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 09 Mar 2022
Insightec receives FDA IDE approval and breakthrough designation for NSCLC brain mets study
9 March 2022 - Designation and approvals mark key milestones in advancing Insightec blood brain barrier clinical roadmap using acoustic ...
Posted by Michael Wonder on 09 Mar 2022
Bayer submits applications in the U.S. and EU for additional indication of Nubeqa (darolutamide)
9 March 2022 - Submissions are based on data from the pivotal Phase 3 ARASENS trial recently published in The New ...
Posted by Michael Wonder on 09 Mar 2022
SMC approval welcome news for breast cancer patients
9 March 2022 - Trodelvy is accepted for use in metastatic triple negative breast cancer. patients who have already received two ...
Posted by Michael Wonder on 09 Mar 2022
NICE unable to provide guidance on a new use of lenalidomide
9 March 2022 - NICE is unable to make a recommendation on the use of lenalidomide for the treatment of patients ...
Posted by Michael Wonder on 09 Mar 2022
More Government regulation of biopharma would harm patients and the economy
8 March 2022 - The United States leads the world in creating the new drugs and vaccines that cure or control ...
Posted by Michael Wonder on 09 Mar 2022
Pūahoaho: clarity around PHARMACs priority lists
9 March 2022 - PHARMAC has released up to date information about its priority lists, including a list of ...
Posted by Michael Wonder on 09 Mar 2022
7 Hills Pharma’s clinical stage novel immunostimulant 7HP349 granted FDA fast track designation for anti-PD-1 resistant metastatic melanoma
8 March 2022 - 7 Hills Pharma announced today that the U.S. FDA has granted fast track designation to 7HP349, 7HP’s ...
Posted by Michael Wonder on 08 Mar 2022
Vaccine approval before Phase 3 trial results: a consequence of vaccine access inequity
2 March 2022 - The final Phase 3 clinical data for CanSino Biologics' adenovirus type 5 vector vaccine show that Ad5-nCoV ...
Posted by Michael Wonder on 08 Mar 2022
Key considerations in the health technology assessment of advanced therapy medicinal products in Scotland, The Netherlands and England
8 March 2022 - Advanced therapy medicinal products are highly innovative therapies. Their costs and uncertain value claims have raised concerns ...
Posted by Michael Wonder on 08 Mar 2022
Saluda Medical receives FDA approval for the Evoke spinal cord stimulation system to treat chronic intractable pain
8 March 2022 - Evoke system deemed superior to open loop spinal cord stimulation in treating overall back and leg pain. ...
Posted by Michael Wonder on 08 Mar 2022
NICE yet to support the use of pralsetinib on the NHS
3 March 2022 - NICE publishes appraisal consultation document for a new medicine for certain patients with non-small-cell lung cancer. ...
Posted by Michael Wonder on 08 Mar 2022
ISPOR launches “About Real-World Evidence” content
8 March 2022 - Introductory information is designed to make RWE more accessible for health care audiences. ...
Posted by Michael Wonder on 08 Mar 2022
FDA effort to improve clinical trial diversity failed to make a difference for Black patients, study finds
7 March 2022 - Six years ago, the U.S. FDA launched a five year action plan to improve the diversity and ...
Posted by Michael Wonder on 08 Mar 2022
NICE draft guidance does not recommend pembrolizumab plus chemotherapy for triple negative breast cancer
8 March 2022 - The evidence showed that pembrolizumab plus chemotherapy is more effective than paclitaxel or nab-paclitaxel, although the ...
Posted by Michael Wonder on 08 Mar 2022
FDA offers funding for biosimilar regulatory science pilot
7 March 2022 - The US FDA is offering funding for several research proposals under the regulatory science pilot for ...