Thursday, July 3, 2025

Please note: Teva Daily News will not publish Friday, July 4 in observance of the U.S. Independence Day holiday. Publication will resume on Monday, July 7.

US Open to 'Creative Solutions' On Pharma Trade with EU, Irish Minister Says

(7/2, Conor Humphries, Reuters) ...U.S. Trade Representative Jamieson Greer made clear in a meeting with Irish Trade Minster Simon Harris last month that Washington was open to "creative solutions" on pharmaceutical trade between the U.S. and European Union, Harris said on Wednesday. "He made it clear that he was open to creative solutions when it comes to pharma and I think that's an important recognition that actually pharma between the U.S. and the EU, the U.S. and Ireland, is much more interdependent than perhaps people were led to believe in certain quarters at the start of this process," Harris told reporters... Full

How Could MFN Pricing Impact Commercial Market?

(7/2, Angela Maas, Pink Sheet) ...Most stakeholders agree that applying most-favored nation drug pricing to the commercial market would be extremely difficult, potentially more so with the proposal not codified in the One Big Beautiful Bill pending in the House of Representatives. Administration officials had said lawmakers were interested in enacting the policy, but also could create a demonstration project through the US Center for Medicare and Medicaid Innovation... Global Sub. Full

Trump's Ongoing Tariff Chaos Will Make Medications Less Affordable And Harder To Find

(7/2, Aaron S. Kesselheim and Jerry Avorn, Health Affairs) ...In his first term, Trump made a lot of noise about lowering drug prices but accomplished little of consequence. The noise continues, but it is now accompanied by new ill-conceived initiatives, including rapidly shifting surcharge threats that are likely to fail or to make these problems even worse. A steep new tariff-driven rise in the price of a new iPhone would be an annoyance for many consumers and create havoc for one of the country's most successful companies. But sharp increases in the costs of the medicines people depend on could be lethal... Full

DOJ, HHS Working Group To Crack Down On Drug Price, MA False Claims

(7/2, Gabrielle Wanneh, Inside Health Policy) ...HHS and the Justice Department have formed a working group to crack down on false claims violations across the health care industry, including those that increase prices for prescription drugs and medical devices, pose barriers to patient access to care, and involve kickbacks related to drugs, devices, durable medical equipment or other products covered by the federal government... Sub. Req’d

Medicare's Combo Products Negotiation Plan Conflicts With US FDA Standards, Firms Argue

(7/2, Cathy Kelly, Pink Sheet) ...CMS' proposal to treat fixed dose combinations that do not offer a "clinically meaningful" improvement over older drugs with the same active moiety as the drug for Medicare price negotiation conflicts with the FDA's regulation of combinations, pharma manufacturers said. The proposal in recent draft guidance could impact subcutaneous versions of Keytruda, Opdivo, Darzalex and Tecentriq. Even if CMS modifies the approach to combinations, it should recognize the value of subQ versions of oncology treatments and avoid creating a disincentive for the innovation, Bristol Myers Squibb said... Global Sub. Full

How the Tax-Cut Bill that Just Passed the Senate Would Upend Health Care

(7/2, Daniel Payne, Chelsea Cirruzzo, and John Wilkerson, STAT+) ...Senate Republicans passed President Trump's landmark tax bill Tuesday morning, putting transformational health provisions a major step closer to enactment. The bill slashes health care spending by more than $1 trillion over a decade, cuts that would affect patients, hospitals, and doctors nationwide. It will force states to make tough decisions about how to balance their budgets as the federal government pulls back... Sub. Req’d

Let's Fix Our Own Prescription Drug Policies

(7/3, Mark Merritt, RealClearHealth) ...Instead of copying Europe's government-controlled approach, Washington must stop protecting middlemen and favoring those in government programs over those with private health insurance. It's time to focus on what actually matters: reducing pharmacy costs for all Americans, not just expanding government control over healthcare decisions. In short, the solution isn't importing Europe's problems -- it's fixing our own... Full

Memo Said to Describe Biotech Industry Meeting Calls RFK Jr. a ‘Direct Threat to Public Health'

(7/2, Allison DeAngelis and Elaine Chen, STAT+) ...The four-page document purportedly details topics of conversation at an April 3 meeting of a vaccine policy committee of the trade group BIO, in which attendees discussed anxieties about Kennedy's positions on vaccines and strategies to engage with more conservative influencers. The document also includes an apparent quote from someone in attendance: "it is time to go to The Hill and lobby that it is time for RFK Jr to go."... Sub. Req’d

AbbVie Loses Bid to Block Tennessee's 340B Contract Pharmacy Law

(7/2, Alexis Kramer, Endpoints News) ...The decision is another blow to pharmaceutical companies trying to curb what they call fraud and abuse in the program and limit the number of pharmacies that they supply discounted drugs to...District Judge Aleta Trauger this week denied AbbVie's bid for a preliminary injunction against Tennessee's law. The pharma giant will likely fail to show that some of the law's provisions preempt the federal 340B statute, she wrote... Sub. Req’d

