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New wave of high-tech cancer drugs coming
Pipeline: Australia is likely to see a wave new of high-tech cancer drugs next year if Pfizer follows its orphan drug designation with an approval application for CAR-T cell therapy Besponsa.
EBOS nods to future M&A
Wholesalers: EBOS CEO Patrick Davies suggests the company is still keen for more acquisitions as it posts a full year profit of close to five per cent, driven in part by the high-cost HCV DAAs.
Companies hit by ATO tax action
Industry: Senate inquiry into corporate tax avoidance hears there are 20 'active files' on pharma companies, some of them 'coercive'.
November PBAC to be a battleground for checkpoint inhibitors
Reimbursement: The appearance of Roche's Tecentriq on the PBAC agenda sparks a three way battle between the checkpoint inhibitors, with lung cancer the first battleground.
Health Minister Hunt's big day out
Policy: In the start of what appears to be a regular bi-annual series of roundtables, the Health Minister saw the main representatives of both the medicines industry and health consumer groups in Melbourne yesterday.
Type I diabetes pill could head to Aust by 2019
Pipeline: A potential first oral treatment for type I diabetes, Sanofi's sotagliflozin, could be coming down the pipeline after posting clinical success.
Most Popular
Pfizer dominates PRIME Awards nominations - again
Marketing: Pfizer scores big with 13 nominations in the annual pharma sales and marketing excellence awards to be announced next month, followed by Sanofi with six and GSK with five.
PBAC wanted 90% discount; Hunt should overrule says Vertex
Reimbursement: Vertex has taken the extraordinary step of revealing the PBAC sought a 90 per cent discount before rejecting its latest cystic fibrosis drug for a third time, and is calling on Health Minister Greg Hunt to intervene.
Blueprint for Amazon to move into prescription drug sales
Retail: A global investment firm has provided a blueprint for Amazon to enter the prescription drug distribution business while Google has reportedly made its first big move into digital health.
How TGA compares with global counterparts
Regulatory: The TGA has landed near the middle of 12 major regulatory authorities according to research published by the Nature group.
PBAC outcomes a nervous wait for some
Reimbursement: AbbVie, Roche, AZ and Lilly are among companies with lots at stake as industry awaits Friday's PBAC outcomes announcement.
Earlier
Pfizer says drug mix-up didn't happen on its turf
Medicines Safety: Following a TGA recall of Heparin and Lignocaine and an internal investigation Pfizer says packaging mix-up did not occur in its distribution chain.
PBAC to be flat out to end of 2017
Reimbursement: The PBAC agenda for November, published today, is expected to be bursting at the seams but leftovers will necessitate a special meeting in December.
Hunt praises departing Bowles for MA pact
Leadership: Minister says forging an agreement with the medicines industry after years of uncertainty was one of the greatest achievements of departing Health Secretary Martin Bowles.
Biosims not enough for Bioepis
Innovation: Samsung Bioepis is moving into the patented drug market after inking a deal with Japanese pharmaco Takeda to jointly fund and develop multiple original biologicals.
Huge spike in J&J talc damages
Litigation: Johnson & Johnson has been slapped with a USD400m-plus verdict in a case alleging its talc-based products cause cancer, with thousands of cases yet to be heard.
Special Report
PBAC reveals giant November agenda
As anticipated, the November 2016 PBAC agenda is huge with 36 major submissions and 26 minor but comparatively few on the parallel processing track.
Approvals Action
Apotex sets sights on $146m Novartis drug
Apotex has registered two new brands for one of Novartis' biggest selling products as patent expiry looms.
PBAC Outcomes
PBAC in major denial mode
The PBAC either rejected or deferred 16 major submissions and resubmissions at its July meeting with another three parallel submissions held off because TGA data was insufficient; only seven majors were recommended for listing.
Pipeline Monitor
Gilead wins speedy review for HIV hope
Gilead has filed its latest drug combo in the US with hopes of maintaining HIV sales as hep C blockbusters fall back.
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