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3 September 2010
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    INDUSTRY ISSUES 
    In Silico: More signs the FDA is toughening up


    IT’S no secret the US Food and Drug Administration has been under sustained pressure over the last few years to toughen up its approvals process. While the FDA has traditionally been regarded as one of the more conservative drug approvals agencies, a number of public scandals in recent years has increased public and legislative pressure on the agency to raise the barriers.
    Full Story...


    MORE INDUSTRY ISSUES

    In Silico: The verdict – a plague on both their houses


    Innovators re-elected, Australia waits


    Libs abandon R&D tax credit to 'bring certainty'


    VIEW ALL STORIES

    GOVERNMENT BUSINESS 
    In Silico: The verdict – a plague on both their houses


    WHICHEVER way the chips fall in Canberra in the coming weeks, the outcome will certainly be a minority government. And the other certainty is that it will be a lean few years for life science companies hoping for a little more assistance from the federal government.
    Full Story...


    MORE GOVERNMENT BUSINESS

    FDA knocks back GBH fantasy


    Innovators re-elected, Australia waits


    Libs abandon R&D tax credit to 'bring certainty'


    VIEW ALL STORIES

    AGRICULTURAL BIOTECH 
    Biotech, a great education


    PRIME Minister Julia Gillard says her niece, biotechnology graduate and Bridge8 science and industry analyst Dr Jenna Malone, is known as the smart one in the family.
    Full Story...


    MORE AGRICULTURAL BIOTECH

    Bio Briefs: Virax, Acrux, Tissue Therapies and more


    Solagran takes BioProspect dispute to lawyers


    VIEW ALL STORIES

    HEALTH BIOTECH 
    Pam-beating rat whisperer makes debut


    DRUG discoverer Bionomics has found its anti-anxiety and anti-depressant compound BNC210 reduced anxiety in rats without sedating them, as diazepam did.
    Full Story...


    MORE HEALTH BIOTECH

    Bio People: CogState, IM Medical, Sigma and more


    Bio Briefs: Phosphagenics, IM Medical, RA


    Clinuvel seeks thriller re-pigmentation


    VIEW ALL STORIES

    INDUSTRIAL BIOTECH 
    ASIC eyeballs bottom line


    FOLLOWING the transfer of market supervision from the Australian Securities Exchange to the Australian Securities and Investments Commission earlier this month, ASX queries are rolling in, with Giaconda, AnaeCo and Benitec being the latest to respond to questions about their financials.
    Full Story...




     


    Avexa bioadvisors on board


    AS punters ignored a rumour a Calzada-led extraordinary meeting would take place this morning, Avexa progressed an options and assets review with the appointment of Bioadvisory Group managing director and former Progen Industries vice-president John Grew.
    Full Story...


    Progen-Medigen progress muparfostat


    PROGEN’S decision to send lead asset muparfostat (PI-88) out to shareholder Medigen Biotechnology is starting to pay off, as the licensee lodged a special protocol submission with the US Food and Drug Administration ahead of a new drug administration filing.
    Full Story...


    Approval boosts Unilife


    CHASING news of Unilife Corporation’s $28.7 million increase to net loss, the company has gained 2.7% on small volumes after the US Food and Drug Administration gave its second safety syringe clearance in the US.
    Full Story...

       

    AusBiotech

    AusBiotech CEO urges independent MPs to support Australian innovation

    Changes to members-only section of AusBiotech website

    Introducing the AusBiotech team

    Seek out grant programs

    Coalition policy, no new funding for biotech, medtech






       TODAY'S STORIES CONTINUED


    Bio Briefs: Benitec, Tissue Therapies, Epichem and more


    AS Benitec waits to hear whether a number of Graham patent claims will be re-allowed by the US Patent and Trademark Office, the agency has granted CSIRO and Benitec another patent in the same family.
    Full Story...

    South Korea trial adds 220 linxs


    DIAGNOSTICS developer HealthLinx has finalised research agreements with investigators in South Korea for a 220-patient study of its OvPlex ovarian cancer diagnostic test required for a South Korea food and drug administration approval.
    Full Story...

    Aspermont reports profit


    AS BioTechnologyNews.net joint-publisher Aspermont celebrates the 175th anniversary of one of its magazines, the company has returned to the black after bringing in $23 million in revenues last year.
    Full Story...

    Clinuvel adds to family


    AS Clinuvel centralises operations at its new headquarters in Switzerland, the company has added a new skin-protectant molecule to its pipeline, CUV9900.
    Full Story...

    pSivida lifted on FDA news


    DUAL-listed pSivida gained 5.2% overnight on the NASDAQ after its licensee Alimera was granted priority review status for eye drug Iluvien by the US Food and Drug Administration for a diabetic macular edema indication.
    Full Story...

    Pharmaxis reps dance Quintiles-style


    AS Pharmaxis chief executive Dr Alan Robertson returns to work on light duties, the company has finalised a sales and marketing agreement with powerhouse Quintiles for commercialisation of Bronchitol for cystic fibrosis in Europe.
    Full Story...

    In Silico: More signs the FDA is toughening up


    IT’S no secret the US Food and Drug Administration has been under sustained pressure over the last few years to toughen up its approvals process. While the FDA has traditionally been regarded as one of the more conservative drug approvals agencies, a number of public scandals in recent years has increased public and legislative pressure on the agency to raise the barriers.
    Full Story...

    It's a Sunshine day


    IN an important first Sunshine Heart physicians participating in clinical trials of the C-Pulse Heart Assist System for moderate heart failure have completed their first minimally invasive implants of the device at a leading US hospital.
    Full Story...

    Pam-beating rat whisperer makes debut


    DRUG discoverer Bionomics has found its anti-anxiety and anti-depressant compound BNC210 reduced anxiety in rats without sedating them, as diazepam did.
    Full Story...

    Revenue Matters: Unilife, Sirtex, Halcygen and more


    US-based Unilife Corporation has increased its net loss by 5840% to $US29.7 million as revenues declined by 43% and payroll costs increased.
    Full Story...

    Giaconda offloads trio, keeps duo


    SYDNEY-based Giaconda has sold commercialisation company RedHill three patents and rights to future gastrointestinal treatments developed by Centre for Digestive Diseases or its medical director Professor Thomas Borody.
    Full Story...






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