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 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 ...
Posted by Michael Wonder on 13 Jan 2022
Mitsubishi Tanabe Pharma America announces FDA acceptance of new drug application for oral edaravone formulation for the treatment of ALS
12 January 2022 - Mitsubishi Tanabe Pharma America today announced the U.S. FDA has accepted the new drug application for an ...
Posted by Michael Wonder on 13 Jan 2022
Quebec to impose health tax on unvaccinated Canadians
12 January 2022 - The Canadian province of Quebec will charge a health tax to residents who are not vaccinated ...
Posted by Michael Wonder on 13 Jan 2022
JAMP and Alvotech announce Canadian approval of Simlandi, a high concentration biosimilar to Humira, providing access to previously unavailable versions in Canada
10 January 2021 - Health Canada rules that 40 mg/0.4 mL and 80 mg/0.8 mL presentations of Simlandi are not subject ...
Posted by Michael Wonder on 13 Jan 2022
CMS proposes Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease
11 January 2022 - Today, the Centers for Medicare & Medicaid Services released a proposed National Coverage Determination decision memorandum. ...
Posted by Michael Wonder on 12 Jan 2022
Biden-Harris Administration requires insurance companies and group health plans to cover the cost of at home COVID-19 tests, increasing access to free tests
10 January 2022 - As part of its on-going efforts across many channels to expand Americans’ access to free testing, the ...