International – ATMPs: Global regulators eye harmonization for ultra-orphan products

Top regulators from the US, EU, UK and Japan view harmonization as a critical factor in enabling the development of advanced therapy medicinal products...

International – Pfizer est « en train de mettre au point deux médicaments contre le...

"Nos chercheurs ne relâchent pas leurs efforts." C’est la promesse faite le samedi 10 avril par David Lepoittevin, porte-parole de Pfizer France, dans les...

International – Moderna’s COVID-19 vaccine can protect for 6 months

There's good news for the millions of Americans who've already received a dose or two of Moderna's COVID-19 vaccine: New research shows the vaccine...

International – FDA, EMA team up on pediatric oncology drug development template

In a move that dovetails with other cooperative efforts in regulation of pediatric oncology drugs, regulators in the US and Europe have come together...

International – Le vaccin AstraZeneca change de nom

Nouveau nom, nouvel emballage, pour un vaccin qui a beaucoup fait parler. Selon les informations du site de La Libre Belgique, l'Agence européenne du médicament a...

International – Sanofi and Translate Bio launch phase 1/2 trial of mRNA-based COVID-19 vaccine

The randomised, placebo-controlled trial will evaluate the safety, tolerability and immunogenicity of MRT5500 and is expected to enrol 415 healthy adults aged 18 years and older. Participants...

International – Five things to know about the AstraZeneca/Oxford vaccine

Here are five facts about the much-anticipated vaccine. Practicality The AstraZeneca/Oxford vaccine has the major advantages of being inexpensive, costing about £2.50 ($3.40, 2.75 euros) per...
US, EU Pledge to Cooperate on UDI Specifications

International – Orphan product designation requests climb in the US, remain steady in the...

The number of new requests for orphan drug designation in the United States increased 41% from 2019 to 2020, bringing the number of requests...

International – New real-world evidence for Pfizer/BioNTech COVID-19 vaccine

The latest analysis from Israel’s MoH found that protection is stronger two weeks after the second dose of the vaccine – effectiveness was at least...

International – Moderna launches COVID-19 vaccine booster study to address new variants

The phase 2 trial amendment has enrolled 60 participants who have already received Moderna’s original mRNA-1273 vaccine. They will receive a single booster dose of a...

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