3050 rounds · 1930 startups · 3549 investors
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Peplin has begun a second Phase 3 trial of its skin-lesion gel, seeking to confirm earlier clearance results at non-head sites, with a regulatory filing planned for mid-2010.
ChemGenex Pharmaceuticals has hired Thomas DeZao as senior vice president and chief commercial officer to lead US commercialisation of its leukemia drug omacetaxine; his past roles span Genitope, Corixa/Coulter, Asta Medica and Chiron.
ASX-listed drug developer ChemGenex will quit NASDAQ and SEC reporting to cut compliance costs, and three directors step down in July while staying on as advisers.
ChemGenex Pharmaceuticals reports pre-clinical findings that omacetaxine destroys leukemic stem cells in chronic myeloid leukemia models, presented at the European Hematology Association congress, with collaborators in Glasgow and a US leukemia specialist.
ChemGenex reported Phase 2/3 trial results for omacetaxine in resistant CML patients at ASCO, with investigators suggesting it could become the first workable therapy for T315I-mutant patients; regulatory filing targeted for Q3.
A Brisbane skin-cancer biotech reports successful late-stage results for its sun-spot gel, saying it remains on schedule for a US regulatory filing and a 2011 market launch.
Sunshine Heart's board will weigh ways to secure extra funding after starting its US heart device trial; finance chief Brian Bolton retires, with Rowena Hubble becoming company secretary.
Biotech Hatchtech announced chief executive Paul MacLeman is resigning to lead another listed biotech; chairman Stewart Washer praised the head lice product's progress toward Phase II trials as a replacement is sought.
Sunshine Heart reports the first two US implants of its C-Pulse heart assist device, performed at Ohio State under a 20-patient FDA-approved feasibility trial running across six American hospitals.
A 2009 GBS Ventures news stub whose only content is a download link to a document about Sunshine Heart's first implants of its Pulse device; the page itself states no deal, amount or people.
GBS Ventures' letter to Arana Therapeutics shareholders covers Cephalon's proposed cash takeover, an attached dividend, the board's recommendation to accept, and Cephalon's pre-bid purchase of a 19.8% stake.
Cephalon has announced plans to buy out Arana Therapeutics shareholders at $1.40 a share, potentially $1.45, valuing the ASX-listed target around $318 million; its independent directors back the bid unless a better one emerges.
Fibrotech Therapeutics raised $3 million in Series A backing from Brandon Capital-managed funds MRCF, BBF1 IIF and Uniseed to advance fibrosis drug FT011 through Phase Ib trials.
Peplin reports its PEP005 gel met the primary endpoint in a Phase IIb actinic keratosis trial, clearing lesions safely across doses and moving toward Phase III development.
ASX-listed biotech Peplin has finished enrolling 250 patients in the first Phase III trial of its PEP005 Gel treatment for actinic keratosis, with results expected in H1 2009.
Sunshine Heart says a Kentucky hospital is the first US site cleared by an ethics board to join its FDA-approved C-Pulse heart failure trial, with patient enrolment expected once contracts are signed.
Sunshine Heart won complete US regulator clearance to run its first American trial of the C-Pulse heart device, having satisfied conditions attached to September's conditional clearance; enrolment of trial participants was anticipated that year.
NSW Government's 2008 announcement of ten BioBusiness Proof of Concept grants totalling $950,700 for life science ventures, including Minomic International and E-Nose, to advance their research toward commercialisation.
Sunshine Heart has eliminated its chief operating officer role, with Victor Windeyer departing as the company restructures its St Leonards operation; chief technical officer Dr William Peters resumes managing development.
Board change at Sunshine Heart: Nicholas Callinan takes the chairman role at the October 2008 annual meeting as Malcolm McComas steps down from it but stays a director; Callinan's venture capital career is profiled.
Sunshine Heart says the US FDA approved a reimbursement category for its C-Pulse heart assist trial, opening Medicare reimbursement; it retained Quorum Consulting and expects patient enrollment at six US institutions in late 2008.
US regulators have conditionally cleared Sunshine Heart to begin its first American trial of the C-Pulse heart assist device in moderate heart failure patients, with enrollment at six institutions.
Sunshine Heart says the US regulator has conditionally cleared its first American trial of the C-Pulse heart assist device, with about twenty patients to enrol across six US hospitals from late 2008.
