Thursday, March 6, 2025

Trust, Tech, and Tomorrow: A Pharmaceutical Executive's WEF Insights

(3/5, Lori Ellis, BioSpace) ...In this discussion, Konstantina Katcheves, senior VP of innovative global business development at Teva Pharmaceuticals discusses her takeaways from her time at the World Economic Forum (WEF). She stresses the importance of data-driven healthcare and AI innovation in the pharmaceutical value chain, and the critical need to address global health equity, particularly women's health... Full

Teva Pharma (TEVA) PT Lowered to $20 at BofA Securities

(3/6, StreetInsider.com) ...[BofA Securities analyst Jason Gerberry] comments "We revise & lower our FY26-27E EBITDA by -4% and -1%, respectively, on read-through from competitor disclosure pertaining to Gx Revlimid profitability. In 2026, Teva is expected to face challenging comps as its g-Revlimid contribution won't recur (market converts to true generic) – an estimated $1bn in '25E sales at a 65% GM...Absent any surprises on Austedo IRA (price negotiation), we believe TEVA can reaccelerate bottom line growth in ‘27+ driven by three high value brands (olanzapine-LAI, ICS/SABA and TL1a) poised to launch with competitive profiles..."... Sub. Req’d

Court Approves $700M Prescription Opioid Class-Action Settlement for Acute Care Hospitals

(3/5, Dave Muoio, Fierce Healthcare) ...A federal court has signed off on a $700 million class action settlement that will see drug manufacturers and distributors pay more than 1,000 acute care hospitals over alleged misconduct regarding prescription opioids. The deal consolidates four class-action settlements involving, among other defendants, Cencora (formerly AmerisourceBergen), Cardinal Health, McKesson, Johnson & Johns, Teva and Allergan... Full

Federal Circuit Refuses to Rehear Case Involving Orange Book Listing of Device Patents

(3/5, Chad A. Landmon, Andrew M. Solomon , The National Law Review) ...On Monday, March 3, 2025, the Federal Circuit entered an Order denying Teva's rehearing request. Teva may still attempt to appeal the December 2024 Federal Circuit decision to the United States Supreme Court, but there is no guarantee that the Supreme Court will agree to hear the case. If left undisturbed by the Supreme Court or further legislative or regulatory actions, the Federal Circuit decision begins to provide some clarity regarding whether device patents can be listed in the Orange Book when they do not recite the active ingredient... Full

With Patent Losses On the Horizon, Amgen Refocuses its Business Strategy

(3/5, Alexandra Pecci, PharmaVoice) ...As it looks ahead, the company, like many across the industry, has refocused its long-term strategy to answer the question: What now? For Amgen, the answers lie in a wide range of goals, including acquisitions, developing new products in four therapeutic areas, boosting its biosimilar business and maximizing the impact of its portfolio. The roadmap ties to "ambitious growth aspirations over the next eight to 10 years," according to Ian Thompson, Amgen's senior vice president and general manager of U.S. business operations... Full

Bavarian Nordic CEO Says it Can Take Years to Move Pharma Manufacturing to the US

(3/5, Anna Brown, Endpoints News) ...While reshoring pharma production to the US is not impossible, government officials need to be aware that it could take five to 10 years to complete the process, Bavarian Nordic CEO Paul Chaplin warned...As a way to potentially ease the impact of tariffs, South Korean CDMO Celltrion said it is considering buying sites in the US, and Pfizer has reassured investors that it has an existing US network to which it could shift production if necessary. As for Bavarian, the Danish company has two sites in the US — one for commercial and another for R&D manufacturing — so it would be largely unaffected by Trump's tariffs, Chaplin said... Full

Novo Nordisk to Sell Wegovy for $499 a Month to Cash-Paying US Customers

(3/5, Patrick Wingrove, Manas Mishra, Reuters) ...Novo Nordisk said on Wednesday it would begin selling its weight-loss drug Wegovy at a discounted price of $499 per month to patients paying cash, as it grapples with shifts to the competitive dynamic of the U.S. obesity drug market... Full

US FDA Expands Use of ARS Pharma's Allergic Reaction Nasal Spray in 15-30 kg Patients

(3/5, Christy Santhosh, Reuters) ...The U.S. Food and Drug Administration approved the expanded use of ARS Pharmaceuticals' nasal spray for severe allergic reactions in patients who weigh between 15 and 30 kilograms, the company said on Wednesday...Deschner said the expanded approval will accelerate prescriptions for neffy going into August, as it is traditionally the big "back to school" peak for epinephrine sales. ARS said neffy 1 mg is expected to be available by the end of May in the U.S... Full

Biocon Biologics and Civica, Inc. Collaborate to Expand Insulin Aspart Access in the United States

