Clinical Trials

24 Mar 2020
- Clinical Trials
- Human Trials
AbbVie announces positive topline results from phase 3 trial of VENCLEXTA, Azacitidine combo in AML

By PBR Staff Writer

AbbVie announced the VIALE-A (M15-656) trial of VENCLEXTA (venetoclax) in combination with azacitidine versus azacitidine in combination with placebo met its dual primary endpoints of statistically significant improvement of overall survival (OS) and composite complete remission rate (CR + CRi) for patients with previously-untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.
24 Mar 2020
Clinical Trials
Human Trials
FDA approves COVACTA trial for RA drug Actemra in COVID-19 patients

By PBR Staff Writer

Genentech has secured approval in the US to go ahead with the COVACTA trial to assess the use of its rheumatoid arthritis drug (RA drug) Actemra (tocilizumab) in COVID-19 patients.
23 Mar 2020
Clinical Trials
Human Trials
Feinstein Institutes begins three clinical trials for COVID-19 patients

By PBR Staff Writer

Northwell Health’s Feinstein Institutes for Medical Research has announced the recruitment of patients in three clinical studies, which are designed to eliminate the COVID-19 novel coronavirus.
20 Mar 2020
Clinical Trials
Human Trials
Roche to begin Actemra/RoActemra trial with COVID-19 pneumonia patients

By PBR Staff Writer

Roche has announced that it will begin a phase III clinical trial of Actemra/RoActemra (tocilizumab) in hospitalised patients with severe COVID-19 pneumonia.
19 Mar 2020
Clinical Trials
Human Trials
Pfizer’s abrocitinib meets co-primary efficacy endpoints in phase 3 AD trial

By PBR Staff Writer

US pharma company Pfizer said that the phase 3 JADE COMPARE trial for abrocitinib in atopic dermatitis (AD) met its co-primary efficacy endpoints.
19 Mar 2020
Clinical Trials
Human Trials
Novartis announces NEJM publication of three pivotal trials showing durable and potent efficacy of inclisiran

By PBR Staff Writer

Novartis announced today the publication of three pivotal Phase III clinical trials for inclisiran, a potential first-in-class small interfering RNA (siRNA) investigational agent for hyperlipidemia in adults.
18 Mar 2020
Clinical Trials
Human Trials
Imfinzi delivers sustained OS benefit in final analysis of CASPIAN trial

By PBR Staff Writer

AstraZeneca said that Imfinzi (durvalumab) has been demonstrated to have delivered a sustained overall survival (OS) benefit in the final analysis of the phase 3 CASPIAN trial in extensive-stage small cell lung cancer.
18 Mar 2020
Clinical Trials
Human Trials
Merck announces top-line results from phase 3 trials evaluating Gefapixant

By PBR Staff Writer

Merck announced top-line efficacy results from two ongoing pivotal Phase 3 trials (COUGH-1 and COUGH-2) evaluating the efficacy and safety of gefapixant (MK-7264), an investigational, orally administered, selective P2X3 receptor antagonist, for the treatment of refractory or unexplained chronic cough.
17 Mar 2020
Clinical Trials
Human Trials
Moderna doses first patient with mRNA-1273 in coronavirus vaccine trial

By PBR Staff Writer

Moderna has announced the dosing of the first participant in a phase1 study of mRNA-1273, the company’s mRNA vaccine candidate against the novel coronavirus (SARS-CoV-2).
16 Mar 2020
Clinical Trials
Human Trials
Pfizer, EMD Serono to scrap phase 3 study of avelumab in LA SCCHN

By PBR Staff Writer

Pfizer and EMD Serono are set to scrap the phase 3 JAVELIN Head and Neck 100 study as it was found that avelumab in addition to chemoradiotherapy (CRT) is unlikely to deliver the desired result.

Drug Discovery

Research & Development

Superluminal Medicines secures $60m to advance rare obesity therapy

Takeda and Weave Bio collaborate on AI-driven automation in drug development

Clinical Trials

Patient Enrollment

US FDA approves Avacta Group’s IND application for AVA6000

AM-Pharma enrols first patients in Covid-19 phase III trial

Regulation

Drug Filing

Viatris files applications in Japan for approval of Effexor to treat GAD

Scholar Rock submits application of SMA therapy to FDA

Production & Sales

Manufacturing

ENCell and Lucy Biotech forge alliance for mesenchymal stem cell therapy

Merck introduces single-use reactor to accelerate ADC manufacturing

Packaging & Supply Chain

Packaging

Uwe Röhrhoff Steps Down as Interim CEO of Gerresheimer AG

Gerresheimer at CPHI Frankfurt 2025

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Clinical Trials

AbbVie announces positive topline results from phase 3 trial of VENCLEXTA, Azacitidine combo in AML

FDA approves COVACTA trial for RA drug Actemra in COVID-19 patients

Feinstein Institutes begins three clinical trials for COVID-19 patients

Roche to begin Actemra/RoActemra trial with COVID-19 pneumonia patients

Pfizer’s abrocitinib meets co-primary efficacy endpoints in phase 3 AD trial

Novartis announces NEJM publication of three pivotal trials showing durable and potent efficacy of inclisiran

Imfinzi delivers sustained OS benefit in final analysis of CASPIAN trial

Merck announces top-line results from phase 3 trials evaluating Gefapixant

Moderna doses first patient with mRNA-1273 in coronavirus vaccine trial

Pfizer, EMD Serono to scrap phase 3 study of avelumab in LA SCCHN

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Research & Development

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