Tagged with US

China Global pharma has been stepping up M&A activity in Asia while also looking to access Asian markets through local partners and tap into the region’s huge growth potential. As a result, the role of Business Development (BD) at international pharma companies has evolved. In a recent PharmaBoardroom interview, Servier’s Asia…

USA In the latest government-driven initiative to tackle drug prices in the US after the Inflation Reduction Act (IRA), California plans to cut drug prices by buying opioid overdose reversal drug naloxone directly from its generics manufacturer and distributing it under its own CalRx initiative.   California will continue to be…

Global 2023 was a breakthrough year for cell and gene therapies. The field saw a record number of FDA approvals, as other promising therapies in a broad range of therapeutic areas progressed through the pipeline. 2024 looks to be another important year with up to 17 new therapies poised for regulatory…

Global Having been quietly working away on its mRNA platform for years, Moderna stepped into the limelight during the COVID-19 pandemic and became a commercial-stage outfit almost overnight with its vaccine. After generating sales of USD 18.4 billion in 2022, demand for the company’s Spikevax shot, still its only commercialized product…

India US FDA India Office Director Sarah McMullen discusses the importance of maintaining India’s role as a global supplier of low-cost generics while also navigating the complexities of innovating and producing more complex pharmaceutical products. She notes that increased product complexity will inevitably lead to more regulatory challenges, emphasizing the need…

China In recent years, global pharma’s Business Development (BD) operations in Asia have evolved from primarily managing global agreements locally to engaging in more complex tasks like contract negotiation and due diligence. Servier’s Asia BD Head Cynthia Xin Wang explains how this shift reflects changing market dynamics and the growing importance…

Global AVAC is a global advocacy group focused on HIV prevention. It aims to accelerate ethical research and effective deployment of HIV prevention tools while working to ensure their equitable access. In an exclusive PharmaBoardroom interview, AVAC Executive Director Mitchell Warren looks back on the terrific advances that HIV science has…

USA Johnson & Johnson has been building its medtech arm and creating a differentiated pipeline through strategic M&A, an approach that generated USD 30.4 billion in medical device sales last year, representing growth of 12.4 percent. The company has now acquired Shockwave Medical, bringing its IVL technology on board for USD…

Global ISPOR—The Professional Society for Health Economics and Outcomes Research (HEOR), and PharmaBoardroom’s content partner, continues to monitor healthcare trends and conduct horizon scanning around the world. The “ISPOR 2024-2025 Top 10 HEOR Trends” marks the fifth publication of the Society’s biennial report, which is based on input from its members…

Pharma Legal Handbook An intro to the legal situation for regulatory, pricing and reimbursement in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What are the regulatory authorities with jurisdiction…

Pharma Legal Handbook All about preclinical and clinical trial requirements in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. Are clinical trials required to be conducted locally as a condition (stated or…

Pharma Legal Handbook Learn more about marketing, manufacturing, packaging & labeling, and advertising in Russian pharma. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What is the authorization process for the marketing of…