Tuesday, June 17, 2025

Teva, Fosun Pharma Partner to Develop Anti-PD1-IL2 Therapy TEV-56278

(6/17, Vidya Sagar Maddela, World Pharmaceuticals Frontiers) ...Teva Pharmaceutical Industries and Shanghai Fosun Pharmaceutical have entered a strategic partnership to advance the development of TEV-56278. The collaboration aims to enhance the clinical data generation for TEV-56278, an investigational anti-PD1-IL2 therapy created using Teva's in-house Attenukine technology... Full

Teva, Fosun Pharma Partner to Develop Immuno-Oncology Therapy

(6/16, Rachel Klemovitch, Contract Pharma) ..."This partnership with Fosun Pharma in the development of our internally developed TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy with the potential to treat devastating cancers, is the latest advance to ensuring acceleration of our pipeline," commented, Eric Hughes, MD, PhD, Executive Vice President, Teva Global R&D and Chief Medical Officer. "TEV-56278 demonstrates the strength of Teva's innovative drug development capabilities and how strategic partnerships with companies such as Fosun Pharma play a pivotal role in advancing therapies on behalf of patients."... Full

Teva, Shanghai Fosun Partner To Develop TEV-56278

(6/16, RTTNews) ...Teva's TEV-56278 utilizes the company's proprietary Attenukine technology, a new mechanism of action, potentially offering high efficacy and low toxicity in a broad array of oncology indications. As per the deal, which aims to accelerate clinical data generation for TEV-56278, Fosun Pharma gets an exclusive license to develop and sell TEV-56278 in Chinese mainland, Hong Kong Special Administrative Region (SAR), Macau SAR and Taiwan region and select Southeast Asian countries. Teva retains its rights to the licensed molecule in the rest of the world... Full

Pharma Tariffs Coming 'Very Soon', Says Trump

(6/17, Jeff Mason and Martin Claffey, Irish Examiner) ...Speaking to reporters on Air Force One on the way back from attending a meeting of G7 leaders, Trump said also said pharmaceutical tariffs were coming very soon. "We're going to be doing pharmaceuticals very soon. That's going to bring all the companies back into America," he said. "It's going to bring most of them back into, at least partially back in."... Full

Donald Trump's 'Tariffs Coming Soon' Remark Sinks Pharma Stocks Yet Again

(6/17, Hormaz Fatakia, CNBC TV-18) ...Currently, Pharma, as a sector, is being investigated by the US Commerce Department, under Section 232, which is used to determine the effects the imports of a goods or service could have on national security. Section 232 is exempt from the baseline and reciprocal tariffs...In case there is no pass through, companies with the highest exposure to the US generics market will likely take a one-time hit to their Earnings Before Interest, Tax, Depreciation and Amortisation (EBITDA) in the range of 9% to 12%, according to Citi... Full

Tariffs Are Driving 2026 Health Insurance Premiums Up

(6/16, Matt McGough, KFF) ...President Trump has vowed to impose tariffs on a wide variety of goods from multiple countries. While consumers may expect the price of some imported goods to go up, what may be surprising is that these tariffs are already driving health insurance premiums up. That is because some health insurance companies expect tariffs to drive up their own costs for prescription drugs that are imported into the United States. Retail prescription drugs represent about 12% of all private health insurance spending... Full

The Impact of Formulary Controls On Medicare Patients in Five Chronic Therapeutic Areas

(6/16, IQVIA) ...To understand how payer controls may impact Medicare Part D patients, we conducted an in-depth, longitudinal study of payer rejections occurring January 2020 through September 2024 across five chronic therapeutic areas (TAs) — pulmonary arterial hypertension (PAH), osteoporosis, multiple sclerosis (MS), immunology, and migraine. Top brands, as determined by market share, within each TA were selected for analysis... Full

I-MAK Report Reveals How Extending Patent Terms Inflates Prices of Medicare's Top Negotiated Drugs

(6/16, The Initiative for Medicines, Access, and Knowledge) ...The new data brief exposes how these systemic flaws impact Eliquis, a top-selling blood thinner, and the semaglutide family of diabetes and weight-loss drugs including Ozempic, Rybelsus, and Wegovy..."What we're seeing is a patent system that is designed to help drugmakers extend their patent monopolies so they can maximize profits at the expense of affordable medicines patients can access," said Tahir Amin, CEO and co-founder of I-MAK. "We need to change these different incentives in the patent system as they are being exploited to the detriment of the public."... Full

Threat in Your Medicine Cabinet: The FDA's Gamble On America's Drugs

(6/17, Debbie Cenziper, Megan Rose, Brandon Roberts and Irena Hwang, ProPublica) ...Sun Pharma's transgressions were so egregious that the [FDA] imposed one of the government's harshest penalties: banning the factory from exporting drugs to the United States. But the agency, worried about medication shortages, immediately undercut its mission to ensure the safety of America's drug supply. A secretive group inside the FDA gave the global manufacturer a special pass to continue shipping more than a dozen drugs to the United States even though they were made at the same substandard factory that the agency had officially sanctioned...A ProPublica investigation found that over a dozen years, the same small cadre at the FDA granted similar exemptions to more than 20 other factories that had violated critical standards in drugmaking, nearly all in India... Full

