Dimerix Limited (ASX: DXB), is pleased to announce that a detailed analysis of the data from the DMX-200 Phase 2a clinical trial in Chronic Kidney Disease will be announced to the ASX coincident with its feature as a poster presentation at the American Society of Nephrology (ASN) Kidney Week 2017, to be held in New Orleans, Louisiana from October 31 to November 5, 2017.
Clinigen Group plc (AIM: CLIN, ‘Clinigen’ or the ‘Group’), the global pharmaceutical and services company, announces that its Commercial Medicines operation received a European Commission (EC) approval to update the current product information for Cardioxane.
LONDON, BOSTON, SAN FRANCISCO, TOKYO - Today EP Vantage, the independent news and analysis arm of Evaluate Ltd, releases its 2017 half-year reports on pharma & biotech and medtech sector performance. Report authors Elizabeth Cairns and Jon Gardner provide their expert viewpoints, powered by Evaluate data and consensus forecasts.
LONDON, BOSTON, SAN FRANCISCO, TOKYO — According to life science commercial intelligence firm, Evaluate, the enforcement of a much more stringent pricing revision policy in Japan, both for new products as well as off-patent brands, is behind the decline of the products currently on the market which are forecast to drop about 2% annually in sales through 2022.
Sydney, Australia - Recce Limited (ASX: RCE), a pre-clinical stage pharmaceutical company engaged in the development of a new class of synthetic antibiotics, today confirmed it remains on track to submit its Investigative New Drug Application (IND) to the US Food and Drug Administration (FDA) for its lead compound RECCE® 327, following additional positive pre-clinical study data on mode of administration, drug clearance, dosing and efficacy.
London, UK and Melbourne, Australia – Leading healthcare investment specialist BioScience Managers Limited (BioScience Managers) announces today that it has appointed Elizabeth Klein as an Investment Consultant, to facilitate BioScience Managers’ UK investment deal flow, in particular to support its collaboration entered into in December 2016 with London-based investment firm Downing LLP. Her primary focus will be on sourcing and reviewing investment opportunities for BioScience Managers’ and the Downing FOUR Healthcare Share Class Venture Capital Trust (VCT) plc (Downing FOUR Healthcare).
Oxford, UK, e-Therapeutics plc (AIM: ETX): Upon the completion of Ray Barlow’s first three months as CEO of e-Therapeutics, the Company outlines below the conclusion of the strategic review for its investors and other stakeholders.
LONDON, BOSTON, SAN FRANCISCO, TOKYO — Today life science commercial intelligence leader, Evaluate, released case studies highlighting the value of granular patient segmentation and epidemiological data to support commercial valuations, whitespace identification and product differentiation ultimately leading to enhanced portfolio decision-making. Therapy areas covered include: CAR-T, MPS-III and Age-related Macular Degeneration.
SYDNEY, Australia: Recce Limited (ASX: RCE), a pre-clinical-stage pharmaceutical company engaged in the development of a new class of synthetic antibiotics, today announced its new automated manufacturing facility in Sydney is now producing at name-plate standard its antibiotic compounds at volumes in preparation for human clinical trials.
Clinigen Group plc’s (AIM: CLIN, 'Clinigen') Idis Managed Access division and Sarepta Therapeutics Inc. (NASDAQ: SRPT) have initiated a Managed Access Program (MAP) for eteplirsen in certain geographies to treat Duchenne Muscular Dystrophy (DMD) patients amenable to exon 51 skipping. This MAP (also known as an early / expanded access, or named patient program) provides a mechanism through which physicians can legally and ethically prescribe eteplirsen to patients who meet pre-specified medical criteria and where funding can be secured.
Cambridge, UK and Melbourne, Australia – Abzena plc (AIM: ABZA, ‘Abzena’), the life sciences group providing services and technologies to enable the development and manufacture of biopharmaceutical products, has signed a licence agreement with Telix Pharmaceuticals Limited (‘Telix’), a biopharmaceutical company specializing in the development and commercialisation of radiopharmaceuticals for diagnostic (imaging) and therapeutic use (the “Agreement”).
London, UK and Carlsbad, CA, USA – DNA Electronics (‘DNAe’), the inventor of semiconductor DNA sequencing technology and developer of a new, revolutionary sample-to-result diagnostic platform to rapidly determine the causative agent of infectious diseases, provided an update on its LiDia™ test for serious bloodstream infections (BSI), a condition which can lead to the potentially life-threatening complication of sepsis if not diagnosed and treated quickly. The test is on track for commercial launch in 2018.
