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Latest biotech news from B3C newswire (short version)

Last Build Date: Tue, 12 Dec 2017 06:09:22 +0100


Genomic Health: New Validation Shows Oncotype DX Breast Recurrence Score® Test Predicts Clinical Response to Neoadjuvant Hormonal Therapy to Improve Surgical Outcomes in Certain Patients with Large Tumors

Mon, 11 Dec 2017 09:00:00 +0100

Ten Oncotype DX® studies presented at the 40th San Antonio Breast Cancer Symposium

Geneva, Switzerland, December 11, 2017 / B3C newswire / -- Genomic Health today announced highlights from new data presentations with the Oncotype DX Breast Recurrence Score® test at the 2017 San Antonio Breast Cancer Symposium (SABCS).

“These latest presentations further our understanding of breast cancer biology across the continuum of the disease and highlight the unique value of the Oncotype DX® test in providing critical information to personalize and improve the quality of treatment decisions in both the adjuvant and neoadjuvant settings,” said Calvin Chao, Vice President of Global Medical Affairs ...

Sartorius Stedim Biotech Launches New Versions of Data Analytics Software Solutions

Thu, 07 Dec 2017 14:00:47 +0100

SIMCA® and SIMCA®-online software updates in the Umetrics™ Suite help manufacturing industries make better business decisions and optimize process control

Goettingen, Germany and Malmö, Sweden, December 07, 2017 / B3C newswire / -- Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has introduced a new version of its SIMCA® and SIMCA®-online data analytical solutions, which are offered by its subsidiary Sartorius Stedim Data Analytics, formerly known as Umetrics.

Every day, businesses generate a vast array of data derived from a variety of different sources. This data holds the key to better performance. The challenge is ...

Agendia and UZ Leuven Partner to Co-Validate MammaPrint® BluePrint® Breast Cancer Risk of Recurrence and Molecular Subtyping Kit Ahead of European Launch

Thu, 07 Dec 2017 09:00:00 +0100

Irvine, CA, USA, Amsterdam, Netherlands and Leuven, Belgium, December 07, 2017 / B3C newswire / -- Agendia , a world leader in personalized medicine and molecular cancer diagnostics, and University Hospitals Leuven (UZ Leuven) in Belgium have partnered to co-validate Agendia’s new in vitro diagnostic (IVD) MammaPrint® BluePrint® Breast Cancer Risk of Recurrence and Molecular Subtyping Kit. The study is a key step in preparation for CE-marking and European launch of the kit in early 2018.

In June 2017, Agendia announced an extension of its relationship with Agilent Technologies Inc. to develop an RNA sequencing-based version of its ...

Vetter Receives Corporate Health Award’s Recognition of Excellence

Wed, 06 Dec 2017 15:30:00 +0100

Provider of prefilled drug-delivery systems recognized for its occupational health management

  • Award highlights company’s commitment to occupational health management
  • Achievement acknowledges targeted investments in creating and expanding a sustainable concept
  • Recognition serves both as an indicator where the company stands in this field and as a further source of motivation

Ravensburg, Germany, December 06, 2017 / B3C newswire / -- In addition to being a leading global contract development and manufacturing organization, Vetter is also a leader in the area of occupational health management. That is the conclusion reached by the initiative Corporate Health Award, which annually recognizes companies that ...

Agendia Collaborates with Prestigious Cancer Center, Institut Curie, for MammaPrint® BluePrint® Breast Cancer Kit Co-Validation Study

Tue, 05 Dec 2017 09:00:00 +0100


Institut Curie is one of an increasing number of major European cancer centers to become a co-validation partner for the new NGS-based MammaPrint BluePrint Kit

Irvine, CA, USA, Amsterdam, the Netherlands, and Paris, France, December 05, 2017 / B3C newswire / -- Agendia , a world leader in personalized medicine and molecular cancer diagnostics, and Institute Curie in Paris, France, a leading player in the fight against cancer, announce a co-validation partnership for Agendia’s new in vitro diagnostic (IVD) MammaPrint® BluePrint® Breast Cancer Risk of Recurrence and ...

