Wednesday, February 5, 2025

SaverOne Announces New Deployment of Its Driver Distraction Prevention System in Teva Pharmaceutical’s Truck Fleet

(2/4, SaverOne) ...Mr. Ronen Talmor, Traffic Safety Officer at Teva, commented, "As a company that places safety as a top priority, whether workplace safety or road safety, we invest significant time and money in technological solutions and training to prevent accidents. When we discovered SaverOne's system, which essentially complements our efforts as a company to prevent road accidents and eliminate the number one cause of such accidents - driver distraction, we immediately recognized its value. I believe that any company that, like us, prioritizes safety will not overlook this highly significant system."... Full

Amgen Profits Rise, Next MariTide Studies Start by Mid-Year

(2/5, Deena Beasley, Reuters) ...Amgen posted a higher quarterly profit on Tuesday as product sales rose 11% and said late-stage studies of key obesity drug candidate MariTide will start before mid-year but regulators have placed a hold on an early-stage trial of a different experimental weight-loss drug... Full

Amgen Discloses FDA Paused Study of Early-Stage Obesity Drug

(2/4, Madison Muller, Bloomberg) ...Investors are focused on obesity for good reason, analysts expect that market to hit $130 billion by 2030. Meanwhile, almost a third of Amgen's portfolio is facing patent expirations and two of its best-selling bone medicines, Prolia and Xgeva, will face competition from cheaper biosimilars this year...Amgen sees the potential for 2025 revenues to top Wall Street estimates thanks to growth in cholesterol and cancer drugs. Annual sales will be $34.3 billion to $35.7 billion this year, the company said in the statement... Full

GSK Lifts 2031 Sales Target After Better-Than-Expected Q4

(2/5, Yadarisa Shabong, Reuters) ...GSK posted a better-than-expected fourth quarter on Wednesday and lifted its 2031 sales target to nearly $50 billion as the British drugmaker aims to invest heavily in its specialty medicines to offset weakness in vaccines..."We are increasing and prioritising R&D investment to promising new long-acting and specialty medicines in Respiratory, Immunology & Inflammation, Oncology and HIV," CEO Emma Walmsley said in a statement... Full

India's Zydus Life Beats Profit View On Strong US Demand

(1/5, Kashish Tandon, Reuters) ...New product launches helped Zydus Life increase its revenue from the United States at a time when stiff competition has weighed on the margins of Indian generic drugmakers, which earn a major chunk of their revenues from the region. Among Zydus Life's rivals, Sun Pharma and Cipla beat third-quarter profit estimates, while Dr Reddy's missed expectations. However, all three saw muted growth in their key North American market... Full

Stada CEO Sees Strong Investor Demand Ahead of Top European IPO

(2/4, Eyk Henning and Sonja Wind, Bloomberg) ...The company saw "huge" interest during early educational meetings it held with about 60 investors, Stada Chief Executive Officer Peter Goldschmidt said in an interview Monday at the company's headquarters in Bad Vilbel, on the outskirts of Frankfurt. Stada could list as soon as the post-Easter window in April, according to people with knowledge of the matter, though Goldschmidt declined to comment on a specific timeline... Full

Lilly Needs a Plan to Spur Weight-Loss Drug Sales, Investors Say

(2/5, Patrick Wingrove, Reuters) ...Eli Lilly investors and analysts said they want to hear details from the company on how exactly it plans to grow U.S. sales of popular weight-loss drug Zepbound after it last month forecast lower-than-expected fourth-quarter revenues for the drug. Lilly, which reports its fourth-quarter earnings on Thursday, said in January that wholesalers had not restocked their Zepbound inventories as expected, driving shares down 8%. It was the second time in a year its sales had come up short due to issues it attributed to the supply chain... Full

Wegovy Sales Double to Boost Novo Nordisk's Fourth Quarter But Slower Growth Predicted

(2/5, Maggie Fick, Stine Jacobsen, Reuters) ...Obesity drug maker Novo Nordisk forecast slower growth this year after Wegovy sales more than doubled in the final quarter of 2024, with analysts and investors describing the results as "good enough" to ease nerves about stiff competition from rival Eli Lilly. The Danish company said it expects sales growth in local currencies to range between 16% and 24% in 2025, less than the 26% growth seen in 2024. That compares with analysts expectations of just under 20%... Full

Novo Nordisk CEO: Side-Effects Not a Problem in CagriSema Study

(2/5, Maggie Fick and Stine Jacobsen, Reuters) ...Novo Nordisk's CEO said on Wednesday side-effects were not a problem in the trial of its next-generation obesity drug candidate CagriSema as the company considers dosage escalation and trial length for a new study...The company said on Wednesday it plans to submit CagriSema for regulatory approval during the first quarter of 2026, slightly later than its previous expectation of end-2025... Full

