Blog
RSS FeedPosted by Michael Wonder on 13 Feb 2023
Assessment of FDA approved drugs not recommended for use or reimbursement in other countries (2017-2020)
13 February 2023 - In this cross-sectional study of all 206 new US drug approvals in 2017 through 2020, 47 drugs ...
Posted by Michael Wonder on 10 Feb 2023
A new Alzheimer's drug gave patients hope. Millions can't get it.
10 February 2023 - Jay Reinstein, a former assistant city manager in Fayetteville, NC who was diagnosed with Alzheimer’s disease ...
Posted by Michael Wonder on 07 Feb 2023
Miracle’ cystic fibrosis drug kept out of reach in developing countries
7 February 2023 - Vertex Pharmaceuticals is not making its drug, Trikafta, available in poorer countries, where thousands of diagnosed patients ...
Posted by Michael Wonder on 31 Jan 2023
Amjevita (adalimumab-atto), first biosimilar to Humira, now available in the United States
31 January 2023 - Four years of real world experience in more than 300,000 patients and over 60 countries. ...
Posted by Michael Wonder on 19 Jan 2023
Multiple sclerosis patients in US left without essential patient support program will now receive equivalent backing from Cycle Pharmaceuticals following FDA’s approval of Tascenso ODT (fingolimod)
17 January 2023 - Tascenso ODT is now approved by the US FDA as a bioequivalent to Gilenya (fingolimod hydrochloride), for ...
Posted by Michael Wonder on 02 Jan 2023
With FDA accelerated approval of Alzheimer’s drug lecanemab likely 6 January, discussion turns to price and reimbursement
2 January 2023 - Lecanemab’s PDUFA date for its potential accelerated approval is 6 January. ...
Posted by Michael Wonder on 02 Jan 2023
A new weight loss drug could become the best-selling drug of all time. Who can afford it?
1 January 2023 - An Eli Lilly drug if approved for weight loss could become the best selling drug of ...
Posted by Michael Wonder on 04 Oct 2022
Newly approved ALS drug Relyvrio to face its next challenge: pricing and reimbursement
4 October 2022 - There’s a swirl of controversy surrounding last week’s regulatory approval of Relyvrio (sodium phenylbutyrate and taurursodiol), which ...
Posted by Michael Wonder on 04 Oct 2022
Auvelity, newly approved drug for major depressive disorder, to face payer pricing and reimbursement challenges
3 October 2022 - In August, the FDA approved Axsome Therapeutics’ Auvelity (dextromethorphan/bupropion) extended release tablets for the treatment of major ...
Posted by Michael Wonder on 15 Aug 2022
Ensuring a future for gene therapy for rare diseases
15 August 2022 - Haematopoietic stem cell gene therapy has proven to be an effective treatment for several primary immunodeficiencies, and ...
Posted by Michael Wonder on 06 Aug 2022
Patients seeking novel weight loss drugs find a ‘wild west’ of online prescribers
4 August 2022 - Briana Lawson was ready to knock her diabetes into remission. For years, the 47 year old ...
Posted by Michael Wonder on 01 Aug 2022
Marinus Pharmaceuticals announces U.S. commercial launch of Ztalmy (ganaxolone) for seizures associated with CDKL5 deficiency disorder
1 August 2022 - ZTALMY One™ offers comprehensive patient services, including access and prescription drug support. ...
Posted by Michael Wonder on 18 Jul 2022
Mycovia Pharmaceuticals announces U.S. availability of Vivjoa (oteseconazole) capsules, the first and only FDA approved medication for recurrent vulvovaginal candidiasis (chronic yeast infection)
18 July 2022 - Vivjoa is now available in a network of partner pharmacies that includes mail order and local pickup ...
Posted by Michael Wonder on 29 Jun 2022
Clinical benefit and expedited approval of cancer drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia
22 June 2022 - Regulatory agencies have sought to speed up the review of new cancer medicines and reduce delays in ...
Posted by Michael Wonder on 27 Jun 2022
FDA introduces innovative proposal to advance consumer access to non-prescription drugs
27 June 2022 - Proposed rule is intended to increase options for the development of safe and effective non-prescription drugs. ...