Polyganics Awarded €1.2 Million to Complete Clinical Development of Dura Sealant Patch

Fri, 01 Dec 2017 09:00:00 +0100

First-in-human clinical studies of the device expected to begin in early 2018

Groningen, The Netherlands, December 01, 2017 / B3C newswire / -- Polyganics , a privately held medical technology company that develops, manufactures and commercializes bioresorbable medical devices, today announced it has been awarded funding from the European Fund for Regional Development (ERDF) by the European Union, to support clinical validation of its dura sealant patch. The grant, together with contributions from the city and province of Groningen, totals EUR 1.2 million. 

The device has been developed using Polyganics’ proprietary bioresorbable polymers, creating a dressing suitable for resealing ...

New Data at the San Antonio Breast Cancer Symposium Demonstrate the Value of MammaPrint® and BluePrint® Across Breast Cancer Patient Populations

Thu, 30 Nov 2017 15:00:00 +0100

Irvine, CA, USA and Amsterdam, the Netherlands, November 30, 2017 / B3C newswire / -- Agendia, Inc. , a world leader in personalized medicine and molecular cancer diagnostics, announces the presentation of extensive new data at the upcoming 2017 San Antonio Breast Cancer Symposium (SABCS), highlighting the value of its MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test and BluePrint® Breast Cancer Molecular Subtyping Test . A total of eleven posters and discussions are being presented at SABCS, which will take place at the Henry B. Gonzales Convention Center in San Antonio, Texas from December 5-9, 2017.

The posters and presentations feature important new data from the I-SPY ...

Selvita Promotes Edyta Jaworska to the Management Board to Strengthen Development in Integrated Drug Discovery Services

Thu, 30 Nov 2017 14:00:00 +0100

Krakow, Poland, November 30, 2017 / B3C newswire / -- The Supervisory Board of Selvita S.A. (WSE:SLV) has appointed Mrs. Edyta Jaworska to the position of a Management Board Member, responsible for the development of its integrated drug discovery services.

Mrs. Jaworska joined Selvita in 2012, starting  as a Business Development Manager responsible for the sales and development of Selvita offer in selected Western European countries. In 2014, she was promoted to the position of Business Development Director, taking over management of a sales team responsible for sales & development of Selvita services offer in Western Europe, Israel ...

Orchard Therapeutics Announces Expansion of Technical Operations in California

Thu, 30 Nov 2017 09:00:00 +0100

London, UK, November 30, 2017 / B3C newswire / -- Orchard Therapeutics (“Orchard”), a clinical-stage biotechnology company dedicated to transforming the lives of patients with rare disorders through innovative gene therapies, today announced the opening of a second facility for technical operations in the San Francisco Bay Area.

In combination with the existing Foster City site, the new facility located at 1360 O’Brien Drive, Menlo Park, Calif., quadruples Orchard’s laboratory footprint for the technical operations that support development and validation of processes and controls for the manufacture of the Company’s ex-vivo lentiviral gene therapy products.

Stewart Craig, Ph.D., chief ...

Second Sartorius Research Xchange Forum Focuses On Regenerative Medicine and Cell Therapy

Wed, 29 Nov 2017 14:00:00 +0100

  • Event for experts from academia and industry on March 20 and 21, 2018
  • Lectures by academia and industry experts
  • Guest lecture to be held by Nobel Prize laureate Dr. Stefan W. Hell
  • Presentation of “The Sartorius & Science Prize for Regenerative Medicine & Cell Therapy”

Goettingen, Germany, November 29, 2017 / B3C newswire / -- Promoting interdisciplinary exchange between science and industry on the topics of regenerative medicine and cell therapy: this is the objective Sartorius will be pursuing by hosting its second Research Xchange Forum on March 20 and 21, 2018, at Sartorius College in Goettingen. Experts from the biotechnology ...

