Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 16 Oct 2021
Merck receives positive CHMP opinion for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) in individuals 18 years of age and older
15 October 2021 - Merck today announced that the EMA’s CHMP has recommended the approval of Vaxneuvance (Pneumococcal 15 valent ...
Posted by Michael Wonder on 16 Oct 2021
Bristol Myers Squibb receives positive CHMP opinion for Zeposia (ozanimod) as a treatment for adult patients with moderately to severely active ulcerative colitis
15 October 2021 - CHMP recommendation based on positive results from the Phase 3 True North trial, in which Zeposia demonstrated ...
Posted by Michael Wonder on 16 Oct 2021
Janssen receives Positive CHMP opinion for Rybrevant (amivantamab) for the treatment of patients with advanced non-small cell lung cancer with EGFR exon 20 insertion mutations after failure of platinum-based therapy
15 October 2021 - If approved by the European Commission, amivantamab will be the first treatment in the European Union specifically ...
Posted by Michael Wonder on 16 Oct 2021
AbbVie receives CHMP positive opinion for risankizumab (Skyrizi) for the treatment of adults with active psoriatic arthritis in the European Union
15 October 2021 - CHMP positive opinion is based on data from two Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2. ...
Posted by Michael Wonder on 15 Oct 2021
TLV's web application for TNF inhibitors shows room for savings
15 October 2021 - The TLV, has developed a web application that will show the regions' use of TNF inhibitors ...
Posted by Michael Wonder on 15 Oct 2021
NICE clears Opdivo for resected oesophageal or gastro-oesophageal junction cancer
15 October 2021 - The UK NICE has recommended BMS' Opdivo (nivolumab) as a treatment option for certain resected oesophageal ...
Posted by Michael Wonder on 15 Oct 2021
FDA approves atezolizumab as adjuvant treatment for non-small-cell lung cancer
15 October 2021 - Today, the FDA approved atezolizumab (Tecentriq) for adjuvant treatment following resection and platinum-based chemotherapy in patients ...
Posted by Michael Wonder on 15 Oct 2021
Recommendations made between March 2021 and November 2021 PBAC meetings
15 October 2021 - Recommendations made by the PBAC between the March 2021 and November 2021 have been published. ...
Posted by Michael Wonder on 15 Oct 2021
Highlights from CHMP 11-14 October 2021 meeting
15 October 2021 - EMA’s CHMP recommended six medicines for approval at its October 2021 meeting. ...
Posted by Michael Wonder on 15 Oct 2021
Updates to the procedure guidance for listing medicines on the PBS
15 October 2021 - The Department has updated Section 5.8 New brand of existing pharmaceutical item submissions (not requiring PBAC consideration) ...
Posted by Michael Wonder on 14 Oct 2021
COVID-19 rapid antigen self-tests approved in Australia
13 October 2021 - The TGA has approved COVID-19 self-tests (home use tests) for supply in Australia from 1 November ...
Posted by Michael Wonder on 14 Oct 2021
Rhythm Pharmaceuticals completes submission of type II variation application to the European Medicines Agency for Imcivree (setmelanotide) for Bardet-Biedl and Alström syndromes
14 October 2021 - Rhythm Pharmaceuticals today announced that it has submitted its type II variation application to the EMA for ...
Posted by Michael Wonder on 14 Oct 2021
Celltrion applies for product approval for Avastin biosimilar in EU
12 October 2021 - Celltrion said that it has completed the approval application procedure for CT-P16, a biosimilar of Avastin ...
Posted by Michael Wonder on 14 Oct 2021
Drug pricing tug of war expected over CAR-T therapy Kymriah
14 October 2021 - The world’s first CAR-T therapy, Kymriah (tisagenlecleucel), passed the review of a panel at the Health ...
Posted by Michael Wonder on 14 Oct 2021
Biden eyeing FDA veteran Robert Califf to lead the agency
14 October 2021 - If nominated and confirmed, Califf would take over an agency poised to make key decisions on coronavirus ...