Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 29 Jun 2022
Reimbursement price of GERD drug Fexclu finalised at $0.73
29 June 2022 - The Ministry of Health and Welfare’s health insurance policy committee set the reimbursement price of Fexclu ...
Posted by Michael Wonder on 29 Jun 2022
Accuretic supply issue, almost 36,000 New Zealanders taking the blood pressure medicine will need to change treatments
30 June 2022 - PHARMAC has updated health care professionals that supply of quinapril with hydrochlorothiazide (branded as Accuretic), from supplier ...
Posted by Michael Wonder on 29 Jun 2022
Janssen announces U.S. FDA breakthrough therapy designation granted for talquetamab for the treatment of relapsed or refractory multiple myeloma
29 June 2022 - Novel GPRC5DxCD3 bispecific antibody receives breakthrough therapy designation based upon results from the Phase 1/2 MonumenTAL-1 study. ...
Posted by Michael Wonder on 29 Jun 2022
Bavarian Nordic announces grant of PRIME eligibility from the EMA for its RSV vaccine candidate for the prevention of respiratory syncytial virus in older adults
28 June 2022 - Bavarian Nordic announced today that the EMA has granted access to its priority medicines (PRIME) scheme for ...
Posted by Michael Wonder on 29 Jun 2022
ObsEva announces UK MHRA marketing authorisation for Yselty (linzagolix), an oral GnRH antagonist, for the treatment of uterine fibroids
28 June 2022 - Theramex to commercialise Yselty; ObsEva to receive royalties on commercial sales, as well as development, commercial, and ...
Posted by Michael Wonder on 29 Jun 2022
NICE publishes its 800th technology assessment
29 June 2022 - TAs 799 and 800 are for the same technology. ...
Posted by Michael Wonder on 29 Jun 2022
Eylea (aflibercept) injection sBLA for every 16 week dosing regimen in patients with diabetic retinopathy accepted for FDA review
29 June 2022 - If approved, extended regimen would provide a longer treatment interval and additional dosing flexibility, alongside approved ...
Posted by Michael Wonder on 29 Jun 2022
Ipsen announces U.S. FDA priority review for palovarotene new drug application in patients with fibrodysplasia ossificans progressiva following resubmission
29 June 2022 - Ipsen today announced that the U.S. FDA has accepted for priority review its resubmitted new drug ...
Posted by Michael Wonder on 28 Jun 2022
Health Canada approves Opdivo (nivolumab) as monotherapy for the adjuvant treatment of adults with urothelial carcinoma at high risk of recurrence after undergoing radical resection of urothelial carcinoma
28 June 2022 - First adjuvant Immunotherapy for patients at high risk of disease recurrence. ...
Posted by Michael Wonder on 28 Jun 2022
The Innovative Medicines Fund - good news for patients but has an opportunity been missed to be more ambitious?
27 June 2022 - NHS England and Improvement has announced the launch of the Innovative Medicines Fund. The ABPI’s Director ...
Posted by Michael Wonder on 28 Jun 2022
Monkeypox: EMA starts review for Imvanex
28 June 2022 - The EMA’s CHMP has started a review of data to extend the use of the smallpox ...
Posted by Michael Wonder on 28 Jun 2022
Apnimed granted FDA fast track designation for AD109, a novel first in class oral pharmacologic combination for the treatment of obstructive sleep apnoea
28 June 2022 - Additional Phase 2b data evaluating AD109 as potential treatment for obstructive sleep apnoea anticipated in Q3 ...
Posted by Michael Wonder on 28 Jun 2022
Janssen receives positive CHMP opinion for Imbruvica (ibrutinib) in a fixed-duration combination regimen for adult patients with previously untreated chronic lymphocytic leukaemia
24 June 2022 - The positive opinion is based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated ...
Posted by Michael Wonder on 28 Jun 2022
Kyowa Kirin receives positive CHMP opinion for use of Crysvita (burosumab) for the treatment of tumour-induced osteomalacia
24 June 2022 - Crysvita could offer access to the first biologic treatment for EU patients with tumour-induced osteomalacia who cannot ...
Posted by Michael Wonder on 28 Jun 2022
Gilead resubmits new drug application to U.S. FDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor
27 June 2022 - NDA Resubmission Addresses Issues Related to Vial Compatibility. ...