Thursday, August 28, 2025

Teva's Pivot To (Innovative) Growth: Re-Rating Should Continue

(8/28, Joon Jeon, CFA, Seeking Alpha) ...TEVA stands at an inflection point, ready to turn its page from past legacy overhangs and present a credible growth story to investors. Biosimilars is stabilizing its generics revenue base against persistent price erosion, while promising branded assets like Austedo, Ajovy, and Uzedy are driving consistent growth. Further launches scheduled from its pipeline targeting additional therapeutic areas create a believable revenue path extending well into the 2030s... Full

GBMA Appoints Teva APAC Director Stephen Jenkins to its Board of Directors

(8/27, GBMA) ...The Generic and Biosimilar Medicines Association (GBMA) has today announced the appointment of Dr Stephen Jenkins, PhD, Director of Government and Corporate Affairs APAC, Teva Pharmaceuticals, to its Board of Directors, following the Association's annual strategic meeting...GBMA CEO, Marnie Peterson, congratulated Stephen and acknowledged outgoing director and Teva Vice President APAC, Jim Margaritis. "Stephen's leadership at Teva and his deep understanding of the medicines landscape comes at a critical time as global demand and economic pressures continue to challenge healthcare systems worldwide," Ms. Peterson said. "And on behalf of the Board, we also thank Jim Margaritis for his dedication and significant contribution over the past two years," she added... Full

GBMA Appoints Teva's Dr Stephen Jenkins to Board of Directors

(8/28, Pharmacy Daily) ...His insights will be valued as GBMA continues its work to strengthen the PBS sustainability and improve medicine accessibility at a time of intensifying global market pressures and supply chain challenges, the peak body said. GBMA Independent Chair, Professor Jane Halton, welcomed the appointment, and said, "Stephen's strategic expertise and global perspective will be an asset to the Board as we continue to advocate for policies that safeguard continuity of supply for Australian patients."... Full

HHS Uses Tariff Threats To Push For Lower Domestic Drug Prices

(8/27, Maaisha Osman, Inside Health Policy) ...At the cabinet meeting, Trump suggested drugmakers and foreign governments are already moving toward agreement because of the threat of U.S. tariffs. "They're not agreeing because they think I'm a nice person," he said. "They're agreeing because I will put charges and tariffs onto them that will be many times more." He predicted the changes would deliver the "biggest price event" ever in health care, lowering costs across Medicare, Medicaid, Social Security and private insurance...It remains unclear how HHS would bring drug prices down to MFN levels if manufacturers do not voluntarily comply with the threat of tariffs... Sub. Req’d

Tariffs Could Increase Prescription Drug Costs And Premiums For Medicare, Other Insurance

(8/27, Bob Carlson, Forbes) ...A number of medical insurers have started to notify states that they plan to charge higher premiums for individual and small group policies in 2026. Tariffs are one reason for the increases. Insurers expect tariffs to increase the cost of prescription drugs, medical devices and other medical products and services, according to the Kaiser Family Foundation. Prescription drug price increases appear to be the biggest tariff-related concern of the insurers. The insurers say tariffs alone account for planned premium increases of 2.2% to 3.6%... Full

Tariff Heat: Why the US May Be Paying the Bigger Price After Slapping 50% Duty On India

(8/29, Amit Shukla, News18) ...India is a global pharmaceutical powerhouse, supplying nearly 40 per cent of all generic drugs used in the United States. Although the sector has been exempted from the 50 per cent duty, the threat of future inclusion, or regulatory pressure on US pharma firms to shift supply chains, looms large. If the exemption is lifted or narrowed, the resulting price hikes would not just impact consumer drug prices but could also strain insurance payouts, Medicare spending, and hospital procurement. Even the fear of tariff risk is already affecting procurement strategies, leading to costlier and slower access to critical medications... Full

Pharmaceutical Blackout: The Hidden Threat to U.S. Security

(8/28, Tim Ray and Stuart Glickman, RealClearDefense) ...Americans' health hangs on economically unstable supply chains that are concentrated overseas. Rebuilding domestic pharmaceutical manufacturing is not just an economic issue but a national security imperative. By guaranteeing fair prices for U.S. generics, prioritizing U.S. manufacturing, investing in factories, and reducing regulatory approval time, we ensure that if global politics turn hostile, Americans will still have their medications. The policy roadmap is available; the crisis is real... Full

