USA / Impact of COVID-19 on US Clinical Studies Conducted by Japan-Based Pharmaceutical Companies
Writing in the June edition of DIA’s Global Forum magazine, representatives of Japanese pharmaceutical companies…
USA
Patients / Inserting the Patient Voice: Ethical Challenges in the Use of Healthcare Data
Patient advocate and regular PharmaBoardroom contributor Monica Weldon examines how healthcare’s data revolution has thus far largely ignored the patient voice and argues for a more inclusive approach to drive…
USA / FDA Calls for Federal Investigation of Itself on Aduhelm; Funding Boost for Medicare, Medicaid, ObamaCare; Questions over Benefits of New Science Agency
The latest from US health care policy, including the Senate budget deal funding for a range of major health care…
Aducanumab Approval / Opening the Floodgates for a New Era of Alzheimer’s Treatment?
With the US FDA’s controversial recent decision to approve Biogen and Eisai’s aducanumab – the first approval…
In Conversation
Tatsuya Kaihara – Corporate Officer, Head of North America Business, Santen Pharmaceutical Co., Ltd. & CEO, Santen Inc.
Tatsuya Kaihara, head of US operations for Japanese eyecare specialist Santen, describes his excitement at bringing two new ophthalmic advancements to the US market, the similarities, differences, and synergies of Japanese and American innovation, and the challenges of building a unified corporate culture. This is a very exciting moment for the Santen US affiliate Tatsuya, you were appointed president…
USA / FDA Drug Approvals 2020
In 2020, the US FDA’s Center for Drug Evaluation & Research (CDER) approved 53 novel drugs, up from 48 in…
Related Report
Asli Özelli – Executive Director, AmCham Turkey
AmCham Turkey’s executive director, Asli Özelli, examines the impact of US companies on the Turkish economy with…
Mid-Cap Strategies / LFB USA CEO Optimistic on Hemophilia Launches Amid COVID Crisis
French firm LFB is targeting the lucrative US market with its hemophilia products and recently received two FDA…
The Future of Biosimilars in the USA
Despite the savings and increased patient access biosimilars have brought to health care systems across Europe, the…
USA / Paying for Cell & Gene Therapy: Is the Future Already Here?
Certara’s Ulrich Neumann looks at the challenges that payment models for cell and gene therapy (CGT) have faced,…
Alzheimer's / Aducanumab: On the Regulatory Home Stretch in the USA
In the third of a series of articles chronicling Biogen/Eisai’s Alzheimer’s Disease (AD) treatment…
USA / Is Its Innovation Leadership Position At-Risk?
David H. Crean, managing director for Objective Capital Partners, provides insights on US innovation and long term…
The USA’s Safe Importation Action Plan: Trump’s Pharma…
In a bid to make tangible progress on the issue of lowering prescription drug pricing before the 2020 presidential…
Novavax / From No-Hoper to COVID-19 Vaccine Saviour?
From almost being de-listed by the NASDAQ stock index in 2018 due to poor financial performance, US vaccine firm…
Opinion / If the "Primary Endpoint" in an Alzheimer's Study is Outcomes, Think Biogen + Spotify
Taking the example of music’s effect on Alzheimer’s disease patients, John G Singer makes the case for…
Mexico-US Vaccine Tourism / Closed Borders, Fear of Fakes & Plane Crashes
While Mexico struggles with its COVID-19 vaccination campaign, residents of the country’s northern states have…
How the USA’s CREATES Act Restores Competition to the Pharmaceutical…
Chester “Chip” Davis, Jr, the President and CEO of the Association for Accessible Medicines (AAM) discusses…
USA / Impact of COVID-19 on US Clinical Studies Conducted by Japan-Based Pharmaceutical Companies
Writing in the June edition of DIA’s Global Forum magazine, representatives of Japanese pharmaceutical companies…
Moderna / Bullish Bancel “Not Losing Sleep” over COVID-19 Vaccine IP Waiver, Looking to mRNA’s Future in Rare Diseases & Oncology
The day the Biden administration announced its support for the waiver of IP rights for COVID-19 vaccines,…
Patients / Inserting the Patient Voice: Ethical Challenges in the Use of Healthcare Data
Patient advocate and regular PharmaBoardroom contributor Monica Weldon examines how healthcare’s data revolution…
USA / The Long Read: Innovation, Access & Affordability
A Tale of Two Americas The US stands as the biopharma innovation champion of the world, a global leader on nearly…
USA: The Biosimilars Trade Opportunity
Chip Davis of the Association for Accessible Medicines argues for greater provision for access to affordable…
USA / U-Turn as Biden Pledges Support for Waiver on COVID-19 Vaccine IP
In a shock move, Joe Biden’s administration looks set to support a waiver on intellectual property (IP)…
USA / 2 Things the Biden Administration can do Now to Lower Costs at the Pharmacy
PhRMA’s Stephen J. Ubl outlines two ways in which the new US presidency can help lower healthcare costs and why…
USA / Takeda’s Ramona Sequeira Talks “Culture as Strategy”
After five years with Takeda heading up the Japan-headquartered pharma company’s US business, following the…