AusMedtech responds to the TGA's review of the low value turnover exemption scheme
03 June, 2014AusMedtech has told the TGA's review that it is concerned that only a very low number of small businesses are taking advantage of the low value turnover exemption (LVT) scheme, despite the eligibility of their products.
Benitec treats first patient in HCV trial
02 June, 2014 by Dylan Bushell-EmblingBenitec Biopharma (ASX:BLT) has commenced a phase I/IIa trial of ddRNAi-based therapeutic TT-034, marking the first time the treatment candidate has been used in humans.
Cochlear to launch new implant in EU in June
02 June, 2014 by Dylan Bushell-EmblingCochlear (ASX:COH) will this month launch the first in its Nucleus Profile line of implants - the successor to its Cl500 series - in Europe.
Mesoblast accelerates Singapore manufacturing plans
30 May, 2014 by Dylan Bushell-EmblingMesoblast (ASX:MSB) has secured economic incentives in Singapore, as part of efforts to prepare for commercial manufacturing of Prochymal, an allogenic stem cell product awaiting approval in GVHD.
Orthocell launches $8m IPO
30 May, 2014 by Dylan Bushell-EmblingWA's Orthocell has commenced an $8m IPO, as it seeks to raise funds to expand the reach of its two TGA-approved regenerative medicine products and complete development of a third.
Joint position to grow Australia's biopharmaceutical industry
29 May, 2014AusBiotech and Medicines Australia have provided a joint statement to the Minister for Industry, the Hon Ian Macfarlane, proposing steps that the federal government could take to build a stronger biopharmaceutical industry in Australia.
Minomic to seek CE Mark for prostate cancer test
28 May, 2014 by Dylan Bushell-EmblingMinomic International announced that it aims to complete the process of applying for a CE Mark for prostate cancer diagnostics test MiSat ELISA by the fourth quarter.
ATP Innovations named incubator of the year
27 May, 2014 by Dylan Bushell-EmblingSydney life science and ICT business incubator ATP Innovations has won the Incubator of the Year Award at the NBIA's 2014 International Conference.
AusBiotech submission re: tax impediments for small business
27 May, 2014AusBiotech has made a submission to the Board of Taxation, which is conducting a review to identify features in the tax system that are hindering or preventing small businesses from reaching their commercial goals.
FDA knocks back QRxPharma's third Moxduo NDA
26 May, 2014 by Dylan Bushell-EmblingQRxPharma (ASX:QRX) has, as expected, received a third Complete Response Letter from the US FDA covering a New Drug Application for pain drug Moxduo.
Nasal devices improve breathing
23 May, 2014 by Susan WilliamsonPositive results for Rhinomed’s sport and respiratory technology, Turbine, will be followed later this year with the release of its first products targeting snoring and sleep quality.
ResMed refines APAP therapy for women
23 May, 2014 by Dylan Bushell-EmblingResMed (ASX:RMD) has presented research into a new algorithm for providing APAP therapy that has been customised to reflect the distinct symptoms of female sleep apnoea patients.
Clinuvel gets orphan status for Scenesse in US too
22 May, 2014 by Dylan Bushell-EmblingClinuvel (ASX:CUV) has in one week been granted orphan status for its Scenesse drug in Hailey-Hailey disease in both the US and the EU.
Commercialisation Australia closes for new applications
22 May, 2014Commercialisation Australia (CA) is now closed for new applications, following the announcement in last week's federal Budget that it will cease from 1 January 2015 and the funds will be rolled into the new Entrepreneurs' Infrastructure Program (EIP).
Immuron signs SK distribution deal for Travelan
22 May, 2014 by Dylan Bushell-EmblingDB Pharm Korea has signed a deal giving it exclusive rights to distribute Immuron's (ASX:IMC) travellers' diarrhoea treatment Travelan in South Korea.