(3/6, Biocon Biologics) ...Under the terms of the agreement, Biocon Biologics will supply Insulin Aspart drug substance to Civica, Inc., who will use the drug substance to produce Insulin Aspart drug product, a rapid-acting insulin analog, at its manufacturing facility in Petersburg, Virginia. Civica will commercialize the medicine for patients in the United States, after completion of development work and clinical trials... Full

Regeneron's Injunction On Eylea Biosimilar Holds Up On Appeal

(3/5, Michael Shapiro, Bloomberg Law) ...In the latest turn in the case—which also involves major drugmakers including Mylan Pharmaceuticals Inc., Amgen Inc., Biocon Biologics Inc., and Samsung Bioepis Co.—a three-judge panel on Wednesday rejected Celltrion's arguments that a West Virginia federla court lacked jurisdiction over it and that Regeneron wouldn't suffer irreparable harm connected to its product launch... Sub. Req’d

Granules Slammed in FDA Warning Letter Detailing Discarded Documents, Intruding Birds at Indian Plant

(3/5, Fraiser Kansteiner, Fierce Pharma) ...Shortly after making an M&A play to break into the CDMO business, Granules' manufacturing bona fides have come under fire in a newly published rebuke by the U.S. FDA. In a warning letter dated Feb. 26, the FDA upbraided Granules over a slate of production shortfalls at its production facility in Telangana, India, including subpar cleaning, building maintenance, equipment upkeep and more. The agency posted the letter to its website Tuesday... Full

Mark Cuban Cost Plus Drug Co. Clients See Promising Early Returns

(3/6, Lauren Berryman, Modern Healthcare) ...Purchasing through Cost Plus Drugs can yield noticeable savings for patients in high-deductible health plans, said Scott Musial, chief commercial officer at Rightway, a PBM that started using the company's online pharmacy in 2022. "The first $1,500, $2,000 or $2,500 in a year is all out of the member's pocketbook, so they're thinking, 'I can go to Cuban, and this is $40, versus I go someplace else, and it's $4,000,'" Musial said. "There's some dramatic differences in how Cuban prices versus others that you have to take advantage of if you're paying cash."... Sub. Req’d

The Biosimilars Report Card

(3/5, Peter Wehrwein, Managed Healthcare Executive) ...Thomas Newcomer, MBA, says biosimilars have yielded $36 billion in savings so far for the U.S. healthcare system. "So from that standpoint, have they made a difference? Absolutely. Have they made a difference to the level where we would expect? I would say no. There's still a huge opportunity in the United States for these products," says Newcomer, the vice president and head of U.S. commercial operations and market access for Samsung Bioepis, one of the major biosimilar manufacturers...Asked to grade the biosimilars market, Craig Burton, MBA, executive director of the Biosimilars Council, a trade group for the industry, gives it an incomplete... Full

Novartis Not Panicking Over Potential US Pharmaceutical Tariffs, Chairman Says

(3/6, John Revill, Reuters) ...Novartis is not panicking about higher tariffs on pharmaceutical imports that U.S. President Donald Trump could impose, the drug maker's Chairman Joerg Reinhardt said in an interview published on Thursday..."Rhetoric is one thing, what actually happens is another. Traditionally, pharmaceutical products have always been exempt from tariffs. So this would be something new," Reinhardt said... Full

Novo Nordisk CEO Warns of Drug Shortages and Price Hikes in US

(3/6, Sushmita Panda, Financial Express) ...Lars Fruergaard Jørgensen, CEO, Novo Nordisk on Thursday revealed that that Novo Nordisk is one of the biggest investors in the United States and these tariffs can harm the American patients especially with respect to generic medicines...The CEO also maintained that the medicines are produced with a relative, low margins and arbitrage done across drug categories. "So I think it will lead to, the risk of, shortage of medicines or inflation on some of these medicines that can be felt in the market," he said... Full

‘You're Going To See A Much More Aggressive Approach' – AAM Chief Murphy Sets Out Plans To Engage On Tariffs, Shortages And The IRA

(3/5, Dave Wallace, Generics Bulletin) ...In a wide-ranging conversation, the AAM's president and CEO John Murphy talks to Generics Bulletin about how the US industry association is planning to gain traction with the new Trump administration by adopting "a much more aggressive communications approach" on topics including medicines shortages, trade tariffs, PBM reform, the IRA and biosimilar interchangeability... Global Sub. Full

Report: A Decade of Biosimilars and Barriers Remain

(3/5, The Biosimilars Council) ..."Today's report highlights the immense opportunity and challenges facing biosimilar competition," said Craig Burton, Executive Director of the Biosimilars Council. "Biosimilars provide lower prices and expand patient access to care, but policy and market barriers continue to stymie biosimilar competition. Policymakers must ensure a robust and sustainable biosimilar market by streamlining the FDA approval pathway, removing the unnecessary and confusing interchangeability designation, ensuring PBM coverage of new biosimilars, and reforming Medicare reimbursement policy for biosimilars."... Full

