22:24 , Sep 18, 2018 |  BC Extra  |  Clinical News

Sosei, Allergan to delay trials of dementia candidate

Sosei Group Corp. (Tokyo:4565) and partner Allergan plc (NYSE:AGN) have suspended clinical development of neurodegenerative candidate HTL0018318 to investigate a toxicity signal -- a rare tumor -- found in a non-human primate treated with the...
17:36 , Sep 13, 2018 |  BC Innovations  |  Translation in Brief

Keeping CRISPR on target

Editas Medicine Inc. (NASDAQ:EDIT) has developed an in silico model of Staphylococcus aureus Cas9 (SaCas9) gene editing to help it select guide RNA sequences with minimal risk of off-target effects. Editas’ lead candidate EDIT-101 is built...
00:00 , Sep 8, 2018 |  BioCentury  |  Product Development

Data distribution

TransCelerate BioPharma Inc. is taking its data sharing initiative to the next level with a new platform that will integrate clinical and preclinical data sets in a single repository and provide new analytical tools. DataCelerate,...
18:46 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Allergan uterine fibroids therapy hits regulatory setback

Allergan plc (NYSE:AGN) said FDA issued a complete response letter for its NDA for ulipristal acetate to treat abnormal uterine bleeding in women with uterine fibroids. The company said FDA requested additional information and cited...
19:34 , Aug 24, 2018 |  BC Extra  |  Politics & Policy

Allergan, Mohawk Tribe request rehearing in sovereign immunity IPR case

Allergan plc (NYSE:AGN) and the Saint Regis Mohawk Tribe filed a petition on Aug. 20 for an en banc rehearing of their patent case in front of the full U.S. Court of Appeals for the...
22:44 , Aug 21, 2018 |  BC Extra  |  Company News

Allergan uterine fibroids therapy hits regulatory setback

Allergan plc (NYSE:AGN) said FDA issued a complete response letter for its NDA for ulipristal acetate to treat abnormal uterine bleeding in women with uterine fibroids. The company said FDA requested additional information and cited...
21:40 , Aug 20, 2018 |  BC Extra  |  Company News

Management tracks: Athenex, Intra-Cellular

Cancer company Athenex Inc. (NASDAQ:ATNX) said Director of Corporate Development and Investor Relations Randoll Sze will become CFO. Neurology play Intra-Cellular Therapies Inc. (NASDAQ:ITCI) hired Suresh Durgam as SVP of late-stage clinical development and medical affairs....
03:20 , Aug 17, 2018 |  BC Week In Review  |  Company News

Almirall acquires U.S. dermatology products from Allergan

Almirall S.A. (Madrid:ALM) will acquire a portfolio of five dermatology products marketed in the U.S. from Allergan plc (NYSE:AGN) for $550 million in cash. The portfolio, which generated 1H18 sales of $70 million, includes acne and...
21:03 , Aug 13, 2018 |  BC Extra  |  Company News

Management tracks: FDA, Allergan

Patrick Frey will depart as chief of staff in FDA’s Office of New Drugs (OND) on Aug. 24 to become director of global regulatory policy and R&D at Amgen Inc. (NASDAQ:AMGN). Khushboo Sharma becomes OND’s...
06:28 , Aug 10, 2018 |  BC Week In Review  |  Company News

Allergan exercises option for Editas' EDIT-101

Allergan plc (NYSE:AGN) exercised its option under a 2017 deal and will receive worldwide rights to develop and commercialize in vivo CRISPR-based therapy EDIT-101 from Editas Medicine Inc. (NASDAQ:EDIT) to treat Leber congenital amaurosis type...