News & Events
Peplin Completes Enrolment for its First Phase III AK Clinical Trial
16 / 12 / 2008
Peplin, Inc. (ASX:PLI) today announced the completion of enrolment of its 250 patient pivotal Phase III US and Australian clinical trial in actinic (solar) keratosis (AK), a common pre-cancerous skin condition affecting between 40 and 60 percent of adult Australians and accounting for at…
KaloBios Raises Additional $12 Million in Series D Venture Financing for a New Total of $32 Million
12 / 12 / 2008
aloBios Pharmaceuticals, Inc. today announced that the company has raised an additional $12 million in the second closing of its Series D venture financing, which along with the $20 million it raised in September brings the round to $32 million. This tranche was dominated by a new…
ChemGenex's Omacetaxine Demonstrates 80% Complete Hematological Response Rate in Drug-Resistant CML Patients with the T315I Mutation
09 / 12 / 2008
ChemGenex Pharmaceuticals (ASX: CXS, NASDAQ: CXSP) announced today positive interim clinical data from 44 patients enrolled in its ongoing phase 2/3 trial of omacetaxine mepesuccinate in chronic myeloid leukemia (CML) patients with the T315I mutation. Clinical investigators reported…
Hatchtech $2.5m new funding for Phase II head lice trials. Hatchtech to attain proof of clinical concept in affected patients
08 / 12 / 2008
Hatchtech Pty Ltd has secured $2.5 million in further funding from the University of Melbourne Endowment Trust (advised by GBS Venture Partners) and from Uniseed. The investment will be used to progress its unique head lice treatment into Phase II safety/efficacy studies in humans. The new…
First US Institutional Review Board Approval
24 / 11 / 2008
Sunshine Heart, Inc. (ASX: SHC) announces that the Institutional Review Board (IRB) of the Jewish Hospital, University of Louisville, Kentucky has approved the hospital's participation in the US clinical trial for C-PulseTM. The trial has been fully approved by the US Food and Drug…
FDA Grants Full Approval of US Clinical Trial
21 / 11 / 2008
Sunshine Heart, Inc. (ASX: SHC) announces that it has received full approval from the United States Food and Drug Administration (FDA) to begin its first US clinical trial for C-PulseTM, a heart assist therapy for patients suffering from moderate heart failure. The Company…
Xenome and Flinders Partners to develop peptides to treat acute
19 / 11 / 2008
Xenome Limited today announced it has licensed intellectual property from Flinders Partners Pty Ltd (the technology transfer arm of Flinders University) in South Australia to develop peptides for the treatment of inflammation of the pancreas (acute pancreatitis). Acute pancreatitis is a…
Landmark Tinnitus Treatment Study Published
14 / 11 / 2008
Bethlehem, Pa - Neuromonics Inc has announced publication of the largest private-practice study evaluating the Neuromonics Tinnitus Treatment, which comprehensively targets the condition's neurological processes. Published in the November issue of Annals of Otology, Rhinology & Laryngology,…
Executive Change
10 / 11 / 2008
Sunshine Heart, Inc. (ASX SHC) today announced that as part of its focus on US activities, including the recently approved 20 patient US clinical trial, it has restructured its St Leonards operation and eliminated the position of Chief Operating Officer held by Mr Victor Windeyer who will…
Executive Change
10 / 11 / 2008
Sunshine Heart, Inc. (ASX SHC) today announced that as part of its focus on US activities, including the recently approved 20 patient US clinical trial, it has restructured its St Leonards operation and eliminated the position of Chief Operating Officer held by Mr Victor Windeyer who will…
NSW GOVERNMENT ANNOUNCES PROOF OF CONCEPT GRANTS FOR LIFE
10 / 11 / 2008
Minister for State Development and Acting Minister for Small Business Ian Macdonald today announced nearly $1 million in grants to help innovative life science companies develop and commercialise new research projects. Mr Macdonald said 10 grants have been…
Nicholas Callinan appointed Chairman
30 / 10 / 2008
At the conclusion of the Company's annual general meeting today, Nicholas Callinan was appointed Chairman of Sunshine Heart, Inc. following the retirement of Malcolm McComas who remains as a non-executive director. Mr Callinan is the founder and managing partner of Collins…
2008 Annual General Meeting Chairman's Address
30 / 10 / 2008
