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Sunday, 21 December 2014
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PBAC holds back a third of new drugs
The PBAC rejected close to a third of new listing submissions in the year to November 2014 but the government has already listed almost four fifths of those that passed muster.
New diabetes, heart drugs on PBS
Boehringer Ingleheim's type 2 diabetes treatment
will join its SGLT-2 counterparts on January 1, 2015 when it lists on the PBS along with MSD's
Generics denied $33.9m bone market
Novartis's case against Apotex and Hospira over its osteoporosis drug
has come to an end by consent, though the generics have been locked out of the market until the patents expire.
Generic suspensions 'disproportionate'
European regulatory agencies' decisions to suspend marketing authorisations for products tested by GVK was 'disproportionate' to the actual risk, says the Indian CRO.
Latest PBS cuts will take $400m-plus
Simplified price disclosure cuts set to take place on April 15 next year will add more than $400 million to PBS savings already generated by the price disclosure system.
SPD now 'unsafe' says GMiA chief
The fundamental assumption underlying the government's price disclosure system is 'unsafe' and could compromise the reliable supply of essential medicines, new GMiA CEO, Belinda Wood has said.
Gilead backs multimillion Aust study
Gilead has given multimillion-dollar backing to a world first study of hep C medications to be conducted by three major Melbourne institutions.
Actavis names new global leadership
In the lead up to the finalisation of the US$66 billion deal to buy Allergan, Actavis CEO Brent Saunders has revealed his new leadership team.
April price cuts up to 75 per cent
Simplified price disclosure cuts confirmed for April next year range up to 75 per cent but many are at the lower end of the scale.
Belinda Wood wins top GMiA job
Belinda Wood has been appointed GMiA CEO, after acting in the role since August when her predecessor Kate Lynch resigned.
Pessimism rife in clinical research
Three-quarters of clinical research staff working in Australian pharma believe the level of research activity carried out nationally either stagnated or declined in 2014 and almost half believe it will decline further in 2015.
Sigma bullish as 2014 deals mature
Wholesaler Sigma says it is positioned to deliver significant revenue gains on the back of recent acquisitions and wholesale agreements.
New tune on pertussis, zoster vax
Changes to the recommendations and existing clinical advice for pertussis and herpes zoster vaccines have been included in a consultation draft for the 2015 update of the Australian Immunisation Handbook.
Tamoxifen has protective effect
Tamoxifen, originated by AstraZeneca as
, has a 'protective effect' over time in reducing the incidence of breast cancer, a long-term follow up study that included Australian patients has shown.
Budget update boosts PBS squeeze
Figures released in the mid-year budget update show the government intends to spend $65 million less on new PBS listings over the next four years and save $105 million from price adjustments.
Hearts take a fifth of PBS dollars
The PBS is spending around 20 per cent of its funds on treatments for cardiovascular disease but it remains the nation's leading cause of death according to a new Heart Foundation report.
API adjustments counter PBS risk
Drug wholesaler API has found that cutting discounts on generic drugs has helped it weather the PBS price cutting storm.
NZ looks to biosimilars for savings
New Zealand's reimbursement authority Pharmac says it is looking to biosimilars to create future savings after spending $806.9 million in 2013-14 on its tender- based access system.
TGA on alert as EU suspends generics
As European regulators move to suspend the authorisations of generics tested for bioequivalence by India's GVK Bioscience, the TGA says it is reviewing information on whether any action is required locally.
Bayer tops advisory board spend
Bayer has moved into top spot for advisory board spending, ahead of rival Novartis, despite overall outlays being down in the latest reporting period, newly released MA data shows.
Millions to be saved if pill had sponsor
A cadio polypill, given up on by Dr Reddy's, could save the health system millions of dollars says new owner, Sydney's George Institute, and it's looking for a sponsor.
Sponsored event costs on the rise
The latest sponsored event reports from Medicines Australia show members sponsored more events and spent more per head in the six months between April and September 2014 than in the previous six months.
Antipsychotic in skin safety scare
The TGA is reviewing new information that links antipsychotic drug ziprasidone to a rare, potentially fatal skin reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms.
Class action over Sovaldi pricing
Gilead's tactic of charging wildly divergent prices in different territories for blockbuster hep C drug
has got it into legal trouble in the US where a class action law suit has been filed.
Wide local variation found in GP prescribing patterns
GP prescribing varies significantly from one local area to another, a new report has found, leading to strong criticism from Consumers Health Forum head Adam Stankevicius.
CROs churning staff at 24 per cent
Turnover in Australia's clinical research organisations was at 24 per cent on average in 2013, the 15th highest out of 41 countries that were part of a global survey.
Death prompts call to curb Stilnox
A Victorian Coroner has recommended sale of zolpidem, popularly known as
, be limited to 5mg tablets and that dosages for women be halved, after he found a Melbourne woman had sleepwalked and fallen down a rubbish chute while on the drug.
Roche's Avastin appeal rejected
Roche has failed in a bid to extend the use of cancer drug
with radiotherapy and temozolomide to treat patients with newly diagnosed glioblastoma.
Texting boosts medication adherence
Text message reminders to take blood pressure and cholesterol-lowering medicines improved adherence by 16 per cent, even in those who had stopped their medication says a new study.
NHMRC urges better use of research
NHMRC CEO Professor Warwick Anderson has said that while Australia has a vibrant and high quality research effort, it needs more active use of research to make healthcare affordable in the future.
Substitution surge speeds price cuts
Increasing substitution of generic for originator brands is speeding up the effects of price disclosure to the point where big selling molecules could drop another 50 per cent in the next round of price cutting.
Code crusaders refuse to compromise
A just-released account of last month's ACCC pre-decision meeting on the MA Code shows opponents gave little ground, rejecting the peak body's position on a number of key issues.
Govt report backs Aust pharma future
Medicines Australia has welcomed the release of a government report that sees great potential for the future of pharma in Australia.
Pradaxa antidote succeeds in trials
Idarucizumab, Boehringer Ingelheim's FDA breakthrough investigational drug, has been shown to immediately and completely reverse the anti-coagulation effect of it novel oral anti-coagulant
TGA ponders new tramadol risk
New evidence has emerged of the link between tramadol and the risk of hypoglycaemia which the TGA says it will review to ascertain if any regulatory action is required.
First Humira biosimilar launched
Indian drug company Zydus Cadila is claiming to be the first to launch a biosimilar for AbbVie's
, the world's most valuable drug.
Wrong ideas about drug costs need to change
Merck chief medical officer, Michael Rosenblatt, says much of the recent press about high prices for new drugs has taken a narrow view of the topic and demands a broader perspective.
Psoriasis battle heats up
is shaping up as serious competition for Janssen's
in psoriasis while CSL has filed a new long-acting haemophilia treatment in the US.
Naughty or nice? Workplace wish lists
What do pharma staff want most with their jobs? Find out what's on the wish lists of various job sectors - and what's not.
Pharmacor targets antipsychotic market
Generics maker Pharmacor is taking aim at the $95 million market for antipsychotic olanzapine with the registration of three new brands in four dose forms.
Top stories of 2014
The last 12 months have seen interesting times for Australian pharma as the PBS remained under pressure from cost cutting while industry, patients and clinicians lamented continuing slow access to important medicines but for
Pharma in Focus
readers, it was events inside the tent - especially around employment - that proved the most compelling.
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