Merck Is Suffering From a Classic Pharma Problem

(2/5, David Wainer, The Wall Street Journal) ...On Tuesday, the company reported fourth-quarter earnings that beat expectations, with $15.6 billion in sales surpassing Wall Street estimates. But Merck's vaccine business in China is slowing much more than the company had previously estimated. In a grim update, Merck announced it is temporarily halting shipments of HPV vaccine Gardasil -- its second-biggest product -- to China... Sub. Req’d

Henlius’ Perjeta Biosimilar Under FDA Review Ahead Of Potential Entry In 2026

(2/4, Dean Rudge, Generics Bulletin) ...Organon is one step closer to introducing US biosimilar competition to Roche's Perjeta blockbuster after partner Shanghai Henlius Biotech saw its application accepted for review by the US FDA. Roche meanwhile has spoken about how it expects to defend its loss of exclusivity, beginning potentially in 2026... Global Sub. Full

Sandoz Eyes New Biosimilars Head As Stenico Succeeds Retiring Ballester

(2/4, Dean Rudge, Generics Bulletin) ...A vacancy is to open for one of industry's most high-profile jobs, Sandoz's global biosimilars head, after its former holder Peter Stenico was appointed as president of Sandoz's International region, ahead of the forthcoming retirement of the company's long-serving exec Francisco ‘Paco' Ballester... Global Sub. Full

Lotus Pharmaceutical Becomes Strategic Partner for the Commercialization of Formycon’s Eylea® Biosimilar FYB203/AHZANTIVE® in the Asia-Pacific Region

(2/5, Formycon AG) ...Klinge Biopharma GmbH, the exclusive owner of the global commercialization rights of FYB203/AHZANTIVE®1 (aflibercept), Formycon's biosimilar to Eylea®2, informed Formycon AG, that it has concluded an exclusive license agreement with Lotus Pharmaceutical, a multinational pharmaceutical company, for the commercialization of FYB203/AHZANTIVE® in Asia-Pacific countries: Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam as well as the Special Administrative Region Hong Kong. In parallel, Formycon has signed an agreement with Lotus under which Formycon will supply the finished product... Full

Alvogen Recalls Fentanyl Patches Due to Possible Overdose Risk

(2/3, Joseph Keenan, Fierce Pharma) ...Alvogen has issued a voluntary recall on a single lot of fentanyl transdermal patches due to the risk that some of the products could be "multi-stacked" and stuck together in a single pouch. Patients who apply the stacked pouches run the risk of taking a higher dose than intended, potentially leading to serious, life-threatening or fatal breathing issues, Alvogen warned... Full

Federal Appeals Court Axes $650M Opioid Judgment Against CVS, Walmart and Walgreens

(2/4, Heather Landi, Fierce Healthcare) ...A federal appeals court axed a $650 million judgment and corresponding injunction against CVS Pharmacy, Walgreens Boots Alliance and Walmart stemming from a lawsuit filed by two Ohio counties in 2018... Full

The Banking of Biosimilars: Insights From a Leading Health Economist

(2/4, Skylar Jeremias and James D. Chambers, PhD, MPharm, Msc, The Center For Biosimilars) ...Biosimilars are increasingly recognized for their potential to reduce healthcare costs and expand patient access to life-saving treatments. However, several economic and policy-related factors influence their adoption and overall impact on the health care system. To explore these critical dimensions, The American Journal of Managed Care® (AJMC®) spoke with James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies... Full

Trump Tariffs May Play Havoc With Health Prices, Supply Chains

(2/5, Tina Reed, Axios) ...A trade war with China could shock fragile global health care supply chains, driving up the cost of medical supplies, intensifying shortages of common drugs and limiting U.S. medical device makers' ability to import critical parts..."Make no mistake, if there are widespread tariffs anywhere from the 10% to 25% range, I anticipate there will be corresponding price increases," Jason Hollar, CEO of health care services and products company Cardinal Health, told analysts during the company's earnings call last week... Full

Trump's Tariffs Could Make it Harder for Americans to Get Their Medications

(2/5, Dylan Scott, Vox) ......The last-minute deals with Canada and Mexico have (at least temporarily) softened some of the blow. But China is a bigger importer of prescription drugs than either of our neighbors. It may take time for the consequences to be felt. But if bad outcomes do eventually befall American patients because of the tariffs, it should come as no surprise. It's basic economics. And it's entirely avoidable... Full

Novo Nordisk Says it's Not Immune to Potential Trump Tariffs, But Business is Well-Positioned

