Thursday, July 2, 2026

 

 

Teva Deploys Hydrogen Truck for Pharmaceutical Logistics in Germany

(7/1, Fuel Cell Works) ...The pharmaceutical company Teva, best known in Germany for its ratiopharm brand, has put hylane's first hydrogen vehicle into operation...Teva sources the new vehicle via the use-based rental model of hylane. This allows easy access to zero-emission trucks without investment risk... Full

 

 

Preparing for the July 31 Pharma Tariff Deadline

(6/30, Mike Hollan, PharmExec.com) ...Pharmaceutical Executive spoke with Ryan Last, a senior associate at Troutman Pepper Locke, about the situation pharmaceutical and biotech companies face with just one month remaining before the initial deadline hits. While previous deadlines have passed by, pharma companies still have time to prepare and make plans, while also bracing for the larger impact that these tariffs may have... Full

 

The Pill and the Price: What 2025's Pharmaceutical Tariffs Actually Did and What They Left Unfinished

(7/1, James Buteera, Medium) ...Economic theory tells us that if the U.S. has market power as the world's largest pharmaceutical importer, it should be able to force foreign exporters to lower their pre-tariff prices - improving what economists call the "terms of trade." That did not happen. Foreign suppliers in Ireland, Switzerland, Germany, and India did not blink. They did not lower their prices. Instead, the full burden of the tariff fell on American importers, manufacturers, and ultimately, patients... Full

 

Congress Created a Drug Pricing Program to Deliver Affordability. Instead, It's Raising Costs

(7/1, Amanda Krzepicki, Washington Examiner) ...The problem persists largely because 340B operates with too little accountability. Participating hospitals are not required to show whether the savings they generate lower patients' costs or expand access to care. Public reporting remains limited, and federal oversight has failed to keep pace with the program's size and complexity... Full

 

US FDA Leadership Team Announcements Coming As HHS' Klomp Focuses On 'Trust'

(7/1, Ramsey Baghdadi, Pink Sheet) ...The White House and HHS appear close to announcing the new FDA senior leadership team and apparently has a diverse roster of potential candidates from inside and outside the administration. "I think you will hear about our FDA leadership nominees shortly," Chris Klomp, HHS chief counselor and nominee for deputy secretary, said in late June during the Aspen Ideas health care meeting... Global Sub. Full

 

FDA Asked to Clarify AI Pilot Objectives for Early-Phase Clinical Trials

(7/1, Ferdous Al-Faruque, Regulatory Focus) ...Industry and academic stakeholders have asked the US [FDA] to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) technologies can help improve early-phase clinical trials. They also said the agency should develop a governance structure with specific metrics and goals and consider aligning its thinking with other regulators... Full

 

A Former AI Regulator, Now in Industry, Says Biopharma Is Reading FDA's Guidance Wrong

(7/2, Nrittany Trang, STAT+) ..."When we wrote the AI guidance, it was meant to be, flexible, agile, not telling sponsors exactly the steps that they need to do to show that their AI use is credible for a specific context," [Tala Fakhouri] told STAT at the BIO conference in San Diego. As part of her role at Parexel, she advises pharma companies on AI policy and how to deploy the technology..."I've been encouraging former colleagues at the FDA to issue more use cases, show how you actually expect validation of these AI tools to happen so that industry knows how to use them," she said... Sub. Req'd

 

Novartis Stumbles in Challenge to Missouri Discounted Drug Mandate

(7/1, Joe Harris, Courthouse News Service) ...In a unanimous ruling, a three-judge panel found Novartis' arguments that a federal court erred in denying a preliminary injunction because it was unlikely to succeed on the merits fell flat... Full

 

Colorado's Pathfinder Medicine Price-Cap Move Stalls

(7/2, Phil Taylor, pharmaphorum) ...A federal judge in the US has sided with Amgen in a dispute over a price cap imposed by the state of Colorado on its blockbuster immunology drug Enbrel...The preliminary injunction pauses the cap, which had been due to come into effect at the start of next year, while the underlying lawsuit proceeds... Full

 