A Better Prescription for Affordable Medicine

(8/28, Tim Chapman and Marc Wheat, NR Capital Matters) ...Importing foreign-style price controls would further drain the investments needed to fuel the R&D that drives future breakthroughs and makes new treatments possible. Price controls are essentially a tax on success: Tax something more, expect less of it...Free-market solutions driven by competition, transparency, and innovation are a better prescription and offer better results: lower prices, higher-quality care, and a future of lifesaving breakthroughs for patients... Full

US CDC Chief Fired After Weeks in Role, Challenges Ouster as Four Top Officials Resign

(8/28, Ahmed Aboulenein; Dan Levine; Michael Erman, Reuters) ...U.S. Centers for Disease Control and Prevention Director Susan Monarez has been fired, the White House said on Wednesday, less than a month after being sworn in, and four senior officials have resigned amid growing tensions over vaccine policies and public health directives...One of the officials who quit said the CDC's vaccination recommendations were putting young Americans and pregnant women at risk. White House spokesman Kush Desai late on Wednesday said Monarez was not "aligned with the President's agenda of Making America Healthy Again"... Full

Hospital Lobby 'Confident' 340B Pilot Program 'Will Ultimately Fail'

(8/27, Dave Muoio, Fierce Healthcare) ...In a public comment letter submitted Wednesday, the American Hospital Association (AHA) outlined "bare minimum requirements" for the program—but also made clear its belief that the experiment should be scrapped entirely. "As the agency recognized in its Notice, any approval of a rebate model will ‘fundamentally shift how the 340B program has operated for over 30 years.' There is no sound reason for HRSA to make such a profound change," AHA General Counsel and Secretary Chad Golder wrote in the organization's comment letter to the Health Resources and Services Administration... Full

Colorado Board Adopts Medicare Maximum Fair Price For Enbrel, Assumes Amgen ‘Amenable'

(8/27, Cathy Kelly, Pink Sheet) ...The Colorado prescription drug affordability board adopted the Medicare-negotiated maximum fair price as the upper payment limit for Amgen's Enbrel in a new proposed rule. The action demonstrates a way that Medicare-negotiated prices could influence other insurance markets. The payment limit could be the first by a state PDAB, which others may follow... Global Sub. Full

Medical Innovation Takes Center Stage in State Legislatures

(8/27, Stami Turk, PhRMA) ...With the right political environment, states are the perfect place to host collaboration, bring promising treatments to patients through clinical trials, and act as the hub for significant economic and workforce benefits in the process... Full

First Post-Natal Depression Drug Approved in UK

(8/28, The Pharma Letter) ...Biogen noted that Zuranolone represents a novel therapeutic approach, offering the first targeted treatment for PND in the UK, with a mechanism of action distinct from traditional antidepressants. This regulatory milestone addresses a critical, unmet need in maternal health, where the current standard of care for PND involves psychological interventions, such as talking therapies and off-label use of antidepressants that that typically taken four to six weeks to show effectiveness, though some cases may require up to 12 weeks... Sub. Req’d

Biosimilars Help Stada Build First-Half Growth Momentum

(8/28, Dave Wallace, Generics Bulletin) ...Stada's group sales growth of 6% to €2.12bn in the first half of 2025 was credited largely to the firm's Specialty segment, particularly its Alvotech-partnered Uzpruvo biosimilar ustekinumab rival to Stelara. Specialty sales were up by 18% as the Generics and Consumer Healthcare segments each advanced by 2% in the first six months of the year. Five new biosimilar launches are expected in 2026, with Stada pointing to a slate that includes aflibercept, denosumab, golimumab and tocilizumab. CEO Peter Goldschmidt also provided the latest update on a potential IPO for Stada, suggesting that it could take place within the next few months... Global Sub. Full

Celltrion Aims to Strengthen Biosimilar Lineup in Vietnam

(8/28, Choi Kyong-ae, Yonhap News) ...Celltrion launched two biosimilars in Vietnam this year -- Remsima, for the treatment of autoimmune diseases, in June, and Herzuma, for breast and stomach cancer, in August, the company said in a press release. The company aims to obtain approval from Vietnamese authorities later this year for Remsima SC, a subcutaneous formulation of its autoimmune treatment, and Truxima, a therapy for blood cancer, it said... Full

Sandoz Launches Rivaroxaban in Germany, Expanding Access to High-Quality Antithrombotic Treatment Options

(8/28, Sandoz) ...Sandoz...today announced the launch of generic rivaroxaban in Germany, in new generic strengths of 10 mg, 15 mg and 20 mg. Rivaroxaban - 1 A Pharma® offers patients in Germany a high-quality, affordable alternative to reference product Xarelto®*, with a list price advantage across all three strengths. Following successful litigation in Germany, where Sandoz was the first company to challenge the relevant dosage patent3, this launch marks a significant step in expanding access to high-quality, affordable anticoagulant therapies... Full

