Blog
RSS FeedPosted by Michael Wonder on 22 Jul 2021
Roche is discussing Alzheimer’s drug with FDA following regulators controversial approval of Biogen’s Aduhelm, CEO says
22 July 2021 - Roche is discussing its potential Alzheimer’s treatment with the U.S. FDA, CEO Severin Schwan said Thursday, ...
Posted by Michael Wonder on 21 Jul 2021
Vaccine mandates more likely once FDA grants full approvals, health experts say
20 July 2021 - The regulatory sign-off would remove a significant legal and public relations barrier to requirements, former government officials ...
Posted by Michael Wonder on 21 Jul 2021
Recently approved Alzheimer drug raises questions that might never be answered
21 July 2021 - The FDA’s approval June 7 of the drug aducanumab was notable for a number of reasons. ...
Posted by Michael Wonder on 21 Jul 2021
Pfizer provides update on U.S. FDA review of abrocitinib and Xeljanz filings
21 July 2021 - Pfizer announced today that the U.S. FDA has notified the company that it will not meet the ...
Posted by Michael Wonder on 21 Jul 2021
How an unproven Alzheimer’s drug got approved
19 July 2021 - Though some of its own senior officials said there was little evidence of benefit for patients, the ...
Posted by Michael Wonder on 20 Jul 2021
Biden administration seeks higher penalties for hospitals that don't publish prices
19 July 2021 - The Biden administration is proposing to increase the penalty for hospitals that don't comply with a ...
Posted by Michael Wonder on 20 Jul 2021
Pharma CEOs, lobbyists showered Democrat with cash after his attempt to torpedo Pelosi’s drug pricing bill
20 July 2021 - The very next day after Republican Scott Peters attempted to torpedo House Speaker Nancy Pelosi’s signature drug ...
Posted by Michael Wonder on 20 Jul 2021
The Democratic majority depends on slashing drug prices
19 July 2021 - Last month, Republicans and Democrats in Congress came together to announce a historic bipartisan deal on ...
Posted by Michael Wonder on 20 Jul 2021
Streamlining proprietary ingredient categories
20 July 2021 - To help make the medicines application process more efficient, the TGA no longer allocates proprietary ingredient ...
Posted by Michael Wonder on 20 Jul 2021
Clinical trial national approach will benefit patients and our economy
20 July 2021 - Medicines Australia welcomes the clinical trial ‘one-stop-shop’ consultation, recently announced by the Australian Commission on Safety ...
Posted by Michael Wonder on 19 Jul 2021
CMS proposes rule to increase price transparency, access to care, safety & health equity
19 July 2021 - The Centers for Medicare & Medicaid Services is proposing actions to address the health equity gap, ...
Posted by Michael Wonder on 19 Jul 2021
Making sense of the FDA’s ‘indefensible’ decision to approve Aduhelm
19 July 2021 - There are three sides to every story that defies logic: the defenders’ side, the critics’ side and ...
Posted by Michael Wonder on 18 Jul 2021
Pfizer agrees to pay $345 million to resolve EpiPen pricing lawsuit
17 July 2021 - Pfizer has agreed to pay $345 million to resolve claims by consumers who say they overpaid ...
Posted by Michael Wonder on 16 Jul 2021
International regulators work towards alignment on development and authorisation of second generation COVID-19 vaccines
16 July 2021 - Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 ...
Posted by Michael Wonder on 15 Jul 2021
ATAGI update following weekly COVID-19 meeting (14 July 2021)
15 July 2021 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 14 ...