Tagged with USA,

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…

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…

USA In an exclusive interview, Janet Woodcock, head of the Center for Drug Evaluation and Research (CDER) at the US Food & Drug Administration (FDA) outlines how the world’s gold-standard agency for regulatory science is adapting to game-changing and often extremely expensive new therapies, why a sizeable impact from data and…

Coronavirus The 2019 Wuhan coronavirus outbreak has seen a surge in demand for protective masks as publics across the world seek to protect themselves from infection. Manufacturers of the masks have seen their stocks boom, but supply is outstripping demand and hoarding practices may leave healthcare professionals on the frontline of…

USA In 2019, several drug companies testified to the US Senate Finance Committee on medicine price hikes with a narrative of discounts given to health insurance companies and pharmacists, but not then passed onto consumers. In a recent conversation with PharmaBoardroom, Matt Eyles, president & CEO of the Association of Healthcare…

USA Takeda’s Jessica S. Scott examines the steps already being taken to bring greater patient engagement to drug development and the regulatory decision-making process in the USA; as well as what more needs to be done in this crucial area.   Steps Taken by FDA Under the Food and Drug Administration…