Biologic Drugs

Oct 11, 2017
By Pharmaceutical Technology Editors
AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.
Oct 11, 2017
By Pharmaceutical Technology Editors
Amgen is seeking approval for an additional indication in glucocorticoid-induced osteoporosis for its blockbuster osteoporosis therapeutic, Prolia.
Oct 06, 2017
By Pharmaceutical Technology Editors
Under an agreement, ProBioGen will develop a stable cell-line for and manufacture an anti-cancer antibody for Chiome using its proprietary cancer cell-killing technology.
Sep 28, 2017
By Pharmaceutical Technology Editors
KBI Biopharma, a biopharmaceutical contract development and manufacturing organization, will manufacture an antibody and a fusion protein developed by Heat Biologics’ subsidiary.
Sep 28, 2017
By Pharmaceutical Technology Editors
Amgen will collaborate with China’s Simcere Pharmaceutical Group, a R&D-driven pharmaceutical company, to co-develop four biosimilars for the Chinese market.
Sep 27, 2017
By Pharmaceutical Technology Editors
FDA rejected the company’s biologics license application for its anti-rheumatoid arthritis biologic and has requested additional clinical safety data.
Sep 26, 2017
By Pharmaceutical Technology Editors
Glythera gains exclusive access to Cancer Research UK’s novel CDK11 inhibitor program for the development of ADCs conjugated using its highly stable conjugation platform, PermaLink.
Sep 26, 2017
By Pharmaceutical Technology Editors
This latest FDA approval expands the blockbuster anti-cancer biologic’s indications in oncology.
Sep 25, 2017
Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.
Sep 21, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.
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