Clinical Trial News
Alvotech Expands European Presence with Successful Nasdaq Stockholm Listing
• Alvotech's Swedish Depository Receipts (SDRs) offering was multiple times oversubscribed, attracting over 3,000 new shareholders and raising approximately SEK 39 million.
• The biosimilar developer's strategic expansion includes acquiring Xbrane's R&D operations at the Karolinska life-science hub, strengthening its research capabilities and establishing a footprint in Sweden's biotech sector.
• Trading of Alvotech's SDRs on Nasdaq Stockholm commenced on May 19, 2025, under the ticker "ALVO SDB," enhancing the company's access to Nordic and European investors and capital markets.
Endo Expands ADRENALIN® Ready-to-Use Premixed Bag Line with New 8 mg/250 mL Concentration for Septic Shock
• Endo has launched ADRENALIN® (epinephrine) 8 mg/250 mL premixed IV bag, expanding its portfolio of the first and only FDA-approved manufacturer-prepared epinephrine premixed solutions.
• The ready-to-use formulation eliminates compounding requirements, features single-port IV tubing to reduce inadvertent mixture risk, and offers a 24-month room temperature shelf life.
• This expansion addresses healthcare workflow challenges by reducing preparation time and potential errors, with additional 5 mg/250 mL and 10 mg/250 mL concentrations planned for future release.
FDA Deputy Commissioner Signals Potential Overhaul of PDUFA Reauthorization Structure
• The FDA is preparing to renegotiate its multibillion-dollar, five-year user fee agreements with the pharmaceutical industry later this summer, with potential structural changes on the horizon.
• A newly appointed FDA deputy commissioner suggested on Friday that the current PDUFA framework may need significant restructuring to better serve regulatory needs.
• The Prescription Drug User Fee Act (PDUFA) represents a critical funding mechanism for FDA drug review processes, with negotiations set to impact future drug approval timelines and requirements.
Remedy Plan Therapeutics Secures $18 Million to Advance Novel NAMPT Inhibitor for AML and MDS Treatment
• Gaithersburg-based Remedy Plan Therapeutics has raised $18 million in an oversubscribed insider financing round, bringing their total funding to $55 million to date.
• The funding will accelerate the development of RPT1G, their first-in-class NAMPT inhibitor, into Phase 1/2 clinical trials for acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS).
• Remedy Plan's innovative "hyperbolic" approach to NAMPT inhibition avoids the on-target toxicities that have hindered previous development efforts, potentially addressing over 20 diseases spanning oncology, autoimmunity, and metabolic disorders.
Highlighted Clinical Trials:
Remedy Plan, Inc.
Posted 11/18/2024
Amneal Pharmaceuticals Reports Strong Q1 2025 Results with 5% Revenue Growth and Margin Expansion
• Amneal Pharmaceuticals reported Q1 2025 revenue of $695 million, a 5% year-over-year increase, with growth across all three business segments despite falling short of analyst expectations.
• The company's Parkinson's disease treatment CREXONT continues to gain market traction, with insurance coverage expanding from 30% to 60% of U.S. covered lives in just six months.
• Adjusted EBITDA increased 12% to $170 million, with adjusted diluted EPS rising 50% to $0.21, reflecting improved gross margins and operating expense leverage.
Gan & Lee Pharmaceuticals Partners with Brazil to Localize Insulin Production in Landmark Agreement
• Gan & Lee Pharmaceuticals has signed a cooperation commitment letter with Brazil's Ministry of Health, becoming the first Chinese pharmaceutical company to participate in Brazil's PDP program for localizing insulin production.
• The partnership between Gan & Lee, Brazilian pharmaceutical company Biomm, and state-funded research center Fiocruz will focus on producing insulin glargine locally, addressing insulin shortages and expanding treatment access for Type 2 diabetes patients.
• Brazil's Minister of Health Alexandre Padilha emphasized that the collaboration will not only ensure medication accessibility but also systematically upgrade Brazil's biopharmaceutical capabilities, establishing the foundation for domestic insulin production.
FDA Recalls Nearly 76,000 Cases of Eye Care Products Due to Manufacturing Deviations
• The FDA has issued a recall for approximately 76,000 cases of over-the-counter ophthalmic products following an audit that revealed significant manufacturing deviations at BRS Analytical Services.
• Five different eye care products are affected, including artificial tears and lubricant eye drops, distributed nationwide between May 2023 and April 2025, with expiration dates ranging through March 2027.
• The recall stems from concerns about "lack of assurance of sterility," which could potentially compromise product safety, though the specific health hazards remain unknown.
Brainomix's e-Lung AI Technology Validated for Progressive Pulmonary Fibrosis Detection in Boehringer Ingelheim Collaboration
• New studies presented at the American Thoracic Society Conference validate Brainomix's FDA-cleared e-Lung technology as a reliable tool for identifying progressive pulmonary fibrosis with greater sensitivity than conventional methods.
• The validation studies utilized data from Boehringer Ingelheim's landmark INBUILD clinical trial, demonstrating e-Lung's ability to predict disease progression and patient outcomes independent of traditional CT imaging markers.
• Brainomix's AI-powered imaging solution enables earlier treatment decisions and better patient prioritization, potentially addressing the critical diagnostic delay that affects pulmonary fibrosis patients who often wait up to two years for diagnosis.
Moderna Advances Oncology Pipeline with First Dosing in Phase 1 Trial of Novel mRNA Cancer Therapy
• Moderna has initiated dosing of mRNA-4106, an innovative cancer therapy candidate, in a Phase 1 clinical trial, marking a significant step in expanding its oncology pipeline beyond vaccines.
• The advancement comes amid financial challenges for the company, with analysts projecting continued negative earnings for the next three years despite the potential for new revenue streams.
• Despite a 3% stock decline last week contrary to broader market gains, analysts maintain a consensus price target of $46.96, suggesting potential upside if the company's oncology strategy proves successful.
Denosumab Shows Promise as Immune Modulator in Breast Cancer Treatment
• The D-BIOMARK clinical trial reveals that denosumab, commonly used for osteoporosis and bone complications, enhances immune cell infiltration in breast cancer tumors despite showing no direct anti-proliferative effects.
• The drug's immune-boosting properties were most pronounced in luminal B breast cancer, a subtype that typically responds poorly to current immunotherapies, potentially opening new treatment avenues.
• Researchers from ICO, IDIBELL, and CNIO collaborated on this study, demonstrating how denosumab inhibits the RANK pathway, which plays a key role in breast cancer development and progression.