Tagged with R

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…

Pharma Legal Handbook The key facts about biosimilars and biologics in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, in…

Pharma Legal Handbook Want to know more about localization in Ukraine? Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.     1. Are there any rules or regulations requiring and/or encouraging localization in your country? What…

Global Drawing on the findings of EY’s recently published life sciences M&A firepower report, EY Global Life Sciences Deals Leader Subin Baral makes the case for big biopharmas to seek out alliances and partnerships as an alternative to M&A and lists ten considerations that these firms should bear in mind if…

Global Merck Group’s Vice President Global Market Access & Pricing Strategic Planning Marco Rauland casts his eye over blockchain-based smart contracts and their applications for pharma across supply chain enhancement, improving clinical trials, and outcome-based contracting.   Smart contracts are self-executing digital contracts based on blockchain technology that provides decentralized data…

Global Less than two months passed between the WHO’s official pandemic declaration and remdesivir’s emergency use authorisation in the United States in May 2020. Today, the intravenous antiviral, sold by Gilead Sciences under the brand name Veklury, has generated over USD 8 billion in sales.   Remdesivir’s success as a treatment…

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…

Spain Madrid’s Minister of Health, Enrique Ruiz Escudero, explains in detail how the Autonomous Community executed a different COVID-19 strategy from other Spanish regions, following a “basic health zones” model, why it might be too soon to speak about “flu-isation”, and their plan to boost home hospitalisation and telemedicine.   We…

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…