Thursday, August 21, 2025

Teva Believes Education is Vital to Support Staff with Financial Pressures

(8/21, Zoe Wickens, Employee Benefits) ...Global pharmaceutical firm Teva supports employees with financial pressures by providing relevant and appropriate benefits...Claire Blomley, senior benefits manager, UK and Northern Ireland at Teva, explains: "Financial education is vital. Stability in this area acts as a foundation for managing life's other challenges. I believe all employees can benefit from financial coaching. Whether it's learning how to manage debt, plan for retirement, or better understand available benefits, there's always room to grow."... Full

Winners Announced for the EuroFinance Treasury Excellence Awards 2025

(8/20, EuroFinance) ...This year's accolades are awarded in five categories: Cash champion, Risk & resilience, Financing & liquidity, Technology transformation, and the Rising Star award. Cash Champion. Winner: Teva Pharmaceutical. Teva Pharmaceuticals' treasury team took a bold, company-wide approach to cash management, driving working capital ratios down to more efficient levels. Their reforms didn't stop at numbers — they built cash discipline into the culture of every business unit and embedded ESG objectives into financial planning. The result is a treasury function is delivering operational excellence while advancing the company's long-term sustainability goals... Full

U.S. And EU Spell Out Tariffs For Autos, Pharmaceuticals, And More

(8/21, Sophie Kiderlin, Sam Meredith, Karen Gilchrist, CNBC) ...After weeks of heated negotiation, Brussels and Washington finally arrived at a trade agreement late last month, setting out 15% blanket tariffs on EU exports to the U.S. Under the deal, the EU also committed to purchase $750 billion worth of U.S. energy and invest at least an additional $600 billion in the U.S...Europe's pharmaceutical sector — the U.S.'s top source for pharma imports — will also see tariffs capped at up to 15%. Critically, the rate will not stack on top of other EU-wide tariffs. From Sept. 1, the Trump administration has also agreed to only apply its MFN drug pricing policy to generic pharmaceuticals... Full

US Caps Tariffs On European Cars, Medicines at 15 Percent

(8/21, Camille Gijs, Politico) ...The four-page text, dated Aug. 18, locks in the key points of the deal that U.S. President Donald Trump agreed with European Commission President Ursula von der Leyen when the two met at his Turnberry golf resort in Scotland on July 27. The two leaders' account of the deal differed on the day, notably on pharma, causing concern that drug producers in Europe could end up being priced out of the U.S. market entirely... Full

J&J To Invest $2 Billion To Boost US Manufacturing As Drug Tariffs Loom

(8/21, Mariam Sunny, Reuters) ...Johnson & Johnson said on Thursday it would invest $2 billion in North Carolina as it aims to expand its U.S. manufacturing presence amid looming drug import duties proposed by President Donald Trump's administration...J&J said on Thursday it has reached a 10-year agreement with Tokyo-based contract drug developer Fujifilm Diosynth for its more than 160,000-square-foot manufacturing facility in Holly Springs, North Carolina, which would create about 120 new jobs... Full

Tariffs Won't Fix Our Medicine Supply Chain

(8/19, Justin Leventhal, DC Journal) ...President Trump is threatening tariffs again — this time, a 200 percent tariff on pharmaceuticals. This move would drive up the cost of medicine and reduce access to affordable generic drugs. If the administration wants to protect American pharmaceutical supply lines, a better strategy would be to incentivize production in countries other than China. While some claim tariffs are a tax on foreign businesses, the reality is that tariffs are paid by U.S. businesses and consumers in the form of higher prices. Whether at the pharmacy counter or through higher insurance premiums, patients — not China — will be the ones who pay... Full

Indegene Exec On DTP Distribution As A ‘Tactical Solution', Feasibility Of MFN Model

(8/21, Anju Ghangurde, Pink Sheet) ...Indegene's VP - strategic initiatives, PRMA, William Lobb, talks about why the DTP model is not universally applicable. Challenges include navigating state-level pharmacy regulations. DTP isn't a "scalable replacement" for an effective access and reimbursement system in his view. MFN pricing fundamentally "antithetical" to a capitalist market, he states. Standardizing prices via MFN could reduce the flexibility that payers rely on and policies like MFN could deal a devastating blow to global health, he cautions... Global Sub. Full

