Tagged with USA

USA Dr Peter Marks MD, PhD, director of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), highlights the Center’s contributions related to the regulatory science behind vaccine development, including vaccines to prevent COVID-19; the Center’s efforts to facilitate the advancement of the field…

USA Regular PharmaBoardroom contributor Brendan Shaw weighs in on the potential implications for US pharma of President Donald Trump’s latest executive order on medicine pricing, its wider impact on other high income economies, and why a Democratic victory in the upcoming presidential election will not see this issue go away.  …

USA As part of our upcoming US Healthcare and Life Sciences Review, we spoke to key stakeholders – former Association for Accessible Medicines (AAM) president & CEO Chip Davis; Carol Lynch, president of Sandoz US, head of Sandoz North America and member of the Sandoz Executive Committee; and Amgen’s biosimilars business…

USA With US still the reigning global champion in biotech innovation, the dynamic and vibrant biopharma ecosystem in the world’s largest healthcare market continues to churn out ground-breaking innovations with companies aspiring to follow in the footsteps of success stories like Regeneron, Celgene, and Amgen. Once US biotechs achieve the significant…

USA Michael Ciarametaro, VP for Research at the US National Pharmaceutical Council (NPC), outlines issues surrounding the outdated Medicaid Best Price (MBP) and why there is a dire need for payment innovations to provide a way for US payers and manufacturers to share financial risk and ultimately ensure that patients can…

Japan Following PharmaBoardroom’s recent interview with Ivan Cheung, chairman of Eisai’s US affiliate and president of Eisai’s global neurology business, we take the opportunity to look back on the interesting history and particularities of Japanese pharma companies’ entry and expansion into the US market.   Japan is one of the world’s…

USA Karyopharm Therapeutics’ Dr Michael G. Kauffman outlines the genesis of the company he co-founded with his wife, the approval journey of key product XPOVIO®, his ambitious internationalisation plans, and the challenges of being a biotech entrepreneur.   From my experience, many great ideas actually come from people unconstrained by the…

USA Ivan Cheung, head of Japanese firm Eisai’s US operations, highlights the significance of a potential 2021 US FDA approval for Alzheimer’s Disease drug aducanumab, developed in collaboration with Biogen. Cheung also compares the differing challenges of the oncology and neuroscience markets and outlines the unique Eisai company culture.   We…

Opinion Holmusk’s Nawal Roy outlines why a cure for Alzheimer’s Disease is the “Holy Grail” of medicine today, the reasons for so many biotech companies failing to develop effective treatments for the disease, and why a more holistic systems approach may be the key to future success.   The ingenuity of…

M&A In the wake of Sanofi’s USD 3.7 billion tie-up for US biotech Principia, J&J has moved to bolster its autoimmune portfolio with the acquisition of Momenta Pharmaceuticals for USD 6.5 billion, a further signal of Big Pharma’s prioritisation of rare disease treatments.   The all-cash deal sees J&J’s pharmaceutical division…

USA PharmaBoardroom recently spoke to CNS-focused Danish biopharma company Lundbeck’s EVP and Head of North America Peter Anastasiou, who highlighted the long-term damage COVID-19 is causing to the general mental health of society, and how Lundbeck is well-positioned to address this in North America.   As the global pandemic rages on,…

Sanofi Sanofi has agreed a deal to buy out its partner, US biotech company Principia Biopharma for USD 3.7 billion in cash, giving the French giant full ownership of Principia’s pipeline of BTK inhibitors for autoimmune disorders.   The deal, whereby Sanofi is set to pay USD 100 a share to…