Relief from Drug Industry Middlemen Stalled in Kentucky as Independent Pharmacies Struggle

(7/3, Deborah Yetter, Kentucky Lantern) ...The new law — passed with overwhelming support by the legislature and signed into law by Gov. Andy Beshear last year — takes aim at the role of PBMs in commercial health plans, such as those purchased by individuals or provided by employers. But a year later, it has stalled, with Beshear's Department of Insurance claiming it can't enforce parts of it because of a conflict with federal law that regulates commercial insurance plans... Full

Biocon Arm Gets Market Authorisation in EU for Two Biosimilars of Denosumab

(7/3, Shloka Badkar, CNBC TV-18) ...Biocon Ltd. on Thursday, July 3, said the European Commission granted its subsidiary Biocon Biologics marketing authorisation in the Euorpean Union for the two biosimilars of Denosumab — Vevzuo or Evfraxy. Vevzuo is authorised for the prevention of bone complications in adults with advanced cancer involving bone and the treatment of adults and skeletally mature adolescents with giant tumour of bone, the company said in an exchange filing... Full

Where Art Thou Celltrion? Kabi Pushes Past With US Denosumab Launches

(7/2, Dean Rudge, Generics Bulletin) ...Fresenius Kabi has launched its denosumab biosimilars, Conexxence and Bomyntra, in the US, becoming the second company to do so after Sandoz. Fresenius Kabi settled patent litigation with Amgen, which allowed for US launches to occur mid-2025 – while biosimilars developed by Celltrion were set to launch in June 2025. Amgen commented recently that it had seen minor differences in WAC pricing following the launch of competitor products... Global Sub. Full

Sunshine Biopharma Launches NIOPEG(R) Into $10 Billion Biologics Market

(7/2, Sunshine Biopharma Inc.) ...NIOPEG® is a Biosimilar comparable to the reference biologic drug NEULASTA® (Pegfilgrastim). Like NEULASTA®, NIOPEG® is a long-acting, pegylated form of recombinant human granulocyte colony-stimulating factor (filgrastim). It is indicated to decrease the incidence of infection in patients with non-myeloid malignancies receiving chemotherapy. NIOPEG® is available in a prefilled syringe of 6mg/0.6mL. As of 2024, the global market size for NEULASTA® and its biosimilars was estimated at $4.5 billion, with projections suggesting it could reach $9.2 billion by 2033, growing at a compound annual growth rate (CAGR) of 8.5% (Verified Market Reports)... Full

Sam Chun Dang Pharm Launches Canada Sales of Biosimilar Macular Degeneration Drug SCD411

(7/2, Yeom Hyun-a, ChosunBiz) ...SCD411 is a biosimilar that replicates Eylea from Regeneron in the United States, and macular degeneration is considered a major cause of blindness in the elderly. Last year, global sales of Eylea reached approximately $9.523 billion (Hanwha 13.33 trillion won). The U.S. substance patent expired last year, and the European patent is expected to end in November... Full

Aurobindo Pharma Arm Gets European Commission Nod for Cancer Drug Dazublys

(7/2, Megha Rani, CNBC TV-18) ...This regulatory milestone follows the positive opinion issued in April 2025 by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), which recommended Dazublys for approval based on its demonstrated similarity to the reference biologic, Herceptin. Dazublys is indicated for the treatment of HER2-positive breast and gastric cancers, offering a more accessible therapeutic option in oncology care. The biosimilar has shown comparable quality, safety, and efficacy to the original trastuzumab product, supporting its use across EU member states... Full

Bridging The Void: How Biocon Biologics Sees The Future Of Biosimilars In Europe

(7/2, Dave Wallace, Generics Bulletin) ...Biocon Biologics has just picked up a UK approval for its Stelara (ustekinumab) biosimilar, Yesintek. Blake Leitch, head of Europe at Biocon Biologics, speaks about how the UK is a leading, progressive market for biosimilars – but acknowledges that some aspects remain challenging. Recent EMA steps toward regulatory streamlining for biosimilars are seen positively, but concrete action is needed to make them a reality. Securing European approvals for denosumab rivals to Prolia and Xgeva will be the next major milestone on the horizon for Biocon Biologics... Global Sub. Full

The Future of Top-Selling Biologics: Biosimilars On the Rise

(7/2, Matthew Haddad, Pharmacy Times) ...The biosimilar era is rapidly accelerating, with several high-profile biologics facing patent expirations and new competitors entering the pipeline. Pembrolizumab, dupilumab, risankizumab, and adalimumab each illustrate different stages in the biosimilar life cycle, from active market presence to future potential. As biosimilars gain ground, they may redefine which drugs dominate the pharmaceutical market and how pharmacists help shape that future... Full

