Blog
RSS FeedPosted by Michael Wonder on 06 Feb 2025
Bayer files for approval of finerenone in heart failure in the EU
3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...
Posted by Michael Wonder on 03 Mar 2025
PHARMAC CE resigns
28 February 2025 - The Board of PHARMAC wishes to announce that its Chief Executive for the last 7 years, ...
Posted by Michael Wonder on 03 Mar 2025
New Zealand Pharmaceutical Schedule - 1 March 2025
1 March 2025 - The March 2025 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 03 Mar 2025
Avobis Bio receives FDA fast track designation for AVB-114 implantable cell therapy for Crohn's perianal fistulas
27 February 2025 - Only implantable cell therapy for Crohn's perianal fistulas with FDA IND clearance and fast track designation. ...
Posted by Michael Wonder on 02 Mar 2025
Authorisations of human medicinal products with a new active substance and additional indications 2024
28 February 2025 - 46 human medicinal products with new active substances authorised. ...
Posted by Michael Wonder on 02 Mar 2025
Highlights from the 24-27 February 2025 CHMP meeting
28 February 2025 - Four new medicines recommended for approval; another 16 medicines recommended for extension of their therapeutic indications. ...
Posted by Michael Wonder on 02 Mar 2025
mRESVIA RSV vaccine approved to protect patients aged 60 and over
28 February 2025 - A study found that around 4 months after vaccination, people who received the respiratory syncytial virus vaccine had ...
Posted by Michael Wonder on 02 Mar 2025
We stand to lose billions in blockbuster drug patent challenge
27 February 2025 - One of the reasons rare earths brought Presidents Trump and Zelinsky together is the looming boom ...
Posted by Michael Wonder on 02 Mar 2025
Krystal Biotech receives positive CHMP opinion for Vyjuvek for the treatment of dystrophic epidermolysis bullosa
28 February 2025 - EC approval decision anticipated in second quarter of 2025. ...
Posted by Michael Wonder on 02 Mar 2025
Teva and Medincell announce FDA acceptance of supplemental new drug application for Uzedy (risperidone) extended release injectable suspension as a treatment for patients with bipolar I disorder
25 February 2025 - Uzedy is currently approved in the US as a subcutaneous long-acting injectable for use every one or ...
Posted by Michael Wonder on 01 Mar 2025
Outlook Therapeutics resubmits biologics license application for ONS-5010 as a treatment for wet AMD to the US FDA
28 February 2025 - Outlook Therapeutics today announced it has re-submitted its biologics license application to the US FDA for ...
Posted by Michael Wonder on 01 Mar 2025
Valneva receives EMA’s positive CHMP opinion for adolescent label extension for chikungunya vaccine Ixchiq
28 February 2025 - If granted, Ixchiq will become the first vaccine against the chikungunya virus available in the EU ...
Posted by Michael Wonder on 01 Mar 2025
Bimzelx (bimekizumab) negotiations with pCPA concluded successfully following positive CDA and INESSS recommendations for adults with active psoriatic arthritis and adults with active ankylosing spondylitis
28 February 2025 - Positive CDA and INESSS reimbursement recommendations are an important step towards public access to Bimzelx, the first ...
Posted by Michael Wonder on 01 Mar 2025
AbbVie receives positive CHMP opinion for upadacitinib (Rinvoq) for the treatment of adults with giant cell arteritis
28 February 2025 - The positive opinion is based on results from the pivotal Phase 3 SELECT-GCA trial that evaluated the ...
Posted by Michael Wonder on 01 Mar 2025
Lilly's Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with relapsed or refractory chronic lymphocytic leukaemia previously treated with a BTK inhibitor
28 February 2025 - The positive opinion is based on results from the Phase 3 BRUIN CLL-321 trial, recently presented at ...
Posted by Michael Wonder on 01 Mar 2025
Enhertu recommended for approval in the EU by CHMP for patients with HER2 low or HER2 ultra-low metastatic breast cancer following at least one endocrine therapy
28 February 2025 - Recommendation based on DESTINY-Breast06 Phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with ...