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BioCentury | Dec 31, 2020
Regulation
Dec. 30 Quick Takes: A first for Chi-Med; plus Orphazyme, BMS, FDA REMS, Pfizer, Astellas, Alkermes, Osmotica, Quanterix, Ampio and Novartis
Chi-Med’s surufatinib approved in ChinaChina’s National Medical Products Administration (NMPA) approved an NDA from Hutchison China MediTech Ltd. (NASDAQ:HCM; LSE:HCM) for Sulanda
BioCentury | Nov 17, 2020
Regulation
Alkermes expects quick resolution to FDA setback for antipsychotic
Alkermes expects a swift resolution to a manufacturing issue that led to FDA’s issuance of a complete response letter for ALKS 3831, but the company isn’t yet committing to a launch
BioCentury | Oct 10, 2020
Product Development
Oct. 9 Quick Takes: Sobi’s Phase III miss; plus Alkermes, COVAX, Warp Speed-AZ, Lilly-Gates, Pfizer, Everest and Affamed-Kissei
Sobi’s avatrombopag misses in Phase III for chemotherapy-induced thrombocytopenia Swedish Orphan Biovitrum AB (SSE:SOBI) sank 18% on Friday, shedding $1.3 billion in market cap, after
BioCentury | Jan 29, 2020
Company News
Jan. 28 Company Quick Takes: Kite, Alkermes, Regeneron-Sanofi, Incyte, NantHealth-NantOmics, Sorrento, MicroCures, Paion-Mundipharma
BioCentury | Oct 23, 2019
Company News
With MS approval looming, Alkermes restructures to seek sustainable profits
BioCentury | Jul 15, 2019
Company News
July 15 Company Quick Takes: Boehringer takes out cancer vaccine company Amal; plus Farxiga setback, Alkermes and more
BioCentury | Nov 30, 2018
Clinical News
Alkermes planning NDA for schizophrenia combo after passing weight gain test
BioCentury | Nov 29, 2018
Clinical News
Alkermes planning NDA for schizophrenia combo after passing weight gain test
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