Agendia’s MammaPrint® Breast Cancer Risk-of-Recurrence Test Obtains Favorable Final Payment Determination from CMS for New, Unique Category 1 CPT Code

Tue, 28 Nov 2017 15:00:00 +0100

  • CMS established the 2018 payment rate for MammaPrint’s new CPT code 81521 thus securing continued access to MammaPrint for Medicare/Medicaid beneficiaries
  • The new determination and increased allowance follows an impressive Q3 which saw MammaPrint’s U.S. case volume grow by over 30% compared to the same period in 2016

Irvine, CA, USA and Amsterdam, the Netherlands, November 28, 2017 / B3C newswire / --  Agendia, Inc. , a world leader in personalized medicine and molecular cancer diagnostics, announces that its MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test has received a favorable payment determination for CY 2018 from the Centers for Medicare and ...

SOTIO Broadens Its Phase II Clinical Trial Program in Ovarian Cancer

Tue, 28 Nov 2017 11:05:00 +0100

Prague, Czech Republic, November 28, 2017 / B3C newswire / -- SOTIO , a biotechnology company owned by the PPF Group, today announced the enrollment of the first patient to a Phase II study testing DCVAC/OvCa in combination with standard of care chemotherapy for patients with ovarian cancer after first relapse. Based on positive signals from ongoing trials, SOTIO is also expanding its ongoing study testing DCVAC/OvCa as a maintenance therapy in first line treatment of patients with ovarian cancer.

The newly initiated clinical trial SOV06 (Eudra CT: 2017-002196-26) is an open-label, single-group, multicenter Phase II ...

NBE-Therapeutics Appoints Dr. Nicole Onetto to Its Board of Directors

Tue, 28 Nov 2017 11:00:00 +0100

Basel, Switzerland, November 28, 2017 / B3C newswire / -- Today NBE Therapeutics AG , a biopharmaceutical company developing next-generation antibody drug conjugates (ADCs) carrying highly potent, immune-stimulatory anthracycline toxins, announces the appointment of Dr. Nicole Onetto to its Board of Directors.

Nicole is a medical doctor with over 20 years of industry experience in clinical development of targeted cancer therapies. She has held senior medical positions at Hoechst/Canada, Immunex, Bristol-Myers-Squibb, Gilead, OSI Pharmaceuticals and Zymogenetics. In addition, she served on the Board of Immunogen Inc. for eleven years, one of the pioneers in the ADC field. Most recently Nicole ...

Cristal Therapeutics Awarded €2.5 Million Horizon 2020 Grant to Advance Its CriPec®-docetaxel Through Phase 2 Trials

Tue, 28 Nov 2017 09:00:00 +0100

Maastricht, The Netherlands, November 28, 2017 / B3C newswire / --  Cristal Therapeutics , a clinical stage biopharmaceutical company developing targeted nanomedicines for the treatment of cancer and other diseases with high unmet patient need, today announced that it secured a €2.5 million grant from the European Commission’s Horizon 2020 programme. The funds will be used to perform the upcoming Phase 2 trials of Cristal Therapeutics’ lead nanomedicine candidate CriPec®-docetaxel to evaluate efficacy and safety in specific solid tumour indications, and to generate supportive evidence for the beneficial bio-distribution profile.

In addition, the grant will support Cristal ...

Orchard Therapeutics Announces Extension of its Collaboration with Manchester University to Include Sanfilippo Syndrome Type B

Mon, 27 Nov 2017 09:00:00 +0100

London & Manchester, UK, November 27, 2017 / B3C newswire / -- Orchard Therapeutics Limited (“Orchard”), a clinical-stage biotechnology company dedicated to transforming the lives of patients with rare disorders through innovative gene therapies, announces today that it has acquired an exclusive license to develop lentivirus-based autologous ex-vivo gene therapy for Sanfilippo syndrome type B (or MPS-IIIB) from The University of Manchester, UK.

The technology, developed in Professor Brian Bigger’s laboratory, and recently published in the journal Brain, involves the use of a high-titre lentiviral vector to drive the expression of a codon-optimized α-N-acetylglucosaminidase (NAGLU) gene under the control ...