Force Drugmakers to Report Delays in Offering Generics

(5/28, Mark Richardson, Public News Service) ...Groups advocating for New York retirees are backing a State Legislature bill requiring drug manufacturers to notify officials of any "pay-for-delay" actions preventing a brand-name medication from becoming a lower-cost generic drug. Senate Bill 488 would require drug-makers to inform the state of any steps they take to maintain brand-name status after the patent on a drug is scheduled to expire. For many Medicare patients, the price difference between a brand-name drug and its generic equivalent is substantial... Full

Some Michigan Hospitals Marking Up Drug Prices by Up to 800%, Report Finds

(5/29, Kristen Jordan Shamus, Detroit Free Press) ...Some Michigan hospitals are marking up prescription drug prices by 800% above what they they pay manufacturers, according to a new report from the Michigan Health Purchasers Coalition. The MIHPC issued a report detailing its analysis of the prices for the same three drugs across 53 Michigan hospitals and found a broad range of pricing for Neulasta, Orencia and Humira... Full

Could EU Collective Procurement Counter US Most Favored Nation Policy?

(5/28, Francesca Bruce, Pink Sheet) ...Collaborative procurement, as set out under the EU's Critical Medicines Act, could prove a useful tool for EU member states responding to potential challenges posed by US policy changes, including the "most favored nations" strategy aimed at driving down US drug prices, the European Commission has told the Pink Sheet... Global Sub. Full

Swiss-Irish Pharma Duo Meeting to Discuss Tariff Tactics

(5/28, Brian Maguire, Euractiv) ...Swiss President Karin Keller-Sutter will visit Ireland this week for high-level talks, the first presidential visit since 2012. Keller-Sutter, who also serves as finance minister, is expected to discuss bilateral relations, European policy, and concerns within the pharmaceutical industry amid recent shifts in U.S. drug pricing. Euractiv spoke with Irish pharmaceutical industry consultant Lawrence Lynch about his expectations for the Swiss-Irish meet-up... Full

British Columbia's Biosimilar Policy Shows No Impact on Hospital Visits

(5/28, Skylar Jeremias, The Center For Biosimilars) ...Despite a dramatic shift toward biosimilar use following British Columbia's policy, researchers found no rise in hospital visits or complications, underscoring the real-world reliability of etanercept biosimilars in managing inflammatory arthritis... Full

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