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 13 Jan 2023
COVID treatment molnupiravir to hit Chinese market on Friday
12 January 2023 - The COVID-19 treatment molnupiravir is expected to hit the Chinese market on Friday, after passing its ...
Posted by Michael Wonder on 13 Jan 2023
As CMS asks for the public’s feedback on implementing the Inflation Reduction Act, unresolved issues related to drug price negotiations remain
11 January 2022 - On 11 January, the Centers for Medicare and Medicaid Services (CMS) announced a timeline for implementation of ...
Posted by Michael Wonder on 13 Jan 2023
Enhertu approved by Health Canada as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer
12 January 2023 - Approval based on the DESTINY-Breast04 results which showed Enhertu reduced risk of disease progression or death ...
Posted by Michael Wonder on 12 Jan 2023
Medcura receives breakthrough device designation for its LifeGel absorbable surgical hemostat
13 January 2023 - Medcura announces that the US FDA has granted the coveted breakthrough device designation for its LifeGel absorbable ...
Posted by Michael Wonder on 12 Jan 2023
Eton Pharmaceuticals announces FDA acceptance of NDA response for dehydrated alcohol injection
11 January 2023 - Application assigned a PDUFA date of 27 June 2023. ...
Posted by Michael Wonder on 12 Jan 2023
Intellia Therapeutics awarded Innovation Passport in the United Kingdom for NTLA-2002, an investigational genome editing treatment for hereditary angioedema
11 January 2023 - NTLA-2002 is a single dose genome editing therapeutic candidate designed to prevent angioedema attacks in people ...
Posted by Michael Wonder on 12 Jan 2023
Eisai submits marketing authorisation application for lecanemab as treatment for early Alzheimer's disease in Europe
11 January 2023 - Eisai and Biogen announced today that Eisai has submitted a marketing authorisation application for lecanemab, an investigational ...
Posted by Michael Wonder on 12 Jan 2023
Pfizer's Paxlovid not included in China's national insurance
9 January 2023 - China will not include Pfizer’s COVID-19 treatment drug in a national reimbursement list that would have allowed ...
Posted by Michael Wonder on 11 Jan 2023
First and only rescue medication approved in the US for as needed use to reduce risk of asthma exacerbations
11 January 2023 - Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as needed ...
Posted by Michael Wonder on 11 Jan 2023
Treadwell Therapeutics announces fast track designation granted by the FDA to CFI-402257 for the treatment of ER+/HER2- breast cancer
10 January 2023 - Treadwell Therapeutics announced today that the US FDA has granted fast track designation to CFI-402257, a best ...
Posted by Michael Wonder on 11 Jan 2023
UNION therapeutics receives FDA fast track designation for oral orismilast for the treatment of moderate to severe hidradenitis suppurativa
10 January 2023 - Orismilast is a high potency PDE4 inhibitor with broad anti-inflammatory properties also in development for oral ...
Posted by Michael Wonder on 11 Jan 2023
Nivolumab in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with advanced, HER2 negative gastric, gastro-oesophageal junction or oesophageal adenocarcinoma
11 January 2023 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...
Posted by Michael Wonder on 11 Jan 2023
Lupin and Exeltis announce reimbursement approval of NaMuscla in Spain for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic disorders
9 January 2023 - Agreement enables sustainable patient access of the only EU approved treatment for myotonia symptoms in non-dystrophic ...
Posted by Michael Wonder on 11 Jan 2023
Prescription drug policy, 2022 and 2023: the year in review and the year ahead
9 January 2023 - This past year featured many significant developments in the prescription drug policy area, most notably the passage ...
Posted by Michael Wonder on 11 Jan 2023
CDER director calls for simplifying clinical trials to boost diversity
10 January 2023 - Encouraging researchers and sponsors to simplify clinical trials and employ a fit for purpose protocol is ...