Tagged with USA

USA PhRMA President and CEO Stephen J. Ubl takes aim at the health insurers and pharmacy benefit managers (PBMs) driving medicines costs up in the US, and the Inflation Reduction Act (IRA) which he sees as failing to address the patient affordability conundrum. Ubl calls for a policy framework able to…

China In light of ongoing geopolitical tension, a globally unfavourable macroeconomic environment and new drug-pricing legislation in the US, at the recent BIO CEO and Investor Conference industry stakeholders evaluated the risks and the opportunities for cross-border deal-making between US and China and found a number of reasons to be optimistic.…

USA With the passage of the US Inflation Reduction Act (IRA) that will begin to take effect this year, the biopharma industry continues to grapple with the implications of the new law while deciding how to move forward in response to it. At the recent BIO CEO and Investor Conference, stakeholders…

USA Global e-commerce giant and the world’s fifth largest company by market capitalisation, Amazon is continuing its expansion into the healthcare space with the launch of a five dollar monthly medicine subscription plan for Amazon Prime members in the US.   The plan, named ‘RxPass’ covers 60 generic medications used to…

USA An up-to-date list of the US FDA’s Center for Biologics Evaluation & Research (CBER)’s biological license application approvals for 2022. There were nine such approvals in 2022, down from 13 in 2021. For the list of non-biological approvals from the FDA’s Center for Drug Evaluation & Research (CDER), click here.…

Global For a  biotech that had never before brought a drug to market, Moderna’s COVID-19 vaccine was a revelation. Not only did the vaccine validate the company’s focus on mRNA technology, it also led to huge profits, namely a net income of USD 12.2 billion in 2021 and vaccine sales adding…

Global David H. Crean, Managing Partner for Cardiff Advisory, highlights the tone and tenor of J.P. Morgan’s recent 2023 Healthcare Conference held in San Francisco in light of the uncertain economic environment that saw fewer IPOs in 2022 than in previous years and numerous negative enterprise value companies trading below cash…

USA Initial public offerings (IPOs) —a vital source of cash for up-and-coming biotechs— saw a huge decline in 2022 with respect to the previous year. After 2021’s record of more than 100 biotech IPOs that raised almost USD 15 billion in funds, 2022 saw a mere 17 biotechnology companies launch IPOs…

USA A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)’s new drug therapy approvals for 2022. CDER approved 37 new drugs in 2022, down from 50 in 2021, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics…

Global Antimicrobial resistance (AMR), or the resistance of pathogens to antibiotics, antivirals, antifungals and antiparasitics has been declared by the World Health Organization (WHO) as one of the top 10 global public health threats and was associated with the death of some 5 million people in 2019. The latest WHO report…

USA David H. Crean, Managing Partner for Cardiff Advisory, discusses the economic impact of the signing and implementation of the Inflation Reduction Act (IRA) on the biopharmaceutical industry and innovation.   America’s biopharmaceutical research companies are researching and developing new medicines to meet unmet needs and continuing research and development even…

Global Insights from US President Joe Biden’s chief medical adviser, Anthony Fauci, who served on the White House Coronavirus Task Force at the height of the pandemic, on the end of COVID-19, the danger of China’s recent surge in cases, preparedness for future pandemics, and the misinformation in the US that…