Tagged with B

Middle East & Africa Apart from a maturing regulatory environment and the expansion of healthcare coverage across the region, a number of other factors are contributing to the evolution of the MEA pharma market. Results from the second wave of a PhRMA-commisioned IQVIA market access study covering Saudi Arabia (KSA), UAE, Kuwait, Lebanon, Jordan,…

Global Merck has agreed to front USD 150 million for Orna Therapeutics’ new investigational class of engineered circular RNA (oRNA) therapies in a collaboration agreement that will also provide the biotech series B financing. This broad strategic collaboration brings together Merck’s significant expertise … with Orna’s compelling circular RNA technology to…

Egypt The head of the Pharmaceutical Chamber of the Federation of Egyptian Industries, Gamal El-Leithy, shares his view on the positive developments driving the growth of Egypt’s pharma market, including the creation of an independent regulatory body and a procurement agency. In addition, he analyses the country’s response to the COVID-19…

Global Sarah Pope Miksinski, executive director/CMS regulatory affairs, and Gregory Rullo, senior director regulatory affairs, at AstraZeneca discuss the need for common ground among regulators and industry when it comes to patient centricity and for strategic leadership to address differing regulatory control-strategy requirements. In today’s increasingly complex and intricate pharmaceutical landscape,…

Italy Guerbet’s Alessandro Bocci – General Manager Italy & Iberia – describes the nearly 100-year-old company’s firm position in the field of contrast media for radiology and its plans for developing a portfolio in artificial intelligence (AI). In addition, he outlines how the Italy, Spain and Portugal cluster made its way…

Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? No. At present, a “biosimilar” is not the same as a generic drug. Previously, some biological marketing authorization licenses were obtained by using the same registration pathway of generic medicines (i.e., without the submission of pre-clinical or…

Pharma Legal Handbook The key facts about biosimilars and biologics 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.   1. Are biosimilar medicines considered the same as generic medicines in your country? A…

Pharma Legal Handbook The key facts about localization 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. Are there any rules or regulations requiring and/or encouraging localization in your…

Pharma Legal Handbook Keen to learn more about cannabinoid drugs, medicinal cannabis and opioid drugs in Japan? Read on! 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.   Cannabinoid Drugs 1. Are…

Pharma Legal Handbook The ins and outs of orphan drugs & rare diseases 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 is the definition of Rare Diseases…

USA While patient groups view the United States’ new Inflation Reduction Act as a positive move towards capping out-of-pocket drug costs for older Americans, the innovative pharma industry, after aggressively lobbying against it, still argues that the new legislation will hamper drug development. [The new law] is a significant step in…

Pharma Legal Handbook The key facts about regulatory reforms 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 there proposals for reform or significant change to the…