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PharmTech Europe
12 March 2019

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Top Stories

CHMP Recommends Authorization of Phenylketonuria Treatment

The CHMP has recommended for authorization a new medicine for patients aged 16 years and older with phenylketonuria—Palynziq (pegvaliase).
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FDA to Miss Gottlieb's Leadership

Gottlieb's tenure included record new drug approvals and steps taken to curb opioid abuse.
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Industry News

RAPS Prepares to Hold its Inaugural European Regulatory Conference in May

The Regulatory Affairs Professional Society (RAPS) has unveiled the details of its inaugural European regulatory conference, RAPS Regulatory Conference–Europe 2019.
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CEPI, CureVac Partner to Develop mRNA Vaccine Manufacturing Platform

The Coalition for Epidemic Preparedness Innovations (CEPI) and CureVac partner to develop a transportable mRNA vaccine manufacturing platform.
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Regulatory News

Orion and Bayer Submit Marketing Authorization Application to EMA for Darolutamide

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.
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OSE Immunotherapeutics Announces Authorization for Phase I Clinical Trial for its Checkpoint Inhibitor

OSE Immunotherapeutics has been granted authorization to commence a Phase I clinical trial for checkpoint inhibitor BI 765063 (previously OSE-172).
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Bio/Pharma News

Biogen to Acquire Gene-Therapy Company Nightstar in $800-Million Deal

The acquisition will establish a clinical pipeline for Biogen of gene–therapy candidates in ophthalmology.
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Biotech Receives €1.5 million in Funding to Develop a New Class of Antibiotics

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.
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Supplier News

SSB, Novasep to Develop Membrane Chromatography Systems

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.
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Oxford Gene Technology Expands Cytocell Operations in UK

Oxford Gene Technology (OGT) has revealed it is expanding its operations with a new facility in Cambridge, UK, to house its expanding Cytocell brand.
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FEATURED TOPICS

MANUFACTURING

Mind the Gap: Tech Transfer from Early Stage Cell Culture to Phase I Clinical Manufacture

Tech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.
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ANALYTICS

Analysis of Sub-Visible Particles

Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.
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OUTSOURCING

Determining Drug Stability

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.
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EU REGULATORY WATCH

Spotlight on Assessing the Environmental Impact of Medicines

Various groups and stakeholders from pharma, healthcare, and government are responding to a new draft environmental risk assessment guidance from EMA.
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TAKE THE SURVEY

Biopharmaceutical Manufacturing Survey

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Event Profile

13th Annual BIO-Europe Spring® Conference

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.
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Events

Parenteral Packaging Conference

Venice, Italy

19–20 March 2019

2019 ISPE Europe Annual Conference

Dublin, Ireland

1–4 April 2019

APACT '19

Chester, UK

30 April–2 May 2019


more events

eBOOKS

Laboratory Best Practices 2018 eBook

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.

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