Quality is not anymore limited to the functional and esthetic products features and its handling use. The attention is now focused on the commercialization phase, innovative and efficacy features, profitability and usability of instruction for final users, as well as Eco-friendly features...
China: 2018 was another eventful year for the pharmaceutical industry, highlighted by the Chinese government’s radical attempts to slash drug prices by the annual national drug price negotiation and along with the introduction of a national procurement program.
Assobiomedica, the body representing the medical device sector in Italy, published an update to the report ‘Public Policies for the Purchase of Medical Devices’ in October 2018. Boston healthcare outline procurement trend in the Italian reimbursement environment.
A recent proposal by Jens Spahn, Federal Minister for Health in Germany, would limit the decision-making power of the Joint Federal Committee (G-BA) and lead to new evidence approaches for healthcare decision making.
Earlier this month, the Food and Drug Administration announced a new draft guidance for companion diagnostics. The guidance describes considerations for the development and labeling of companion diagnostics to support the indicated uses of multiple therapeutic oncology products.
Press Releases and Publications
Diagnostics Developers Rapidly Utilizing New Payment Codes Established by PAMA
7 November 2018
Access the article from 360Dx here.
Compliance Conundrum: Genomic Health Faces DoJ Investigation after CMS Changes Date of Service Regs
Genomic Health has disclosed that it is the subject of a U.S. Department of Justice investigation into its compliance with changes that took effect in January to Medicare’s Date of Service billing regulation. Adam Crowther, Manager, spoke with Clinical Omics about the impact on diagnostics companies. Access the Article Here.
Medical Device & Diagnostics Industry
Considering Market Access Risk as Part of Today’s M&A Process
In an exclusive published today in Medical Device and Diagnostics Industry, Vice President, Rob Wenthold discusses the key market access issues examined during the M&A process and demonstrates the importance of market access to inform M&A through case studies and business decision-making in general. Read the article here.
Boston Healthcare Adds Seasoned Market Access Leader to Global Life Science Consulting Team.
Cost-Conscious MedSeq Project Provides Snapshot to Suggest Genomic Sequencing does not Increase Downstream Healthcare Costs
CEO, Joseph V. Ferrara commented on the value sequencing might bring to the clinical setting in the May-June 2018 Issue of Clinical Omics. Access the article here.
Global Business Reports
United States Biopharmaceuticals 2018
Thomas F. Goss spoke to Global Business Reports on the US Biopharmaceutical Industry. Read the report here.
Real-World Evidence in the Era of Advanced Diagnostics
Shivang Doshi, Director at Boston Healthcare wrote an op-ed for the March-April edition of Clinical Omics on real-world evidence for advanced diagnostics. Access the article here.
International Regulatory Group Proposes Principles for Evaluating Safety, Performance of Diagnostics
Joseph V. Ferrara, CEO of Boston Healthcare spoke with 360Dx News about the proposed Principles for safety and performance of medical devices, including IVD medical devices, put forward by the International Medical Device Regulators Forum (IMDRF). Read the article here.