16:12 , Feb 20, 2019 |  BC Innovations  |  Distillery Therapeutics

Musculoskeletal

INDICATION: Muscular dystrophy Cell culture and mouse studies suggest EGF could help treat Duchenne muscular dystrophy (DMD). In cultures of single extensor digitorum longus myofibers from a mouse model of DMD, EGF increased the number...
21:30 , Feb 19, 2019 |  BC Extra  |  Company News

HaiHe forms joint venture with CSPC, narrows focus to oncology

Shanghai HaiHe Biopharma Co. Ltd. (Shanghai, China) formed a joint venture with CSPC Pharmaceutical Group Ltd. (HKSE:1093) to develop and commercialize five of HaiHe’s programs, mostly outside of oncology. Financial terms were not disclosed. HaiHe...
03:20 , Feb 16, 2019 |  BioCentury  |  Product Development

ADCs’ inflection point

Industry is writing a new rule book for antibody-drug conjugates that could take the modality beyond the one-size-fits-all approach that has limited its success. By 2Q20, late-stage data from at least four ADCs testing new...
19:42 , Feb 15, 2019 |  BC Week In Review  |  Clinical News

Priority Review for Keytruda in RCC, head and neck cancer

FDA accepted and granted Priority Review to two sBLAs for anti-PD-1 mAb Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK). The agency assigned a June 10 PDUFA date to an sBLA for Keytruda as a...
18:47 , Feb 15, 2019 |  BC Week In Review  |  Financial News

MacroGenics raises $110M in follow-on

Days after its shares more than doubled based on a Phase III breast cancer readout, MacroGenics Inc. (NASDAQ:MGNX) raised $110 million in a follow-on. MacroGenics sold 5.5 million shares at $20, pricing at a 5%...
15:05 , Feb 15, 2019 |  BC Extra  |  Company News

Keytruda-Inlyta combo under Priority Review for first-line RCC

Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to its sBLA for Keytruda pembrolizumab plus Inlyta axitinib as a first-line treatment for renal cell carcinoma. Its PDUFA date is June 20....
01:35 , Feb 15, 2019 |  BC Week In Review  |  Company News

India's Glenmark spinning out innovative assets into U.S. unit

Glenmark Pharmaceuticals Ltd. (NSE:GLENMARK; BSE:532296) will spin out its innovation business to help accelerate its pipeline towards commercialization. The spinout will be a wholly owned subsidiary based in the U.S and have a new CEO...
22:45 , Feb 14, 2019 |  BC Extra  |  Company News

MedImmune vanishes as AZ restructures, returns to growth

AstraZeneca plc (LSE:AZN; NYSE:AZN) recorded its first year of product sales growth since 2009 and unveiled a new R&D structure in its 2018 earnings report Thursday. With the restructuring, AZ will drop the MedImmune unit...
21:57 , Feb 14, 2019 |  BC Innovations  |  Emerging Company Profile

Indalo: Integral to fibrosis

Indalo Therapeutics Inc. is targeting the root causes in fibrosis by antagonizing multiple integrins simultaneously to disrupt disease-associated processes, not just those driven by a single integrin or TGFβ signaling. Indalo President and CEO Robert...
21:47 , Feb 14, 2019 |  BC Extra  |  Company News

India's Glenmark spinning out innovative assets into U.S. unit

Glenmark Pharmaceuticals Ltd. (NSE:GLENMARK; BSE:532296) will spin out its innovation business to help accelerate its pipeline towards commercialization. The spinout will be a wholly owned subsidiary based in the U.S and have a new CEO...