DUBLIN – The EMA’s Committee for Medicinal Products for Human Use (CHMP) diverged from the FDA on a key decision at its monthly meeting, which concluded Feb. 28. It refused to back an application from Eli Lilly and Co. for a line extension to its migraine prevention drug, Emgality (galcanezumab), which would have authorized the drug for preventing attacks during an episode of cluster headaches.

LONDON – The COVID-19 epidemic has reached a “decisive point” as the number of new cases in the rest of the world exceeded the number of new cases in China, and seven countries reported infections for the first time.

PARIS – Vygon SA, of Ecouen, France, has acquired Advanced Perfusion Diagnostics SA (APD), a startup based in Lyon, France, that has developed Ikorus, a device that detects changes in visceral microvascular blood flow in the most critically ill hospital patients. Vygon did not disclose the financial details behind the agreement.

LONDON – The COVID-19 outbreak appears to be sliding toward pandemic status, with the virus spreading to four more countries and confirmed cases and deaths mounting in infection hotspots in Italy, Iran and South Korea. Parts of northern Italy are in lockdown, with 200-plus cases and seven deaths. Austria and Switzerland are reported to be considering closing their borders with Italy, and the EU has responded with a €232 million (US$252 million) package of aid, including €90 million for development of a vaccine and €10 million for therapeutics and diagnostics.

PARIS – The Syndicat National de l'Industrie des Technologies Médicales (SNITEM), the French national association of medical technology manufacturers, has just released a study looking at the development of this industrial sector in that country. This snapshot, produced every two years by the firm D&Consultants SAS on behalf of Courbevoie, France-based SNITEM and the bank Bpifrance SA, is based on a dual quantitative and qualitative approach.

U.S.-based device makers have been grappling with FDA cybersecurity requirements for some time, but now the European Union (EU) is working on cybersecurity regulations as well. Throw in privacy requirements by the state of California and the EU’s General Data Protection Regulation (GDPR), and device makers are facing an increasingly complicated world of enforcement and litigation.

LONDON – The COVID-19 outbreak appears to be sliding toward pandemic status, with the virus spreading to four more countries and confirmed cases and deaths mounting in infection hotspots in Italy, Iran and South Korea.

DUBLIN – Meda AB’s acquisition in 2014 of the veteran Italian specialty pharma firm Rottapharm generated a €1.975 billion (US$2.2 billion) payday for the latter firm’s owners, the Rovati family. A small fraction of that amount is now being recycled into a new investment initiative, Aurora Science, which is a three-way partnership among Monza-based Rottapharm Biotech Srl (the R&D arm of the company that was not part of the Meda transaction), the Milan-based specialty pharma Italfarmaco SpA and Aurora-TT Srl, a Milan-based commercial technology transfer company.

The 2.3% medical device tax is a thing of the past, and now Medicare coverage is one of the issues that is front and center for the Medical Device Manufacturers Association. MDMA President and CEO Mark Leahey told BioWorld also that while member companies are keen on regulatory harmonization, the struggles in standing up the new European regulatory framework is a far more pressing concern.

SEATTLE – As it enters its third year, the Human Cell Atlas project has mapped 100 million of 100 billion cells, and by comparing gene expression profiles of normal and aberrant cells and building networks of cellular interactions, is leading to breakthroughs in understanding of disease at a molecular level.