Last month, Sunshine Heart achieved the most significant milestone in the short history of the Company. In September, the US Food and Drug Administration (FDA) granted conditional approval to undertake a 20 person US feasibility trial for the C-PulseTM heart assist device. …
Uptake Medical Presents Data from Safety & Feasibility Clinical Trial for Patients with Heterogeneous Emphysema at 2008 CHEST Meeting in Philadelphia
26 / 10 / 2008
Uptake Medical Corp., a developer of medical technologies for the minimally-invasive treatment of lung diseases including emphysema, announced today that it will present data from their first safety & feasibility clinical trial at the 2008 CHEST meeting in Philadelphia. The trial,…
Phenomix and Forest Laboratories to Collaborate on Development and Commercialization of Dutogliptin in Diabetes
23 / 10 / 2008
Forest Laboratories, Inc. (NYSE: FRX) and Phenomix Corporation today announced that they have entered into a definitive collaboration agreement to develop and commercialize dutogliptin (PHX1149) in North America. Dutogliptin is Phenomix' proprietary orally administered, small molecule…
FDA Approves Reimbursement Category for C-Pulse
25 / 09 / 2008
Sunshine Heart (ASX: SHC) announces that the US Food and Drug Administration (FDA) has approved Reimbursement Category B for the C-PulseT US clinical trial. C-Pulse is a heart assist therapy for patients suffering from moderate heart failure. This approval will provide…
Xenome initiates Phase II clinical trial of Xen2174 in acute pain
25 / 09 / 2008
Xenome Limited ("Xenome") announced today that it has initiated its latest clinical trial of Xen2174, a new drug for the treatment of moderate to severe pain. The phase II study is the first trial of Xen2174 for the control of acute postoperative pain and will enrol approximately 200…
Change of Chairman
24 / 09 / 2008
Sunshine Heart (ASX: SHC) announces the retirement of Malcolm McComas as Chairman at the conclusion of the Annual General Meeting on 30 October, 2008 and the appointment of Nicholas Callinan as new Chairman. Malcolm McComas to retire The Company's chairman Malcolm…
KaloBios Raises $20 Million in Series D Venture Financing
23 / 09 / 2008
KaloBios Pharmaceuticals, Inc. today announced that the company has raised $20 million in the first closing of its Series D venture financing. The financing was co-led by Mitsubishi UFJ Capital and Genzyme Ventures, both new investors, with the participation of the company's previous…
FDAOKs IDE for trial of C-Pulse in moderate heart failure patients
18 / 09 / 2008
By LYNN YOFFEE Medical Device Daily Staff Writer Patients with heart failure who no longer get symptom relief from medications may have a new treatment option on the horizon with the FDA's conditional approval this week of an investigational device exemption (IDE) to…
ChemGenex Completes $A12.9 Million Capital Raising Announces Share Purchase Plan for existing Australian resident shareholders
17 / 09 / 2008
ChemGenex Pharmaceuticals Limited (ASX:CXS and NASDAQ:CXSP) announced today the successful completion of a $A12.9 million capital raising through a share placement to institutional and sophisticated investors (15,216,153 shares at $0.85 per share). In addition to the placement, ChemGenex is…
FDA Approval for C-Pulse US Clinical Trial
12 / 09 / 2008
Sunshine Heart (ASX: SHC) announces that it has received conditional approval from the US Food and Drug Administration (FDA) to begin its first US clinical trial for C-PulseT, a heart assist therapy for patients suffering from moderate heart failure. With FDA conditional…
Spinifex Secures A$12m Investment to Develop Pain Drug
04 / 09 / 2008
Investment by GBS Venture Partners, Brandon Capital and Uniseed First A$6m Tranche Received, Second at Phase II Phase II Trial Targeted for 2009 Spinifex Pharmaceuticals, an Australian pain drug development company, today announced it has secured venture…
Spinifex Pharmaceuticals
03 / 09 / 2008
Spinifex says it has investment of $12 million from GBS Venture Partners, Brandon Capital Partners and Uniseed to development pain management drug EMA401. Spinifex said the funding was in two tranches, with the first $6 million received and the second tranche targeted for…
Peplin Announces Executive Management Appointments
18 / 08 / 2008
Peplin, Inc. (ASX:PLI) announced today that Tom Wiggans has been appointed Chief Executive Officer effective immediately. Mr Wiggans is currently Chairman of Peplin's board of directors and will also continue in that role. Prior to joining Peplin, Tom Wiggans served as…