As the spread of COVID-19 accelerates across the globe, everyone wants to find a way to tackle the pandemic, from Governments asking manufacturers to urgently make vital equipment to inventors creating innovative solutions. ...more
In response to the global outbreak of the COVID-19 virus, the EU and various member states have taken measures to ensure continuity of supply of personal protective equipment (PPE) and address shortages of healthcare...more
Due to the COVID-19 emergency and the consequent lockdown that is affecting non-essential services in Italy, including some health care services, on March 12, 2020 the Italian Medicines Agency ("AIFA") issued a Guidance,...more
3/16/2020
/ China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
EU ,
Good Clinical Practices ,
Infectious Diseases ,
Italy ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health
In Italy, the cultivation and the industrial use of hemp has a long tradition and recent changes in the law have led to a revival. While a law enacted in 2016 promotes the cultivation of hemp as a means to preserve...more
7/31/2019
/ Agribusiness ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cosmetics ,
Decriminalization of Marijuana ,
EU ,
Hemp ,
Italy ,
Marijuana ,
Medical Foods ,
Plant Based Products ,
Regulatory Oversight ,
Regulatory Requirements
Read the latest news on antitrust, competition, and economic regulation in this summer edition of our quarterly ACER newsletter.
...more
9/19/2018
/ Algorithms ,
Anti-Competitive ,
Anti-Steering Rules ,
Antitrust Provisions ,
Antitrust Violations ,
AT&T ,
China ,
Competition ,
Competition Act ,
EU ,
Excessive Pricing ,
False Advertising ,
Foreign Investment ,
Internet Retailers ,
Legislative Agendas ,
Merger Controls ,
Monopolization ,
National Health Service Corp (NHSC) ,
Ohio v American Express ,
Pfizer ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards ,
SCOTUS ,
Single Entity Rule ,
Telecommunications ,
Time Warner ,
UK ,
UK Competition and Markets Authority (CMA) ,
UK Competition Appeal Tribunal (CAT) ,
Unfair or Deceptive Trade Practices
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
4/4/2018
/ 3D Printing ,
Acquisitions ,
Artificial Intelligence ,
Biologics ,
Biosimilars ,
Biotechnology ,
Blockchain ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Digital Health ,
Distributed Ledger Technology (DLT) ,
Drug Pricing ,
Emerging Markets ,
EU ,
General Data Protection Regulation (GDPR) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
Medical Reimbursement ,
Mergers ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Private Equity ,
Regulatory Oversight ,
Supply Chain ,
Transfer Pricing ,
UK Brexit ,
Yates Memorandum
Fast track for orphan diseases and rare forms of cancers -
By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more
The Board of Appeal of the Italian Patent Office (Commissione dei Ricorsi), by decision published on June 26, 2017, acknowledged the right of the patent holder to ask the Italian Patent Office for the limitation of the...more
7/10/2017
/ Appeals ,
Direct Marketing Association ,
EU ,
European Court of Justice (ECJ) ,
European Medicines Agency (EMA) ,
Generic Drugs ,
Intellectual Property Protection ,
Italy ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supplementary Protection Certificate
By Ministerial Circular of 23 March 2017, AIFA clarified the conditions under which unauthorized medicinal products may be purchased abroad further to the procedure laid down by the Ministerial Decree of 11 February 1997....more
The EU Medicines Agency (EMA), the most sought after EU regulator, is looking for a new home. 900 jobs will move from London to an EU Member State when Brexit is complete. In a series of blog posts, our European life science...more
By judgement of January 3rd, 2017, the Turin Court of Appeal delivered a monumental decision in a longstanding patent dispute concerning the validity and infringement of patents relating to an Electronic Program Guide (EPG)...more
2/6/2017
/ Appeals ,
Digital Goods ,
Digital Services ,
EU ,
Infringement ,
Intellectual Property Protection ,
Italy ,
Patent Infringement ,
Patent-Eligible Subject Matter ,
Patents ,
Satellites ,
Software Patents ,
Technology ,
Technology Sector ,
Television Programming