MELBOURNE, Australia: Dimerix Limited (ASX: DXB), a clinical-stage biotechnology company today announced positive safety and efficacy data (primary endpoint met) following its now completed 27 patient Phase 2a Proof of Concept, Dose Escalation Study in Chronic Kidney Disease (CKD) for lead program, DMX-200. Dimerix will now progress with the design for the planned Phase 2b DMX-200 study.
Paris, France – Seventure Partners, one of Europe’s leaders in financing innovation, today announces that it has participated in two financing rounds in Machtfit and Push Doctor, both companies specialising in connected health, reflecting the growth potential in this innovative area. The investments were made from Seventure’s Health for Life Capital™ investment vehicle.
IRVINE, CA and AMSTERDAM – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announces that the American Society of Clinical Oncology (ASCO®) has today published revised early-stage breast cancer guidelines in the Journal of Clinical Oncology, titled The Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women with Early Stage Invasive Breast Cancer: American Society of Clinical Oncology Practice Guideline.
Cambridge, UK, Taipei, Taiwan – Abzena plc (AIM: ABZA, ‘Abzena’ or the ‘Group’), the life sciences group providing services and technologies to enable the development and manufacture of biopharmaceutical products, has signed a licensing agreement and a master services and clinical supply agreement with OBI Pharma, a Taiwanese biopharmaceutical company (‘OBI’, TPEx: 4174).
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the ‘Group’), the global pharmaceutical and services company and Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX, ‘Cumberland’), a U.S. specialty pharmaceutical company, today announce they have obtained FDA approval for Totect® (dexrazoxane hydrochloride) in the U.S.
Stevenage, UK – Autifony Therapeutics Limited (“Autifony”), which is pioneering the development of novel pharmaceutical treatments for serious disorders of the central nervous system, today announced that the U.S. Food and Drug Administration (FDA) has granted AUT00206 an Orphan Drug Designation for the treatment of Fragile X Syndrome, the most common known cause of inherited learning disabilities.
IRVINE, CA and AMSTERDAM - Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announces that the 15th St. Gallen International Breast Cancer Guidelines recently published in Annals of Oncology have recommended the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test for the third time to help guide treatment decision-making for patients with early-stage breast cancer.
Paris, France – Seventure Partners, one of Europe’s leaders in financing innovation, and a world-leader in the venture investment in the microbiome sector, today announces that it has participated in a $13.1m financing of Japanese biotech company Anaeropharma Science. The investment is made from Seventure’s Health for Life Capital™ investment vehicle.
IRVINE, Calif. & AMSTERDAM - Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics announces new data published today in JAMA Oncology.1 Following the retrospective analysis and 20-year follow-up data from the prospective, randomized Stockholm Tamoxifen Trial, a Late Recurrence (20yr) Low Risk result (referred to as the ‘indolent’ threshold in the study) of the MammaPrint® Test has demonstrated the ability to identify a sub-group of patients with exceedingly low metastatic risk 20 years after diagnosis. These patients, of which a majority only received two years of hormonal therapy, had an observed 20-year breast cancer specific survival of 97%.
Paris, France - Seventure Partners, one of Europe’s leaders in financing innovation, and a world-leader in the venture investment in the microbiome sector, today announces that it has invested in Israel-based personalized nutrition microbiome app company DayTwo through its Health for Life Capital™ investment vehicle, as part of a $12m series A fundraising.
Cambridge, UK – Mission Therapeutics, a drug discovery and development company focused on selectively targeting deubiquitylating enzymes (DUBs) to treat serious diseases including mitochondrial diseases, neurodegeneration, inflammation and cancer, today announced the formation of its inaugural Scientific Advisory Board (SAB).
Naarden, The Netherlands – BioGeneration Ventures (BGV), the early stage life sciences venture capital firm with funds focussed on European biotechnology companies, announces today an investment by the European Investment Fund (EIF) and other new investors in BGV III, taking the total capital commitments to EUR 66m, out of a maximum EUR 75m. The Fund is supported by the “InnovFin – EU Finance for Innovators” initiative under Horizon 2020 and the European Fund for Strategic Investments.