PBMs Are Hiding Hurdles to Essential Care

(8/20, Caroline Dunne, PhRMA) ...PBMs and insurers are getting between patients and their medication through a new process called embedded step therapy according to a new study from Avalere...This study reveals that embedded step therapy can ignore FDA labeling by making patients try additional medicines beyond what is recommended. For three of the therapies reviewed in the study, patients could be made try up to 10 medicines beyond what the FDA recommends in its labels... Full

GLP-1s In Crosshairs As Employers Worry About Health Costs – And Their Own Reliance On Rebates

(8/20, Cathy Kelly, Pink Sheet) ...Health care costs in employer sponsored insurance are growing rapidly, driven in large part by the GLP-1 drugs for diabetes and obesity, according to the Business Group on Health survey on employer health care strategies. The percentage increase in plan sponsors covering the drugs for obesity will "stagnate" as employers look to stabilize health care costs and those that do cover the treatments will look for ways to contain their costs, the group predicted. Employers are also concerned about their continued reliance on rebates but only a minority of respondents expressed a willingness to move to non-traditional pharmacy benefit manager model... Global Sub. Full

Opinion: Look to Competition, Not Mandates, To Lower Drug Prices

(8/20, Kirsten Axelsen and Kenneth E. Thorpe, BioSpace) ...While it may seem reasonable to align U.S. prices with those in countries like Canada, Germany or the U.K., which have a single-payer model, this overlooks a critical trade-off: those lower prices, determined by local governments, local budgets and local judgments of their value, often come at the cost of delayed or restricted access to innovative treatments. In contrast, the U.S. has allowed market competition to drive down prices while maintaining faster access to new therapies and supporting a robust biopharmaceutical sector. As policymakers are looking to expand top-down price controls, the private sector is already demonstrating a competitive, healthy and successful market. Prices are coming down through competition, particularly in treatments for diabetes, stroke, hepatitis C and obesity... Full

Don't Let Middlemen Off the Hook in the Drug Pricing Debate

(8/19, Robert Levin, DC Journal) ...Rather than alleviating systemic cost pressures, this shift risks creating a dangerous two-tiered system, one where patients must choose between affordability and insurance coverage. It's a patchwork solution that treats a symptom but ignores the underlying problem that remains, a profit-driven intermediary system that forces patients to pay more, one way or another. Instead of regulating these middlemen, the MFN model targets manufacturers, leaving PBMs' profits untouched... Full

PBMs Partner with Rural Pharmacies to Support Patients

(8/20, PCMA) ...Especially in rural areas, patients may depend on their pharmacist for more than just filling prescriptions; for example, providing clinical services such as vaccinations and helping manage chronic conditions. Amanda Frost, Ph.D., PCMA's Vice President, Research, spoke with 10 separate pharmacy benefit managers (PBMs) to learn how they support rural pharmacies... Full

Industry and Consumer Groups Call for Improved Review Practices, Transparency in PDUFA VIII

(8/20, Joanne S. Eglovitch, Regulatory Focus) ...Industry and consumer groups are calling for the US Food and Drug Administration (FDA) to fix inconsistent review practices, hold more face-to-face meetings, and provide greater transparency in the drafting of commitment letters in the next iteration of the Prescription Drug User Fee Act (PDUFA VIII). Patient groups said they feel shut out of the negotiations and want that to change... Full

RFK Jr. Pitches Trump On Repurposing Drugs To Treat Chronic Disease

(8/20, Gabrielle Wanneh, Inside Health Policy) ...HHS Secretary Robert F. Kennedy Jr. is pitching the White House on a plan for FDA and National Institutes of Health (NIH) to investigate whether older drugs could be repurposed and quickly approved to treat chronic diseases. The proposal, included in a leaked Make America Healthy Again report, comes as health care experts propose a similar idea... Sub. Req’d

