BioCentury | Mar 6, 2021
Product Development

March 5 Quick Takes: A regulatory first for Actemra; plus updates from Lilly-Incyte, Kronos, Junshi, United Therapeutics, Pfizer, Sumitomo Dainippon, Arena, Oyster Point, Azura

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said FDA approved Actemra tocilizumab to treat systemic sclerosis-associated interstitial lung disease, making it the first approved biologic for the disorder. FDA based the approval on data...
BioCentury | Feb 22, 2021
Product Development

Otonomy looking beyond Meniere disease after latest Phase III miss

Otonomy will look ahead to a pipeline addressing tinnitus and hearing loss after its latest Phase III failure in Meniere disease.  With Monday’s readout, Otonomy Inc. (NASDAQ:OTIC) shares fell $2.39 (44%) to $3.00, cutting the...
BioCentury | Feb 6, 2021
Product Development

Incyte continues layering on new opportunities

The next stage of Incyte’s growth strategy is already well under way as the company continues to expand its cancer portfolio and prepares to bring its first dermatology program to market.  Much of the current...
BioCentury | Jan 27, 2021
Emerging Company Profile

Nuvalent: Structure-based design to address selectivity, tumor resistance

After more than three years in stealth mode during which it subsisted on a $50 million series A round from Deerfield, Nuvalent is headed into the clinic with two targeted programs for non-small cell lung...
BioCentury | Jan 22, 2021
Regulation

CAR T Yescarta among new approvals by Japanese regulator

Yescarta became the second approved CAR T therapy in Japan, joining a basket of new approvals by the country’s Ministry of Health, Labour and Welfare. The therapy, developed by Gilead Sciences Inc. (NASDAQ:GILD) and partnered...
BioCentury | Jan 20, 2021
Emerging Company Profile

Aulos: Tackling the IL-2 space with computational biology

Apple Tree Partners launched Aulos into the crowded IL-2 space last week with a $40 million series A round and a computationally designed IL-2-binding antibody it thinks could have an edge in efficacy...
BioCentury | Jan 15, 2021
Management Tracks

Frates joins ALS company Amylyx; plus Artios, Valneva, Viravaxx

After two decades at Alkermes plc (NASDAQ:ALKS), James Frates will join neurodegenerative diseases company Amylyx Pharmaceuticals Inc. as CFO on Jan. 25. Frates said he felt a “calling” to do more to combat amyotrophic lateral sclerosis after his cousin...
BioCentury | Jan 15, 2021
Product Development

Jan. 14 Quick Takes: Pancreatic cancer data lifts NantKwest; plus NIH-Alkermes, Abbott, Inzen

NantKwest Inc. (NASDAQ:NK) rose $3.01 (20%) to $17.79 Thursday after announcing positive interim data from the Phase II QUILT 88 trial in metastatic pancreatic cancer. Early data showed that treatment with PD-L1 t-haNK therapy led...
BioCentury | Jan 7, 2021
Management Tracks

Alkermes promotes two to oversee growth plan as CFO Frates departs

As James Frates prepares to depart Alkermes after two decades, the neuroscience company has promoted a pair of executives to lead implementation of the company’s “value enhancement plan” unveiled in December in the wake of...
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 surufatinib to treat non-pancreatic neuroendocrine tumors. The FGFR, VEGFR and CSF1R inhibitor is...
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