23:44 , Nov 1, 2018 |  BC Extra  |  Company News

FDA panel snubs Alkermes’ antidepressant

An FDA panel voted 21-2 that Alkermes plc (NASDAQ:ALKS) did not demonstrate a favorable benefit risk profile for ALKS 5461 to support approval for adjunct treatment of major depressive disorder. Panelists also voted 20-3 that...
18:10 , Oct 12, 2018 |  BC Week In Review  |  Clinical News

Phase II data for Merck's Btk inhibitor highlighted at ECTRIMS

Merck KGaA (Xetra:MRK) reported 24-week data from a Phase II trial to treat relapsing multiple sclerosis showing that evobrutinib (M2951) reduced the mean total number of gadolinium-enhancing T1 lesions by up to 2.7 over placebo....
12:15 , Oct 12, 2018 |  BC Extra  |  Clinical News

Phase II data for Merck's Btk inhibitor highlighted at ECTRIMS

Merck KGaA (Xetra:MRK) reported 24-week data from a Phase II trial to treat relapsing multiple sclerosis showing that evobrutinib (M2951) reduced the mean total number of gadolinium-enhancing T1 lesions by up to 2.7 over placebo....
16:42 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

AZ says Phase IIIb data of Bevespi Aerosphere in COPD are 'inconsistent with previous data'

AstraZeneca plc (LSE:AZN; NYSE:AZN) said Bevespi Aerosphere glycopyrrolate/formoterol fumarate met one of three primary endpoints in the Phase IIIb AERISTO trial to treat moderate to very severe chronic obstructive pulmonary disease (COPD). Bevespi Aerosphere was...
03:01 , Sep 1, 2018 |  BioCentury  |  Politics, Policy & Law

A pathway to Biopharma 3.0

As market and social forces continue to tighten around the biopharmaceutical industry, drug companies need to start evolving toward a new business model that both capitalizes on the potential of new technologies and accommodates society’s...
17:37 , Aug 31, 2018 |  BC Week In Review  |  Company News

CNS company Seelos reverse merging with Apricus

Seelos Therapeutics Inc. (New York, N.Y.) will reverse-merge with Apricus Biosciences Inc. (NASDAQ:APRI). Seelos shareholders are expected to own about 86% of the merged company. Apricus shareholders are expected to own the remaining 14%, and...
03:32 , Aug 17, 2018 |  BC Week In Review  |  Clinical News

FDA accepts applications for Circassia COPD products Duaklir, Tudorza

Circassia Pharmaceuticals plc (LSE:CIR) said FDA accepted for review an NDA for Duaklir Pressair aclidinium bromide/formoterol fumarate to treat chronic obstructive pulmonary disease (COPD). The company also said the agency accepted an sNDA for Tudorza...
19:22 , Aug 10, 2018 |  BC Week In Review  |  Clinical News

Spring Bank details peak HBV DNA and HBV RNA reductions for 100 mg dose of inarigivir

Spring Bank Pharmaceuticals Inc. (NASDAQ:SBPH) reported data from 20 patients in the third cohort of Part A of Phase II ACHIEVE trial to treat chronic HBV infection showing that 100 mg inarigivir soproxil led to...
16:56 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

Merck's doravirine similar to ritonavir-boosted darunavir in Phase III for HIV-1 infection

Merck & Co. Inc. (NYSE:MRK) said once-daily oral doravirine (MK-1439) in combination with other antiretroviral therapies (ARTs) led to viral suppression at week 96 in 73.1% of patients vs. 66% of patients treated with ritonavir-boosted...
21:33 , May 11, 2018 |  BioCentury  |  Finance

Seroquel stepping stone

The $538 million acquisition by Luye Pharma Group Ltd. (HKSE:2186) of Seroquel quetiapine fumarate from AstraZeneca plc (LSE:AZN; NYSE:AZN) will lay the commercial groundwork in new emerging markets for the Chinese pharma’s internal CNS pipeline....