The CHMP has recommended for authorization a new medicine for patients aged 16 years and older with phenylketonuria—Palynziq (pegvaliase). / read more /
The Regulatory Affairs Professional Society (RAPS) has unveiled the details of its inaugural European regulatory conference, RAPS Regulatory Conference–Europe 2019. / read more /
The Coalition for Epidemic Preparedness Innovations (CEPI) and CureVac partner to develop a transportable mRNA vaccine manufacturing platform. / read more /
Orion Corporation and Bayer have announced the submission of a marketing authorization application to the EMA for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer. / read more /
OSE Immunotherapeutics has been granted authorization to commence a Phase I clinical trial for checkpoint inhibitor BI 765063 (previously OSE-172). / read more /
Procarta Biosystems has received investment from Novo Holdings REPAIR Impact Fund to the tune of €1.5 million, which will be used to develop a new class of antibiotics to tackle AMR. / read more /
Sartorius Stedim Biotech (SSB) and Novasep will partner to develop systems for membrane chromatography using Novasep's BioSC platform and SSB's single-use technology. / read more /
Oxford Gene Technology (OGT) has revealed it is expanding its operations with a new facility in Cambridge, UK, to house its expanding Cytocell brand. / read more /
Pharmaceutical Technology spoke with Lisa Crandall, MS, associate director CMC Project Management, and Peter Angus, PhD, director of Pharmaceutical Sciences, at Velesco Pharma, which provides a full range of stability testing of API and drug products, about best practices in stability testing. / read more /
Various groups and stakeholders from pharma, healthcare, and government are responding to a new draft environmental risk assessment guidance from EMA. / read more /
Participate in BioPlan's 16th Annual Global Biopharmaceutical Manufacturing Study. Share your insight on current global and regional trends affecting biomanufacturing and receive a free aggregated summary of this year's results and an updated Top Trends in Biopharmaceutical Manufacturing White Paper. If you complete, the survey, BioPlan will donate $15 (up to $3000) on your behalf to global health charities or you can receive a $15 Amazon e-gift card. Take the survey
Date: 25 – 27 March 2019 Venue: Messe Wien Exhibition & Congress Center, Vienna, Austria
The thirteenth annual BIO-Europe Spring® conference is the premier springtime partnering conference for the biotechnology industry. For its 2019 edition, BIO-Europe Spring comes to Vienna, Austria on March 25–27, 2019. / Read more/
The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing.