Blog
RSS FeedPosted by Michael Wonder on 04 Dec 2022
Statistical approaches to establishing bioequivalence
2 December 2022 - Requirements for submitting bioavailability and bioequivalence data in investigational new drugs, new drug applications, abbreviated new drug ...
Posted by Michael Wonder on 01 Dec 2022
Aurinia announces the Great Britain marketing authorisation of Lupkynis (voclosporin) for the treatment of lupus nephritis
30 November 2022 - MHRA Approval follows European Commission marketing authorisation of Lupkynis to treat adults with active lupus nephritis in ...
Posted by Michael Wonder on 30 Nov 2022
Swiss National Council votes to accept FDA approved medical devices
29 November 2022 - On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to ...
Posted by Michael Wonder on 29 Nov 2022
FDA looks to modelling and simulation tools to streamline product reviews
28 November 2022 - The US FDA recently published a report on how it uses modelling and simulation, highlighting the untapped ...
Posted by Michael Wonder on 28 Nov 2022
Bayer’s Nubeqa receives MHRA approval to treat metastatic prostate cancer
28 November 2022 - The treatment will be made available immediately through an early access deal with NHS England. ...
Posted by Michael Wonder on 28 Nov 2022
An open letter to doctors from the TGA
28 November 2022 - The TGA welcomes feedback and is committed to continuously improving processes and communications. ...
Posted by Michael Wonder on 23 Nov 2022
DARWIN EU welcomes first data partners
23 November 2022 - EMA has selected the first set of data partners to collaborate with DARWIN EU, the Data Analysis ...
Posted by Michael Wonder on 21 Nov 2022
Bristol Myers Squibb warns US price reforms will dent drug development
20 November 2022 - Biggest shake-up in pharma pricing in decades prompts companies to shelve some potential therapies. ...
Posted by Michael Wonder on 21 Nov 2022
FDA cancer chief wants quicker ways to pull failed drugs
17 November 2022 - Makena highlights need to make system more nimble. ...
Posted by Michael Wonder on 21 Nov 2022
Getting the price right: lessons for Medicare price negotiation from peer countries
9 November 2022 - The US pays more for brand-name prescription drugs than any other country and new legislation from August ...
Posted by Michael Wonder on 19 Nov 2022
Inflation Reduction Act drug pricing provisions aren’t at all like price controls in Europe
18 November 2022 - The opposition to the prescription drug pricing provisions in the Inflation Reduction Act can be hyperbolic. ...
Posted by Michael Wonder on 17 Nov 2022
A tussle over medicines pricing is looming in Britain
15 November 2022 - Agreement to limit the size of the NHS drugs bill under strain. ...
Posted by Michael Wonder on 11 Nov 2022
CHMP issues opinion related to review of medicines within the Janus kinase inhibitor class
11 November 2022 - AbbVie announced today the EMA's CHMP has adopted an opinion following a nine month review of the ...
Posted by Michael Wonder on 11 Nov 2022
Implementation of the Patented Medicine Prices Review Board's proposed Guidelines will harm Canadian patients
10 November 2022 - Innovative Medicines Canada is calling on Health Canada to direct the Patented Medicine Prices Review Board (PMPRB) ...
Posted by Michael Wonder on 10 Nov 2022
Aleta Biotherapeutics receives Innovation Passport Designation for biologic CAR T-cell therapy engager ALETA-001
7 November 2022 - ALETA-001 was developed to address the urgent unmet need of patient relapse after CD19 targeted CAR ...