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RSS FeedPosted 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 ...
Posted by Michael Wonder on 07 Jun 2021
FDA grants accelerated approval for Alzheimer’s drug
7 June 2021 - Today, the U.S. FDA approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 ...
Posted by Michael Wonder on 07 Jun 2021
Innovative regenerative medicine therapies – patient safety comes first
3 June 2021 - The U.S. FDA continues to facilitate the development and availability of innovative medical products, such as regenerative ...
Posted by Michael Wonder on 06 Jun 2021
The parents hoped an existing drug might keep their kids from having seizures. Then they saw the price.
3 June 2021 - When Amber Freed heard in 2020 that a drug might help save her young child from ...
Posted by Michael Wonder on 06 Jun 2021
FDA’s decision on Biogen Alzheimer’s drug will be a watershed moment for the agency — and the biotech industry
4 June 2021 - In the coming days the FDA will make one of its most important — and controversial — ...