Tags : plans

Formycon with its Partner BIOEQ Plans to Initiate P-III MAGELLAN-AMD

Shots: BIOEQ will sponsor the P-III study which will assess the FYB203 vs Eylea in patients with neovascular age-related macular degeneration (nAMD) to evaluate its efficacy, safety and immunogenicity. Additionally, the design of the study is developed in collaboration with the USFDA, EMA, PMDA The second program in ophthalmology will aim to strengthen and expand […]Read More

Celltrion Plans to Initiate P-I Trial for its CT-P41 (biosimilar,

Shots: In H1’21, Celltrion plans to initiate P-III trial for CT-P41 and is expected to commercialize in Feb 2025 when Amgen’s patents for Prolia expire in the US Celltrion is also planning for the onset of P-III for CT-P16 in H1’21 targeted for metastatic colorectal cancer, metastatic breast cancer, and non–small cell lung cancer. Additionally, […]Read More

Gilead Plans to Submit MAA to CDSCO for its Remdesivir

Shots: Gilead seeks CDSCO’s MAA for its anti-viral therapy remdesivir for the treatment of COVID-19. The company had a discussion with Union Health Ministry and Drugs Controller General of India (DCGI) prepare a road map for introducing remdesivir in India Following the US FDA’s approval, CDSCO can approve the therapy by waiving off clinical trials […]Read More

Bayer Plans Two P-III Studies to Evaluate Aflibercept 8mg Formulation

Shots: The two P-III studies, PHOTON and PULSAR will assess aflibercept 8mg formulation for intravitreal injection in adults with visual impairment due to DME & wet AMD respectively for 12wks with their expected initiation in 2020 In 2006, the companies collaborated for aflibercept, under which Regeneron retains rights to Eylea (aflibercept, 2mg) in the US […]Read More

Lupin Plans to Launch Two of its Biosimilars in the

Shots: Lupin is planning for EU approval of etanercept biosimilar in Mar 2020 with its expected launch in July 2020 in European markets, further planning its launch in the US and has also received approval in Japan in Mar 2019 Additionally, Lupin has also signed an agreement with Mylan to launch its drug in Asia, […]Read More

Dr. Reddy Plans the Onset of P-III trial for DRL_RI

Shots: The P-III trial involves assessing of DRL_RI vs Roche’s MabThera (rituximab) in 284 patients including 26 Koreans, with stage II-IV, CD20 positive, and follicular lymphoma previously treated have low tumor burden, evaluating its efficacy, safety, and immunogenicity Dr. Reddy’s plan to evaluate DRL_RI in Korea while Paraxel to provide clinical research services and Korea’s […]Read More

MacroGenics Plans to Advance the Development of Flotetuzumab for Acute

Shots: Macrogenic plans for the onset of a trial evaluating flotetuzumab + MGA012 to broaden the DOR of flotetuzumab in AML patients. Macrogenic will regain WW rights to develop and commercialize flotetuzumab with the termination of the license agreement with Laboratoires Servier signed on Sept’2012, which will be effective on Jan 15, 2020 MacroGenics has […]Read More

Alcon (Novartis Division) Plans to Develop SMART Suite Equipment for

Shots: The SMART Suite will be developed on Philips HealthSuite digital platform, providing services and technical tools to facilitate secure, open data exchange between facilities, clinicians and patients SMART Suite will be market-leading cataract refractive equipment connecting multiple diagnostic and surgical devices, providing easy access to patients’ data with simplified clinical process, consistency, greater efficiency […]Read More