Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study

Candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis

10-Nov-2020 - Pfizer Inc. and BioNTech SE announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 ...

Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia

24-Mar-2020 - Roche announcedthat it are working with the Food & Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services ...

Merck and Pfizer Initiate Phase III Trial to Evaluate Avelumab as First-line Treatment for Ovarian Cancer

08-Jul-2016 - Merck and Pfizer announced the initiation of a Phase III study, JAVELIN Ovarian 100, to evaluate the efficacy and safety of avelumab in combination with, and/or as follow-on (maintenance) treatment to, platinum-based chemotherapy in patients with locally advanced or metastatic disease (Stage III ...

Ferrer successfully completes second phase III clinical trial in adult and paediatric patients with impetigo for antibacterial Ozenoxacin

04-Aug-2015 - Ferrer announces that it has successfully completed a second phase III clinical trial in adult and paediatric patients aged two months and older with impetigo, utilizing Ozenoxacin 1% cream as a topical treatment for dermatological infectious conditions.The study demonstrated the superiority of ...

UCB announces Phase 3 clinical trial program for epratuzumab in Systemic Lupus Erythematosus did not meet primary endpoint

30-Jul-2015 - UCB announced that the two EMBODY™ Phase 3 clinical studies for epratuzumab in Systemic Lupus Erythematosus (SLE) did not meet their primary clinical efficacy endpoints in either dose in both studies. Treatment response in patients who received epratuzumab in addition to standard therapy was not ...

Biotie announces start of tozadenant Phase 3 Study in Parkinson's disease

22-Jul-2015 - Biotie announces the start of the Phase 3 clinical study of tozadenant, an investigational adenosine A2a receptor antagonist, in patients with Parkinson's disease (PD) experiencing levodopa related end-of-dose "wearing-off".The Phase 3 study (TOZ-PD) is a randomized, double-blind, placebo ...

AbbVie Announces New Phase 3b Results in Genotype 1b Chronic Hepatitis C Patients with Compensated Liver Cirrhosis

26-Jun-2015 - AbbVie announced TURQUOISE-III study results demonstrating 100 percent (n=60/60) sustained virologic response at 12 weeks post-treatment (SVR12) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis. Patients received 12 weeks of VIEKIRAX® ...

Sanofi's Lyxumia Demonstrated Cardiovascular Safety in People with Type 2 Diabetes and High CV Risk

10-Jun-2015 - Sanofi announced the presentation of full results of the Phase IIIb ELIXA study, which was designed to assess the cardiovascular (CV) safety of Lyxumia® (lixisenatide) in adults with type 2 diabetes and high CV risk. As previously reported, lixisenatide met the pre-specified criterion of ...

Intercept Pharmaceuticals Announces Pivotal Phase 3 Clinical Trial of Obeticholic Acid in NASH

21-May-2015 - Intercept Pharmaceuticals, Inc. announced its plans for an international Phase 3 trial of obeticholic acid (OCA), the company's lead FXR agonist, in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. OCA has received breakthrough therapy designation in this ...

Synthon Announces Successful Outcomes from Phase III Study of Synthon’s Glatiramer Acetate

04-May-2015 - Synthon announces that data from the open-label extension of the Phase III GATE study of the Company’s generic glatiramer acetate in patients with relapsing remitting multiple sclerosis (RRMS) demonstrate that efficacy, safety and tolerability were maintained over the entire two-year study ...