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

...Lorbrena lorlatinib as a first-line treatment for ALK-positive non-small cell lung cancer. The inhibitor of ALK...
...and ROS1 previously had accelerated approval in second- and third-line settings following treatment with other ALK...
BioCentury | Feb 22, 2021
Product Development

Otonomy looking beyond Meniere disease after latest Phase III miss

...clinical programs are based on delivery technology that provides sustained exposure. A partner, ALK-Abello A/S (CSE:ALK...
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

...months as its clinical preparations begin.Nuvalent’s two lead programs are selective inhibitors of ROS1 and ALK...
...due to begin a Phase I/II trial next half. A Phase I/II trial of the ALK...
BioCentury | Jan 22, 2021
Regulation

CAR T Yescarta among new approvals by Japanese regulator

...from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) as a first- or second-line therapy to treat ALK-positive...
...from Grifols S.A. (Madrid:GRF; NASDAQ:GRFS); and Orladeyo berotralstat from BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX). TARGETSALKAnaplastic lymphoma kinase Paul...
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

...patient registry to monitor for accidental exposure, misuse, abuse, addiction and overdose.Priority review for Pfizer’s ALK...
...accepted for priority review an sNDA for Lorbrena lorlatinib from Pfizer Inc. (NYSE:PFE) to treat ALK-positive...
Items per page:
1 - 10 of 1941