Monday, July 6, 2026

 

 

Trump Administration Proposes a Rule it Says Could Save Medicare Patients $1.1 Billion on Drugs

(7/2, Josh Boak, Associated Press) ...The Trump administration is proposing a new rule on Thursday to keep hospitals from charging markups on discounted drugs for Medicare patients and says that could save consumers $1.1 billion next year, according to estimates obtained by The Associated Press....Under the proposed rule, the Centers for Medicare & Medicaid Services would change the formula for what hospitals participating in the program can get reimbursed... Full

 

New 340B Drug Discount Crackdown Gets Bipartisan Bill in House

(7/6, Victoria Knight, Bloomberg Government) ...The new bill, shared first with Bloomberg Government, would establish eligibility requirements for the patients who can receive discounted drugs as part of the 340B program, as well as implement standards for the facilities that are affiliated with the primary safety-net providers and distribute the discounted drugs... Sub. Req'd

 

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

(7/1, Ferdous Al-Faruque, Regulatory Focus) ...Since announcing the RFI, almost 240 entities have submitted their feedback to FDA on how AI technologies can help streamline early-phase clinical trials, including the Pharmaceutical Research and Manufacturers of America (PhRMA). The drug industry group was optimistic about AI's potential to accelerate innovation and said the pilot could realize that promise... Full

 

New Model Bill Would Let States Use MFP Drug Caps Without PDABs

(7/2, Inside Health Policy) ...The National Academy for State Health Policy...told Inside Health Policy their new model allows states to select the medications they believe would yield the highest savings, which differs from previous versions of model legislation that capped reimbursement for all drugs with CMS-negotiated prices... Sub. Req'd

 

 

Roche KRAS Drug Succeeds in Head-to-Head Lung Cancer Study

(7/2, Kristin Jensen, BioPharma DIVE) ...The Phase 3 trial compared divarasib with Amgen's Lumakra and Bristol Myers Squibb's Krazati in patients with KRAS G12C non-small cell lung cancer who had already received previous treatment. Researchers found significant improvements in both overall survival and progression-free survival for the group taking divarasib, Roche said Thursday... Full

 

SEC Asks Abbvie to Conduct Phase III Study on Subcutaneous Drug for Parkinson's Disease

(7/3, PharmaBiz.com) ...A Subject Expert Committee (SEC), which advises the Central Drugs Standard Control Organisation (CDSCO) in clinical trials and approval of new drugs in the Neurology and Psychiatry segment, has asked Abbvie Healthcare India to conduct Phase III clinical trial study on its subcutaneous drug to treat advanced Parkinson's disease, refusing a waiver on clinical trials... Full

 

HDSA 2026: Huntington's Gene Therapy May Move to Clinical Trials

(7/2, Andrea Lobo, Huntington's Disease News) ...The application, which the company expects to file in the current quarter, leverages promising results in Huntington's animal models showing the treatment reached brain regions affected by the disease and slowed CAG repeat expansion, a genetic process linked to disease onset and progression. The FDA has 30 days after submission to review the data, and if the agency approves, the company will start a first-in-human trial of LTS-201 in the U.S... Full

 

Inside the NHS Hospital Trialling Psychedelics to Treat Depression

(7/6, Laura Hughes, Financial Times) ...Mehul Vaghani, head of corporate development at Clerkenwell Health, said the trials marked the first time these psychedelics had been administered in the North East under legal conditions....The hope underpinning the trial is that if these drugs are approved and become medicines, NHS staff from the hospital will already have experience of caring for the patients who are eligible to take them... Sub. Req'd

 

 

Celltrion Leads The Way In US With Interchangeable Rituximab Biosimilar

(7/3, Anabel Costa-Ferreira, Generics Bulletin) ...The US Food and Drug Administration has granted interchangeability status for Celltrion's rituximab biosimilar Truxima, marking it as the first Rituxan biosimilar in the US to obtain these rights. Celltrion and US marketing partner Teva also notably obtained the one-year exclusivity rights granted to the first interchangeable biosimilar... Global Sub. Full

 

Biosimilar Makers Push Forward on Regulatory and Commercial Fronts

(7/2, Skylar Jeremias, The Center for Biosimilars) ...Teva Pharmaceutical Industries announced the European launch of Ahzantive (aflibercept), a biosimilar to Eylea (aflibercept), marking the company's entry into the ophthalmology biosimilar space. The launch of Ahzantive prefilled syringes began in May 2026 across several European markets, including France, Germany, Spain, and the Netherlands, with Teva expecting to launch in additional markets later in the year... Full

 

Samsung Bioepis in Partnership with Harrow Relaunches Byooviz in United States

(7/3, Pharmabiz.com) ...Samsung Bioepis Co., Ltd. announced the relaunch of Byooviz (ranibizumab-nuna) in the United States (US), in partnership with Harrow. Harrow became responsible for commercialization of Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab), and Opuviz (aflibercept-yszy), a biosimilar referencing Eylea (aflibercept), upon full transition of commercialization rights from Biogen back to Samsung Bioepis by the end of 2025... Full

 

