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 04 Nov 2021
Libtayo (cemiplimab) approved in Canada for locally advanced basal cell carcinoma patients
29 October 2021 - The approval is based on data from the open-label, multi-center, non-randomised study 16201. ...
Posted by Michael Wonder on 04 Nov 2021
OS Therapies receives rare paediatric disease designation in osteosarcoma for OST-HER2 (Listeria monocytogenes)
3 November 2021 - Pathway to priority review voucher and expedited review by the FDA. ...
Posted by Michael Wonder on 04 Nov 2021
Impact of Medicare only limits on drug prices
4 November 2021 - Congress is considering legislation that would set limits on drug prices through price negotiation for certain high-cost, ...
Posted by Michael Wonder on 04 Nov 2021
Lipocine announces FDA grants fast track designation to LPCN 1144 for treatment of non-cirrhotic NASH
4 November 2021 - Lipocine today announced that the U.S. FDA has granted fast track designation to LPCN 1144 as a ...
Posted by Michael Wonder on 04 Nov 2021
ICER publishes evidence report on tezepelumab for severe asthma
4 November 2021 - Tezepelumab reduces asthma exacerbations, but there is uncertainty about long-term safety as with all new biologic ...
Posted by Michael Wonder on 04 Nov 2021
NICE recommends Namuscla for NHS to treat genetic disorder
4 November 2021 - NICE has published draft guidance which recommends a rebranded form of the drug mexiletine (Namuscla), for ...
Posted by Michael Wonder on 04 Nov 2021
UNION therapeutics receives FDA fast track designation for oral orismilast for the treatment of moderate to severe atopic dermatitis
4 November 2021 - FDA's fast track designation for oral orismilast underscores the urgent need for new treatment option with potential ...
Posted by Michael Wonder on 04 Nov 2021
Epizyme receives fast track designation from U.S. FDA and announces initiation of Phase 1/1b study of its novel SETD2 inhibitor, EZM0414
4 November 2021 - Epizyme today announced that the U.S. FDA has granted fast track designation to EZM0414, the Company’s novel, ...
Posted by Michael Wonder on 04 Nov 2021
TecTraum’s pro2cool receives FDA designation as a breakthrough device for the treatment of concussions
3 November 2021 - TecTraum today announced that the U.S. FDA has designated its flagship technology, pro2cool, as a breakthrough ...
Posted by Michael Wonder on 04 Nov 2021
Funding hole makes cracking COVID-19 vaccine code a tougher ask
4 November 2021 - Australia has the expertise to crack the code in the biggest challenge facing the COVID-19 vaccination ...
Posted by Michael Wonder on 04 Nov 2021
A breakthrough treatment for cystic fibrosis needs funding now
3 November 2021 - Let’s just kick this off by addressing the elephant in the room. Trikafta, the breakthrough treatment ...
Posted by Michael Wonder on 04 Nov 2021
COVID-19 vaccine weekly safety report (4 November 2021)
4 November 2021 - To 31 October 2021, the TGA has received 253 reports which have been assessed as likely to ...
Posted by Michael Wonder on 03 Nov 2021
NICE releases guidance on medicine for patients with thyroid cancer
3 November 2021 - Selpercatinib is used to treat patients with advanced RET fusion positive thyroid cancer. ...
Posted by Michael Wonder on 03 Nov 2021
Trastuzumab deruxtecan type II variation application validated by EMA for the treatment of HER2 positive advanced gastric cancer
3 November 2021 - Application based on DESTINY-Gastric01 and DESTINY-Gastric02 phase 2 trials. ...
Posted by Michael Wonder on 03 Nov 2021
PhRMA statement on Democrats' drug pricing deal in reconciliation package
2 November 2021 - The following can be attributed to PhRMA President and CEO Stephen J. Ubl. ...