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 28 May 2024
The impact of proposed price regulations on new patented medicine launches in Canada: a retrospective cohort study
27 May 2024 - The Patented Medicine Prices Review Board (PMPRB), the agency that regulates the prices of patented medicines in ...
Posted by Michael Wonder on 28 May 2024
Telix submits NDA for new prostate cancer imaging agent
27 May 2024 - Telix Pharmaceuticals today announces it has submitted a new drug application to the US FDA for ...
Posted by Michael Wonder on 27 May 2024
EMA publishes agenda for 27-30 May 2024 CHMP meeting
27 May 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 25 May 2024
Issues, challenges and opportunities for economic evaluations of orphan drugs in rare diseases: an umbrella review
25 May 2024 - There are significant challenges when obtaining clinical and economic evidence for health technology assessments of rare diseases. ...
Posted by Michael Wonder on 25 May 2024
FDA Advisory Committee Panel strongly recommends approval of Shield blood test for colorectal cancer screening as a primary non-invasive screening option
23 May 2024 - Shield remains on track to become the first FDA approved blood test that meets performance requirements for ...
Posted by Michael Wonder on 25 May 2024
EMA validates Henlius and Organon filings for Prolia and Xgeva (denosumab) biosimilar candidate HLX14
24 May 2024 - Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation applications for ...
Posted by Michael Wonder on 25 May 2024
Celltrion receives European Commission approval of Omlyclo (CT-P39), the first and only omalizumab biosimilar approved in Europe
23 May 2024 - The European Commission decision is based on clinical evidence, including results from a Phase 3 clinical trial ...
Posted by Michael Wonder on 25 May 2024
Verastem Oncology announces the initiation of a rolling submission of NDA to FDA seeking accelerated approval of avutometinib and defactinib combination for the treatment of adult patients with recurrent KRAS mutant low grade serous ovarian cancer
24 May 2024 - Plan to complete NDA submission with the mature RAMP 201 dataset, anticipated to include 12 months of ...
Posted by Michael Wonder on 25 May 2024
Moving forward on Pharmacare for Canadians
24 May 2024 - Pharmacare legislation includes universal access to contraception and diabetes medications. ...
Posted by Michael Wonder on 25 May 2024
Sobi receives US FDA fast track designation for emapalumab-lzsg being investigated in macrophage activation syndrome
24 May 2024 - Sobi North America today announced that the US FDA has granted fast track designation to emapalumab-lzsg being ...
Posted by Michael Wonder on 24 May 2024
NICE and NHS England announce plan to enable innovative tech to be adopted quicker
23 May 2024 - NHS patients in England will benefit from faster access to the most innovative and cutting-edge medical technologies ...
Posted by Michael Wonder on 24 May 2024
Camurus receives EMA acceptance of MAA filing for octreotide SC depot (CAM2029) for the treatment of acromegaly
23 May 2024 - Camurus today announced that the EMA has accepted for review the company’s marketing authorisation application for octreotide ...
Posted by Michael Wonder on 24 May 2024
Bausch Health announces additional public drug plan listings for Uceris (budesonide) aerosol foam to treat mild to moderate distal ulcerative colitis in adults
23 May 2024 - Bausch Health today announced additional Canadian public drug plan listings for Uceris (budesonide) aerosol foam to ...
Posted by Michael Wonder on 23 May 2024
Antengene's Xpovio moves close to getting insurance benefits
3 May 2024 - Xpovio (selinexor), the first drug launched in Korea by Antengene, has won recognition to receive reimbursement ...
Posted by Michael Wonder on 23 May 2024
Jiangsu to ‘reapply for US approval of rivoceranib combo therapy ASAP’
23 May 2024 - Hangseo Hengrui Pharmaceuticals said Thursday that it would meet with the US FDA as soon as ...