Blog
RSS FeedPosted by Michael Wonder on 10 Jun 2023
A review of labeling based on patient reported outcome endpoints for new oncology drugs approved by the EMA (2017-2021)
9 June 2023 - A review of new oncology indications approved by the EMA for 2012-2016 showed that 33% of new ...
Posted by Michael Wonder on 09 Jun 2023
Considering tomorrow’s patients in today’s drug approvals
8 June 2023 - Responding to pressure from patients seeking access to promising new medicines, drug regulatory agencies have worked over ...
Posted by Michael Wonder on 08 Jun 2023
Congress’ misguided plan to ban QALYs
8 June 2023 - Paying for health care is a challenge for many Americans, but the House of Representatives is on ...
Posted by Michael Wonder on 08 Jun 2023
Merck sues to stop the IRA’s ‘extortion’
7 June 2023 - The drug maker makes a compelling case that the Medicare price control bill violates the Constitution. ...
Posted by Michael Wonder on 06 Jun 2023
Merck sues HHS over drug negotiation, claims program ‘tantamount to extortion’
6 June 2023 - In its suit, the drug giant claims that Medicare negotiation program is unconstitutional. ...
Posted by Michael Wonder on 04 Jun 2023
TGA supports MHRA’s new international recognition framework for medicines
2 June 2023 - As a trusted regulatory partner, TGA is committed to support the new international recognition framework that MHRA ...
Posted by Michael Wonder on 01 Jun 2023
Inflation Reduction Act undermines cancer medicine development
1 June 2023 - The price setting provisions in the Inflation Reduction Act acutely impact the research and development (R&D) ...
Posted by Michael Wonder on 31 May 2023
TGA approves pathway for more plasma donors
30 May 2023 - The Government welcomes the Therapeutic Goods Administration’s approval of a ‘plasma pathway’, allowing a larger pool of ...
Posted by Michael Wonder on 30 May 2023
Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants
30 May 2023 - International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and ...
Posted by Michael Wonder on 23 May 2023
Health Canada’s position on the CADTH guidance for reporting RWE to support decision-making
18 May 2023 - Canada’s CADTH collaborated with Health Canada and other stakeholders to develop the guidance for reporting real world ...
Posted by Michael Wonder on 16 May 2023
The decline of science at the FDA has become unmanageable
15 May 2023 - Before 1962, US federal law did not require pre-marketing proof of effectiveness for drugs. But senate hearings ...
Posted by Michael Wonder on 15 May 2023
Drug companies are minting billions on unproven treatments with FDA shortcut
15 May 2023 - Accelerated approvals have helped get promising therapies to market fast — but follow-up research to confirm that ...
Posted by Michael Wonder on 14 May 2023
Negotiations begin for a new medicine pricing scheme
4 May 2023 - Negotiations for a new voluntary scheme for branded medicines pricing to open between the government, NHS ...
Posted by Michael Wonder on 13 May 2023
Pfizer CEO calls US drug price plan 'negotiation with a gun to your head'
11 May 2023 - Pfizer Chief Executive Albert Bourla called US plans to negotiate drug prices for its Medicare health ...
Posted by Michael Wonder on 10 May 2023
Reforming EU and national orphan drug regulations to improve outcomes for patients with rare diseases
9 May 2023 - In Europe, the number of approvals for new drugs targeting rare diseases (orphan drugs) has risen ...