00:06 , Nov 17, 2018 |  BC Extra  |  Company News

Novartis joins call asking FDA to stop biosimilar trash-talkers

Novartis AG (NYSE:NVS; SIX:NOVN) joined Pfizer Inc. (NYSE:PFE) in asking FDA to stop campaigns from branded drugmakers that the pharmas say are misleading the public about the safety of biosimilars. Novartis submitted its comments in...
22:19 , Nov 16, 2018 |  BC Extra  |  Company News

CHMP backs first all-oral sleeping sickness treatment, extensions for Blincyto, Opdivo-Yervoy combo

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including the first all-oral treatment for African trypanosomiasis (sleeping sickness). The agency issued no negative opinions in its monthly roundup. The agency backed...
17:37 , Nov 16, 2018 |  BC Week In Review  |  Clinical News

Pfizer launches U.S.’s first biosimilar epoetin

Pfizer Inc. (NYSE:PFE) launched the first biosimilar of anemia drug epoetin alfa in the U.S., priced at a 33.5% discount to the lowest priced reference product. Amgen Inc. (NASDAQ:AMGN) markets reference drug Epogen and Johnson...
16:04 , Nov 16, 2018 |  BC Week In Review  |  Clinical News

AZ’s Farxiga reduces heart failure, but misses on CV events

AstraZeneca plc (LSE:AZN; NYSE:AZN) presented details of its 17,160-patient Phase III DECLARE-TIMI 58 cardiovascular outcomes trial (CVOT) showing that diabetes drug Farxiga dapagliflozin's primary CV benefit was limited to reducing hospitalizations due to heart failure....
15:59 , Nov 16, 2018 |  BC Week In Review  |  Company News

Arena licenses ralinepag to United, moves S1PR1 agonist to center stage

United Therapeutics Corp. (NASDAQ:UTHR) licensed exclusive, worldwide rights to pulmonary arterial hypertension compound ralinepag from Arena Pharmaceuticals Inc. (NASDAQ:ARNA) in a Nov. 15 deal that highlights how far Arena’s come since it shifted its focus...
00:26 , Nov 16, 2018 |  BC Extra  |  Company News

Arena licenses ralinepag to United, moves S1PR1 agonist to center stage

United Therapeutics Corp. (NASDAQ:UTHR) licensed exclusive, worldwide rights to pulmonary arterial hypertension compound ralinepag from Arena Pharmaceuticals Inc. (NASDAQ:ARNA) on Thursday in a deal that highlights how far Arena’s come since it shifted its focus...
22:03 , Nov 15, 2018 |  BC Extra  |  Company News

Management tracks: Spark, Cabaletta

Spark Therapeutics Inc. (NASDAQ:ONCE) said in an SEC filing that COO John Furey will resign, effective Jan. 1. He will remain a consultant for the gene therapy company through June 28. Cabaletta Bio Inc. (Radnor,...
00:25 , Nov 15, 2018 |  BC Extra  |  Company News

Pfizer launches U.S.’s first biosimilar epoetin

Pfizer Inc. (NYSE:PFE) launched the first biosimilar of anemia drug epoetin alfa in the U.S., priced at a 33.5% discount to the lowest priced reference product. Amgen Inc. (NASDAQ:AMGN) markets reference drug Epogen and Johnson...
23:26 , Nov 13, 2018 |  BC Extra  |  Company News

Management tracks: Anchiano, ContraFect

Cancer company Anchiano Therapeutics Inc. (Tel Aviv:ANCN) appointed Stephen Hoffman chairman. He is CEO of Aerpio Pharmaceuticals Inc. (OTCQB:ARPO). Anchiano also named Robert Connelly a director. He was a venture partner at Flagship Pioneering and...
23:47 , Nov 12, 2018 |  BC Extra  |  Clinical News

AZ’s Farxiga reduces heart failure, but misses on CV events

AstraZeneca plc (LSE:AZN; NYSE:AZN) presented details of its 17,160-patient Phase III DECLARE-TIMI 58 cardiovascular outcomes trial (CVOT) showing that diabetes drug Farxiga dapagliflozin's primary CV benefit was limited to reducing hospitalizations due to heart failure....