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Bumper year for approvals in 2016
Pipeline: TGA approvals of new drugs and expanded indications for existing drugs increased by more than a third in 2016, an exclusive analysis by Pharma in Focus has found.
But this year could see filings fall
Pipeline: Although new drug approvals rose in Australia last year, in the US they dropped substantially, suggesting that 2017 may not be as good for the Australian market as the previous year.
US$625m ends Keytruda patent battle
Cancer Battle: The closure of a Federal Court case instigated by MSD in 2014 is just one result of a global settlement ending litigation between it and BMS over alleged infringement of patents on Opdivo.
Aust not alone in rebate concerns
Reimbursement: As Medicines Australia calls for clearer accounting of PBS rebates in budget figures, US pharma says it's losing a third of its revenue to rebate demands.
Most Popular
GSK appoints Australian as new global pharma boss
Leadership: GlaxoSmithKline has snagged top AstraZeneca executive, Australian Luke Miels to replace the departing Abbas Hussain, who was recently passed over for global CEO.
Industry lays out agenda as Hunt aims for 'world's best health system'
New Minister: Australia's medicines industry yesterday clambered to welcome newly appointed minister Greg Hunt to the health portfolio, with numerous advocacy groups indicating they would soon be knocking on his door.
Eli Lilly brings in new ANZ boss
Leadership: Fifteen year veteran of the company Margaret 'Libby' Driscoll expected to take up the new role sometime in Q1 moving from her current position as GM for Taiwan.
Health gets World's Best Minister
Leadership: Industry, Innovation and Science Minister Greg Hunt has been named as the new Federal Health Minister, replacing Sussan Ley.
Arrow reps go in 'realignment'
Employment: After its first year in operation, local generic business Arrow, has reduced its direct sales force.
Time to account for PBS rebates: MA
Budget 2017: In a 2017-18 budget submission that CEO Milton Catelin describes as 'modest' Medicines Australia has focused on reform of PBS spending data and increased support for innovation.
TGA reform drastically cuts advisers
Regulatory Reform: TGA committee members may be working much harder under the regulator's reformed structure which cuts total membership from 184 to 78.
Industry critics selective on 'evergreening'
Exclusivity: Lawyer takes aim at 'academics and economists' who label branded pharma's use of follow-on patents 'evergreening' while ignoring generic companies' use of the same tactic.
MSD CEO talks up Keytruda
Pipeline: The company's global CEO, Ken Frazier, says Keytruda's market position has been strengthened by the FDA extending a rapid review to it latest filing for a first time combination with chemo in NSCLC.
Aussie IPF drug gets FDA nod
Pipeline: Melbourne-based AdAlta Limited has received Orphan Drug Designation from the FDA for AD-114, its novel first-in-class drug candidate for the treatment of idiopathic pulmonary fibrosis.
Approvals Action
Bayer registers five year contraceptive
Bayer has won TGA approval for an intrauterine contraceptive indicated for contraception up to five years while Aspen Pharma's status as the only PBS supplier of ADHD treatment dexamphetamine looks like it's under threat.
Pipeline Monitor
MSD makes first Keytruda combo filing
European approval for Sanofi's new diabetes combo while MSD and Roche look for new cancer blockbuster indications in the US.
Debating Point
How much damage could Trump do to pharma?
With only a couple of days to go until Donald Trump is inaugurated as the 45th President of the United States, his tendency to bash pharma has many worried. Could he damage the US industry enough to affect Australia?
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