Tagged with USA,

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…

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…

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…

USA The COVID-19 pandemic looked like a turning point for vaccines, but while R&D has made tremendous strides with ground-breaking platform technologies and mRNA, vaccines continue to attract fewer investments than areas such as oncology. As panel members at the “Reviewing Vaccine Pipeline Breakthroughs and Barriers” session during BIO’s recent CEO…

USA At the American trade association’s latest CEO & Investor Conference, the board chair of the Biotechnology Innovation Organization (BIO) Ted W. Love discussed US policies and speculated about the impact of the upcoming American election on the industry while affirming that biotech continues to thrive in spite of recent challenges.…

China The latest news from Chinese pharma, including progress on the US Senate bill targeting BGI and WuXi AppTec, a report on why drug research is slowing in the country, and why Chinese firms are targeting global deals to navigate the capital crunch.   US Senate bill targeting China’s BGI, WuXi…

Global Drawing inspiration from Quentin Tarantino’s directorial breakthrough in the early 1990s, Blue Spoon Consulting’s John Singer explores the pharma sector’s urgent need for a strategic overhaul to ensure success and sustain growth amidst looming patent expirations.   Lex is the flagship investment column of the Financial Times. Its commentaries, currently written…