Tagged with US

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…

USA As healthcare costs are set to be a key issue for voters in the upcoming US presidential election, PhRMA’s Robert Zirkelbach lays out why policymakers must abandon partisan solutions that do not address underlying access and affordability issues. Instead, Zirkelbach urges for greater protection of the USA’s world-leading biopharmaceutical R&D…

India Sanjay Bhutani of Bausch & Lomb outlines why the medical devices sector in India is poised for substantial growth, bolstered by increased government support and a higher healthcare budget. He also explains how the 2023 National Medical Device Policy marks a significant shift towards recognizing the distinct needs of the…

Europe PharmaBoardroom was delighted to attend DIA Europe 2024 in Brussels earlier this month, bringing together a veritable who’s-who of the European and global regulatory community. The politicians, regulators, payers, patient advocates, industry representatives, and service providers in attendance were treated to a three-day buffet of engaging panels and townhalls with…

USA Online pharmacies have still not captured a large share of the fragmented US pharma market, but Eli Lilly’s partnership with Amazon after a direct-sale initiative of its own may serve to shake up the establishment and show what a direct-to-consumer model can offer.   Eliminating the Middleman, or Not Amazon…