Pfizer CDR (CAD Hedged)

New Global Review Reveals Comprehensive Landscape of Interstitial Cystitis Clinical Trials in 2025

3 days ago

• A newly released global clinical trials review provides extensive data on Interstitial Cystitis research, tracking trial numbers and enrollment trends across major countries worldwide. • The report categorizes trials by region, phase, status, and sponsorship, highlighting key pharmaceutical companies including Astellas Pharma, AbbVie, Johnson & Johnson, and Pfizer as prominent sponsors. • This comprehensive analysis serves as a strategic resource for stakeholders making investment decisions in IC research, offering insights into trial success rates and identifying optimal locations for clinical studies.

Pfizer Enters $6 Billion Licensing Deal with China's 3SBio for Novel Cancer Drug

3 days ago

• Pfizer has secured global rights (excluding China) to 3SBio's experimental cancer drug SSGJ-707 for $1.25 billion upfront, with potential additional payments of up to $4.8 billion based on developmental milestones. • SSGJ-707 is currently being evaluated for multiple cancer types including non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors, with Phase III trials in China planned to begin this year. • The deal includes a $100 million equity investment in 3SBio by Pfizer, with manufacturing planned at Pfizer's facilities in North Carolina and Kansas following FDA clearance of the Investigational New Drug application.

Global GVHD Clinical Trials Review Reveals Key Trends and Strategic Opportunities for 2025

3 days ago

• A comprehensive analysis of the global Graft Versus Host Disease clinical trial landscape shows significant activity across G7 and E7 countries, offering strategic insights for pharmaceutical companies. • Major industry players including Sanofi, Novartis, Johnson & Johnson, and Pfizer are actively participating in GVHD trials, highlighting the competitive nature of this therapeutic area. • The report provides detailed enrollment trends, trial status updates, and regional distribution data, enabling more informed decision-making for clinical trial investments and competitive positioning.

Robust Pipeline of 50+ Therapies Reshaping Moderate to Severe Atopic Dermatitis Treatment Landscape

3 days ago

• The moderate to severe atopic dermatitis market is experiencing significant growth with 45+ companies developing over 50 pipeline therapies, driven by rising global prevalence and increased awareness of the condition. • Recent advancements include promising biologics like rezpegaldesleukin (granted FDA fast-track designation), JAK inhibitors such as VC005 and QY201, and novel mechanisms targeting IL-4/IL-13 pathways, offering new hope for patients with inadequate response to current treatments. • Key players including Nektar Therapeutics, Corvus Pharmaceuticals, and Apogee Therapeutics are advancing clinical trials with significant milestones expected in late 2025, potentially transforming the therapeutic landscape for this chronic inflammatory skin condition.

LAVA Therapeutics Reports Q1 2025 Results While Restructuring Operations and Advancing Clinical Trials

8 days ago

• LAVA Therapeutics is implementing significant restructuring, including a 30% workforce reduction and closure of Netherlands operations, while evaluating strategic alternatives to maximize shareholder value. • The company continues to advance its LAVA-1266 Phase 1 trial for CD123+ hematological malignancies, alongside partnered programs with Johnson & Johnson and Pfizer that are also in Phase 1 clinical trials. • With $66.6 million in cash and investments as of March 31, 2025, LAVA expects to fund operations into 2027 despite reporting a net loss of $3.5 million for Q1 2025.

Global Thrombocytopenia Clinical Trials Market Sees Significant Growth in 2025

9 days ago

• The global thrombocytopenia clinical trials landscape is expanding rapidly with over 25 pharmaceutical companies developing 25+ treatment therapies, according to recent market analysis. • Key industry players including GSK, Novartis, Amgen, and Sanofi are leading clinical development efforts, with several promising candidates in late-stage trials showing efficacy in reducing thrombocytopenia events. • Recent advances include Takeda's TAK-755 demonstrating 60% reduction in thrombocytopenia events compared to standard of care, and HUTCHMED completing enrollment for its pivotal Phase III ESLIM-01 trial of sovleplenib for immune thrombocytopenia.