With FDA Nod, CO Now Seeks Buy-In From Pharma, States To Get Import Plan Going

(7/1, Lauren Brensel, Inside Health Policy) ...Colorado Department of Health Care Policy & Financing officials overseeing the state's importation program, the first for private insurance plans, told Inside Health Policy the health department is entering the next phase of drug importation: seeking approval from manufacturers, who must give consent for their medications to be purchased and imported... Sub. Req'd

 

 

Roche's KRAS Drug Tops its Rivals in Lung Cancer Trial

(7/2, Phil Taylor, pharmaphorum) ...The Krascendo 1 study pitted divarasib directly against Amgen's Lumakras (sotorasib) and BMS's Krazati (adagrasib) in patients with previously treated KRAS G12C-mutated non-small cell lung cancer (NSCLC) and, according to Roche, it was better at delaying disease progression and extending survival... Full

 

Abivax Shares Surge as Worries Subside Over Immune Drug's Cancer Risk

(7/1, Jonathan Gardner, BioPharma DIVE) ...Shares of Paris-based biotechnology company Abivax surged nearly 40% Tuesday following the release of supplementary Phase 3 data on its inflammatory bowel disease drug that cleared away investors' concerns about increased cancer risk... Full

 

Merck Scraps a Phase 2 Alzheimer's Asset from Partner Neuphoria

(7/1, Kyle LaHucik, Endpoints News) ...Merck has axed a Phase 2 trial testing an experimental Alzheimer's medicine, Endpoints News has learned. The company terminated a mid-stage test of the oral drug candidate MK-1167, a Merck spokesperson confirmed to Endpoints in an email on Wednesday... Sub. Req'd

 

Approval of Parkinson's Therapy Urged in Europe Under Brand Name Hopledo

(7/1, Andrea Lobo, Parkinson's News Today) ...Subject to the commission's approval, Zambon Biotech - which holds rights to the treatment in Europe - expects to start marketing the Parkinson's therapy in the EU in October, according to a company press release announcing the committee's recommendation... Full

 

Produodopa's Positive RWE for Parkinson's Disease to Boost Clinician Confidence in Crowded Levodopa Market

(7/1, PharmaLive.com) ...Produodopa is the first-to-market, non-surgical, 24-hour/day continuous subcutaneous infusion therapy for adults with advanced Parkinson's disease whose motor fluctuations remain inadequately controlled on oral medications. The ROSSINI study is an ongoing, three-year, multi-country, prospective observational study evaluating the long-term safety and effectiveness of Produodopa in routine clinical practice... Full

 

 

Hybio Submits Paragraph IV Challenge For Its Generic Tirzepatide Pen

(7/1, Urte Fultinaviciute, Generics Bulletin) ...Adalvo and Amneal also announced a partnership on generic tirzepatide, choosing the autoinjector presentation... Global Sub. Full

 

Japan Deal Strengthens EirGenix's HER2 Biosimilar Story

(7/2, Dean Rudge, Generics Bulletin) ...The deal gives the Taiwanese biologics company another route to market for its HER2 oncology franchise, while it continues to promote biosimilars and contract development and manufacturing organization services as twin growth pillars... Global Sub. Full

 

Generics Must Not Be Imperiled Over Data Protection: Satish Reddy, Chairman, Dr Reddy 's Laboratories

(7/2, Rica Bhattacharyya, Vikas Dandekar, The Economic Times) ...India shouldn't accept regulatory data protection in a way that weakens its globally competitive generics industry only to attract investments, Dr Reddy's Laboratories chairman Satish Reddy told ET. He also spoke about India's innovation gap with China, AI-driven drug discovery, and reforms needed to accelerate R&D... Full

 

Orion Partners With Shilpa On Opdivo Biosimilar In Europe

(7/1, Urte Fultinaviciute, Generics Bulletin) ...Orion Pharma has expanded its biosimilars presence following the latest deal with Shilpa Biologicals for its Opdivo (nivolumab) rival. Under the agreement, Shilpa Biologicals, part of India's Shilpa Medicare group, will be responsible for the supply of the product, which is currently under development. Meanwhile, Orion will gain exclusive commercial rights to distribute, market and sell Shilpa's intravenous nivolumab biosimilar in Europe... Global Sub. Full

