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No PBS for CAR-Ts says Novartis
Reimbursement: Novartis has made the first move in bringing its revolutionary CAR-T Kymriah to Australia while revealing the game-changing therapy is ineligible for PBS reimbursement.
Three new drugs, five extensions kick off 2018
Market Access: Ipsen's Cabometyx is the third new drug added to the ARTG this year as five other drugs gain additional indications in what is shaping up to be a big year for the TGA.
Not enough access to cancer trials
Patient Access: Structural and technological barriers mean too few adult patients are able to enjoy the potential benefits of new cancer medicines.
J&J global boss to meet PM, Hunt
Leadership: The global chairman of pharma giant J&J will visit Australia next month, with a meeting with both the Prime Minister and Health Minister on his schedule.
API warns of H1 earnings fall
Retail: API has warned its first-half earnings will fall while a cannabinoid producer has announced a distribution agreement with the pharmacy wholesaler.
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Pharma billionaire hit with $400K speeding fine
Regulation: Billionaire Ernesto Bertarelli, who headed former big pharma Serono for over a decade, has fallen foul of the Swiss fine system which can penalise offenders according to personal wealth and income.
Aust science hero 'cured' in PD-L1 trial
Clinical Trials: A combination using Roche's star checkpoint inhibitor has bagged a high-profile Australian 'cure' with a former chief scientist attributing his miraculous recovery to the treatment.
Collapsed H&T owes millions
Marketing: Specialist healthcare ad agency Hammond & Thackeray has gone into receivership owing millions of dollars to creditors and staff.
Sales and clinical the hot jobs for H1 2018
Employment: Sales folks with strong digital skills will be in demand during the first half of this year, along with CRAs and MSLs.
GSK wins misleading ad battle
Litigation: GSK stands to receive significant damages after a court decision that ads claiming RB's Nurofen was superior to Panadol were not soundly based.
PBS targeted to halt opioid abuse
Regulation: Australia is the eighth biggest consumer of prescription opioids and the TGA says the PBS should play a lead role in curbing abuse.
Call for ad approval backtrack
Regulation: A group of academics and consumers is calling for a backtrack on plans to end pre-approval of ads for OTC products.
Trade deal won't include pharma protections
Leadership: MA is urging the government not to water down IP protection with a reduced Trans Pacific Partnership likely to leave out pharma clauses.
Give us more time say Nurofen lawyers
Litigation: Lawyers behind the Nurofen class action are calling for an extended deadline for clients to claim compensation as claimants find process onerous.
Approvals Action
New GSK COPD med arrives
GSK's COPD combination therapy Trelegy Ellipta has been approved by the TGA after it appeared on the agenda for last December's PBAC meeting.
Pipeline Monitor
Novartis' CAR-T on dual speed tracks
Novartis is poised to speed its CAR-T therapy Kymriah through the EMA and FDA for two different blood cancer indications as the gene therapy space heats up.
No 'safe' level of HCP sponsorship
Australian pharma has made considerable concessions in recent years to prove it has nothing to hide in doctor education payments but is it worth the pain if it fails to silence the critics?
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