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INDUSTRY NEWS AND PRESS RELEASES
 

PharmaFluidics awarded VLAIO research grant

Funding will support product range extension of micro-chip based µPAC™ nano, capillary and microflow LC columns, and accelerated development of manufacturing process know-how.

Ghent, Belgium – June 2, 2020 PharmaFluidics NV, innovative player in the field of analytical chromatography with its unique high-resolution µPAC™ micro-Chip technology, announces that it has been awarded a € 613 k grant from Flanders’ Innovation & Entrepreneurship Agency (VLAIO). The grant will run over two years and will support the further optimization of PharmaFluidics’ manufacturing flow, and to develop complementary new surface-modified µPAC™ products. More>>

 
phone +32 (0)9 241 56 57
web https://www.pharmafluidics.com/
email Technologiepark-Zwijnaarde 82 B-9052 Ghent (Zwijnaarde) BELGIUM
 

Kaye now also offers Cold Chain Monitoring Solution Monitor your sensitive product shipment on your smartphone

Pforzheim, Germany – May 2020; Kaye is pleased to announce Kaye Log – Cold Chain Monitoring during Transportation. More>>

 
phone +49 (0) 7231-14 335 0
email kaye@amphenol-sensors.com
web https://www.kayeinstruments.com/en/
email Germany GmbH Sinsheimer Strasse 6 D-75179 Pforzheim
 

Lynparza recommended for approval in EU by CHMP for BRCA-mutated metastatic pancreatic cancer

Only PARP inhibitor to demonstrate patient benefit in a Phase III trial in this setting

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment of patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the Phase III POLO trial, which were published in The New England Journal of Medicine. More>>

 
phone 0207 604 8000
web www.astrazeneca.com
 

Janssen Announces Phase 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harbouring Exon 20 Insertion Mutations

Amivantamab-treated patients achieved durable remissions in CHRYSALIS study; data will be presented during ASCO Virtual Scientific Programme

BEERSE, BELGIUM, May 18, 2020 – 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.[i] Amivantamab is an EGFR and MET-targeted bispecific antibody, which targets activating and resistance EGFR mutations, and MET pathway activation.[ii],[iii] Investigators assessed efficacy using overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), duration of response, as well as the safety profile of amivantamab,1 which were the basis of the U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation granted earlier this year.[iv] More>>

 
phone 01494 567 567
email medinfo@its.jnj.com
web https://www.janssen.com/
 

Cidara Therapeutics Doses First Patient in Pivotal Phase 3 ReSPECT Trial of Rezafungin for Prevention of Invasive Fungal Disease in Patients Undergoing Allogeneic Blood and Marrow Transplantation

SAN DIEGO, Calif. & CAMBRIDGE, England, May 20, 2020 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, and Mundipharma today announced that the first patient has been dosed in its ReSPECT pivotal Phase 3 clinical trial evaluating the efficacy and safety of the company’s lead antifungal candidate, rezafungin, for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (BMT). Rezafungin is a novel, once-weekly echinocandin being developed for both the treatment and prevention of severe fungal infections. More>>

 
phone +44 (0)1223 424211
web https://mundipharma.com/
email Mundipharma International Limited Cambridge Science Park Milton Road Cambridge CB4 0AB
 

ADM Supports Clinical Trial into Effects of Probiotic Supplements for COVID-19 Patients in Hospital Care

ADM and Hospital de Sagunto, one of the largest medical centers in the Valencia region, today announce their partnership for a clinical trial into the effects of using a food supplement containing live microbial strains to promote gut microbiome balance and help improve health functions related to outcomes for COVID-19 patients in high-risk groups. On 18th March Dr Xavier Cortés, gastroenterologist at Hospital de Sagunto, communicated with medical staff in China who had observed that many COVID-19 patients had exhibited abnormal changes in their gut microbiome. More>>

 
phone 312-634-8100
web https://www.adm.com/
email 77 West Wacker Drive, Suite 4600 Chicago, Illinois 60601
 

Avacta develops SARS-COV-2 neutralising Affimer reagents with therapeutic potential for COVID-19

Affimer reagents discovered that block the virus’ interaction with ACE2 which is key to how the virus infects human cells

Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that several of the Affimer reagents recently generated for development of a point-of-care COVID-19 antigen saliva test have now also been shown to block the interaction between the virus’ spike protein and ACE2, a receptor on human cells that is key to the virus infection pathway1. More>>

 
phone +44 (0) 844 414 0452
web www.avacta.com
 

Janssen Announces Phase 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harbouring Exon 20 Insertion Mutations

Amivantamab-treated patients achieved durable remissions in CHRYSALIS study; data will be presented during ASCO Virtual Scientific Programme

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. Amivantamab is an EGFR and MET-targeted bispecific antibody, which targets activating and resistance EGFR mutations, and MET pathway activation. More>>

 
phone 01494 567 567
email medinfo@its.jnj.com
web https://www.janssen.com/
 

ERT Virtual Visit Capabilities Keep Clinical Trials on Track during COVID-19

Seamless, dynamic solution enables continued interactions between clinical trial patients and investigative sites

ERT, a global data and technology company that captures critical endpoint data while minimizing uncertainty and risk in clinical trials, today announced a Virtual Visit solution that enables the continuation of clinical trials during and after current global stay-at-home mandates. As a result of COVID-19, many clinical trials have been delayed as healthcare providers focus their efforts on patients who require urgent care, which limits clinical trial patients’ access to investigative sites for routine visits. More>>

 
phone +1 800 961 5004
email eresearch@ert.com
web www.ert.com
email 1818 Market Street, Suite 1000, Philadelphia, PA 19103
 

Significant improvement in overall survival with ERLEADA®▼ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer

Final analysis of Janssen’s Phase 3 SPARTAN study presented during ASCO Virtual Scientific Programme suggests 14-month improvement in median overall surviva

BEERSE, BELGIUM, May 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the final analysis of the pivotal Phase 3 SPARTAN study demonstrating ERLEADA®▼ (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved overall survival (OS), compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases.1 Results will be presented at the American Society of Clinical Oncology (ASCO) Virtual Scientific Programme (Abstract #5516) beginning on Friday 29th May. More>>

 
phone 01494 567 567
email medinfo@its.jnj.com
web https://www.janssen.com/
 
 
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News and Press Releases

3P Biopharmaceuticals renews its “Credit Impôt Recherche” (CIR) by the French Ministry of Higher Education and Research

[Noáin, April 22, 2020] 3P Biopharmaceuticals, a European leading Contract Development and Manufacturing Organization (CDMO) specialized in process development and cGMP manufacturing of biologics, has successfully extended its French CIR certificate for another four-year period: 2020-2024.
More info >>


White Papers

Using Device Strategy to Drive R&D Productivity

Phillips-Medisize


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Industry Events

Evolution Summit

20-22 July 2020, The Ritz Carlton, Fort Lauderdale, FL

The 22nd Evolution Summit is the premium forum bringing leading drug development executives and solution providers together. As an invitation-only event, taking place behind closed doors, the Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development.
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