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Saturday, 01 November 2014
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Pharmacists call for flexible PBS fee
The majority of pharmacists in a new poll supports a variable PBS dispensing fee while many are calling for funding of the fee to be reduced with the cash reallocated to provision of clinical services.
TGA and EMA line up on biosimilars
The TGA is to 'consider' formally adopting a revised EMA guideline that the European regulator says will facilitate global biosimilar development, although it says Australian regulatory practice is already in line.
BI/Lilly diabetes rejig won't hurt Aust
Boehringer Ingelheim and Eli Lilly will revise the 'operational and financial structure' of their diabetes alliance from January 1 next year but Australia and NZ arrangements will not be touched.
Gilead skyrockets on hep C sales
again led the sales charge for third-quarter of 2014 though its latest hope
, which launched in the US in October, may yet steal Sovaldi's thunder.
Legal warning on new transparency
Australia is in danger of rushing into a pharma transparency regime whose outcome is uncertain and confusing, and we should wait to see what happens in the US warns a senior lawyer.
December to see nine PBS listings
will list on the PBS from November 1 for the treatment of overactive bladder; and nine new and amended treatments will list from December 1, including Janssen's hep C treatment
Aspen in fast painkiller deal
US pharma Iroko says it has signed an exclusive licence agreement with Aspen Pharma to commercialise pain relief capsules
in Australia and New Zealand.
PBS sustainability continues: MA
Medicines Australia has renewed its cry that the PBS is stable and sustainable due to price disclosure reforms after figures show the cost of filling a script has fallen for both patients and government.
Amgen rejects break-up call
Biotech giant Amgen affirmed this week that it will continue to focus on developing innovative medicines, rejecting calls for a split and promising to cut costs.
Hurry melanoma drugs say patients
Advanced melanoma patients with renewed hope in a new generation of treatments are supporting MSD's call for a fast-track approval process for drugs such as
Under co-pay scripts rising fast
The number of scripts subsidised by the PBS has been steadily increasing in the last three years, but the increase is not as fast as that for those under the co- payment.
J&J launches Innovation Centre
Janssen owner J&J has marked the launch of its new Asia Pacific Innovation Centre today by revealing new collaborations with two Australian universities.
Patients push for Xofigo listing
The Prostate Cancer Foundation Australia is rallying the community to agitate for the listing of Bayer's prostate cancer treatment
on the MBS.
Pharmacy services under-funded
While welcoming the focus of the Pharmacy Guild's current ad campaign on professional services delivered by pharmacists, the PSA says a decline in funding must be reversed.
CSL snaps up Novartis global flu biz
CSL is set to become the second biggest player in global influenza vaccines through an agreement to acquire Novartis' global influenza vaccine business for US$275 million.
Shire sales surge, BMS surprises
Shire is on the upward swing with revenue up 32 per cent compared to the same time last year, a stark contrast to BMS which despite its revenue falling by four per cent performed better than expected.
PBS push for new Roche CLL drug
Roche will seek another PBS listing in 2015 for
its breakthrough treatment for chronic lymphocytic leukaemia, the most common form of the blood cancer.
Celgene and Alexion rise, Lilly slumps
Celgene and Alexion have both reported healthy growth and revenues for the third quarter of 2014; but the news is not so good for Eli Lilly which saw sales fall 16 per cent.
GSK recalls Zovirax for eyes
GSK is voluntarily recalling two batches of
ophthalmic ointment due to the presence of metal particles outside the specification limit in the active pharmaceutical ingredient.
Kalydeco, Soliris listed at last
The contoversial battle for PBS listing of Vertex's cystic fibrosis treatment,
is over as is that for Alexion's
with both to list on December 1.
Sovaldi denial will cause deaths
The PBAC's refusal to recommend government funding for Gilead's
is a crisis for patients with advanced heaptitis C, the Australian Gastroenterology Week conference has been told.
Industry embraces TGA review
Medicines Australia and the GMiA have welcomed the review of Australia's regulatory framework for therapeutic goods and medical devices, dubbing it a 'hallmark of quality'.
Apotex, TGA under media fire
Apotex and the TGA have come under fire in mainstream media over the continuing sale in Australia of medicines banned in the US and Canada.
James sets conditions for investment
Medicines Australias new chief Tim James' first message to the industry places Australia's global competitiveness on the agenda, and calls for regulatory stability.
Fear of budget damage persists
Consumers are worried about the cost of medicines and fear of negative effects from the May budget has not substantially subsided, a survey by Choice has found.
J&J boosts Ebola vax program
J&J plans to invest up to US$200 million to accelerate and expand production of the Ebola vaccine being developed by its Janssen companies for testing in early January 2015.
Aust drug first for EMA patient pilot
An Australian-developed drug is the first to be used in an EMA pilot that involves patients in assessing the benefits and risks of medicines.
GSK in billion-pound restructure
GSK has revealed it is 'exploring' the potential for an initial public offering of HIV joint venture ViiV Healthcare and will be looking at restructuring its operations to save GBP 1 billion a year after disappointing quarterly results.
We've saved PBS $650m says NPS
The NPS claims to have delivered $650m in 'validated' savings to the PBS in a submission to the new Senate Select Committee on Health. Pfizer, MA and the GMiA have also had their say.
Sales growth but loss for API
Despite a $90.8m statutory loss for the year to August 31, API boss Stephen Roche says his company's retail result was very strong with the wholesaler's sales up by more than five per cent and an boost to underlying net profit.
GPs prove conservative on NOACs
Uptake of novel oral anticoagulants (NOACs) has been increasing slowly since their listing on the PBS - from 6.8 per cent in September 2013 to 18 per cent by July 2014 - but warfarin remains the anticoagulant of choice for GPs.
Tax fear can't stop Abbott and Mylan
Unlike AbbVie and Shire, Abbott and Alphapharm-owner Mylan are determined to go ahead with their $5.3 billion merger deal - with a few changes to protect tax gains.
Wholesale providers win in data stakes
While it may be hard to pick a winner in the upcoming Melbourne Cup, market data users in Australian pharmaceuticals have come up with one in the inaugural Aussie data provider stakes.
Keytruda wins second breakthrough
Merck's cancer drug
has won a second breakthrough therapy designation from the FDA.
Gender balance in Aussie pharma still a pipedream
A recent study of the representation of women on boards and in executive positions in biotech companies in Europe and the US found women are still vastly under-represented. Are women in Australian pharmaceutical companies on the path to equal opportunity?
Celgene puts up new brand of Vidaza
Celgene has registered a new brand of leukaemia treatment
while Apotex and Cipla have been active in the OTC space.
Not much action at CT action committee
Has the task of dealing with Australia's problems in fostering clinical trials been consigned to the bureaucratic wilderness? The latest communique from the Clinical Trials Action Group might lead one to think so.
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