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Big 2017 looming for PBAC
Reimbursement: More than sixty notable TGA approvals took place in 2016. Many can be expected move on to the PBAC this year, not to mention a potential flood of resubmissions from 2016 rejections. Pharma in Focus identifies the top candidates and markets.
Warning on biosim pharmacovigilance
Biosimilars: Australian Prescriber flags ongoing concern around data on biosim switching as Australia's biosim education vacuum continues.
Appeal for CT tax carveout
Innovation: ARCS CEO Shanny Dyer fears proposed R&D incentive reduction proposal will have a 'big impact' on Australia's clinical trials scene as she calls for trials and MTP sector to be spared.
MA welcomes Sansom bill
TGA Reform: MA CEO Milton Catelin says the bill, which is likely to be passed early next year, tackled 'head-on' improvements in registration approval processes, promising faster medicines access and reducing red tape for industry.
Extra funding for nation's biggest trial
Clinical Trials: Funding for Australia's largest clinical trial has been almost doubled in the latest round of research grants from the National Health and Medical Research Council.
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Greens take a swipe at pharma
Reputation: Greens Senator Sarah Hanson-Young lets fly at pharma over US trade negotiation tactics.
Patent expiries hit markets worth $100m today
Generics: Generics will list against originator brands for drugs currently worth $100 million in R/PBS benefits today, affecting a number of major companies.
Another 'buyers club' tries to bypass access barriers
Medicines Access: A Netherlands-based 'buyers club' is offering Australian cancer patients medicines they can't get locally.
Actelion confirms takeover talks
Mergers: Actelion has confirmed a takeover approach from J&J with price speculation reaching as high as US$20 billion.
AMA boss decries pharma demonisation
Reputation: Although pharma was 'not without sin' the view that the industry has drugs approved without huge scrutiny is 'ludicrous', AMA president Michael Gannon has said.
TGA reform bill comes to parliament
Regulatory Reform: Legislation giving the TGA power to undertake reforms recommended by the Sansom review and agreed by government has come before parliament on the last sitting day of the year.
Chemist Warehouse forced to pay back millions
Retail: The massive pharmacy discounter enters compliance partnership with Fair Work Ombudsman after underpayment scandal sees backpay going to two-thirds of its workforce.
Hep C props up HSDP spend
Reimbursement: Were it not for two months of outlays on new hep C drugs, government spending on the Highly Specialised Drugs Program would hardly have grown in 2015-16.
CSL plans new local trials
Innovation: Three new generation, high tech medicines based on targeted monoclonal antibody techniques will be the subject of the Australian-based phase I trials CSL will undertake over the next 12 months.
Pipeline Monitor
New blockbuster hopes filed
Three potential blockbuster drugs filed on both sides of the Atlantic while PD-1 stars Keytruda and Opdivo continue to rack up indications in the US and EU.
Debating Point
The year of very little - how 2016 played out
As the parliamentary year draws to a close, many will be pleased to see the last of it and just as many more will be hoping for better in 2017.
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