Johnson & Johnson and Karolinska Institutet Celebrate Decade of Collaboration Advancing Medical Innovations
• The ten-year partnership between Johnson & Johnson Innovative Medicine and Karolinska Institutet has yielded significant scientific advances across nine disease areas, with researchers working side by side since 2015.
• Over 150 researchers have participated in the collaboration, producing more than 30 scientific papers and 50 presentations at international conferences, focusing on critical medical needs in oncology, neurology, immunology, and ophthalmology.
• The partnership exemplifies successful innovation through academic-industry collaboration, with both organizations now exploring new opportunities to develop innovative therapies for complex conditions like Alzheimer's disease and cancer.
HIV Vaccine Breakthrough: Clinical Trials Show Promise for Broadly Neutralizing Antibody Development
• Two phase 1 clinical trials demonstrate successful activation of rare immune cells needed to develop broadly neutralizing antibodies against HIV, marking significant progress in vaccine development.
• The innovative stepwise vaccination strategy using mRNA technology showed 100% success rate in generating VRC01-class antibody responses in participants who received both prime and boost doses.
• Results from trials conducted in North America and Africa showed similar immune responses, supporting the potential for a globally effective HIV vaccine targeting regions most affected by the pandemic.
Phase 3 ECOG-ACRIN EA4151 Trial Evaluates Necessity of Auto-HCT in Modern MCL Treatment
• The phase 3 ECOG-ACRIN EA4151 trial is investigating whether autologous hematopoietic cell transplantation (auto-HCT) still benefits mantle cell lymphoma patients in the era of improved first-line therapies.
• The study enrolled 650 patients across four treatment arms, comparing auto-HCT plus rituximab versus rituximab alone in patients achieving MRD-negative complete remission after frontline therapy.
• This research follows the phase 3 TRIANGLE trial, which previously showed auto-HCT provided no added benefit when combined with rituximab, ibrutinib, and high-dose cytarabine regimens in MCL patients.
SystImmune to Present Promising Data on Iza-bren for HER2-Negative Breast Cancer at ESMO Breast 2025
• SystImmune will present updated safety and efficacy data for izalontamab brengitecan (iza-bren), an EGFRxHER3 bispecific antibody-drug conjugate, in locally advanced or metastatic breast cancer at ESMO Breast 2025 on May 16.
• Early clinical results show encouraging efficacy across all HER2 levels in HER2-negative breast cancer patients, including HER2 0 patients, suggesting potential therapeutic benefits for patients with limited treatment options.
• Iza-bren, being jointly developed by SystImmune and Bristol Myers Squibb, works by blocking EGFR and HER3 signals to cancer cells while delivering a therapeutic payload that induces cancer cell death.
Dostarlimab Shows Promise in Eliminating Need for Surgery Across Multiple dMMR Cancer Types
• Phase 2 trial results reveal dostarlimab (Jemperli) induced complete clinical responses in 100% of rectal cancer patients and 65% of non-rectal cancer patients with mismatch repair-deficient tumors, allowing 82 of 84 responders to avoid surgery.
• The groundbreaking study demonstrated 92% recurrence-free survival at two years, with some patients maintaining complete responses for up to five years, potentially transforming treatment approaches for dMMR cancers.
• Researchers highlight the significant quality-of-life benefits of avoiding surgical resection, particularly important for younger patients facing colorectal cancer diagnoses, as surgery can be debilitating and financially burdensome.
Balancing Efficacy and Cost Sustainability in Modern CLL Treatment: Insights from Dr. Pierluigi Porcu
• Clinicians treating chronic lymphocytic leukemia (CLL) face growing challenges in balancing clinical efficacy with long-term cost sustainability, requiring a holistic approach to patient care.
• Dr. Pierluigi Porcu emphasizes that effective CLL management requires understanding disease risk, patient comorbidities, and practice environment constraints including payer considerations.
• Despite its importance, value-based care adoption remains insufficient in oncology, with challenges in defining and measuring value across patient outcomes, quality of life, and treatment costs.
