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€2m raised in seed funding to develop novel therapies for Cystic Fibrosis  

Drug Discovery World

This investment from the AFB FII fund stems from the AdBio-Inserm Transfert partnership announced in May 2022 to finance, support and grow Europe’s most innovative life science startups. Anoat will use the funds to conduct additional in vivo and in vitro pharmacology assessments and select a lead candidate.

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Considerations for Mobile Health Technology Developers: Part 1

pharmaphorum

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.

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Budget 2021: Sunak focuses on vaccine development to restart economy

pharmaphorum

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. A scheme providing £500 payments to people self-isolating has been extended in England until the summer.

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Innovative Nipocalimab Trial for HDFN Treatment Powered by BillionToOne

XTalks

This results in anemia, characterized by a decreased number of RBCs, and jaundice, indicated by high bilirubin levels, typically appearing within the first days or weeks of life. Although recruitment has not started, AZALEA plans to enroll and assess the therapy in 120 participants.

Trials 97
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Fantastic News – EU initiative: Extension of the transition period for medical devices

Pharma Business Blog

A proposal has been put forward to amend the transitional provisions for certain medical devices and in vitro diagnostic medical devices (amending Regulations (EU) 2017/745 (MDR) 1 and (EU) 2017/746 (IVDR) 2. Sandra Ragaz, Partner, Leader Pharma & Life Science – International Indirect Tax & Regulatory Sandra.ragaz@pwc.ch

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New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

pharmaphorum

Why is guidance needed? Uses of social media is continually expanding and it has been difficult for companies to apply general advertising rules and guidance to the modern world. What is the scope of the Guidance? Information on social media and digital channels should be kept up to date and date stamped, with the date posted or last updated.

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Microscopic innovations in women’s health 

Drug Discovery World

This transfer imparts immune advantages: Infants born vaginally have a greater concentration of Bacteroides, Bifidobacteria, and Lactobacillus , as well as more diverse microbial compositions in their first weeks of life compared to children born by C-section (caesarean section). The influence of these microbiomes extends to children as well.