Latest From Biocon Ltd.
Aurobindo has received further Form 483s from the FDA, while Biocon has received an EIR for its Bengaluru facility. The FDA has also successfully concluded inspections for Indoco and Lupin, while ANI, Aptar and MicroSphere have made strategic moves.
Mylan is preparing to launch a trastuzumab biosimilar in the US, while progress of developing bevacizumab and aflibercept biosimilars continues. Insulin aspart and glargine are also in Mylan’s pipeline.
The latest drug development news and highlights from our US FDA Performance Tracker include a Neulasta biosimilar approval for Sandoz, novel approvals for Celgene's Reblozyl and Giskit B.V.'s ExEm Foam, and a submission for Regeneron's Ebola candidate.
The European Medicines Agency has received 11 new marketing authorization applications, including three for orphan products from Vertex, MYR Pharmaceuticals and AstraZeneca.
- Large Molecule
- Medical Devices
- Therapeutic Areas
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- Biocon Ltd.
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Arun Chandavarkar, PhD, CEO
Siddharth Mittal, CFO
Ravi Limaye, Pres., Mktg.
Narendra Chirmule, PhD, SVP & Head, R&D
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