Alvotech Focuses On Value Over Volume As Sales Continue To Grow

(8/20, Dave Wallace, Generics Bulletin) ...Biosimilars specialist Alvotech says it is pursuing a long-term play of focusing on product margin and value rather than chasing volumes and high market share. First-half results outpaced expectations for Alvotech, but management noted that third- and fourth-quarter results were expected to be "lumpy". Alvotech says its marketed adalimumab and ustekinumab biosimilars are making good progress, while also providing updates on its substantial pipeline in the wake of several recent deals... Global Sub. Full

Advanz Pharma and Alvotech Receive European Approval for Mynzepli®, Biosimilar to Eylea®

(8/21, Advanz Pharma) ...Mynzepli® (aflibercept) is approved in all European Economic Area member countries for the treatment of various retinal diseases including neovascular (wet) age-related macular degeneration (AMD). Approval is based on comprehensive analytical, non-clinical and clinical similarity data, including a confirmatory efficacy study comparing Mynzepli® with the reference biologic Eylea® in patients with neovascular AMD... Full

Sam Chun Dang's Eylea Biosimilar Wins European Approval

(8/20, Kim Ji-hye, Korea Biomedical Review) ...In a statement, Sam Chun Dang called the decision "proof of the competitiveness" of its Eylea biosimilar in Europe, the world's second-largest drug market after the United States. The drug was registered under two brand names to separate sales in Eastern and Western Europe, though the company declined to disclose them. The company said manufacturing is on track to allow sales to begin once Eylea's patents expire. It noted that about 80 percent of global Eylea sales come from pre-filled syringes and suggested it may be the first to offer that format in Europe, after doing so in Canada... Full

Aurobindo Pharma Set to Tap Biosimilars Revenue in Europe

(8/21, G Naga Sridhar, The Hindu BusinessLine) ...According to Satakarni Makkapati, CEO of Aurobindo Biosimilars, Vaccines, and Peptide Businesses at Aurobindo Pharma, the company expects revenue from the Biosimilars segment vertical in Europe to start from the third/fourth quarter of the current financial year. The Hyderabad-based company had already obtained necessary regulatory approvals from the European Union and commenced manufacturing for commercial supplies, and had already supplied some drugs to the UK.  Initial focus on launch quantities and supply chain... Full

Natco Pharma Sues Novo Nordisk in Generic Drug Push

(8/21, Vikas Dandekar, The Economic Times) ...The lawyers representing Natco Pharma informed the court that over the past few months it had approached Novo Nordisk to communicate on its non-infringing patents but received no response, said people familiar with the matter. "A clear communication from the innovator may trigger a generic launch of the drug in India, sinking the prospects for Wegovy's sales and so that may be seen as a delaying tactic," said an expert, who did not wish to be identified... Full

Aurobindo Addresses Rumor Of $5Bn Zentiva Buyout

(8/20, Dave Wallace, Generics Bulletin) ...Media reports have suggested that Aurobindo could be set to take ownership of Zentiva in a $5bn transaction with current owner Advent International. Aurobindo has described the reports as "premature" and indicated that "no binding agreement or definitive decision has been made," without outright denying the rumors. The valuation reflects the significant growth that has been seen for Zentiva since it was acquired by Advent from Sanofi for €1.9bn six years ago... Global Sub. Full

Debt Not a Concern, Will Pursue Large Deals With Financial Discipline: Aurobindo Pharma CFO

(8/21, Surabhi Upadhyay, Ekta Batra, Prashant Nair, Nigel D'Souza, CNBC TV-18) ...Debt is not a concern for Aurobindo Pharma as it evaluates potential large acquisitions, including Prague-based Zentiva, said Chief Financial Officer Santhanam Subramanian...Subramanian explained that Aurobindo's strong balance sheet and steady cash generation provide enough room to explore inorganic growth. The company has been generating about $100 million in cash every quarter and currently holds close to $900 million in liquidity across the US and Europe... Full

FDA Delays 2 Decisions On Regeneron's Eylea HD Because of Manufacturing Issues

(8/20, Kevin Dunleavy, Fierce Pharma) ...Wednesday, the FDA extended its target action dates for two applications to expand the use of Eylea's high-dose formulation. The U.S. regulator was originally scheduled to make its Eylea HD decisions by Aug. 19, but it has now has pushed those back to the fourth quarter, Regeneron said. The delay was not unexpected. During its second-quarter earnings presentation three weeks ago, Regeneron revealed that problems were identified in a general FDA inspection of its third-party contract manufacturer... Full

