相关临床试验
0
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
暂无试验阶段数据
暂无试验数据
暂无试验数据
暂无批准数据
- Infant Bacterial Therapeutics received positive FDA feedback in May 2026, indicating existing evidence may be sufficient for market approval submission without requiring additional post-marketing studies. - The company's live biotherapeutic product IBP-9414, containing L. reuteri bacteria, targets mortality reduction in very low birth weight premature infants based on Phase III "Connection Study" results. - Manufacturing validation work is proceeding on schedule with analytical methods now complete and Process Performance Qualification runs planned for June-July 2026 at partner facilities. - IBT maintains its goal to submit a Biologics License Application to the FDA during 2026 while simultaneously pursuing European regulatory approval.
- Scinai Immunotherapeutics has acquired 100% of Recipharm Israel Ltd., which operates a cGMP manufacturing facility in Yavne, Israel, significantly expanding its contract development and manufacturing organization capabilities. - The acquisition includes a comprehensive commercial collaboration agreement with Recipharm that creates an integrated pathway for clients from early-stage development through commercial manufacturing. - The combined operations will now cover recombinant proteins, small molecules, peptides, antibodies, and oligonucleotides, addressing a key industry challenge of seamless program transitions between development stages. - The strategic partnership positions Scinai to participate economically in client programs that progress to late-stage clinical supply or commercial manufacturing at Recipharm's global facilities.
- The University of Oxford and ReciBioPharm have expanded their collaboration to manufacture two blood-stage malaria vaccine candidates, R78C and RH5.1, for Phase 1/2 clinical trials. - This partnership marks the sixth malaria vaccine candidate delivered since their collaboration began in 2016, with ReciBioPharm providing drug substance, drug product, and large-scale fill and finish services. - The collaboration addresses a critical global health need, as malaria caused 608,000 deaths in 2022, with 76% occurring in children under five in Africa according to WHO data. - ReciBioPharm is now fully producing RH5.1, which was previously manufactured by another CDMO, while expanding large-scale fill and finish activities for R78C to meet increased vial demand.
- Recipharm and ProductLife Group have established a strategic partnership combining manufacturing capabilities with regulatory expertise to accelerate pharmaceutical product development timelines. - The collaboration integrates Recipharm's development infrastructure for small molecules, biologics, and ATMPs with PLG's 2,000 regulatory experts operating across 150 countries, creating a comprehensive end-to-end solution. - This alliance aims to reduce time to clinical trials and market approval by embedding regulatory strategy directly into early development stages, ultimately benefiting patients with high unmet medical needs.
- NewBiologix has granted ReciBioPharm a non-exclusive license to its Xcell-Eng-HEK293 cell lines, enabling more efficient and cost-effective production of viral vectors for cell and gene therapies. - The partnership has achieved industry-leading results across multiple AAV programs, consistently exceeding 2E15 vg/L viral yields even with large gene constructs and delivering >95% full capsids in final formulations. - ReciBioPharm has validated high-yield AAV production across more than 10 serotypes, providing customers with a seamless path from research to GMP manufacturing while significantly reducing development costs.
- Recipharm has strengthened its pharmaceutical development capabilities through targeted investments in Oral Solid Dosage, Sterile Fill & Finish, and analytical services across facilities in Europe, the US, and India. - The CDMO has established new product development labs for sterile liquids and lyophilized products, alongside GMP pilot scale lines for various delivery systems, enhancing its ability to support the complete lifecycle from API development to commercial manufacturing. - Recipharm has partnered with ProductLife Group to combine manufacturing expertise with regulatory services, aiming to accelerate time to clinical trials and market approval while reducing supply chain and compliance challenges.
