Human Trials

29 May 2020
- Clinical Trials
- Human Trials
SAB Biotherapeutics confirms neutralising antibodies to SARS-CoV-2 and begins clinical manufacturing of novel Covid-19 therapeutic candidate

By PBR Staff Writer

SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a proprietary technology to produce fully human polyclonal antibodies without the need for human plasma donors, today announced in vitro data demonstrating that SAB-185, its COVID-19 therapeutic candidate, has highly-potent neutralizing antibodies to SARS-CoV-2 that are four times higher than the most potent human convalescent plasma serum sample evaluated.
29 May 2020
Clinical Trials
Human Trials
Roche to begin Covid-19 pneumonia trial with Actemra/RoActemra plus remdesivir

By PBR Staff Writer

Roche has announced the commencement of phase III clinical study of Actemra/RoActemra plus remdesivir in hospitalised patients with severe Covid-19 pneumonia.
28 May 2020
Clinical Trials
Human Trials
PhaseBio gets FDA nod to begin Covid-19 trial with VIP receptor agonist PB1046

By PBR Staff Writer

PhaseBio Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) to begin a VANGARD pivotal clinical to assess PB1046 as a treatment for hospitalised Covid-19 patients.
26 May 2020
Clinical Trials
Human Trials
Algernon submits IND application with FDA for possible Covid-19 treatment

By PBR Staff Writer

Algernon Pharmaceuticals has completed the submission of an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to assess the Ifenprodil in the phase 2b/3 clinical study to treat Covid-19 patients.
22 May 2020
Clinical Trials
Human Trials
Antisense ATL1102 final phase 2 DMD results meet primary endpoint and exceed expectations on secondary endpoints

By PBR Staff Writer

Antisense Therapeutics is pleased to advise that the Phase II clinical trial of ANP’s immunomodulatory therapy, ATL1102 for Duchenne Muscular Dystrophy (DMD) has met its primary endpoint confirming the safety and tolerability of ATL1102 for advancement into a potentially pivotal Phase IIb clinical trial.
22 May 2020
Clinical Trials
Human Trials
Appili set to evaluate favipiravir as preventive measure against Covid-19

By PBR Staff Writer

Appili Therapeutics has secured regulatory clearance from Health Canada to move ahead with a phase 2 study for studying FUJIFILM Toyama Chemical’s favipiravir as a preventative measure against the outbreak of novel coronavirus (Covid-19).
21 May 2020
Clinical Trials
Human Trials
Gilead and Galapagos announce positive topline results of phase 2b/3 trial of filgotinib in moderately to severely active ulcerative colitis

By PBR Staff Writer

Gilead Sciences and Galapagos announced positive topline results from SELECTION, a randomized, double-blind, placebo-controlled, Phase 2b/3 trial evaluating the efficacy and safety of the investigational, oral, once-daily, selective JAK1 inhibitor filgotinib in 1,348 biologic-naïve or biologic-experienced adult patients with moderately to severely active ulcerative colitis (UC).
21 May 2020
Clinical Trials
Human Trials
FDA approves Octapharma USA’s IND application to begin trial with severe Covid-19 patients

By PBR Staff Writer

Octapharma USA has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application to begin a phase three clinical trial to assess the efficacy and safety of Octagam 10% [Immune Globulin Intravenous (Human)] therapy in Covid-19 patients with severe disease progression.
20 May 2020
Clinical Trials
Human Trials
Janssen announces phase 1 results for amivantamab in advanced NSCLC harbouring Exon 20 insertion mutations

By PBR Staff Writer

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 1 CHRYSALIS study evaluating amivantamab (JNJ-6372) in the treatment of patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.
19 May 2020
Clinical Trials
Human Trials
Moderna’s Covid-19 vaccine shows significant effect in early human trial

By PBR Staff Writer

Moderna announced that its mRNA-1273 vaccine candidate against novel coronavirus (SARS-CoV-2) has demonstrated a significant effect in an early human trial.

Drug Discovery

Research & Development

ISM Sensors for M800 and M300 Transmitters

Gilead signs $1.97bn worth collaboration deal with Arcus Biosciences

Clinical Trials

Patient Enrollment

Artugen Therapeutics announces first patient dosed with ART24

Horizon Therapeutics initiates PROTECT clinical trial of KRYSTEXXA

Regulation

Drug Filing

Bird Rock Bio files IND application for phase 2 study of Nimacimab for treatment of renal diseases

FDA grants priority review of Nucala for patients with Hypereosinophilic Syndrome

Production & Sales

Manufacturing

ISM Sensors for M800 and M300 Transmitters

Cipla enters into a licensing agreement with Gilead to expand access to Covid-19 treatment

Packaging & Supply Chain

Packaging

Gerresheimer

PCI Pharma announces bottling line expansion at Rockford site

Suppliers

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Human Trials

SAB Biotherapeutics confirms neutralising antibodies to SARS-CoV-2 and begins clinical manufacturing of novel Covid-19 therapeutic candidate

Roche to begin Covid-19 pneumonia trial with Actemra/RoActemra plus remdesivir

PhaseBio gets FDA nod to begin Covid-19 trial with VIP receptor agonist PB1046

Algernon submits IND application with FDA for possible Covid-19 treatment

Antisense ATL1102 final phase 2 DMD results meet primary endpoint and exceed expectations on secondary endpoints

Appili set to evaluate favipiravir as preventive measure against Covid-19

Gilead and Galapagos announce positive topline results of phase 2b/3 trial of filgotinib in moderately to severely active ulcerative colitis

FDA approves Octapharma USA’s IND application to begin trial with severe Covid-19 patients

Janssen announces phase 1 results for amivantamab in advanced NSCLC harbouring Exon 20 insertion mutations

Moderna’s Covid-19 vaccine shows significant effect in early human trial

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Research & Development

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Drug Filing

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