Tagged with USA

Romania Dan Minoiu, partner at Romanian law firm Mușat & Asociații, shares his insights into the main trends shaping the healthcare environment in Romania from a regulatory and legal perspective, the challenges currently facing his clients, and his hopes for the future of the country.   Our clients always stress how…

Opinion AAM Interim President Jeff Francer outlines the vital role that biosimilar and generics firms will play in filling supply chain gaps during the ongoing coronavirus pandemic.   Like the rest of society, executive and scientific teams working in the US generic and biosimilar pharmaceutical industries have never experienced anything quite…

Artificial Intelligence Artificial intelligence (AI) is increasingly being utilised in the drug discovery process, with the latest breakthrough being the development of an antibiotic that is powerful enough to combat resistant bacteria strains via a deep learning algorithm.   AI has the power to enable biopharmaceutical companies to reduce costs and improve…

India The US generics market stood at USD 69 billion in 2018 and is expected to grow to USD 86 billion by 2022. Made with Visme Infographic Maker   Abbreviated New Drug Applications (ANDAs), whereby a company seeks authorisation from the US FDA for a generic copy of a previously approved…

India A recent IQVIA report highlights the increasing importance of Indian firms to the USA’s burgeoning generic pharmaceuticals market.   Now accounting for over 90 percent of all prescriptions dispensed in the USA, generic drugs play a vital role within US healthcare and have come a long way since their use…

Coronavirus Over the past few years, innovative Swiss giant Roche has combined its position as the world’s number 1 biotech company and its strength in in vitro diagnostics to brand itself as the frontrunner in personalized healthcare. In 2012, CEO Severin Schwan set the ambitious target of pairing more than 60…

Romania Iulia Arif-Percă executive director of the Local American Working Group (LAWG), shares her insights on the launched initiatives to finding new funding alternatives that will increase Romanian patients’ access to innovative medicines. She highlights the constraining environment in which innovative companies operate in, and how LAWG’s work contributes to the…

Italy Italian mid-cap firm Chiesi is continuing its expansion in the USA market with the launch of a Boston-based subsidiary focusing on rare and ultra-rare diseases.   We are very excited to put Chiesi’s decades of experience in drug development and dedication to patients to work to make a positive difference…

USA Annual numbers of new molecular entities (NMEs) and biologics license applications (BLAs) approved by the FDA’s Center for Drug Evaluation and Research (CDER). Approvals of products such as vaccines and gene therapies by the Center for Biologics Evaluation and Research (CBER) are not included in this drug count. Made with…

USA Barbara Lopez Kunz, CEO of the Drug Information Association (DIA) in the USA, outlines the association’s four key areas of focus – regulatory science, patient engagement, translational science, and value and access – and highlights how it works with stakeholders across the healthcare continuum and across the globe.   Across…

Coronavirus The ongoing coronavirus outbreak and the subsequent shutdown of factories in China is having severe repercussions for Indian pharma manufacturers and could lead to global shortages.   Shortages and Price Rises in India India depends on China for 80 percent of the Active Pharmaceutical Ingredients (APIs) that it uses in…

Opinion Jonathan Kimball of the Association for Accessible Medicines (AAM) in the USA outlines why the signing of the US-Mexico-Canada Agreement (USMCA) in January 2020 may mark a turning point for greater access to generic and biosimilar medicines globally.   US trading partners should take note. There is no longer a…