Indivior Slims Headcount, Weighs Opvee Divesture in First Phase of Multiyear Restructuring Plan

(8/27, Zoey Becker, Fierce Pharma) ...The first phase of the company's "Indivior Action Agenda," which looks to "generate momentum" and lay the groundwork for the rest of the three-pronged plan, is ongoing through the end of 2025. Along with growing its opioid use disorder treatment Sublocade in the U.S. and pinpointing the "actions and investments" necessary to further penetrate the long-acting injectable market, the agenda includes actions to simplify the organization by "eliminating all non-essential activities," the company explained in a Tuesday SEC filing... Full

Stada CEO Says IPO Planned This Year in Boost to European Market

(8/28, Eyk Henning, Bloomberg) ..."A larger pipeline of in-licensed drugs and our European footprint bode well for Stada," CEO Peter Goldschmidt said in an interview this week. The company secured a record number of 50 new in-licensing deals in the first half of this year, he added. Stada would join a group of multi-billion dollar businesses such as alarm company Verisure, specialist lender Shawbrook Group Plc and financial data provider ISS Stoxx GmbH with plans for an IPO, giving a boost to the region's market after the slowest first half in more than a decade... Sub. Req’d

MSN Seeks Supreme Court Review in Challenge of Novartis Patent

(8/27, Michael Shapiro, Bloomberg Law) ...The company is challenging the appeals court's rejection of MSN's argument that a Novartis Pharmaceuticals Corp. patent filed in 2002 and covering a combination of the drugs valsartan and sacubitril to treat heart failure is invalid. MSN says the patent's claims were read broadly for infringement purposes to cover its "complexed" drug that merged the compounds together as a single entity but narrowly with regard to its arguments the patent was invalid... Sub. Req’d

Cipla Recalls Inhalation Drug in US

(8/27, Press Trust Of India) ...In its latest Enforcement Report, the US Food and Drug Administration (USFDA) stated that Cipla USA, Inc., an arm of the Mumbai-based drug major, is recalling Ibuterol Sulfate Inhalation Aerosol. The company is recalling 20,352 packs of the inhalation drug due to "Failed Stability Specifications", it stated. "Out-of-specification results were observed in Induction Port during the analysis of Particle size distribution at the 12-month time point," USFDA added... Full

NHS to Lose Out On New Drugs, Pharma Firm Warns

(8/27, Pritti Mistry, BBC) ...The warning comes after talks over the cost of medicines for the UK between Health Secretary Wes Streeting and pharma firms broke down last week. A body assesses whether a new drug is value for money before approving it for use on the NHS, but Novartis said its methods were outdated and made it harder for innovative drugs to be approved and launched. Norvartis's UK boss Johan Kahlstrom said costs meant the UK was "largely uninvestable", but Streeting has vowed he will not allow firms to "rip off" taxpayers... Full

Eli Lilly Temporarily Halts UK Shipments of Weight-Loss Drug Mounjaro

(8/27, Sriparna Roy, Reuters) ...Lilly said that, in order to manage its supply and ensure that patients maintain access, it has allocations in place for pharmacies and providers that order medicines from the company. There are legal protections in place to prevent inappropriate stockpiling of medicines by providers, the company said on Wednesday. It will resume orders on September 1... Full

Patients Struggle to Get Weight Loss Drug Ahead of Price Rise

(8/27, Philippa Roxby, BBC) ...Some patients taking the weight-loss drug Mounjaro have told BBC News they are struggling to obtain the medicine, and are worried about the impact on their health...The drug giant has warned against "inappropriate stockpiling of medicines" and has now asked UK distributors to stop taking orders from pharmacies from the end of today. Pharmacies say they are prioritising patients already taking the drug, rather than those just starting it, and predict supplies will return to normal in early September... Full

Prices of 50 Life-Saving Drugs May Get Cheaper

(8/27, Ashish Srivastava, The New Indian Express) ...About 50 essential medicines, including those for diabetes and blood pressure, are likely to become cheaper as the government considers lowering their Goods and Services Tax, the Indian Medical Association (IMA) claimed on Wednesday...Members said the body has recommended zero tax on insulin, oral anti-diabetic drugs, antihypertensives, cardiac medicines, and treatments for chronic kidney disease, thyroid disorders, osteoporosis, asthma, and COPD... Full

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