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The EU AI Act: will regulation drive life science innovation away from Europe?

European Pharmaceutical Review

When the General Data Protection Regulation (GDPR) 1 came into effect in 2018, this appeared to accelerate the migration out of Europe for pharmaceutical clinical trials. About the authors Mike King is Senior Director, Product & Strategy (Quality, Regulatory, Safety & Detect), Digital Products & Solutions at IQVIA.

Medical 105
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Everything You Need to Know About Prior Authorizations in Healthcare

Referral MD

Patient Safety Prior authorization protects patients by: Verifying that prescribed medications or treatments are safe. According to a 2018 AMA survey, 26% of healthcare providers reported waiting three days or more for a decision, highlighting the need for improvements in efficiency. Identify more cost-effective alternatives.

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PhRMA lies to protect pharma profits

World of DTC Marketing

He leads the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital in Boston. Data were mainly accessible for smaller firms, products in some therapeutic regions, orphan drugs, first-in-class drugs, therapeutic agents that received accelerated approval, and products between 2014 and 2018.

Pharma 255
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MHRA approves biosimilar for vision disorders in Great Britain

European Pharmaceutical Review

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Ximluci ® (ranibizumab), a biosimilar referencing Lucentis®, to help treat a leading cause of blindness globally. First bispecific antibody approved in EU to combat leading causes of vision loss.

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Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

Since 2018, biotech company Mikrobiomik has been researching, development and producing innovative biological medicines based on the human microbiome. Donor of stools for MBK-01 were screened for pathogens and viruses to ensure safety. Safety and quality of life of the patients participating in the study were also assessed.

Safety 111
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Brii Bio acquires Vir’s antibody rights for Hepatitis B in Greater China

Pharmaceutical Technology

The companies signed a partnership, option and license agreement in May 2018 under which Brii Bio gained the option for the acquisition of exclusive rights to some programmes of Vir in Greater China.

Medical 111
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Activ Surgical Secures CE Mark Approval for ActivSight™ Intelligent Light

Legacy MEDSearch

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.