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LUNA 3: Rilzabrutinib Phase III immune thrombocytopenia trial meets primary endpoint
Rilzabrutinib met both the primary endpoint of durable platelet response and various secondary endpoints in patients who were refractory to prior therapy
Fasenra for EGPA: addressing unmet needs
Benralizumab could offer patients with EGPA more treatment options, while reducing dependency on oral corticosteroids
Catalent and AstraZeneca to expand support for COVID-19 vaccine AZD1222
Catalent will prepare the Harmans facility, close to Baltimore-Washington International (BWI) airport, to enable multiple production trains to run in parallel to produce the...
Chemistry, manufacturing and control (CMC) as key drivers for drug discovery success
Embracing collaborative strategies not only accelerates drug development programmes but also fosters science-based milestone decisions, mitigates risks and prepares for...
Bristol Myers Squibb and Cellares partner to expand CAR-T manufacturing capabilities
Cellares will optimise and automate select Bristol Myers Squibb CAR-T cell therapies onto its high-throughput manufacturing program, the Cell Shuttle
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Ingredients
Biocon collaborates to commercialise generic formulas in South East Asia
Biocon Pharma and DKSH Business Unit Healthcare have signed an agreement under which DKSH will sell and distribute seven of Biocon Pharma's generic formulations in Singapore and Thailand
Biocon appoints new CEO
Siddharth Mittal has taken over from Dr Arun Chandavarkar as CEO & Joint Managing Director of India-based Biocon
Regulatory
Biocon biologics facility gets FDA nod
India's biopharmaceutical giant has been investing in expanding manufacturing capacity in line with expectations of higher biosimilars penetration in developed and emerging market
Ingredients
Biocon recieves GMP status for Malaysian insulin facility
Indian Biocon’s Malaysia facility manufactures drug substance and drug products in vials, cartridges and insulin delivery devices
Finance
Biocon strikes up MYR 300 million ($68m) contract for insulin with Malaysia
Malaysia's Ministry of Health three-year contract for rh-Insulin will reduce its reliance on imports
Regulatory
Delhi High Court puts restrictions on Biocon and Mylan breast cancer drug marketing
Court allowed the sale and manufacture of affordable cancer drugs by Biocon and Mylan with certain restrictions on packaging and labelling and regulatory process
Regulatory
Biocon's partnership with Mylan makes significant progress
Biocon will be filing for regulatory approvals in key developed markets in a phased manner during 2016 for four biosimilars
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