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RSS FeedPosted by Michael Wonder on 04 Nov 2023
How should the FDA evaluate psychedelic medicine?
4 November 2023 - Drug companies are spending millions of dollars to incorporate psychedelic agents into health care. Working with ...
Posted by Michael Wonder on 04 Nov 2023
Key Senate panel to consider PBM, drug pricing reform package
2 November 2023 - A key Senate panel announced it will consider more policies to regulate pharmacy middlemen and ensure ...
Posted by Michael Wonder on 04 Nov 2023
Handok paves the way for a smooth introduction of its new cancer drug
2 November 2023 - The first was Vyxeo, approved by the Ministry of Food and Drug Safety in November last ...
Posted by Michael Wonder on 04 Nov 2023
Medicare is urged to consider Amgen patent manoeuvres when negotiating the price for a drug
31 October 2023 - As Medicare prepares to negotiate prices for its first batch of medicines, an advocacy group argues ...
Posted by Michael Wonder on 04 Nov 2023
Hormone replacement therapy patch shortages are having a big impact on the women who need them
4 November 2023 - Women are being thrust back into the most severe stages of menopause amid long-running national shortages of ...
Posted by Michael Wonder on 04 Nov 2023
Updates to the HTA Policy and Methods Review Reference Committee (3 November 2023)
3 November 2023 - Further documents from the review are now available. ...
Posted by Michael Wonder on 03 Nov 2023
EC approves Ryeqo for the symptomatic treatment of endometriosis
2 November 2023 - Gedeon Richter together with Sumitomo today announce that the European Commission has granted approval of a type ...
Posted by Michael Wonder on 03 Nov 2023
Mounjaro (tirzepatide), the first and only single molecule GIP and GLP-1 receptor agonist for the treatment of adults with type 2 diabetes is now available in Canada
2 November 2023 - Mounjaro represents the first new class of diabetes medicines introduced in nearly a decade and is now ...
Posted by Michael Wonder on 03 Nov 2023
European Medicines Agency validates Pierre Fabre Laboratories' marketing authorisation application for combination Braftovi (encorafenib) and Mektovi (binimetinib) for patients with BRAF V600 mutant advanced non-small cell lung cancer
2 November 2023 - The application is based on results from the PHAROS study, which showed an objective response rate of ...
Posted by Michael Wonder on 02 Nov 2023
Supernus announces SPN-830 apomorphine infusion device NDA accepted for review by FDA
2 November 2023 - PDUFA target action date of 5 April 2024. ...
Posted by Michael Wonder on 02 Nov 2023
Rhythm Pharmaceuticals receives positive CADTH reimbursement recommendation for Imcivree (setmelanotide)
2 November 2023 - Recommendation based on demonstrated clinical benefit in Phase 3 trial. ...
Posted by Michael Wonder on 02 Nov 2023
Ivosidenib for the treatment of patients with advanced IDH1 mutation positive cholangiocarcinoma after at least one line of treatment
2 November 2023 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 02 Nov 2023
Phathom Pharmaceuticals announces FDA approval of Voquenza (vonoprazan) tablets for the treatment of erosive GERD and relief of heartburn associated with erosive GERD in adults
1 November 2023 - Voqeuenza met the primary endpoints and key secondary superiority endpoints in the pivotal Phase 3 PHALCON-EE trial ...
Posted by Michael Wonder on 02 Nov 2023
Health Canada approves Ultomiris for adults with neuromyelitis optica spectrum disorder
1 November 2023 - Ultomiris transforms the treatment landscape for anti-aquaporin-4 antibody positive neuromyelitis optica spectrum disorder patients, with potential to ...
Posted by Michael Wonder on 02 Nov 2023
FDA notes “continued growth” of Orbis collaborative review program, adds EMA as observer
1 November 2023 - There has been “continued growth” in the number of applications submitted to Project Orbis, and the ...