Blog
RSS FeedPosted by Michael Wonder on 19 Oct 2021
FDA to allow ‘mix and match’ approach for Covid booster shots
18 October 2021 - The agency may act this week, when it is expected to authorise booster shots for recipients of ...
Posted by Michael Wonder on 20 Oct 2021
Bringing a consumer perspective to clinical advice
19 October 2021 - PHARMAC is making changes to the way its advisory committees work to strengthen the input of ...
Posted by Michael Wonder on 20 Oct 2021
CMS grants transitional pass through payment for Carlsmed's aprevo personalized interbody device
19 October 2021 - -Carlsmed announced today that CMS has granted aprevo a transitional pass through payment as part of the ...
Posted by Michael Wonder on 19 Oct 2021
Akero Therapeutics receives FDA fast track designation for efruxifermin for the treatment of NASH
19 October 2021 - Akero Therapeutics today announced that the U.S. FDA has granted fast track designation to its lead program ...
Posted by Michael Wonder on 19 Oct 2021
WHO led programme aims to buy antiviral COVID-19 pills for $10
19 October 2021 - A World Health Organization led programme to ensure poorer countries get fair access to COVID-19 vaccines, tests ...
Posted by Michael Wonder on 19 Oct 2021
Strategies for generic/biosimilar market entry in Australia
19 October 2021 - After surviving the Great Patent Cliff of 2011–2016, the pharma/biopharma industry finds itself in the Second Great ...
Posted by Michael Wonder on 19 Oct 2021
Dr. Reddy's Laboratories announces approval for lenalidomide capsules from the U.S. FDA
19 October 2021 - Dr. Reddy’s Laboratories today announced the final approval of its abbreviated new drug application for lenalidomide 2.5 ...
Posted by Michael Wonder on 19 Oct 2021
New medicine for breast cancer approved by the TGA
19 October 2021 - Enhertu has been approved for provisional registration. ...
Posted by Michael Wonder on 19 Oct 2021
Democrats’ drug pricing reforms aren’t what they seem
19 October 2021 - As part of their spending bill, Congressional Democrats are advancing legislation that'll empower Medicare to "negotiate" ...
Posted by Michael Wonder on 19 Oct 2021
Health Canada receives submission from Pfizer-BioNTech to authorise the use of Comirnaty COVID-19 vaccine in children 5 to 11 years of age
18 October 2021 - Today, Health Canada received a submission from Pfizer-BioNTech seeking an authorisation for the use of its Comirnaty ...
Posted by Michael Wonder on 18 Oct 2021
Avadel Pharmaceuticals announces ongoing FDA review of NDA for FT218 for patients with narcolepsy
15 October 2021 - Avadel Pharmaceuticals announced today that the U.S. FDA notified the company that the review of the new ...
Posted by Michael Wonder on 18 Oct 2021
On COVID-19 booster shots, the FDA has overstepped its role
18 October 2021 - Booster shots for all adults six months after being vaccinated against COVID-19 are safe, effective, and ...
Posted by Michael Wonder on 18 Oct 2021
Alnylam receives positive reimbursement recommendation from the CADTH for use of Givlaari for the treatment of acute hepatic porphyria in adults
18 October 2021 - Givlaari reduces chronic pain, improves quality of life and is the first and only therapy proven ...
Posted by Michael Wonder on 18 Oct 2021
U.S. Food and Drug Administration approves expanded indication of Gilead’s Biktarvy for treatment of HIV-1 in paediatric populations
18 October 2021 - FDA approves low dose tablet for HIV treatment in virologically suppressed children weighing at least 14 kg. ...
Posted by Michael Wonder on 18 Oct 2021
United Therapeutics provides an update on the progress of the Tyvaso DPI new drug application
18 October 2021 - Draft label contains both PAH and PH-ILD indications; no contra-indications and no boxed warning. ...