Tagged with BI

UK Oxford Nanopore hogged the UK biotech headlines in 2021, raising GBP 195 million in a single venture capital round – the year’s largest – and scoring a GBP 350 million listing on the London Stock Exchange, according to new data from the UK BioIndustry Association (BIA) and Clarivate. See below…

Spain Soon after reaching its 60th anniversary, in 2015, the largest hospital in Catalonia and a group of sister institutions began working on the creation of a new type of campus. The idea was to follow the footsteps of world-leading healthcare hubs.   The idea of strengthening the cluster was an…

Italy Luca Benatti, one of Italian biotech’s most notable entrepreneurs, outlines some of the key challenges of starting a biotech company in Europe, highlights how these barriers can be overcome, and gives some of the key lessons he has learned in his entrepreneurial journey.   Benatti currently serves as CEO and…

Italy Serial bioentrepreneur Luca Benatti introduces EryDel, an Italian firm based on the concept of using a patient’s red blood cells to deliver drugs. Benatti also weighs in on the strengths and weaknesses of the Italian environment for biotech start-ups and his ambitious roadmap for EryDel’s future growth.   The major…

China A selection of recent top stories from the Chinese pharma industry, including China’s conditional approval of Pfizer’s COVID treatment pill Paxlovid; a new push to combat monopoly practices and unfair competition in the domestic industry; and US FDA concerns about the applicability of Chinese clinical trial results for the US…

Global With Biogen’s recent move to sell off its USD 2.3 billion stake in biosimilars firm Samsung Bioepis against the backdrop of lower-than-expected uptake of its controversial Alzheimer’s Disease drug Aduhelm, PharmaBoardroom takes a look at the contrasting fortunes of two key firms operating in the global biosimilars market today.   Global…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Saudi Food & Drug Authority (SFDA) is the government agency that regulates drugs and medical devices in Saudi Arabia. It is also in charge of biological and chemical substances in Saudi Arabia. …

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? It is mandatory to inform SFDA immediately about any Suspected Unexpected Serious Adverse Reactions (SUSAR) as soon as possible, no later than 15 days. If the SUSAR is fatal or life-threatening, SFDA…

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The MAA of the pharmaceutical product will be subjected to the followings processes:  Submit the application form and pay the fees. Upload the product file; The components of the…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? This presentation comprised a briefing on the current situation of the practice of traditional medicine (TRM) and complementary and alternative medicine (CAM), the availability of two kinds of herbal products, from local and imported crude…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? Product liability is the area of law in which manufacturers, distributors, suppliers and retailers are held responsible for any injuries products cause. Generally, there are three liabilities: Civil liability, punitive liability and disciplinary liability recognised in Saudi Arabia.    2.…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? Trademarks, copyright works, patents, industrial designs and domain names are all capable of being protected in Saudi Arabia and there is an established legal framework that supports the registration and records of these valuable IP rights. Protection can…