Orphan Drug IRA Fix Dropped From Senate Text; PBM, Pharmacy Measures Remain

(6/16, Gabrielle Wanneh, Inside Health Policy) ...The missing House provision would expand the orphan drug exclusion to include orphan drugs approved with more than one treatment indication, one of the few drug pricing measures included in the reconciliation text that passed the House last month... Sub. Req’d

PCMA Statement On Biosimilar Red Tape Elimination Act

(6/16, PCMA) ..."We applaud Senators Mike Lee (R-UT) and Ben Ray Luján (D-NM) for re-introducing the Biosimilar Red Tape Elimination Act to increase competition within the biosimilar market and improve access to more affordable alternatives to brand name prescription drugs. Increased competition in the prescription drug marketplace is a proven path to lower drug costs. Sens. Lee and Lujan's legislation ‘would deem biosimilars as interchangeable with their branded equivalent upon their approval by the FDA. It also allows for use of switching studies in special circumstances.'..."... Full

Makary Says He Wants Nimbler FDA, Calls for New Drug Pathways and Pilots

(6/16, Ferdous Al-Faruque, Regulatory Focus) ..."I think in five years we'll be measured by how nimble we are, how we have adapted to the modern time, how fast we have changed the agency to adapt to the fast pace of medicine," Makary said during a panel at the DIA Global Annual Meeting on Monday... Full

FDA Finalizes Guidance On Pre-Submission Facility Correspondence for Priority Generic Submissions

(6/16, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration (FDA) has finalized guidance detailing the information that sponsors must submit in a pre-submission facility correspondence (PFC) for priority review of abbreviated new drug applications (ANDAs), prior approval supplements (PAS), or amendments to either of these submission types. The guidance also outlines how the agency will review the information contained in the PFC... Full

Amgen Renews Push for Colorado Payment Cap Halt At Appeals Court

(6/16, Celine Castronuovo, Bloomberg Law) ...Judge Nina Y. Wang of the US District Court for the District of Colorado improperly ruled in March that Amgen lacked standing to challenge the law allowing the Colorado Prescription Drug Affordability Board to set payment caps for some of the most expensive drugs in the state, attorneys for Amgen argued in the company's opening appeal brief filed Friday in the US Court of Appeals for the Federal Circuit... Sub. Req’d

Iowa Governor Signs Law That Rightens Oversight of PBMs

(6/16, Paige Minemyer, Fierce Healthcare) ...The law would require PBMs to reimburse independent or unaffiliated pharmacies at the same rate they pay affiliated facilities, and also pay dispensing fees for prescriptions... Full

Binex Inks New Celltrion Deal to Make Clinical-Stage Biosimilars

(6/16, Kim Ji-hye, Korea Biomedical Review) ...Korea-based CDMO Binex has secured a fresh manufacturing deal with Celltrion to produce drug substances for two clinical-stage biosimilar candidates, the company said Monday...That collaboration led to the commercial launch of Avtozma, Celltrion's Actemra (tocilizumab) biosimilar used to treat autoimmune diseases, which Binex now produces at scale for global distribution... Full

Samsung Bioepis, Biogen Lose Humira Biosimilar Patent Fight in Germany

(6/16, Kim Ji-hye, Korea Biomedical Review) ...The ruling, enforceable immediately, bans the sale of Imraldi in Germany and orders Biogen to recall and destroy existing inventory. The court also issued an injunction and demanded financial damages and disclosure of sales and accounting data, raising the stakes for Bioepis, which co-developed Imraldi and has faced similar legal challenges elsewhere in Europe... Full

New Data Support Hulio as an Interchangeable Adalimumab Option

(6/16, Skylar Jeremias, The Center for Biosimilars) ...The FDA's decision to grant an interchangeable biosimilar designation to adalimumab-fkjp, marketed as Hulio, will be driven by compelling evidence from a pivotal clinical study that demonstrated the product's equivalence to the reference biologic, the data from which were published in Advances in Therapy... Full

New Vizient Survey Finds Drug Shortages Cost Hospitals Nearly $900M Annually in Labor Expenses

(6/17, Vizient) ...The new survey, "Beyond the Shortage: The Hidden Cost of Drug Supply Chain Disruptions," revealed that in 2023, hospitals across the U.S. spent roughly 20 million hours managing a range of drug shortages, which translates to nearly $900 million annually in labor costs—more than double the labor costs reported of just under $360 million in the 2019 survey. "The new survey's findings illustrate how staffing burdens have surged since 2019, demanding more time and resources—especially in pediatric facilities—to simply navigate drug shortages," said Nikola Markoski, director, pharmacy sourcing strategic solutions & analytics for Vizient... Full

