Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
In Tuesday's Report: a panel discussion on the U.S. election, Americans warned of COVID-19 surge, Moderna files for FDA EUA, Hong Kong proposes corporate rescue bill, new Foreign Direct Investment rules in Spain, the EU moves...more
12/1/2020
/ Biden Administration ,
Biotechnology ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Foreign Direct Investment ,
Hong Kong ,
Infections ,
Infectious Diseases ,
Insolvency ,
Joint Task Force ,
Life Sciences ,
Moderna Inc. ,
Pharmaceutical Industry ,
Scams ,
Spain ,
Vaccinations
On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more
2/14/2019
/ Biotechnology ,
Commercial Marketing ,
EU ,
European Commission ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Member State ,
Pharmaceutical Industry ,
Regulatory Oversight ,
UK ,
UK Brexit
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more
12/7/2018
/ Biotechnology ,
Data Privacy ,
Digital Health ,
Drug Pricing ,
Emerging Markets ,
General Data Protection Regulation (GDPR) ,
Investment ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Exclusivity ,
Regulatory Standards ,
Sunshine Laws ,
UK Brexit
The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement...more