Biocon Biologics Secures Settlement with Regeneron to Launch Aflibercept Biosimilar in US by 2026
• Biocon Biologics has reached a settlement agreement with Regeneron allowing the launch of Yesafili, an interchangeable biosimilar to aflibercept, in the US by the second half of 2026 or earlier under certain circumstances.
• The agreement resolves pending legal disputes, including an appeal at the US Court of Appeals for the Federal Circuit and litigation in the Northern District of West Virginia, clearing regulatory hurdles for market entry.
• FDA-approved in May 2024, Yesafili will target multiple ophthalmic conditions including neovascular AMD, macular edema due to retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization.
FDA Approves Pre-Filled Syringe for Self-Injection of Efgartigimod in gMG and CIDP Patients
• The FDA has approved a new pre-filled syringe formulation of efgartigimod (VYVGART Hytrulo) for self-injection in adults with generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
• The self-injection option provides patients greater independence and flexibility, allowing treatment at home or while traveling, reducing the need for frequent clinic visits while maintaining the medication's established safety and efficacy profile.
• Developed through argenx's partnership with Halozyme's ENHANZE drug delivery technology, the pre-filled syringe enables rapid 20-30 second subcutaneous administration, with regulatory decisions expected in the EU, Japan, and Canada by 2025.
FDA Approves Biocon Biologics' Bevacizumab Biosimilar JOBEVNE for Multiple Cancer Indications
• Biocon Biologics has received U.S. FDA approval for JOBEVNE (bevacizumab-nwgd), a biosimilar to Avastin, expanding its oncology portfolio to include a seventh FDA-approved biosimilar.
• JOBEVNE, a VEGF inhibitor that restricts tumor blood supply, is indicated for multiple cancer types including metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, and several others.
• The approval follows comprehensive comparative studies confirming JOBEVNE's similarity to Avastin, with U.S. bevacizumab sales reaching approximately $2 billion in 2023, representing a significant market opportunity.
UK Government Unveils Life Sciences Strategy to Strengthen Post-Brexit Industry
• The UK government has revealed a comprehensive life sciences strategy led by Professor Sir John Bell, aiming to strengthen the sector after Brexit through increased funding and policy reforms.
• Key proposals include £160 million in new funding, improved clinical trial capabilities, implementation of the Accelerated Access Review, and benchmarking the UK to be in the top quartile for innovative medicine adoption by 2023.
• Industry leaders from pharmaceutical companies, biotech firms, and healthcare organizations collaborated on the strategy, which addresses challenges in NHS funding constraints while seeking to create a globally competitive life sciences ecosystem.
UK Government Commits £121 Million to Revitalize Clinical Trial Sector Following O'Shaughnessy Review
• The UK government has pledged £121 million over three years to implement recommendations from Lord O'Shaughnessy's review of commercial clinical trials, aiming to double trial recruitment by 2025 and again by 2027.
• Key commitments include reducing approval times to 60 days, establishing a mandatory national approach to contracting, and developing clinical trial acceleration networks for infectious diseases, cancer, and dementia.
• Recent data shows early signs of recovery with a 4.3% increase in commercial trials in 2022 compared to 2021, though numbers remain below historical levels following a 41% decline between 2017-2021.
Legend Biotech Reports Strong CARVYKTI® Growth with $963 Million in 2024 Sales, Treating Over 5,000 Patients
• Legend Biotech reported CARVYKTI® net trade sales of $963 million for full year 2024, with over 5,000 patients treated to date, positioning the CAR-T therapy as a market leader in multiple myeloma treatment.
• The company initiated commercial production at a Novartis facility and secured reimbursement approval from Spain's national health system for CARVYKTI® in second-line plus settings, expanding patient access.
• With $1.1 billion in cash reserves, Legend Biotech expects financial runway into Q2 2026, when it anticipates achieving operating profit excluding unrealized foreign exchange impacts.
Lupin Launches Generic Rivaroxaban in US Market Following FDA Approval
• Lupin has launched Rivaroxaban Tablets USP, 2.5 mg in the US market after receiving final approval from the FDA for its Abbreviated New Drug Application.
• The generic equivalent of Janssen's Xarelto® targets patients with coronary artery disease and peripheral artery disease, with estimated annual US sales of $446 million.
