USA – FDA explains when it will rescind breakthrough designations
The US Food and Drug Administration (FDA) on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy designation (BTD) during its...
France – Cegedim Santé lève 65 millions d’euros et acquiert l’entreprise de télémédecine MesDocteurs
PARIS (TICsanté) - Le groupe Cegedim a annoncé le 16 mai avoir signé un "protocole d'investissement" avec les groupes de protection sociale Malakoff Humanis,...
USA – FDA finalizes guidance on cannabis clinical research
The US Food and Drug Administration has finalized a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs...
International – Industry groups call for changes in ICH M11 guideline on harmonized protocols
In comments to the US Food and Drug Administration (FDA), pharmaceutical industry groups called for revisions to the International Council for Harmonisation’s (ICH) M11...
France – Avis de sécurité des Hospices civils de Lyon sur le LAP Easily
Les Hospices civils de Lyon (HCL) ont émis le 29 décembre un avis de sécurité sur le logiciel d'aide à la prescription (LAP) Easily...
USA – FDA updates statistical approaches for assessing bioequivalence
The US Food and Drug Administration (FDA) has published a draft guidance updating its principles for assessing in vivo or in vitro bioequivalence studies...
UK – Janssen and AbbVie’s Imbruvica combination recommended by NICE for leukaemia
CLL is the common type of leukaemia in adults, with around 3,800 people in the UK diagnosed with the disease each year.
While patient outcomes...
UK – NICE approval for Janssen’s Darzalex combination
Recommendation concerns routine use across the NHS as therapy for multiple myeloma
The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that the National...
USA – FDA finalizes drug-drug interaction guidance for therapeutic proteins
The US Food and Drug Administration (FDA) on Friday issued a final guidance to assist sponsors in determining whether to conduct drug-drug interaction studies...
USA – FDA Approves First Over-the-Counter Naloxone Nasal Spray
Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first...
