隶属于 nidda healthcare gmbh
相关临床试验
2
2 进行中
药物批准
61
批准总数
监管机构
4
监管机构数
成立时间
1895
进行中（未招募）
2
100.0%
- Calliditas Therapeutics will present seven abstracts at the 2026 World Congress of Nephrology, including new secondary analyses from the Phase 3 NefIgArd study evaluating Nefecon's effects on gut-associated lymphoid tissue biomarkers in IgA nephropathy patients. - The presentations will highlight mechanistic data demonstrating Nefecon's immunomodulatory effects in Peyer's patches, reinforcing its disease-modifying role in reducing pathogenic galactose-deficient IgA1 levels. - Additional data will include proteinuria response analyses and preliminary efficacy findings from a Phase 2a trial of setanaxib in Alport syndrome patients. - The company will also sponsor an educational symposium titled "The Evolving IgAN Treatment Paradigm: Why Target the Gut?" featuring international nephrology experts.
- The UK High Court rejected Regeneron and Bayer's injunction request against Alvotech's manufacturing of AVT06, a biosimilar to Eylea (aflibercept), allowing continued production at the company's UK contract manufacturing organization. - The court decision supports commercial launches of AVT06 in the European Economic Area, UK and other countries after the Supplementary Protection Certificate expiry on November 23, 2025. - AVT06 has already received regulatory approval from the European Commission on August 21, 2025, and the UK MHRA on August 28, 2025, with dossiers under review in multiple countries including the United States. - The ruling reinforces the SPC waiver system that allows biosimilar manufacturers to stockpile products six months before patent expiry, supporting market entry and patient access to cost-effective biologics.
- The FDA issued a complete response letter for Alvotech's AVT05, a biosimilar candidate to Simponi (golimumab), citing manufacturing facility deficiencies that must be resolved before approval. - The regulatory setback stems from issues identified during the FDA's pre-license inspection of Alvotech's Reykjavik facility in July 2025, though no other application deficiencies were found. - Alvotech has revised its 2025 financial outlook downward, expecting revenues of $570-$600 million and adjusted EBITDA of $130-$150 million due to continued facility investments and temporary production slowdown. - AVT05 would be the first FDA-approved biosimilar to Simponi, which generated less than $300 million in U.S. sales during the first half of 2025.
- NEXGEL, Inc. announced an expanded collaboration with European pharmaceutical leader STADA Arzneimittel AG to develop and launch digestive enzyme formulas and advanced scar and stretch mark care solutions in North America. - STADA will provide $1 million in non-dilutive capital to support product development, launch activities, and marketing initiatives for these new health product lines. - The partnership leverages NEXGEL's expertise in advanced hydrogel technologies and STADA's established presence in consumer health markets across over 100 countries. - This expansion represents NEXGEL's strategic push into high-demand wellness categories while strengthening STADA's foothold in the growing North American consumer health market.
- Alvotech, a global biosimilar medicines company, has appointed Linda Jónsdóttir as Chief Financial Officer, bringing 15 years of senior leadership experience from Marel food processing technology company. - Joel Morales, who served as CFO since 2020 and helped transform Alvotech from a private R&D-focused company to a profitable public biosimilars leader, is stepping down to prioritize family time. - Jónsdóttir's appointment comes as Alvotech continues its rapid growth trajectory with two approved biosimilars already marketed globally and nine additional candidates in development pipeline.
- Alvotech has acquired Ivers-Lee Group, a Swiss family-owned pharmaceutical packaging company founded in 1947, to expand its assembly and packaging capabilities ahead of three new biosimilar launches in 2025. - The acquisition integrates Ivers-Lee's GMP-licensed and FDA-approved facilities in Switzerland and Germany into Alvotech's Technical Operations division while maintaining the company as a separate legal entity. - Ivers-Lee brings specialized capabilities in autoinjector assembly, pre-filled syringe packaging, and safety device manufacturing to support Alvotech's growing global demand for biosimilar medicines. - The strategic move strengthens Alvotech's manufacturing infrastructure as the company prepares for increased sales growth in global markets with existing approved biosimilars to Humira and Stelara.
- 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.
- Bio-Thera Solutions achieves milestone as the European Medicines Agency accepts marketing application for BAT2506, marking the first golimumab biosimilar from a Chinese company submitted for EU approval. - The biosimilar application is supported by comprehensive analytical data and clinical studies, including a Phase 3 trial in psoriatic arthritis patients demonstrating equivalence to Simponi®. - Through partnership with STADA Arzneimittel AG, BAT2506 aims to provide a more affordable treatment option for multiple inflammatory conditions including rheumatoid arthritis and ulcerative colitis.
- The European Medicines Agency (EMA) has accepted Alvotech's Marketing Authorization Application for AVT03, a biosimilar candidate to Prolia and Xgeva. - AVT03 demonstrated clinical similarity to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics in clinical studies. - Alvotech has partnered with STADA Arzneimittel AG and Dr. Reddy’s Laboratories SA for commercialization of AVT03 in Europe. - The European denosumab market is valued at approximately US$1 billion, and AVT03 could expand patient access at lower costs.
