00:53 , Nov 20, 2018 |  BC Extra  |  Clinical News

Bavencio fails Phase III for ovarian cancer

Hopes for Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE) to get ahead in the ovarian cancer space, where no PD-1/PD-L1 inhibitors are approved, were delayed Monday after the partners reported that PD-L1 inhibitor Bavencio avelumab...
13:51 , Nov 19, 2018 |  BioCentury  |  Regulation

FDA to apply light touch to biopharma apps

Concerned that regulatory uncertainty is preventing biopharma companies from developing digital tools that could help patients manage their health, FDA plans to exempt a broad range of apps and other software from premarket review. In...
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...
22:54 , Nov 16, 2018 |  BC Extra  |  Company News

Pfizer to increase list price of 41 drugs

Pfizer Inc. (NYSE:PFE) said it plans to increase the list price for 41 medicines, effective Jan. 15. Last month, Chairman and CEO Ian Read said the pharma will likely end its agreement to defer drug...
20:42 , Nov 16, 2018 |  BC Extra  |  Clinical News

Imfinzi fails again in MYSTIC trial for first-line NSCLC

In another strike against tremelimumab, AstraZeneca plc (LSE:AZN; NYSE:AZN) said the anti-CTLA-4 mAb in combination with PD-L1 inhibitor Imfinzi durvalumab missed the co-primary endpoint of improving overall survival (OS) in the Phase III MYSTIC trial...
18:04 , Nov 16, 2018 |  BC Week In Review  |  Clinical News

uniQure hemophilia B gene therapy leads to Factor IX activity level of 31% of normal

uniQure N.V. (NASDAQ:QURE) reported that all three patients who received hemophilia B gene therapy AMT-061 in a dose-confirmation Phase IIb trial achieved and sustained therapeutic levels of Factor IX activity. The company has started enrollment...
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...
17:28 , Nov 16, 2018 |  BC Week In Review  |  Clinical News

Eidos' AG10 leads to >90% TTR stabilization at day 28 in Phase II

Eidos Therapeutics Inc. (NASDAQ:EIDX) said AG10 led to >90% stabilization of transthyretin (TTR) at day 28 in all treated patients in a Phase II trial to treat symptomatic TTR amyloid cardiomyopathy. Twice-daily AG10 significantly increased...
16:10 , Nov 16, 2018 |  BC Week In Review  |  Company News

U.K. Supreme Court deals Pfizer setback in Lyrica case

A U.K. Supreme Court decision will likely make it more difficult for branded drugmakers to protect the exclusivity of their products within related indications with its Nov. 14 decision that invalidated second medical use patent...
16:03 , Nov 16, 2018 |  BC Week In Review  |  Clinical News

Concert's hair loss product meets in Phase IIa, but with slower onset than Pfizer's

Concert Pharmaceuticals Inc. (NASDAQ:CNCE) reported Phase IIa data suggesting that its JAK inhibitor CTP-543 may have a later onset in treating alopecia areata than competing Phase IIa products from Pfizer Inc. (NYSE:PFE). Twice-daily 8 mg...