Hyperuricemia Pipeline Shows Promise with 15+ Emerging Therapies in Development

14 days ago

• Global hyperuricemia pipeline comprises 12+ key companies developing 15+ treatment therapies across various clinical stages, according to DelveInsight's 2025 report. • Leading companies in hyperuricemia drug development include LG Chem, Shanton Pharma, InventisBio, Jiangsu HengRui Medicine, and Selecta Biosciences, with treatments spanning oral, intravenous, and subcutaneous administration routes. • A significant development occurred in December 2024 when Atom Therapeutics partnered with China Medical System Holdings to commercialize lingdolinurad (ABP-671), a novel URAT1 inhibitor for chronic gout and hyperuricemia in China.

Novavax COVID-19 Vaccine Shows Fewer Side Effects Than Pfizer-BioNTech in SHIELD-Utah Study

a month ago

• Preliminary results from the SHIELD-Utah study reveal Novavax's COVID-19 Vaccine (2024-2025 Formula) targeting the JN.1 strain produced fewer and less severe reactogenicity symptoms compared to Pfizer-BioNTech's mRNA vaccine. • Healthcare workers receiving Novavax's protein-based vaccine experienced significantly fewer systemic symptoms (1.7 vs 2.8) and lower rates of Grade 2 or higher symptoms (24.2% vs 43.8%) than Pfizer-BioNTech recipients. • The real-world study demonstrated that Novavax recipients reported less impact on daily activities, with fewer hours of missed work and reduced productivity compared to those who received the Pfizer-BioNTech vaccine.

CDMO Market Report: Key Regulatory Approvals and Clinical Advances in March-April 2025

a month ago

• Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases. • AstraZeneca's portfolio saw substantial growth with expanded approvals for Imfinzi, Tagrisso, and Lynparza, strengthening partnerships with contract manufacturers including Lonza, Dottikon, and Samsung Biologics. • Contract manufacturers supporting treatments for autoimmune conditions showed strong performance, with Argenx's Vyvgart Hytrulo receiving expanded indications for myasthenia gravis and CIDP.

FDA Misses Deadline for Full Approval Decision on Novavax's COVID-19 Vaccine

2 months ago

• The U.S. Food and Drug Administration (FDA) has missed its April 1 deadline to decide on granting full approval to Novavax's protein-based COVID-19 vaccine, which currently has Emergency Use Authorization. • The delay comes shortly after the resignation of Peter Marks, the FDA's top vaccine regulator who played a key role in COVID-19 vaccine approvals during the pandemic. • According to reports, FDA senior leaders have indicated that Novavax's application needs more data, making approval unlikely in the near term, though the company maintains it has responded to all information requests.

FDA's Cell and Gene Therapy Champion Peter Marks Departs, Leaving Industry at Critical Juncture

2 months ago

• Peter Marks, head of FDA's Center for Biologics Evaluation and Research since 2016, has resigned, leaving cell and gene therapy developers without their biggest regulatory advocate during a challenging investment period. • Under Marks' leadership, the FDA approved dozens of cell and gene therapies including the first gene therapy, first cellular treatment for cancer, and first CRISPR gene editing medicine, establishing flexible regulatory frameworks for these novel treatments. • Despite concerns about regulatory uncertainty following Marks' departure, incoming FDA Commissioner Marty Makary has signaled support for conditional approval pathways for rare disease treatments where randomized controlled trials aren't feasible.

Nuvation Bio Secures $250M Financing Package to Launch Novel Lung Cancer Drug Taletrectinib

3 months ago

• Nuvation Bio has secured a $250 million non-dilutive financing deal with Sagard Healthcare Partners, including $150 million in royalty financing and up to $100 million in term loans. • The financing package is contingent on FDA approval of taletrectinib, a targeted therapy for ROS1-positive non-small cell lung cancer, expected in mid-2025. • The funding will fully support taletrectinib's U.S. commercial launch and ongoing clinical pipeline development without requiring additional capital raises.

