Blog
RSS FeedPosted by Michael Wonder on 23 Apr 2024
Associations between surrogate markers and clinical outcomes for non-oncologic chronic disease treatments
22 April 2024 - What is the strength of association between surrogate markers used as primary outcomes in clinical trials ...
Posted by Michael Wonder on 22 Apr 2024
Kura Oncology receives breakthrough therapy designation for ziftomenib in NPM1 mutant AML
22 April 2024 - Ziftomenib is the first investigational treatment to be granted breakthrough therapy designation for NPM1 mutant AML. ...
Posted by Michael Wonder on 22 Apr 2024
FDA approves nogapendekin alfa inbakicept-pmln for BCG unresponsive non-muscle invasive bladder cancer
22 April 2024 - Today, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience) with Bacillus Calmette-Guérin (BCG) for adult ...
Posted by Michael Wonder on 22 Apr 2024
Alvotech signs US agreement to expand access for newly approved high concentration interchangeable biosimilar to Humira (adalimumab)
19 April 2024 - Alvotech, in agreement with Teva Pharmaceuticals, has signed an agreement with a strategic partner to bring to ...
Posted by Michael Wonder on 21 Apr 2024
The myth of the free market for pharmaceuticals
20 April 2024 - Critics of US policy aiming to reduce spending on prescription drugs claim that the government is wrongfully ...
Posted by Michael Wonder on 19 Apr 2024
Medicare official says breakthrough device reimbursement rule coming in early summer
19 April 2024 - A federal rule aiming to make reimbursement for breakthrough devices easier is slated for early summer, ...
Posted by Michael Wonder on 19 Apr 2024
US FDA approves subcutaneous administration of Takeda’s Entyvio (vedolizumab) for maintenance therapy in moderately to severely active Crohn’s disease
19 April 2024 - Entyvio is now available in the US in both intravenous and subcutaneous administrations for maintenance treatment ...
Posted by Michael Wonder on 18 Apr 2024
Lumicell’s cutting-edge imaging platform receives historic FDA approval to illuminate residual breast cancer
18 April 2024 - Lumisight and Lumicell DVS previously received FDA fast track and breakthrough device designations, respectively. ...
Posted by Michael Wonder on 18 Apr 2024
AskBio receives FDA fast track designation for AB-1002 investigational gene therapy program in congestive heart failure
18 April 2024 - AB-1002 is being studied for the treatment of adults with non-ischaemic cardiomyopathy and New York Heart Association ...
Posted by Michael Wonder on 18 Apr 2024
FDA approves Genentech's Alecensa as first adjuvant treatment for people with ALK positive early stage lung cancer
18 April 2024 - Approval based on Phase 3 ALINA study showing Alecensa reduced the risk of disease recurrence or death ...
Posted by Michael Wonder on 18 Apr 2024
Alvotech and Teva announce US FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab)
16 April 2024 - Selarsdi is expected to be marketed in the US on or after 21 February 2025, following a ...
Posted by Michael Wonder on 16 Apr 2024
Lexeo Therapeutics granted FDA fast track designation for LX2006, an AAV based gene therapy candidate for the treatment of Friedreich’s ataxia cardiomyopathy
16 April 2024 - Lexeo Therapeutics today announced the US FDA has granted fast track designation to LX2006, the company’s AAVrh.10hFXN ...
Posted by Michael Wonder on 16 Apr 2024
GSK’s 5 in 1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
16 April 2024 - Submission based on results from pivotal Phase III trial showing all primary outcomes met. ...
Posted by Michael Wonder on 16 Apr 2024
TLX101-CDx (Pixclara) granted FDA fast track designation
16 April 2024 - Telix Pharmaceuticals today announces that the US FDA has granted fast track designation for the Company's investigational ...
Posted by Michael Wonder on 16 Apr 2024
Norgine submits marketing authorisation application via Project Orbis for eflornithine (difluoromethylornithine) in high-risk neuroblastoma
15 April 2024 - Norgine today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine ...