Tagged with Pharma

Pharma Legal Handbook All legal aspects surrounding product liability in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. What types of liability are recognized in your jurisdiction? Contract…

Pharma Legal Handbook A brief overview of the situation regarding traditional medicines and OTC products in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. What are the regulatory requirements…

Pharma Legal Handbook Marketing, manufacturing, packaging & labeling, advertising in Japanese Pharma – a comprehensive legal overview. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. What is the authorization process for…

Pharma Legal Handbook The low-down on the situation regarding preclinical & clinical trial requirements in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. Are clinical trials required to…

Pharma Legal Handbook An intro to the legal situation for regulatory, pricing and reimbursement in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 149.   1. What are the regulatory authorities…

Italy Giuseppe Maduri, Chairman, Managing Director, General Manager Italy, Greece, Cyprus, Malta at Astellas Pharma explains the Japanese company’s focus on unmet needs and how Italy, one of its top European markets, is working to ovecome market access challenges.  Greater anticipation would allow patients’ faster access to innovation but requires a…

South Africa Some of the top pharma news coming out of South Africa including Afrigen’s partnership with US National Institutes of Health (NIH), BioNTech’s efforts to bring an mRNA start-to-finish vaccine manufacturing network to Africa and Ascendis Health’s deal with Austell Pharmaceuticals for its pharma division.   Afrigen partners with US National Institutes…

Poland Some of the top stories emanating from Poland’s pharma industry, including Polish biotech Ryvu Therapeutics’ exclusive deal with Exelixis, the partnership between Polpharma and startup Pikralida on a promising epilepsy candidate and Adamed’s expansion of its laboratory facilities.   Exelixis and Ryvu Therapeutics Sign Agreement to Develop Novel STING Agonist-Based…

USA Pharma companies have become vocal about social issues in recent years, championing access and affordability and launching initiatives to address diversity, but in the weeks since the United States’ Supreme Court’s overturn of the Roe v. Wade ruling on abortion the industry’s reaction has been far from consistent. While certain…

Italy Dompé’s Chief Operating Officer, Eriona Gjinukaj, responsible for creating the Italian mid-cap’s US affiliate, reveals the challenges and rewards of that experience and explains how she saw the company go from a primary care-focused Italian company to an internatonal biotech with an EMA and FDA-approved breakthrough therapy. I was lucky…

Spain The outbreak of the COVID-19 pandemic put an end to more than five years of economic growth in Spain. But the country was not alone. Due to strict containment measures, the Europe’s economy went into the greatest recession since the Second World War during the first half of 2020. To…

Canada Some of the top stories coming out of Canadian healthcare and life sciences, including a new GSK flu vaccine deal, Amylyx Pharmaceuticals’ first approval for an ALS drug, and the Public Health Agency of Canada’s recent smallpox contracts with Chimerix and Bavarian Nordic.   GSK flu vaccine deal renewal (Reuters)…