Roche Moves Ahead with Phase 3 Parkinson's Study Despite Mixed Trial Results

(6/16, Lei Lei Wu, Endpoints News) ...Roche and Prothena said they're planning to proceed with a Phase 3 study of an experimental Parkinson's antibody called prasinezumab, even though two previous mid-stage trials failed to meet their primary endpoints. The antibody showed "potential clinical efficacy" in delaying the onset of motor symptoms, as well as longer-term follow-up results, Roche said in a Monday release... Full

Supernus Acquires Struggling Sage for $561M, Taking a Flier On Postpartum Depression Drug Zurzuvae

(6/16, Kevin Dunleavy, Fierce Pharma) ...Neurology specialist Supernus Pharmaceuticals will snap up Sage Therapeutics, which was once valued at more than $9 billion, for $561 million up front, with the hope that it can help transform a newly launched treatment for postpartum depression (PPD) into the indication's standard of care...Supernus said it expects the deal to close in the third quarter of this year. Supernus sees cost savings advantages to adding Sage given their overlapping networks... Full

Targeted Cancer Drugs May Replace Chemo for Some Patients — and Drugmakers Say They're Getting Closer

(6/17, Annika Kim Constantino, CNBC) ...The pharmaceutical industry says a popular class of targeted cancer therapies could one day replace chemotherapy and its potential for harsh side effects. There is still more work to be done to refine antibody-drug conjugates, but some are already becoming the go-to treatment option for certain cancers...Still, some companies say ADCs have shown the ability to replace chemotherapy in certain settings. Other drugmakers say they are inching closer to developing ADCs that can be used before chemo — or at the very least, learning from previous missteps. "We are leading the way towards establishing ADCs as a precision-based approach to replace classic chemotherapy," David Fredrickson, executive vice president of AstraZeneca's oncology business, told CNBC... Full

Purdue Pharma $7.4 Billion Opioid Settlement Wins Broad Support from US States

(6/16, Jonathan Stempel, Reuters) ...A framework for the settlement had been announced in January by New York Attorney General Letitia James and other states, and the support announced on Monday could help Purdue Pharma win court approval for its bankruptcy reorganization. The $7.4 billion payment is intended to resolve claims that the drugmaker's pain medication OxyContin caused a nationwide opioid addiction crisis. It includes about $6.5 billion from the Sacklers and about $900 million from Purdue Pharma... Full

Novo Nordisk, FDA Score Win in Weight Loss Drug Shortage Fight

(6/16, Nyah Phengsitthy, Bloomberg Law) ...The FDA lawfully determined that Novo Nordisk A/S's ozempic drug shortage ended and that drug compounders can't keep making copies of the weight loss medicine, a federal judge ruled...The Outsourcing Facilities Association and compounding pharmacy FarmaKeio Custom Compounding alleged the FDA's decision was arbitrary and capricious, and the agency should have solicited public comments before taking semaglutide—a diabetes and obesity treatment branded as Ozempic and Wegovy—off the shortage list... Sub. Req’d

Global Pharmaceutical Demand is Increasingly Shifting Towards Innovative & Specialty Drugs: Expert

(6/17, Nandita Vijayasimha, Pharmabiz.com) ...India is well known for its robust generic drug ecosystem with an economic and strategic edge over its global counterparts. This advantage stems from a combination of strong manufacturing infrastructure, skilled human resources and low production costs. The companies have played a vital role in supplying affordable medications to both developing and developed countries, especially during public health crises, said Dr. Sujit Paul, group CEO, Zota Healthcare... Full

Will Work With Partner Countries to Advance Regulatory Collaboration, Says Minister Anupriya Patel

(6/16, Pharmabiz.com) ...India continues to be a leader in drug manufacturing, especially when it comes to the generic medicines, and hope to continue to work together with partner countries to advance the regulatory collaboration and promote the recognition of the pharmacopoeial standards, said Union minister of state for health and family welfare and chemicals & fertilizers, Anupriya Patel. She was delivering the keynote address at the inaugural session of the Second Policymakers' Forum organised by Indian Pharmacopoeia Commission... Full

Sustainability Pivot: Pharma Companies Are Shifting To Cleaner Practices

(6/17, Neetu Chandra Sharma, Business Today) ...The CDP's pharma report adds that the growth of the sector must align with environmental responsibility. "Sustainability intelligence and climate resilience are emerging as key drivers of competitive advantage for the Indian pharmaceutical sector. Industry leaders are increasingly prioritising impact pillars such as green chemistry, circularity, energy transition, water stewardship, and equitable access to affordable healthcare," says Nitesh Mehrotra, Partner, Sustainability & Resilience at EY India. But the winds of change are evident, he adds... Full

China Proposes Shorter Clinical Trial Reviews in Efforts to Accelerate Drug Development

(6/16, Angus Liu, Fierce Biotech) ...China, already gaining speed in biotechnology, is looking to further accelerate novel drug development by reducing the time that regulators take to review clinical trials. In a draft policy posted (Chinese) Monday, China's National Medical Products Administration (NMPA) is proposing to cut the clinical trial review waiting period for novel medicines to 30 working days, down from the current 60 working days... Full

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