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Japan An overview of the new medicines approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) between April and November 2021. See the 2020 data here and the full PMDA approval archive here. Made with Visme Infographic Maker

USA A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)’s new drug therapy approvals for 2021. CDER approved 50 new drugs in 2021, down from 53 in 2020, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics…

France French mid-cap pharma Ipsen achieved total sales of EUR 2.869 billion in 2021, a 12.3 percent increase on results from the pandemic-affected 2020 total. The company also announced plans to divest its consumer healthcare business – which currently accounts for around eight percent of total revenues – to fellow French…

USA Ramona Sequeira of Takeda has taken the reins as chair of US industry lobby group PhRMA’s Board of Directors, becoming the first ever woman to hold the role. She succeeds Lilly Chairman and CEO David Ricks at a juncture when the industry is under pressure from proposed US pricing reforms…

Spain Dr Manel Juan is part of the team behind the development of the first European CAR-T-cell therapy to treat multiple myeloma, the second most common type of blood cancer. As head of immunology at the Hospital Clinic Barcelona, he walks us through his personal journey with the project, the challenges…

Spain Ángel Luis Rodríguez de la Cuerda, longtime secretary general of AESEG, the trade association of generic producers in Spain, comments on the key role played by generic medicines during the COVID-19 pandemic and the importance of new investment to increase Spain’s generic production capabilities. In addition, he outlines specific policy…

Spain The president of the Business Federation of Spanish Pharmacists (FEFE), Luis Maria de Palacio Guerrero, reflects on the sector’s key contributions during the COVID-19 pandemic and explains why pharmacists must play a larger role in Spain’s healthcare system. In addition, he reveals why the organisation has “high expectations” of the…

Spain Merck’s general manager for Spain, Miguel Fernández Alcalde, speaks about the company’s shift towards becoming a global specialty innovator, what it means for their portfolio, and explains the group’s broad footprint in Spain, where it maintains three manufacturing sites. In addition, Fernández analyses the Spanish pharma market and what he…

China A selection of recent top stories from the Chinese pharma industry, including China’s conditional approval of Pfizer’s COVID treatment pill Paxlovid; a new push to combat monopoly practices and unfair competition in the domestic industry; and US FDA concerns about the applicability of Chinese clinical trial results for the US…

Pharma Legal Handbook The key facts about biosimilars and biologics in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, in…

Pharma Legal Handbook Want to know more about localization in Ukraine? Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GBP 99.     1. Are there any rules or regulations requiring and/or encouraging localization in your country? What…

Global Drawing on the findings of EY’s recently published life sciences M&A firepower report, EY Global Life Sciences Deals Leader Subin Baral makes the case for big biopharmas to seek out alliances and partnerships as an alternative to M&A and lists ten considerations that these firms should bear in mind if…