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 Jun 2021
Glaukos Announces Australia’s TGA regulatory approval for Preserflo MicroShunt
8 June 2021 - Glaukos Corporation today announced that the TGA has granted regulatory approval for the Preserflo MicroShunt intended for ...
Posted by Michael Wonder on 09 Jun 2021
US FDA approves Prevnar 20, Pfizer’s pneumococcal 20 valent conjugate vaccine for adults ages 18 years or older
8 June 2021 - First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of ...
Posted by Michael Wonder on 08 Jun 2021
Biogen faces tough questions over $56,000 a year price of newly approved Alzheimer’s drug
8 June 2021 - The biotech company’s price for the drug is higher than the $10,000 to $25,000 some Wall Street ...
Posted by Michael Wonder on 08 Jun 2021
Alpha Tau receives breakthrough device designation from the FDA for Alpha DaRT
8 June 2021 - Alpha Tau Medical is pleased to announce that it has received a breakthrough device designation for Alpha ...
Posted by Michael Wonder on 08 Jun 2021
VBI Vaccines granted FDA fast track designation for VBI-1901 for the treatment of recurrent GBM
8 June 2021 - Designation granted based on data from the Phase 1/2a study of VBI-1901 in recurrent GBM patients. ...
Posted by Michael Wonder on 08 Jun 2021
Incyte announces U.S. FDA has extended the sNDA review period for ruxolitinib (Jakafi) in chronic graft versus host disease
8 June 2021 - Incyte today announced that the U.S. FDA has extended the review period for the supplemental new drug ...
Posted by Michael Wonder on 08 Jun 2021
Biogen CEO says $56,000 annually for Alzheimer’s drug is ‘fair,’ promises not to hike price for at least 4 years
7 June 2021 - Biogen CEO Michel Vounatsos told CNBC on Monday that the list price of $56,000 per year ...
Posted by Michael Wonder on 08 Jun 2021
Biogen and Eisai launch multiple initiatives to help patients with Alzheimer’s disease access Aduhelm
7 June 2021 - Value based agreements in progress with Cigna and other payers. ...
Posted by Michael Wonder on 08 Jun 2021
Despite its high price tag, the new Alzheimer’s drug isn’t reigniting the drug pricing debate
8 June 2021 - It has all the makings of a bombastic drug pricing debate: a highly anticipated drug, widespread ...
Posted by Michael Wonder on 08 Jun 2021
BerGenBio receives FDA fast track designation for bemcentinib/anti-PD-(L)1 combination in NSCLC
8 June 2021 - First recognition by a regulator of AXL positive patients as a target population. ...
Posted by Michael Wonder on 08 Jun 2021
Robertson says PHARMAC's bulk buying model is 'different', not 'worse' than other OECD countries
8 June 2021 - The Deputy Prime Minister says the agency’s bulk buying model works for many Kiwis. ...
Posted by Michael Wonder on 08 Jun 2021
NICE recommends Tecentriq for first-line NSCLC
7 June 2021 - NICE has recommended Roche’s Tecentriq (atezolizumab) monotherapy for untreated metastatic non-small cell lung cancer. ...
Posted by Michael Wonder on 08 Jun 2021
FDA’s decision to approve new treatment for Alzheimer’s disease
7 June 2021 - Today FDA approved Aduhelm (aducanumab) to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, ...
Posted by Michael Wonder on 08 Jun 2021
Moderna files for authorisation with Health Canada for its COVID-19 vaccine in adolescents
7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 08 Jun 2021
New Skyrizi (risankizumab) 150 mg presentation pre-filled pen and pre-filled syringe Approved by the MHRA
4 June 2021 - Approval based on results showing the new formulation of risankizumab 150 mg demonstrated bioequivalence to two injections ...