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Germany The biggest pharma industry and healthcare stories from Germany, including the country’s legalisation of cannabis; the MASH potential of Boehringer Ingelheim’s obesity candidate; Bayer’s further share price drop and expansion into the US; the antibody-drug conjugate (ADC) specialist Tubulis’ series B2 financing, and Novartis’ deal with biotech MorphoSys.   Germany’s…

USA Francesco Lanucara of PharmaLex, writing in the November 2023 edition of the DIA’s Global Forum magazine takes a look at how new guidance from the US FDA aims to tackle the myriad challenges of cell and gene therapy manufacturing comparability and complexity.   Development of cell and gene therapy (CGT)…

Egypt The head of the Egyptian Unified Procurement Authority (UPA), Major General Doctor Bahaa El Din Zeidan, outlines the agency’s view on tenders, emphasizing their vision to secure the highest quality at the best price for Egyptian patients, and analyses the country’s healthcare transformation. In addition, he argues in favour of…

Poland Some of the top stories emanating from Poland’s pharma industry, including Polish biotech Ryvu Therapeutics’ exclusive deal with Exelixis, the partnership between Polpharma and startup Pikralida on a promising epilepsy candidate and Adamed’s expansion of its laboratory facilities.   Exelixis and Ryvu Therapeutics Sign Agreement to Develop Novel STING Agonist-Based…

USA In the United States, clinical trials have long been criticized for inadequate inclusion of minority patients and consequently for not representing the country’s diverse population. The FDA recently released new guidance for improving diversity in clinical trials. According to its Drug Trials Snapshots Report for 2019, of the clinical trials…

Europe In an extensive recent PharmaBoardroom conversation, EMA Head of Advanced Therapies Ana-Hidalgo-Simon highlighted some of the most important trends around advanced therapy regulation in Europe. Hidalgo-Simon touched on why moderate growth in regulatory applications is a positive development for the EMA, how patient insights are being better incorporated into the…

Europe Speaking exclusively to PharmaBoardroom, the EMA’s Head of Advanced Therapies Ana Hidalgo-Simon discusses steadily growing numbers of regulatory applications in the advanced therapy field, the vital importance of patient group insights, RWE collection and curation, hospital exemptions, manufacturing challenges, and more.   [Advanced] therapies are complex, difficult, and have a…

Europe A roundup of the latest news from European biotech, including BioNTech and CureVac’s German vaccine manufacturing deal; the revival of Valneva’s plans to manufacture its vaccine in Scotland; and Morphosys’ shuttering of its US R&D footprint.   BioNTech, CureVac part of $3.14B deal to bolster German vaccine capacity through 2029:…

Turkey As an upper-middle-income country with an emerging economy, Turkey could not invest billions in COVID-19 vaccine R&D, but a strong research ecosystem and willing industry allowed it to kickstart multiple vaccine and drug projects, discovering a new collaborative model along the way.   The responsibility for coordinating Turkey’s research and…

Denmark Danish pharma industry veteran Peter Drøidal highlights how he steered the Danish Novartis affiliate through the COVID-19 pandemic period, the strategy in place to navigate an increasingly challenging market access landscape, and the lessons that can be leveraged from the value-based agreement that Novartis was able to strike with the…

Spain The latest from Spanish pharma, including the Patent and Trademark Office’s warning of the importance of IP protection for medical advancements, Grifols’ expansion in Africa through a manufacturing plant in Nigeria, Almirall’s newest EMA approval, and COVID-19 vaccination updates.   Spanish Patent Office: medical advances would be “inconceivable” without patents…

Denmark Ida Sofie Jensen introduces the strong fundamentals underpinning the Danish innovative life sciences industry, including governmental support for early access to medicines, a collaborative approach to pricing and reimbursement, a highly centralised hospital system, and excellent digitalised patient records. Jensen highlights that thanks to these fundamentals, Denmark is home to…