FDA Approves Vancomycin Injection For Ready-to-Infuse Sepsis Therapy

(7/2, Kennedy Ferruggia, Pharmacy Times) ...The FDA has approved vancomycin injection, USP (Tyzavan; Hikma Pharmaceuticals PLC), for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections in adult and pediatric patients 1 month and older for whom appropriate dosing can be achieved... Full

Alembic Pharma Expands US Footprint with $12 Million Acquisition of Utility Therapeutics

(7/3, Meghna Sen, CNBC TV-18) ...Alembic Pharmaceuticals Inc., a wholly owned subsidiary of Alembic Pharmaceuticals Ltd., has acquired Utility Therapeutics Ltd. to expand its UTI drug portfolio in the US. The acquisition includes 100% ownership of Utility Therapeutics. The acquisition cost is approximately $12 million, and the deal is expected to be completed within 30 days... Full

Torrent Acquires JB Chem In 2025's Biggest Deal For Indian Pharma

(7/2, Vibha Ravi, Generics Bulletin) ...During a call, Torrent CFO Sudhir Menon said the acquisition is expected to add to its earnings per share (EPS) only from FY28, with a merger of JB Chemicals and Pharmaceuticals (JB Pharma) expected in 15 to 18 months. The acquisition helps Torrent boost its international formulations business and fill white spaces in its domestic nephrology and ophthalmology portfolio. JB Pharma derived about 42% of its FY25 revenues from international business, Torrent said in a post announcement presentation... Global Sub. Full

Q&A: Can Digital Inhalers Predict Exacerbations of COPD?

(7/3, Physician's Weekly) ...Digital inhalers utilizing remote monitoring data may aid in predicting and identifying early or impending exacerbations of chronic obstructive pulmonary disease (COPD), according to a study published in Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation. Physician's Weekly (PW) spoke with lead study author M. Bradley Drummond, MD, MHS, professor of medicine in the Division of Pulmonary Diseases and Critical Care Medicine at the University of North Carolina, to learn more about the study and its implications for patients with COPD... Full

UK Government, Pharma Industry Still Far Away from Life Sciences Plan Agreement

(7/2, Maggie Fick and Alistair Smout, Reuters) ...The review is intended to outline how the UK can cut red tape and boost a sector the government identifies as one of eight strategic areas for driving economic growth. The disagreement comes amid simmering frustration in the pharma industry. The Times reported on Tuesday that AstraZeneca, the UK stock market's most valuable company, is considering shifting its stock market listing to the United States...The "life sciences review" was due to published on Monday. The Financial Times reported on Wednesday that the delay stemmed from the impasse over drug pricing... Full

Big Pharma On Brink in Britain as Ministers Finalise Health Plans

(7/2, Alex Ralph, The Times) ...With the government seeking to finalise its plan for the life sciences sector as well as an NHS drug pricing deal, the prospects for both the UK industry and relations with its biggest company are set to be cast. In Whitehall, ministers are close to publishing a delayed ten-year plan for the life sciences sector under its industrial strategy, but concurrent negotiations over the contentious NHS drugs scheme are understood to have hit an impasse. Industry sources believe they are critical to the future of the industry in Britain and the commitment of AstraZeneca, the most valuable company on the London Stock Exchange... Sub. Req’d

Federal Drug-Price Regulator Unveils New Guidelines for 2026

(7/2, Chris Hannay, The Globe and Mail) ...The new guidelines from the Patented Medicine Prices Review Board lay out how staff should monitor the prices of drugs brought to the Canadian market. In a break from the past, staff are directed to triage cases and only launch in-depth reviews in certain cases, such as if a Canadian price is higher than an international average or if a price rises faster than inflation. Guillaume Couillard, director general of the PMPRB, said the purpose of the new guidelines is to be transparent to the industry on the how the regulator will operate... Sub. Req’d

China Approves 4 New Drugs, Including a Global First-In-Class Medicine

(7/2, Angus Liu, Fierce Pharma) ...China's National Medical Products Administration (NMPA) has approved four new drugs developed by local biopharma companies, including a first-of-its-kind molecule in blood cancer. Wednesday, Chinese regulators announced (Chinese) the conditional approval of ifupinostat (BEBT-908) for treating diffuse large B-cell lymphoma (DLBCL) patients who have tried at least two prior lines of therapy... Full

Bigger Fonts, Clearer Tags: How the Drug Regulator is Looking to Redesign Hard-to-Read Medicine Labels

(7/3, Priyanka Sharma, Mint) ...The Drug Controller General of India (DCGI) is working on a nationwide overhaul of medicine packaging and labelling norms. The goal is to make expiry dates and batch numbers easier to read, reduce confusion between generic and branded drugs, and help patients, make better-informed choices, two government officials aware of the matter said...There's also a plan to introduce a universal symbol to clearly distinguish generic medicines from branded ones. The regulator had received several complaints regarding the difficulty in differentiating between cheaper generic drugs and their branded counterparts, and consequently, the pricing comparison... Sub. Req’d

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