Global Clinical Trials for Myelodysplastic Syndrome Show Significant Industry Investment in 2025

3 months ago

• A comprehensive review of global Myelodysplastic Syndrome clinical trials reveals extensive research activity across G7 and E7 countries, with major pharmaceutical companies leading development efforts. • The analysis highlights significant participation from industry leaders including Bristol-Myers Squibb, Novartis, and Sanofi, demonstrating strong commercial interest in MDS therapeutics. • The report indicates evolving clinical trial landscapes across multiple regions, with detailed tracking of trial phases, enrollment trends, and success rates over the past five years.

Global Stroke Clinical Trials Landscape Analysis Reveals Key Market Trends for 2025

3 months ago

• A comprehensive analysis of global stroke clinical trials shows significant research activity across G7 and E7 countries, with detailed tracking of trial phases, status, and enrollment trends. • Leading pharmaceutical companies including Boehringer Ingelheim, Bayer, and AstraZeneca emerge as prominent sponsors in stroke therapeutics research, shaping the competitive landscape. • The report highlights strategic opportunities in clinical trial locations and investment, offering valuable insights for stakeholders in cardiovascular research and development.

Global Polycystic Kidney Disease Clinical Trials Landscape Mapped in Comprehensive 2025 Review

3 months ago

• New comprehensive report provides critical insights into the global clinical trial landscape for Polycystic Kidney Disease, covering regional distribution, trial phases, and sponsor involvement across G7 and E7 countries. • Major pharmaceutical companies including Otsuka Holdings, Sanofi, and Pfizer are leading clinical development efforts, with the report highlighting prominent drugs currently in various trial phases. • The analysis offers valuable strategic intelligence for stakeholders by tracking enrollment trends, trial statuses, and success rates, enabling more informed investment and research decisions in PKD therapeutics.

New Global Clinical Trials Report Reveals Comprehensive Landscape of Ewing Sarcoma Research in 2025

3 months ago

• A new comprehensive report on Ewing Sarcoma clinical trials provides critical insights into global research trends, trial distribution, and enrollment patterns across G7 and E7 countries. • The analysis highlights key pharmaceutical players in Ewing Sarcoma research, including Bristol-Myers Squibb, Merck, Pfizer, and AstraZeneca, offering valuable competitive intelligence for industry stakeholders. • The report serves as a strategic resource for identifying investment opportunities, optimal trial locations, and understanding success rates through comparative analysis of completed versus terminated trials.

Expanding Biologic Options Transform Treatment Landscape for Psoriatic Arthritis

3 months ago

• Recent clinical trials demonstrate sustained efficacy of newer biologics like bimekizumab and risankizumab in treating psoriatic arthritis, expanding treatment options beyond traditional TNF inhibitors. • Dr. Philip Mease highlights the growing arsenal of biologics targeting IL-17 and IL-23 pathways, offering multiple therapeutic options for maintaining minimal disease activity in PsA patients. • Long-term safety data and comparative studies are strengthening the evidence base for biologic sequencing, providing clinicians with more confidence in cycling between different mechanisms when treatment effects diminish.

Vaxcyte Advances 31-Valent Pneumococcal Vaccine to Final Phase II Stage in Infant Trial

4 months ago

• Vaxcyte has initiated the final stage of Phase II trials for VAX-31, its 31-valent pneumococcal conjugate vaccine, following successful safety review of Stage 1 data in infants. • VAX-31 demonstrates potential to provide approximately 94% coverage against invasive pneumococcal disease and 93% coverage for acute otitis media in U.S. children under five years. • The company expects to report topline data from the primary three-dose immunization series by mid-2026, with booster dose results following approximately nine months later.

Tisotumab Vedotin Demonstrates Survival Benefit in Chinese Cervical Cancer Subpopulation

4 months ago

• Tisotumab vedotin significantly improved overall survival compared to chemotherapy in Chinese patients with previously treated recurrent or metastatic cervical cancer. • The antibody-drug conjugate reduced the risk of death by 45% in the Chinese subpopulation, consistent with global trial results. • Zai Lab plans to submit a new drug application to China's National Medical Products Administration based on these findings. • The results offer hope for addressing the unmet need for effective treatments after relapse, including after anti-PD-(L)1 therapy.

J&J Seeks FDA Approval for TAR-200 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

4 months ago

• 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.