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 Jan 2022
Accelerating clinical trials in the EU: for better clinical trials that address patients’ need
13 January 2022 - Today, the European Commission, the Heads of Medicines Agencies and the EMA have launched an initiative to ...
Posted by Michael Wonder on 16 Jan 2022
Glenmark receives NDA approval by the United States FDA for Ryaltris nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and paediatric patients 12 years of age and older
14 January 2022 - Ryaltris will be marketed and distributed in the United States through its partner Hikma. ...
Posted by Michael Wonder on 16 Jan 2022
Global regulators discuss path towards regulatory alignment on response to Omicron variant
13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...
Posted by Michael Wonder on 15 Jan 2022
U.S. FDA approves Pfizer’s Cibinqo (abrocitinib) for adults with moderate to severe atopic dermatitis
14 January 2022 - Cibinqo is a once daily oral treatment with proven efficacy to manage symptoms for adults who ...
Posted by Michael Wonder on 14 Jan 2022
Advancing health through innovation: new drug therapy approvals 2021
13 January 2022 - The FDA’s Center for Drug Evaluation and Research has issued its report, Advancing Health Through Innovation: New ...
Posted by Michael Wonder on 14 Jan 2022
Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations
11 January 2022 - The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. ...
Posted by Michael Wonder on 14 Jan 2022
Biogen prepares to fight Medicare over Alzheimer’s drug limits
14 January 2022 - Draft rule limits access to hundreds of patients, CEO says. ...
Posted by Michael Wonder on 14 Jan 2022
U.S. FDA approves Rinvoq (upadacitinib) to treat adults and children 12 years and older with refractory, moderate to severe atopic dermatitis
14 January 2022 - Approval of two dose strengths (15 mg and 30 mg) supported by efficacy and safety data from ...
Posted by Michael Wonder on 14 Jan 2022
Celltrion wins conditional nod for Regkirona in Switzerland
14 January 2022 - Celltrion said that Swiss Medic, Switzerland’s drug administration, has temporary authorisation for Regkirona (regdanvimab). ...
Posted by Michael Wonder on 14 Jan 2022
Senate panel advances Biden's FDA pick in 13-8 vote
13 January 2022 - Two senators on the panel who caucus with Democrats and six Republicans opposed the nomination. ...
Posted by Michael Wonder on 14 Jan 2022
GSK and Vir submit emergency use authorisation application to FDA for intramuscular administration of sotrovimab for the early treatment of COVID-19
13 January 2022 - Submission follows COMET-TAIL Phase 3 data demonstrating that intramuscular administration of sotrovimab was non-inferior and offered ...
Posted by Michael Wonder on 14 Jan 2022
PBAC Public Summary Documents – September 2021 meeting (first time rejections and deferrals)
14 January 2022 - The Public Summary Documents (first time rejections and deferrals) from the September 2021 PBAC meeting are now ...
Posted by Michael Wonder on 13 Jan 2022
The US FDA issues a complete response letter for the biologics license application for insulin aspart
7 January 2022 - The U.S. FDA has issued a complete response letter for the biologics license application for insulin ...
Posted by Michael Wonder on 13 Jan 2022
Orphan drugs: privilege of "fictitious" additional benefit not justified
12 January 2022 - Drugs for orphan diseases should also go through a regular benefit assessment procedure when they enter the ...
Posted by Michael Wonder on 13 Jan 2022
CBMG receives FDA regenerative medicine advanced therapy and fast track designations for bi-Specific anti-CD19/CD20 CAR-T cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma
12 January 2022 - Cellular Biomedicine Group today announced that the FDA granted C-CAR039, a novel autologous bi-specific CAR-T therapy targeting ...