Tagged with Opinion,

Europe Based on current discussions by the European Commission, launch conditionalities would not account for the distinct nature of small and mid-sized companies, OMPs and ATMPs. EUCOPE’s Alexander Natz breaks down this aspect of the revision of the general pharmaceutical legislation and why it would prove unsustainable for smaller companies and…

Global PharmaBoardroom’s network of thought leaders continued to provide some of our top content in 2022, covering topics such as Africa’s first integrated drug discovery platform,  Chinese vaccine exports, inequities in US healthcare, antimicrobial pollution and new pharmaceutical legislation in Europe. See our dedicated op-ed page for all of the year’s contributions…

Europe Writing in the special December 2022 edition of DIA’s Global Forum magazine, Eli Lilly’s Mark Mayer, Pfizer’s Nick Sykes and Julie O’Brien, and the EFPIA’s Sini Eskola, Magda Chlebus, and Chloé Garay look at the EU regulatory system’s resourcing challenges and call for long-term multi-stakeholder engagement to help resolve them.…

China Writing in the special December 2022 edition of DIA’s Global Forum magazine – which focuses exclusively on decentralised clinical trials – on behalf of the DIA China Digital Health Community (DHC), Takeda’s Alicia He and Pfizer’s Mia Sun examine the progress made on decentralised and digitalised trials in China.  …

UK Bernard Ross, a serial entrepreneur with more than 20 years’ senior experience at private and public board level across multiple industries, looks ahead to 2023 and highlights five key trends to watch in the medtech space. With the COVID-19 pandemic having fast-forwarded the adoption of medical device innovations to solve…

China Accestra Consulting’s Zhao Lu* looks back on a year in which China’s Center for Disease Evaluation (CDE) rejected a record-breaking number of drug applications, explores some of the main reasons behind these rejections, and suggests how applicants can avoid them in future.   In 2021, China’s Center for Disease Evaluation…

Europe Writing in the DIA Global Forum’s special November 2022 issue on the Digital Virtuous Loop Karin Van Baelen and Susan Sandler – both of Janssen – and AbbVie’s Álmath Spooner look at Europe’s progress towards true real-world evidence integration and its potential impact on decision making across the healthcare continuum.…

USA A boom in decentralised clinical trials was an unexpected effect of the COVID-19 pandemic and subsequent lockdowns. However, these trials require expertise and technology that can differ significantly from those needed for clinical trials, as Curavit Clinical Research’s Joel Morse writes in the DIA Global Forum’s special November 2022 issue…

Denmark Henrik Brabrand, CEO of life science-focused executive search firm Albright Partners A/S, gives his expert insight into how to stand out above the crowd and get noticed by headhunters.   So, you have decided that you may be up for a new challenge. You may not know it yet, but…

Canada Drs Neil Cashman and Larry Altstiel of ProMIS Neurosciences weigh in on recent progress towards an effective therapy for Alzheimer’s disease, potentially representing a break from three decades of scientific stagnation.   Are we there yet with Alzheimer’s immunotherapies? No. But we have a map, and it’s a good one.…

China DIA Global Forum’s annual review of new drug approvals in China has shown growth in both the number and types of new drugs approved in China from 2019 through 2021: from 34 new chemical drugs and 19 biological products in 2019 to 37 new chemical drugs and 24 biological products…

Asia-Pacific Through compassionate use programs patients suffering from critical, life-threatening conditions can access potential life-saving therapeutic options which have not been formally approved by the responsible health authority in an ethical and regulated way. ChongXiang Tan, Fengyun (Vicky) Han and Annetta C. Beauregard of Janssen Pharmaceutical Companies of Johnson & Johnson…