Japan's Takeda Weighs India for Global Trials to Speed Up Drug Launches

(8/21, Rishika Sadam and Bhanvi Satija, Reuters) ...Japanese drugmaker Takeda Pharmaceutical is exploring the option of conducting global clinical trials in India to accelerate the launch of its innovative drugs in the world's most populous nation, its India head told Reuters..."India is a strategic growth market for Takeda, and we are making significant long-term investments... in terms of innovation and building capabilities," said Annapurna Das, the general manager of Takeda's India operations... Full

Glenmark Targets Revival Of Monroe Manufacturing Unit Following FDA Findings

(8/21, Dean Rudge, Generics Bulletin) ...Glenmark hopes to restart US commercial manufacturing at its stricken injectables manufacturing facility in Monroe, North Carolina, "this year," after a recent US Food and Drug Administration inspection resulted in the agency issuing a Form 483 with five procedural observations of current good manufacturing practice violations... Global Sub. Full

Wockhardt Sees 150 Crore Revenue in the First Year of Its Latest Drug

(8/21, Surabhi Upadhyay, Prashant Nair, CNBC TV-18) ...Wockhardt is gearing up for the launch of its breakthrough anti-bacterial drug Zaynich, which could generate about 150 crore in revenue in its first year in India, with global potential running significantly higher. The company will file the drug with the US Food and Drug Administration (FDA) in the coming weeks, with approvals expected within six to nine months. Founder & Chairman Habil Khorakiwala described Zaynich as a "game-changing drug in antibiotic treatment" that targets drug-resistant bacteria. The product is expected to be available in India by mid-2026 and globally by late 2026... Full

Riding High On Wegovy, Novo Doubled Its Workforce. Now Layoffs Loom

(8/21, Jacob Gronholt-Pedersen and Maggie Fick, Reuters) ...Annual reports show that Novo's workforce grew from around 43,260 employees in 2019 to 77,350 by the end of last year - an average of 131 new roles filled each week, far faster than rival Eli Lilly, whose headcount rose from 36,000 to 47,000 over the same period. Novo's rapid expansion is now under scrutiny from investors and even management, with the drugmaker facing cost pressure and heightened competition from Lilly's Zepbound and cheaper weight loss copycat compounds in the United States... Full

India Levels Up in Solving Complex Drug Formulation Challenges

(8/20, Chetan Shah, Express Pharma) ...India's evolution from bulk API manufacturing to complex drug formulation is more than an industrial shift — it reflects growing scientific and technical strength. As healthcare challenges become more complex, the ability to develop advanced therapies will be essential. With its talent pool, infrastructure, and regulatory expertise, India is positioned to be not just the largest supplier by volume but a valued innovation partner in the global pharmaceutical landscape... Full

China Vows Stronger Biotech Support as Deals With Global Pharmaceutical Giants Surge

(8/21, Alice Li, South China Morning Post) ...Chinese Premier Li Qiang has called for stronger policy support for the biotech industry, as part of efforts to bolster innovation in a sector that has witnessed a boom in recent years. "The biopharmaceutical industry is both a strategic emerging sector and vital to public health," he said during an inspection in Beijing on Wednesday, as reported by the state-run Xinhua News Agency. "Efforts should be made to strengthen original innovation, address core technological challenges and mobilise resources from the government and market to achieve breakthroughs quickly."... Full

Report: Japan's PMDA Had Shortest Review Times for New Drugs, Half of Drugs Submitted to US First

(8/20, Ferdous Al-Faruque, Regulatory Focus) ...According to a recent analysis by the Center for Innovation in Regulatory Science (CIRS), Japanese regulators have the shortest time to approval for new drugs compared to their European, Australian, and US counterparts. The analysis also found that a majority of sponsors submit applications to the US Food and Drug Administration (FDA) before regulators in other markets... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.