Tagged with ARM

Pharma Legal Handbook 1. What is the definition of Rare Diseases in your country? Our law states a specific definition for rare diseases, which is the following: They are mainly considered life-threatening or debilitating in the long term. They have low prevalence and high complexity and constitute many diseases. They are characterized by…

Pharma Legal Handbook 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? New productive investments made from January 2022, including those in the pharmaceutical sector, may be eligible for tax benefits. Investors generally benefit from a 3-point…

China The R&D-Based Pharmaceutical Association Committee (RDPAC) under the China Association of Enterprises with Foreign Investment (CAEFI) represents 46 multinational pharmaceutical companies with a strong R&D presence in China. Managing Director Renaud Gabay discusses how member companies are leveraging synchronized approvals to accelerate access; the evolution of China’s regulatory framework that…

China A roundup of some of the biggest China pharma industry stories, including the progress of the US Biosecure Act targeting Chinese biotechs; Innovent’s obesity and type 2 diabetes contender’s positive phase III trial results; the strategic partnership between Sino Biological and BioGeometry; CSL’s sale of its China-based plasma collection operations…

Switzerland Switzerland’s healthcare system is at a crossroads. Although still one of the world’s bastions of biopharmaceutical innovation, the country’s domestic healthcare environment is under increasing pressure from rising costs, mounting drug shortages, and a regulatory environment that is slow to adapt. What role could pharmacies and the off-patent industry play…

Switzerland Martine Ruggli discusses the evolving role of pharmacists in Switzerland’s healthcare system, addressing challenges and opportunities in digitalization, drug shortages, and regulatory reforms, as well as the need to leverage pharmacists’ expertise more broadly.   Investing in and empowering pharmacists is essential for improving the quality, accessibility, and efficiency of…

Saudi Arabia Saudi Arabia – by many measures the cultural, social, and economic epicentre of the Arab and Islamic worlds – is currently undergoing a once-in-a-lifetime transfiguration. The country’s ‘Vision 2030’ transformation plan has not only been radically reshaping the national economy and reducing its dependence on petroleum revenues but has also…

Global Originally seen as occasional service providers for the pharma industry, contract development and manufacturing organisations (CDMOs) have become vital strategic partners. Helping pharma and biotech companies advance their therapies through their outsourced services, CDMOs have demonstrated their ability to respond to the industry’s shifting priorities as well as its pre-…

Europe Last year the European Commission (EC) came out with a proposal to reform the EU’s core pharmaceutical legislation, aiming to address affordability, accessibility, and availability, among other objectives. One of the key changes proposed was reducing the EU’s baseline regulatory data protection (RDP) timeline, a plan that pleased the generics…

China A roundup of top stories from China’s pharma industry, including BeiGene’s new US R&D and manufacturing facility; Merck’s purchase of investigational B-cell depletion therapy from Curon Biopharma, and the Chinese approval of AstraZeneca and Daiichi Sankyo’s gastric cancer therapy.   China’s BeiGene opens new clinical R&D and biologics manufacturing facility…

Mexico Adium Mexico, recently rebranded to reflect the identity of the broader Adium Group, represents no less than 25 percent of the LatAm group’s sales. General Director José Miguel Fonken Quiroga shares the affiliate’s number one status, stellar growth, vast portfolio, and plans to expand into OTC and vaccines. Fonkel also…

Hong Kong With its dual business approach – commercializing acquired products while developing a novel respiratory disease pipeline – Nuance Pharma, after closing Series D funding and establishing a solid revenue stream, has set its sights on Asia Pacific. Founder and CEO Mark Lotter, discusses the regulatory and talent acquisition challenges in…