(2/5, Maggie Fick, Reuters) ...Wegovy maker Novo Nordisk is not immune to tariffs U.S. President Donald Trump is threatening to levy on the European Union, its chief executive said on Wednesday, but it is confident its business is well-positioned... Full

Pfizer Says it Has at Least $10B Available for Deals in 2025, With a Focus On Pipeline

(2/4, Max Bayer, Endpoints News) ...When asked about working with the noted vaccine skeptic, Pfizer CEO Albert Bourla remained focused on the positive. He noted that he had dinner with RFK Jr. and said, "I focus more not on the things that we clearly disagree, like the vaccines, but on the things that we can agree and we can do things together… I'm cautiously optimistic... Full

Trump Admin To Nix 10 Rules For Each New One

(2/4, Luke Zarzecki, Inside Health Policy) ...The new order and an accompanying fact sheet dated Jan. 31 explain that if an agency issues a new rule, regulation or guidance, the agency must repeal 10 existing rules, regulations or guidance documents. Total costs of all new regulations, taking into consideration scrapped rules, must also be less than zero... Sub. Req’d

Cassidy Says He Secured Key Vaccine Commitments from RFK Jr.

(2/4, Nathaniel Weixel, The Hill) ...Speaking on the Senate floor, Cassidy said Kennedy and the administration reached out "seeking to reassure me regarding their commitment to protecting the public health benefit of vaccination." To that end, Cassidy said the White House and Kennedy pledged to maintain a key federal advisory board; to work within the established, existing vaccine safety systems; and to give Cassidy input on HHS hiring decisions... Full

Association for Accessible Medicines 2025 Advocacy Priorities

(2/4, AAM) ...Overall sustainability: Due to a lack of adequate reimbursement, generic medicines are increasingly at risk of shortages. Without systemic reforms to stabilize and incentivize the generic drug supply chain, patients could face dangerous interruptions in their treatment. If these challenges are not addressed, the consequences will be devastating. America's patients will lose access to reliable, low-cost therapies. Taxpayers will bear a greater burden as healthcare costs soar. The very principles of competition and innovation that have driven the success of generics and biosimilars will be eroded... Full

J&J Asks Court for Quick Decision in 340B Rebate Model Fight

(2/4, Nicole DeFeudis, Endpoints News) ...The company has until Sept. 1 to submit a written plan to CMS with its "intended procedures" for meeting its obligations under the IRA's drug price negotiation program. But J&J said it faces "significant obstacles" to complying with a key requirement: preventing duplicate discounts under the IRA and 340B... Full

Reminder: Employers Value PBMs

(2/4, PCMA) ...A recent survey of nearly 700 employers across the country conducted by NORC at the University of Chicago found 90 percent of respondents are satisfied with their PBM's clarity and transparency of contract terms. Additionally, the survey found that 90 percent of employers who received rebates in the past 12 months used them to offset overall prescription drug benefit costs... Full

US FDA And The ‘Move Fast And Break Things' Government

(2/4, Michael McCaughan, Pink Sheet) ...While there are no indications that DOGE is targeting the FDA, its actions could mean less industry understanding of FDA thinking and less engagement with stakeholder groups, who often help the agency realize its positions need to evolve... Global Sub. Full

States Eye Canadian Drug Imports Despite Delays, Tariff Threats

(2/5, Celine Castronuovo, Bloomberg Law) ...The lack of movement on Florida's program brings uncertainty on the feasibility of prescription drug importation...Another issue is that FDA regulations exclude biologic products from importation, making injectable autoimmune treatments like Humira, Enbrel, and some of the other most expensive brand-name prescriptions in the US ineligible... Sub. Req’d

Can the EU Safeguard Critical Medicines?

(2/4, Stefan Grobe, Euronews) ...Leading the charge in favour of Critical Medicines Act on the EU level was Belgian Public Health Minister Frank Vandenbroucke. What triggered the political initiative was the Covid-19 experience, "one of the worst shortages we ever had", he told Euronews. "And so, indeed, we called for an EU initiative in May 2023, and 23 EU member states joined us - which shows that this was a structural problem present everywhere." The new legislation should focus on those medicines vulnerable to shortages and where there supply chain problems, says Vandenbroucke... Full

Swedish Drug Agency's New Pricing Model Surprises, Concerns Patient and Pharma Groups

(2/5, Monica Kleja, Euractiv) ..."We consider this to be driven by ethical and economic reasons. By taking patient numbers and sales volume into account in our decisions to a greater extent, we can improve access and achieve sustainable costs," Sofie Alverlind, project manager at the TLV, told Euractiv. Meanwhile, the agency will gradually lower the price of medicines for common diseases with high sales volumes. Prices will be reduced in relation to high sales figures... Full

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