Meiji Seika Pharma Co., Ltd
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Latest From Meiji Seika Pharma Co., Ltd
Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Letters
Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.
Deal Watch: Japan’s SNBL To Re-Absorb US Spinout Satsuma
Shin Nippon Biomedical Laboratories would take over migraine candidate STS101, now under FDA review. Blue Water Vaccines to pick up BPH drug from Veru.
Dong-A ST Achieves Therapeutic Equivalence With Stelara Biosimilar
Dong-A has achieved therapeutic equivalence for its ustekinumab biosimilar candidate DMB-3115 in clinical studies and now plans to file for marketing authorization for the product in both the EU and US.
FDA’s Novel Approvals Again Led By Oncology And Neurology, But Dermatology Also Shone In 2022
Pink Sheet infographic breaks down the trends and surprises in 2022 approvals. Cancer therapies and non-malignant hematology exceeded the average use of expedited review programs but were weighted to orphan diseases, while dermatology saw first-in-class approvals for big markets.
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