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RSS FeedPosted by Michael Wonder on 09 Jun 2021
Vertex announces U.S. FDA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 with certain mutations
9 June 2021 - With this approval approximately 1,500 children with one minimal function mutation and one F508del mutation have a ...
Posted by Michael Wonder on 09 Jun 2021
Ibex granted FDA breakthrough device designation
9 June 2021 - Ibex's Galen AI powered platform is recognised by the FDA as breakthrough technology with the potential to ...
Posted by Michael Wonder on 09 Jun 2021
Millions of J&J COVID-19 vaccines are at risk of expiring in June
8 June 2021 - States, hospitals try to reroute such vaccines, while efforts to export them face hurdles. ...
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
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 07 Jun 2021
America’s wary approval of an Alzheimer’s drug offers hope to millions
7 June 2021 - But its makers still have work to do to prove it can slow the advance of dementia. ...
Posted by Michael Wonder on 07 Jun 2021
Alexion announces FDA approval of Ultomiris (ravulizumab-cwvz) for children and adolescents with paroxysmal nocturnal haemoglobinuria
7 June 2021 - Approval based on interim results from Phase 3 study showing Ultomiris demonstrated complete terminal complement inhibition through ...