• This strategic launch strengthens Lupin's position in the high-value anticoagulant market, following the company's strong Q3 performance with a 38.8% increase in profit.
Patent Dispute Emerges Between Merck and Halozyme Over Injectable Keytruda Formulation
• Halozyme Therapeutics and Merck are heading into a patent battle over the development of an injectable formulation of the blockbuster cancer drug Keytruda.
• The dispute centers around Halozyme's drug delivery technology, which could potentially transform Keytruda's administration from intravenous to subcutaneous injection.
• This legal confrontation highlights the growing importance of drug delivery innovations in the pharmaceutical industry, particularly for established cancer therapeutics.
AbbVie Diversifies Portfolio with FDA Priority Review for Upadacitinib as Humira Faces Biosimilar Competition
• AbbVie's JAK1-selective inhibitor upadacitinib has received FDA Priority Review for moderate to severe rheumatoid arthritis, with potential annual sales projected to reach $3 billion.
• The company is strategically expanding its portfolio as its blockbuster Humira faces biosimilar competition in Europe, with international sales already declining 15% despite continued growth in the US market.
• Beyond upadacitinib, AbbVie's diversification strategy includes promising candidates like risankizumab for psoriasis and established cancer drugs Imbruvica and Venclexta, alongside recently approved Orilissa for endometriosis.
FDA Approves Zevtera for S. aureus Bacteremia, Marking First New Treatment in 15 Years
• Basilea Pharmaceutica's Zevtera (ceftobiprole) receives FDA approval for three indications, becoming the first beta-lactam antibiotic approved for Staphylococcus aureus bacteremia.
• The approval addresses a significant medical need, with approximately 120,000 S. aureus bloodstream infections occurring annually in the US according to CDC data.
• The drug's approval includes coverage for antimicrobial-resistant infections, particularly MRSA, targeting a market projected to reach $5.5 billion by 2030.
Anti-IL23p19 Therapies Transform IBD Treatment Landscape Ahead of ECCO 2025
• The anti-IL23p19 class has emerged as a breakthrough in IBD treatment, with three major players - AbbVie's Skyrizi, Eli Lilly's Omvoh, and J&J's Tremfya - reshaping the therapeutic landscape.
• ECCO 2025 will showcase critical data for these therapies, including Omvoh's long-term efficacy in Crohn's disease, Tremfya's subcutaneous induction results, and new bowel urgency endpoints for ulcerative colitis.
• Market dynamics are evolving with the entry of Stelara biosimilars in Europe and the emergence of new therapeutic approaches, including TL1A inhibitors and IL-7R antagonists.
European Commission Approves Stelara for Ulcerative Colitis Treatment
• Johnson & Johnson's Stelara becomes the first IL-12/23 inhibitor approved in Europe for treating moderate-to-severe ulcerative colitis, offering new hope for 2.6 million affected patients.
• Phase 3 UNIFI study demonstrates Stelara's efficacy with 16% of treatment-resistant patients achieving clinical remission compared to 5% in the placebo group.
• The blockbuster drug, which generated over $5 billion in sales last year, adds ulcerative colitis as its fourth indication, following previous approvals for psoriasis, psoriatic arthritis, and Crohn's disease.
Promising Phase III Results for Once-a-Month HIV Treatment
Janssen and ViiV Healthcare have reported positive phase III trial results for their once-monthly injectable HIV treatment, combining cabotegravir and Edurant. This innovative regimen could significantly reduce the treatment burden from daily pills to just 12 injections per year, with comparable efficacy to current oral therapies. The findings, presented at the Conference on Retroviruses and Opportunistic Infections, highlight a potential paradigm shift in HIV treatment.
J&J Seeks FDA Approval for TAR-200 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
• Johnson & Johnson has initiated a New Drug Application (NDA) submission to the FDA for TAR-200.
• TAR-200 is intended for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
• Phase 2b SunRISe-1 study data showed an 83.5% complete response rate with TAR-200 monotherapy.
• The FDA is reviewing the application under the Real-Time Oncology Review (RTOR) program to expedite potential approval.
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