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
3/18/2019
/ Artificial Intelligence ,
Asia ,
Biologics ,
Biotechnology ,
Data Breach ,
Digital Health ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
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
The possibility for the patent owner to prevent the reimbursement of medicinal products before expiry of patent protection is still an open issue. While the law covers prohibition of reimbursement for medicinal generic...more
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
Focus I: International black market trade -
Among the industries that suffer most from black and grey market activities, the pharmaceutical sector sadly holds one of the top positions. The World Health Organization (WHO)...more