Prestige Biopharma And Charles River Align On Biosimilar Development

(7/3, Urte Fultinaviciute, Generics Bulletin) ...Under the agreement, Prestige Biopharma and Charles River intend to offer support for clients seeking entry into major regulated markets, such as Europe and the US. Both partners also said they would create a symbiotic partnership: Charles River will refer clients requiring biopharmaceutical process development and GMP manufacturing to Prestige Biopharma, while Prestige Biopharma will connect clients in need of early-stage discovery, preclinical toxicology, and bioanalytical services to Charles River... Global Sub. Full

 

Sandoz's Direct-to-Patient Platform Is First Step In Long-Term DTP Strategy

(7/3, Dave Wallace, Generics Bulletin) ...Sandoz Direct "will enable patients to skip the line at the pharmacy, and will provide direct access to medicines with convenient door-to-door delivery," the firm said, with the final Sandoz Direct price representing "a transparent, all-in price that includes the product, Rx processing fee, and shipping."... Global Sub. Full

 

Celltrion Poised for Profitability Leap on New Biosimilars

(7/6, Park Ji-soo, Seoul Economic Daily) ..."As Celltrion has already established direct-sales systems in Europe and the US, it has a structure that allows it to directly benefit from market expansion," said Jung Yi-soo, a researcher at IBK Investment & Securities. "The more its product portfolio grows, the higher the utilization of its existing sales network becomes, and we forecast that profitability will continue to improve based on its own production capacity and direct-sales system."... Full

 

 

Novartis to Buy Myricx Bio for Up to $1.5 Billion

(7/6, Aimee Look, The Wall Street Journal) ...Novartis will pay $1.1 billion upfront, with up to $400 million in potential additional payments. The deal, expected to close in the second half of 2026, is subject to regulatory approvals. Myricx Bio has a pipeline of antibody-drug conjugates that show pre-clinical efficacy and tolerability across tumor-associated antigens and cancer cell types, it said... Sub. Req'd

 

Synthon Adds Capacity With Spanish Acquisition

(7/6, Dave Wallace, Generics Bulletin) ...Synthon has bolstered its development and manufacturing capabilities for complex generics by acquiring a facility in Spain that is adjacent to its existing operations in Sant Boi... Global Sub. Full

 

Celltrion's Operating Profit Jumps 77% in Q2 on Strong Biosimilar Sales

(7/3, Lee Han-soo, Korea Biomedical Review) ...Celltrion reported preliminary consolidated results for the second quarter of 2026 on Friday, posting revenue of 1.3 trillion won ($851 million) and operating profit of 430 billion won, marking the company's strongest second-quarter performance on record. Revenue rose 35.2 percent year over year, while operating profit surged 77.3 percent... Full

 

Pan-Cancer AI Tool Boosts Immunotherapy Prediction Accuracy

(7/3, Anna Bratulic, FirstWord PHARMA) ...In a study published Friday in Nature Medicine, researchers described COMPASS, a pan-cancer foundation model that predicts responses to ICIs from tumour gene-expression data, while also highlighting the biological pathways that may drive response or resistance. The approach outperformed 22 existing prediction methods across multiple cancer types and immunotherapy regimens... Full

 

Extreme Dizziness, No Headache: The Migraine Many Doctors Miss

(7/6, Brent Crane, The New York Times) ...Because it involves dizziness, vestibular migraine falls in a gap between two specialties: neurology and otology. It is often mistaken for Ménière's disease, an inner ear disorder, or persistent postural-perceptual dizziness, a chronic neurological condition... Sub. Req'd

 

 

Patients and Generics Sector Urge EU to React to Trump's Drug Pricing Threats

(7/2, Emma Pirnay, Euractiv) ...At an event organised by consumer group BEUC on Thursday, they warned that Trump's plan to tie US drug prices to the lowest in other wealthy countries - known as a 'most-favoured-nation' (MFN) policy - would harm patients on both sides of the Atlantic... Full

 

UK Govt Announces Pilot Projects to Help NHS Patients Get Faster Access to Medicines

(7/4, Pharmabiz.com) ...The UK Government has announced that the National Health Service (NHS) patients could access cutting-edge medicines potentially months earlier under a series of pioneering pilots designed to speed up and improve the fairness of how new treatments reach patients... Full

 

Bulgaria Moves to Shore up Generic Medicines Access amid Shortage Crisis

(7/6, Krassen Nikolov, Euractiv) ...Bulgaria is seeking to preserve pharmaceutical companies' interest in importing and marketing medicines in the country by scrapping mandatory rebates imposed on generic drug manufacturers, as Sofia attempts to reverse a worsening shortage of medicines affecting thousands of patients... Full

 

Informed Consent Continues To Trip Up GCP Inspections, Global Regulators Say

(7/3, Sue Sutter, Pink Sheet) ...Informed consent issues accounted for 16% of all "critical" findings and 5% of all "major" findings in the UK Medicines and Healthcare products Regulatory Agency's GCP inspections from 2020 to 2024, Rachel Mead, a senior GCP inspector with MHRA Compliance Team 1, said during the Drug Information Association's recent annual meeting in Philadelphia... Global Sub. 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.