GBC Blog

The FDA’s Center for Devices and Radiological Health (CDRH) recently released draft guidance — Safer Technologies Program for Medical Devices, or STeP — for the purpose of public comment. In the guidance, the FDA states its belief that STeP “will help patients have more timely access to these medical devices and device-led combination products by…

30 SEP 19, Georgia Green – A new blood test has been shown to identify different cancer types with a high degree of accuracy. When cancer cells die, they shed their DNA into the blood. Previous diagnostic tests work by identifying the genetic mutations present in the cancer cell DNA. However, this technique is limited…

Gunjan Bagla, Amritt, Inc., September 25, 2019 India’s Central Drugs Standard Control Organization (CDSCO), the country’s national regulatory authority for both drugs and medical devices (i.e., India’s equivalent of the United States’ FDA) is acting on a report submitted by its internal Drugs Technical Advisory Board (DTAB) to form a new division under the CDSCO.…

Surge in government initiatives, rise in R&D activities for advanced diagnostics techniques, improvement in healthcare infrastructure, and rising per capita healthcare expenditure are the factors driving the growth of the Asia Pacific IVD market. The reagent segment is expected to maintain dominance, accounting for around three-fifth of the overall Asia-Pacific IVD market. According to a new…

Epigenomics AG, BERLIN, July 24, 2019 (GLOBE NEWSWIRE) — Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”), a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology, today reported new study results suggesting that Epi proColon®, a CRC screening test approved for patients who are unwilling or unable…

Array BioPharma, based in Boulder, Colorado, announced positive results from its Phase III BEACON CRC trial. The trial evaluated a triple combination of Braftovi (encorafenib), a BRAF inhibitor, Mektovia (binimetinib), a MEK inhibitor, and Erbitux (cetuximab), an anti-EGFR antibody, in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC) after one or two lines of therapy.…

Ariana Pharma, a leading digital health Company focused on developing advanced therapeutic decision support systems, will present its latest results on combination therapy biomarker identification using KEM® Artificial Intelligence applied to xenograft mouse model (PDX) based clinical trial simulation, in a poster at the American Association of Cancer Research (AACR) Annual Meeting 2019 in Atlanta,…

QUALITY & COMPLIANCE03.5.2019 Robert Fenton In 2017, the FDA issued 218 more warning letters for 21 CFR 820 than they did the previous year. The 21 CFR 820 regulation, which the FDA uses to monitor the design, manufacturing, packaging, labeling, storage, installation, and servicing for products, ensures that companies create high-quality materials. For a medical device, drug, bioresearch,…

In recent years, rapid advances in scientific discovery have ushered in a new era of medicine. But despite progress, Washington is considering policies that threaten the ability of America’s biopharmaceutical researchers to continue researching and developing new treatments and cures. We’re advocating for the latest innovations so we can continue to go boldly, together. www.innovation.org http://innovation.org/about-us/campaigns/breakthrough