 

Samsung Bioepis Relaunches BYOOVIZ® (ranibizumab-nuna) in the United States in Partnership With Harrow

(7/1, Samsung Bioepis) ...Samsung Bioepis Co., Ltd. today announced the relaunch of BYOOVIZ® (ranibizumab-nuna) in the United States (US), in partnership with Harrow... Full

 

Otsuka Keeps Order Preventing Generic Version of Nuedexta Drug

(7/1, Michael Shapiro, Bloomberg Law) ...The Federal Circuit said Wednesday a Delaware court was right to block Hetero Labs. Ltd. from launching a generic version of Otsuka Pharmaceuticals Inc.'s patent-protected neurological drug Nuedexta. The appeals court, by a 2-1 majority, concluded that the US District Court for the District of Delaware's July 2025 preliminary injunction correctly relied on Otsuka's interpretation of how two chemical compounds-"dextromethorphan" and "quinidine"-are calculated in Otsuka's US Patent No. 7,659,282... Full

 

Jetema Pivots to Korea Rx Market With Zydus GLP-1 Deal, Eyes 2028 Launch

(7/2, Park Su-hyeon, Chosun Biz) ...JETEMA will sign a definitive agreement at the end of this month with India's Zydus Lifesciences for the exclusive introduction and commercialization in Korea of a GLP-1 receptor agonist generic of "semaglutide (Wegovy, Ozempic ingredient)."...A JETEMA representative said, "The semaglutide generic will secure price competitiveness based on Zydus's active pharmaceutical ingredient (API) synthesis technology and a reusable pen design..."... Full

 

 

Takeda, Insilico Strike AI Drug-Discovery Deal Worth Up to $600 Million

(7/2, Jason Chau, The Wall Street Journal) ...Under the partnership announced Thursday, Takeda will pay Insilico to use its proprietary Pharma.AI platform to advance drug candidates across several therapeutic areas. Insilico will lead drug discovery, while Takeda will further development, including advancing candidates past clinical trials... Sub. Req'd

 

Ipsen to Buy Swiss Biotech Memo Therapeutics in Potential $800M Deal

(7/1, Kristin Jensen, BioPharma DIVE) ...The purchase focuses on potravitug, an antibody drug designed to combat BK polyomavirus, a pathogen that frequently affects kidney transplant patients and has no approved targeted treatment. Memo employees and assets unrelated to potravitug will become part of a newly incorporated company called Memorises Bio owned by Memo investors... Full

 

Roche Tops Oncology Reputation Rankings as AstraZeneca Climbs Back to 2nd Place

(7/2, Nick Paul Taylor, Fierce Pharma) ...PatientView polled 505 cancer patient groups from December 2025 to March 2026 to assess perceptions of the biopharma industry and individual companies. Ranking companies they work with, respondents named (PDF) Roche, AstraZeneca and Novartis as the drugmakers with the best reputations. Last year, Servier took (PDF) the top spot ahead of Roche and Pfizer... Full

 

FDA Warns Genzyme's Irish Site Over Quality Questions

(7/1, Zachary Brennan, Endpoints News) ...On data integrity, the warning letter dated June 22 and released Tuesday says the Genzyme site's "data integrity program was not functioning as represented." The agency's nine-day inspection last January found, among other violations, that "quality control personnel used uncontrolled Review Checklists to unofficially document laboratory record reviews, which were subsequently discarded. Additionally, updates to your records were not always traceable or attributable to a specific person."... Sub. Req'd

 

 

Lessons From India's Big Antibiotic Breakthrough

(7/2, Menaka Doshi, Bloomberg) ...In this conversation, Wockhardt Chairman Habil Khorakiwala reflects on the Zaynich journey, from deliberately pursuing a neglected therapeutic area to resisting pressure to license the molecule. He also offers a candid assessment of what holds Indian innovation back... Full

 

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