Blog
RSS FeedPosted by Michael Wonder on 15 Sep 2022
FDA approves treatment to improve kidney function in adults with hepatorenal syndrome
14 September 2022 - FDA has approved Terlivaz (terlipressin) injection to improve kidney function in adults with hepatorenal syndrome with rapid ...
Posted by Michael Wonder on 15 Sep 2022
Can the proposed listing of two medicines from the same supplier really be called a bundle deal?
16 September 2022 - On Wednesday, PHARMAC announced a "medicines bundle to provide more treatment options for New Zealanders." ...
Posted by Michael Wonder on 15 Sep 2022
Advicenne updates on availability of Sibnayal to patients and caregivers in Great Britain
14 September 2022 - Sibnayal has been accepted for use within NHS Scotland. ...
Posted by Michael Wonder on 15 Sep 2022
Jasper Therapeutics announces FDA fast track designation for JSP191, a novel monoclonal antibody targeting CD117, in the treatment of patients with severe combined immunodeficiency undergoing allogeneic haematopoietic stem cell transplantation
15 September 2022 - JSP191 is currently being evaluated in four on-going clinical studies in allogeneic haematopoietic stem cell transplant in ...
Posted by Michael Wonder on 15 Sep 2022
FDA issues final rule on ‘right to try’ reporting requirements
14 September 2022 - Drug firms that agree to supply investigational medicines under the Right to Try Act must submit ...
Posted by Michael Wonder on 15 Sep 2022
FDA’s drug industry fees fuel concerns over influence
15 September 2022 - The pharmaceutical industry finances about 75% of the agency’s drug division, through a controversial program that ...
Posted by Michael Wonder on 15 Sep 2022
Advocates welcome PHARMAC's removal of barriers to menopausal symptoms treatment
15 September 2022 - A women's health expert says today marks a major win for wāhine in Aotearoa, with PHARMAC ...
Posted by Michael Wonder on 15 Sep 2022
Mallinckrodt receives US FDA approval for Terlivaz (terlipressin) for injection for the treatment of hepatorenal syndrome
14 September 2022 - Terlivaz is the first and only FDA approved treatment for adults with hepatorenal syndrome involving rapid ...
Posted by Michael Wonder on 15 Sep 2022
Progesterone to be fully funded for all who need it
15 September 2022 - PHARMAC has today confirmed that it is removing all funding restrictions from progesterone, with tens of thousands ...
Posted by Michael Wonder on 14 Sep 2022
Dexamethasone intravitreal implant for treating diabetic macular oedema
14 September 2022 - NICE has published evidence-based recommendations on the use of dexamethasone intravitreal implant for the treatment of ...
Posted by Michael Wonder on 14 Sep 2022
Improving dose optimisation processes used in oncology drug development to minimise toxicity and maximise benefit to patients
12 September 2022 - We reviewed US FDA initial approvals (2019-2021) of small molecules and antibody-drug conjugates for oncologic indications. ...
Posted by Michael Wonder on 14 Sep 2022
Minoryx‘s marketing authorisation application for its lead candidate leriglitazone validated by EMA for orphan indication X-linked adrenoleukodystrophy
14 September 2022 - 4, 2022 - Minoryx Therapeutics today announces that it has filed a marketing authorisation application for its ...
Posted by Michael Wonder on 14 Sep 2022
Is drug price negotiation a concept whose time has come?
14 September 2022 - The US Congress has just approved the Inflation Reduction Act of 2022, which includes a provision ...
Posted by Michael Wonder on 14 Sep 2022
Has there actually been early resolution for early resolution resubmissions?
15 September 2022 - Following on from this week's article on early re-entry resubmissions, today we took a close look ...
Posted by Michael Wonder on 14 Sep 2022
Growing financial burden from high-cost targeted oral anti-cancer medicines among Medicare beneficiaries with cancer
13 September 2022 - The rapidly rising costs of targeted oral anti-cancer medicines raise concerns over their affordability. ...