22:43 , May 15, 2019 |  BC Extra  |  Company News

May 15 Company Quick Takes: Approvals for Bavencio in RCC, Venclexta-Gazyva combo; plus Adaptimmune, Alpine, Advaxis

Bavencio gets RCC approval with Inlyta  FDA approved Bavencio avelumab from Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE) for first-line treatment of advanced renal cell carcinoma in combination with Pfizer's Inlyta axitinib, making Bavencio the...
00:09 , May 8, 2019 |  BC Extra  |  Company News

Regeneron falls after reporting EPS below the Street and disclosing patient deaths

Regeneron lost $2.4 billion in market cap Tuesday after reporting 1Q19 EPS well below consensus and disclosing two patient deaths in a Phase I trial evaluating its bispecific mAb targeting CD20 and CD3, REGN1979, in...
19:25 , Apr 19, 2019 |  BC Week In Review  |  Company News

Newer drugs lift Roche’s 1Q sales

Driven by newer drugs and expanded indications, Roche beat analyst expectations for its 1Q19 global pharmaceutical sales by 7% at CHF11.9 billion ($11.8 billion) vs. the Street's CHF11.2 billion ($11 billion) estimate. Pharmaceutical sales increased...
00:37 , Mar 27, 2019 |  BC Extra  |  Company News

FDA approves Novartis' Mayzent for MS

FDA's approval of Novartis’ Mayzent siponimod late Tuesday with a broad label could position the multiple sclerosis drug to stand out from a crowded field with its approval for secondary progressive MS, an indication for...
17:34 , Mar 22, 2019 |  BC Week In Review  |  Company News

Roche gets European approval of rituximab to treat skin disease

Roche said the European Commission approved MabThera rituximab to treat pemphigus vulgaris (PV). FDA approved the drug for the indication in June 2018. Genentech Inc. and Biogen Inc. (NASDAQ:BIIB) co-market IV rituximab in the U.S...
21:01 , Mar 15, 2019 |  BC Extra  |  Company News

ICER suggests Novartis' MS therapy siponimod won't be cost-effective

ICER said the price of multiple sclerosis therapy Mayzent siponimod from Novartis would have to reach a monthly net price of $995 to meet its standard cost-effectiveness threshold of $150,000 per QALY. That price would...
17:33 , Mar 8, 2019 |  BC Week In Review  |  Financial News

Genome editing company Precision proposes $100M IPO

With plans to bring an allogeneic CAR T immunotherapy into the clinic, Precision BioSciences Inc. (Durham, N.C.) proposed March 1 to raise up to $100 million in an IPO on NASDAQ. Precision plans to start...
00:53 , Mar 2, 2019 |  BC Extra  |  Financial News

Genome editing company Precision proposes $100M IPO

With plans to bring an allogeneic CAR T immunotherapy into the clinic, Precision BioSciences Inc. (Durham, N.C.) proposed Friday to raise up to $100 million in an IPO on NASDAQ. Precision plans to start this...
02:38 , Feb 28, 2019 |  BC Week In Review  |  Clinical News

China approves first biosimilar, Shanghai Henlius’ HLX01

China's National Medical Products Administration (NMPA) approved the country’s first biosimilar, rituximab biosimilar HLX01 from Shanghai Henlius Biotech Inc. (Shanghai, China). The chimeric mAb against CD20 was approved in China for the same indications as...
23:45 , Feb 25, 2019 |  BC Extra  |  Company News

China approves first biosimilar, Shanghai Henlius’ HLX01

China's National Medical Products Administration (NMPA) approved last Friday the country’s first biosimilar, rituximab biosimilar HLX01 from Shanghai Henlius Biotech Inc. (Shanghai, China). The chimeric mAb against CD20 was approved in China for the same...