PBMs Continue To Deliver Savings On Prescription Drugs For Patients

(3/6, PCMA) ...By negotiating directly with drug companies to lower prices, promoting competition, and managing prescription drug benefits efficiently, PBMs continue to be a critical force in keeping medications affordable and accessible for patients. PBMs are delivering real savings and value for patients, employers, and taxpayers by working to lower drug costs and helping employers and unions offer competitive pharmacy benefits, while giving patients more convenient access to prescriptions drugs and lowering their out-of-pocket costs... Full

Consumers Want Affordable Prescription Drugs

(3/5, JC Scott, RealClearHealth) ...Every day, Americans hear about new pharmaceutical innovations to improve their health and their lives – from personalized medicine to breakthrough treatments for cancer to innovations in weight loss therapies. Make no mistake, this pharmaceutical innovation is a good thing. Consumers not only want – but are rightly demanding – access to these therapies and health care services that deliver on what Americans need to get and stay healthy, affordably and conveniently. At the same time, unprecedented demand for drugs is spurring an affordability challenge... Full

NIH Director Nominee Bhattacharya Not Interested In Policing Drug Prices

(3/6, Cathy Kelly, Pink Sheet) ...NIH Director nominee Jayanta Bhattacharya showed no interest in pursuing price controls as part of the research grant process during his Senate confirmation hearing. He does not believe MMR vaccines in children are linked with autism, but said the NIH should support research to validate the position and overcome vaccine hesitancy. Bhattacharya also supported increased transparency for indirect costs associated with research grants... Global Sub. Full

Science Vs. Politics: Hearing Could Reveal Makary's Approach To Unusual Administration Involvement

(3/6, Sarah Karlin-Smith, Pink Sheet) ...Stakeholders hope that when Makary goes before the Senate Health, Education, Labor and Pensions Committee he will commit to protecting the FDA's science and regulatory work from the political interference. "I hope that Makary is asked about his commitment to maintain the integrity and independence of the FDA, and to allow the career scientists at the agency to do their work without political interference," Robert Steinbrook, director of Public Citizen's Health Research Group, told the Pink Sheet... Global Sub. Full

Novo Nordisk Will Join Legal Row Over FDA's Removal of Semaglutide from Shortage List

(3/5, Max Bayer, Endpoints News) ...Novo Nordisk got the green light to join a lawsuit by compounders against the FDA after the agency deemed that the Danish pharma's blockbuster weight loss drug was no longer in shortage. Judge Mark Pittman of the US District Court for the Northern District of Texas on Wednesday granted the company's request to intervene in the case. He originally denied the company's request because lawyers for the FDA hadn't appeared yet... Full

USP Publishes List of Vulnerable Medicines Susceptible to Shortages

(3/5, Joanne S. Eglovitch, Regulatory Focus) ...The United States Pharmacopeia (USP) has released its inaugural Vulnerable Medicines List (VML), which identifies 100 drugs that may be at risk of shortages. The list aims to help manufacturers, purchasing organizations, and policymakers recognize medications that have a higher risk for shortages so they can take appropriate action to before shortages occur. Medications for pain management, oncology, hospital care, and antibiotics top the list of drugs most vulnerable to shortages... Full

Why ADHD Drugs Are So Hard to Find

(3/6, Ike Swetlitz, Bloomberg) ...Attention deficit hyperactivity disorder medicines like Adderall have been in short supply in the US for over two years, frustrating people who have been unable to easily get their medicines each month. The reasons for the shortage are myriad, but federal drug enforcement officials have identified one impediment that they're looking to address. Matthew Strait, deputy assistant administrator at the Drug Enforcement Administration's diversion control division, laid it out in a recent phone interview... Full

Musk's DOGE Cuts Target FDA Lab Guarding US Drug Supply

(3/5, Anna Edney, Bloomberg) ...The lab's workers said they were notified Wednesday that the facility wouldn't be closed, but the lab remains on the government's target list. Higher-ups with knowledge of the lab's work have advocated to keep it open, people familiar with the situation said... Full

Here's Why Trump's Tariffs Could Hit Ireland's Pharma Sector Hardest

(3/5, Indrabati Lahiri, Euro News) ...Supriya Kapoor, associate professor of finance at Trinity College Dublin, told Euronews: "Relative to the other EU countries, Ireland is more exposed to tariffs because it exports proportionately more to the US. Pharmaceuticals and medical devices make the most of these exports." "And much of this pharmaceutical production is in Ireland for American companies such as Pfizer, Eli Lilly, Johnson and Johnson, to name a few." US tariffs on the EU could therefore have a significant impact on the Irish economy and gross domestic product (GDP) by making exports to the US more expensive, which could in turn contribute to lower demand... Full

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