Tagged News
Dupilumab Shows 31% Greater Likelihood of Avoiding Negative Outcomes in COPD Patients with Type 2 Inflammation
• Patients with COPD and type 2 inflammation treated with dupilumab were 31% more likely to avoid a combination of negative outcomes including death, hospitalization, exacerbations, and lung function decline.
• The win ratio analysis of BOREAS and NOTUS phase 3 trials demonstrated dupilumab's superiority over placebo across all individual clinically important outcomes, with researchers noting that every 16th patient treated completely stopped having exacerbations.
• Dupilumab (Dupixent), already approved for eligible patients with uncontrolled COPD, showed significant benefits in preventing hospitalizations, moderate exacerbations, lung function deterioration, and symptom worsening compared to placebo.
CAR-T Cell Therapy Funding Surges to $141.2 Billion as Industry Expands Globally
• The CAR-T cell therapy industry has raised over $141.2 billion through various financing mechanisms, with estimates suggesting total industry funding could reach $281.7 billion when including undisclosed deals.
• More than 170 companies worldwide are developing CAR-T products with 1,944 therapies in development, while 13 CAR-T cell therapies have received regulatory approval globally since 2017.
• Despite a slowdown in IPOs and M&A activity in 2024, venture capital funding remains strong with 89 CAR-T companies securing $7.7 billion since 2014, supporting advancement in both blood cancer and solid tumor applications.
FDA Initiates PDUFA VIII Reauthorization Process with Public Meeting and Assessment Report
• FDA has announced a hybrid public meeting on July 14, 2025, to begin the reauthorization process for PDUFA VIII, as the current authorization expires in September 2027.
• The agency has completed an independent assessment of product quality information request communications between FDA and sponsors, with findings now available for public comment.
• PDUFA VII introduced several enhancements including new meeting types, pilot programs for rare diseases and real-world evidence, and strengthened support for cell and gene therapy product development.
Vivo Capital Secures $740 Million for Third Cycle of Healthcare Investment Fund
• Vivo Capital has closed the third cycle of its Opportunity Fund with over $740 million in commitments, focusing on preclinical and clinical-stage life sciences companies developing novel therapies.
• The fund has previously backed companies that achieved significant milestones, including FDA approvals for treatments targeting COPD, myelodysplastic syndrome, narcolepsy, and Prader-Willi Syndrome.
• Several Vivo-backed companies have been acquired by pharmaceutical giants in billion-dollar deals, including RayzeBio (Bristol-Myers Squibb, $4.1B), Chinook Therapeutics (Novartis, $3.2B), and Sierra Oncology (GSK, $1.9B).
FDA Approves Ritedose's Albuterol Sulfate Inhalation Solution Amid National Shortage
• Ritedose Pharmaceuticals has received FDA approval for Albuterol Sulfate Inhalation Solution 0.5% (2.5 mg/0.5 mL), completing their portfolio of albuterol treatments amid a nationwide shortage that has persisted since October 2022.
• The newly approved dosage will be manufactured using Blow-Fill-Seal technology in Ritedose's expanded facilities, with availability expected in the second quarter of 2025 to help address critical needs for over 26 million asthma patients.
• This approval strengthens Ritedose's position as the largest provider of nebulizer products in the US, having delivered more than 4.5 billion doses throughout the company's history.
FDA Budget Cuts Linked to Drug Approval Delays as Small Biotech Faces PDUFA Postponement
• Recent government efficiency cuts at the FDA appear to be causing delays in drug approval timelines, with 66% of healthcare professionals surveyed expressing concern about potential PDUFA date postponements.
• Stealth BioTherapeutics' treatment for rare Barth syndrome, elamipretide, has experienced an unexplained decision delay, with no typical safety or manufacturing concerns cited as reasons for the postponement.
• Industry experts warn that while widespread disruption isn't yet evident, continued FDA resource constraints could significantly impact clinical trial oversight and create approval backlogs lasting years.
Cemiplimab Shows Significant Survival Benefit in NSCLC Patients with Brain Metastases and High PD-L1 Expression
• First-line cemiplimab (Libtayo) monotherapy demonstrated a remarkable survival advantage over chemotherapy in advanced NSCLC patients with PD-L1 ≥50% and brain metastases, with median OS of 52.4 vs 20.7 months.
• The EMPOWER-Lung 1 trial's 5-year follow-up data confirms cemiplimab's long-term clinical benefits across all PD-L1 expression levels, with the greatest benefit observed in patients with PD-L1 ≥90%.
• Patients receiving cemiplimab experienced fewer grade ≥3 adverse events compared to chemotherapy (18.3% vs 39.9%), while also reporting improved quality of life measures including better emotional functioning and reduced fatigue.
Related Clinical Trials:
Regeneron Pharmaceuticals
Posted 5/29/2017
Chugai's Vabysmo Becomes First Approved Treatment for Angioid Streaks in Japan
• Chugai Pharmaceutical has received Japanese regulatory approval for Vabysmo as the first-ever treatment for choroidal neovascularization associated with angioid streaks, a rare eye disease that can lead to vision loss.
• The approval follows positive Phase III NIHONBASHI study results showing statistically significant visual acuity improvement of +5.8 letters at week 12 and a reduction in central retinal thickness of -106.4 μm.
• Vabysmo, a bispecific antibody targeting both VEGF-A and Ang-2 pathways, was generally well-tolerated with no new safety concerns identified during the clinical trial.
PharmaMar Expands Global Reach of Zepzelca with Argentina Approval and Merck Partnership for Japan
• PharmaMar and partner Adium Pharma have secured conditional marketing approval for Zepzelca (lurbinectedin) in Argentina for treating metastatic small cell lung cancer, extending the drug's availability to 18 territories globally.
• The company has simultaneously formed an exclusive license agreement with Merck for Zepzelca's development and commercialization in Japan, receiving an initial payment of €22 million with potential for €31 million more in milestone payments.
• These strategic moves strengthen PharmaMar's position in the oncology market while providing new treatment options for patients with an aggressive form of lung cancer across multiple regions.
China's Aphranel MagiCCrystal CaHA Filler Receives Global Regulatory Approvals, Setting New Standards in Regenerative Aesthetics
• Aphranel MagiCCrystal, developed by Shanghai Moyom Biotechnology, has become China's first Class III calcium hydroxylapatite (CaHA) microsphere-based dermal filler to receive NMPA certification.
• The innovative filler features proprietary "raspberry-like" through-hole microsphere morphology and physically crosslinked gel matrix, offering superior biocompatibility with 40% increased porosity compared to competitors.
• With regulatory clearances across Asia, Europe, and Latin America, including EU Medical Device certification and MDSAP compliance, the product marks China's transition from industry follower to global innovator in aesthetic medicine.