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 19 Nov 2020
Trifarotene in moderate acne: no study data for the assessment of the added benefit
16 November 2020 - Only studies with placebo comparisons despite many affected people and existing treatment alternatives. ...
Posted by Michael Wonder on 19 Nov 2020
NICE is getting ready for the end of the transition period after Brexit
19 November 2020 - NICE has a key role in evaluation and access to new and innovative products for the health ...
Posted by Michael Wonder on 19 Nov 2020
EMA organises public meeting on COVID-19 vaccines
19 November 2020 - EMA will organise a public meeting on 11 December 2020 to inform European citizens about the ...
Posted by Michael Wonder on 19 Nov 2020
Kyowa Kirin announces approval for partial change of rituximab biosimilar received by Sandoz in Japan
18 November 2020 - Kyowa Kirin today announced that Sandoz KK, its strategic partner of the anti-CD20 monoclonal antibody rituximab ...
Posted by Michael Wonder on 19 Nov 2020
Pacira receives European Commission approval for Exparel (bupivacaine liposome injectable suspension) for the treatment of post-surgical pain
18 November 2020 - Approval based on four pivotal studies showing Exparel reduced pain scores and opioid use following surgery. ...
Posted by Michael Wonder on 19 Nov 2020
Omeros submits its biologics license application to U.S. FDA for narsoplimab in HSCT-TMA
18 November 2020 - Omeros Corporation announced that it has completed the rolling submission of its biologics license application to ...
Posted by Michael Wonder on 18 Nov 2020
Knight Therapeutics announces filing of supplement to a new drug submission for Nerlynx (neratinib) to treat HER2-positive metastatic breast cancer
3 September 2020 - Knight Therapeutics Inc. announced filing of the supplement to a new drug submission (SNDS) of Nerlynx ...
Posted by Michael Wonder on 18 Nov 2020
TGA grants third provisional determination for a COVID-19 vaccine
18 November 2020 - On 16 November 2020 the TGA granted a provisional determination to Janssen Cilag in relation to ...
Posted by Michael Wonder on 18 Nov 2020
Pfizer will seek regulatory review ‘within days’ for its vaccine
18 November 2020 - The coronavirus vaccine being developed by Pfizer and German biotechnology firm BioNTech is 95% effective at ...
Posted by Michael Wonder on 18 Nov 2020
The vaccines will probably work. Making them fast will be the hard part.
18 November 2020 - Front-runners in the coronavirus vaccine race won’t make nearly as many doses this year as were predicted, ...
Posted by Michael Wonder on 18 Nov 2020
Samsung Bioepis and Biogen announce FDA filing acceptance of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
18 November 2020 - Samsung Bioepis and Biogen today announced that the U.S. FDA has accepted for review the biologics license ...
Posted by Michael Wonder on 18 Nov 2020
European Commission approves Supemtek (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older
18 November 2020 - Contains three times more antigen than standard-dose vaccines. ...
Posted by Michael Wonder on 18 Nov 2020
NICE backs Lilly’s Emgality for migraine, adding pressure on Novartis
18 November 2020 - UK cost-effectiveness agency NICE has said that Eli Lilly’s Emgality can be made available through the ...
Posted by Michael Wonder on 18 Nov 2020
Rilzabrutinib granted FDA fast track designation for treatment of immune thrombocytopenia
18 November 2020 - Phase 3 trial initiated to evaluate rilzabrutinib, the potential first Bruton’s tyrosine kinase inhibitor for the treatment ...
Posted by Michael Wonder on 18 Nov 2020
FDA grants priority review for avalglucosidase alfa, a potential new therapy for Pompe disease
18 November 2020 - Regulatory submission based on positive data from two trials in patients with late-onset and infantile-onset Pompe disease, ...