TGA publishes more details on its approval of COVID-19 medicine Veklury

13 July 2020 - Remdesivir granted conditional approval in record time. ...

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ICER reschedules cystic fibrosis public meeting for 27 August 2020

8 July 2020 - Registration is now open. ...

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Developing a SARS-CoV-2 vaccine at warp speed

6 July 2020 - The coronavirus disease 2019 (COVID-19) pandemic has unleashed major and substantial changes in the provision of health ...

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FDA Commissioner says he can't predict when vaccine will be ready after Trump's timeline claims

5 July 2020 - Food and Drug Administration Commissioner Stephen Hahn said Sunday that he would not make a prediction ...

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Delay in decision on modifying funded access to mifepristone and misoprostol proposal

17 June 2020 - PHARMAC would like to advise all interested parties that there will be a delay in the decision ...

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New Zealand's slow medicine uptake leads to 800 diabetes deaths each year

17 June 2020 - The Diabetes Foundation Aotearoa has estimated in a submission to PHARMAC last month that New Zealand’s ...

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Biogen’s FDA application for Alzheimer’s drug drags on

15 June 2020 - Biogen’s filing of aducanumab, an investigational Alzheimer’s drug, for U.S. approval is drifting from its initial ...

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Analysis of PBAC submissions and outcomes for medicines (2010–2018)

11 June 2020 - Sean Lybrand and I reviewed the Pharmaceutical Benefits Advisory Committee submissions and their related outcomes and timelines ...

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Antimicrobials benefited from expedited FDA programs more than other drugs

12 June 2020 - Amid concerns over the need for more antimicrobials, a new analysis finds these medicines benefited more ...

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U.S. FDA Commissioner says agency seeks fast review of COVID-19 products

11 June 2020 - The U.S. FDA is seeking to review treatments and tests for COVID-19 “as fast as we can” ...

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The FDA should not rush a COVID-19 vaccine

2 June 2020 - Vaccines are widely expected to offer the best way out of the COVID-19 pandemic.  ...

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Antimicrobial approvals are not bottlenecked by FDA

3 June 2020 - Sponsors seeking US FDA approval for anti-microbial drugs accessed expedited clinical testing and review programs at least ...

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Hahn: FDA will make some changes amid COVID-19 permanent

1 June 2020 - The US FDA will look to permanently implement some of the processes and policies adopted in ...

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Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

2 June 2020 - Novartis today announced that it has received notice from the US FDA that the agency has extended ...

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Estimating the cost of delayed generic drug entry to Medicaid

1 June 2020 - Delays in market entry of generic drugs are common.  ...

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