UK – Boehringer Ingelheim’s idiopathic pulmonary fibrosis treatment recommended by NICE
The final draft guidance issued by NICE means that patients will be eligible to receive the antifibrotic treatment, which is currently recommended for patients...
France – Sérialisation: vers une pénalité trimestrielle et reconductible de 2.000€ pour les officinaux
PARIS (TICpharma) - Le gouvernement envisage une pénalité financière trimestrielle et reconductible de 2.000€ pour les pharmaciens d'officine qui contreviennent à leurs obligations en...
UK – MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation...
A series of new measures will be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) with support from partners to make it faster...
Europe – EU recommendations for 2023-2024 seasonal flu vaccine composition
EMA has issued the recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 12...
Review of hydroxyprogesterone started
EMA has started a review of medicines containing hydroxyprogesterone following concerns about the safety and effectiveness of these medicines. In the...
USA – FDA issues guidance on assessing quality of topical ophthalmic drugs
The US Food and Drug Administration (FDA) issued new draft guidance recommending a battery of studies that manufacturers should use to assess the quality...
Europe – First nasal adrenaline spray for emergency treatment against allergic reactions
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Eurneffy (epinephrine), the first medicine to be taken through the...
UK – Bristol Myers Squibb’s active ulcerative colitis treatment bags NICE recommendation
The recommendation is specifically for patients who are intolerant of, or whose condition has had an inadequate response, or loss of response to previous...
USA – Biosimilar facilities usually get onsite inspections
A US Food and Drug Administration (FDA) official said that sites making biosimilars will be inspected in person, as opposed to virtual methods, as...
USA – FDA releases discussion paper on distributed and point-of-care manufacturing
The US Food and Drug Administration (FDA) has released a discussion paper on emerging and advanced manufacturing technologies concerning the distributed manufacturing (DM) and...