ASX-listed biotech Peplin arranged a private placement of roughly US$24 million to advance its keratosis drug into Phase III testing, led by GBS Venture Partners with several existing shareholders also taking part.
Peplin hires Tom Wiggans as CEO and Eugene Bauer as President/CMO while Michael Aldridge steps down; the dermatology company also announces a US$24m capital raising and a merger agreement with Neosil.
Hatchtech, an insect-control biotech, has appointed Dr Stewart Washer as chairman, citing his record founding biotech and agribusiness companies and taking Phylogica through an IPO.
Sunshine Heart's medical director welcomes a US regulator panel's unanimous green light for Thoratec's Heartmate II, arguing his company's C-Pulse targets a larger, earlier-stage patient group.
Melbourne biotech Cryptopharma completed an $800,000 round from GBS Venture Partners, Uniseed and ANU Connect for its cystic fibrosis drug, and appointed Dr David Crump CEO, with Dr Paul MacLeman moving to the board.
ChemGenex Pharmaceuticals has hired oncology drug developer Dr Adam Craig as its chief medical officer, its third senior clinical appointment lately, as it prepares its cancer drug omacetaxine for a regulatory filing.
Sunshine Heart announced Dr Richard Lin will step down from its board at the November 2007 AGM, with Three Arch Partners nominating Dr Conrad Wang to stand for election in his place.
Sunshine Heart's major shareholders CM Capital and GBS agreed a revised schedule for their $6 million share subscription, payable in two 2007 tranches with extra options, as the company seeks US trial approval.
A 2007 announcement that Australian biotech ChemGenex Pharmaceuticals appointed former Amgen executive Dr George Morstyn to its board, with CEO Greg Collier citing his oncology development and commercialisation expertise.
Sunshine Heart's Sydney subsidiary has named Victor Windeyer general manager while he remains chief operating officer of the American-listed parent, overseeing Australian operations ahead of a planned United States clinical trial filing.
Sunshine Heart's CEO showcased its C-Pulse cardiac support technology at a US bioventures conference; backer CM Capital attended, and the medtech firm readied US feasibility trials for its second-generation system.
A trial of Hatchtech's DeOvoT head lice treatment found no side effects in its first human testing, with an FDA filing and a second-phase study planned and crop-spray work ongoing.
A heart-device company has finished building an updated portable driver for its C-Pulse therapy system with a US manufacturing partner, completing preclinical work ahead of an American trial and regulator filing planned for 2007.
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ASX-listed heart device maker Sunshine Heart has finished training clinicians at six US hospitals ahead of its C-Pulse feasibility trial, planned to start later in 2007.
ChemGenex has begun enrolling patients in a second phase 2/3 trial testing Ceflatonin in chronic myeloid leukemia patients resistant to prior tyrosine kinase inhibitor treatment, with data expected in 2008.
ChemGenex completed an A$10.5m rights issue following an equal February institutional placement, a combined A$21m raise, with Alta Partners and GBS Venture Partners increasing their stakes to fund Ceflatonin leukemia trials.
Medical device company Sunshine Heart has contracted US research organisation Alquest to manage its North American clinical trial of the C-Pulse heart assist device.
Sunshine Heart, an ASX-listed medical device company, appoints Brian Bolton as its chief financial officer and company secretary from April 2007, thanking interim CFO Steven Skinner, ahead of United States clinical trials.
Peptech's 2007 announcement of hiring Citigroup as adviser to weigh strategic options after takeover interest from private equity firms; discussions only, with no deal agreed.
Two American heart failure specialists have agreed to serve as co-principal investigators for Sunshine Heart's C-Pulse feasibility trial, which the company says adds credibility as it prepares a wider US study in 2007.
Peptech announces GSK has completed its buyout of Domantis, the UK biotech in which the Australian company held a stake, yielding it 71.3 million pounds and a large gain on its original investment.
Device maker Sunshine Heart said its C-Pulse product moved closer to human trials in America after a positive regulator meeting, with a formal application planned for mid-2007 and hospitals already lined up.
Spinifex Pharmaceuticals won a $1.67 million federal Commercial Ready grant to advance its neuropathic pain drug, after a $3.25 million syndicate raise the previous July; it was spun out of the University of Queensland.
Sunshine Heart's US partners Plexus and Polymer Technology Group hit development milestones for the C-Pulse device ahead of a planned US clinical trial, with the company's operations chief praising the outsourced supplier model.
Heart device company Sunshine Heart added cardiologists Marc Silver and David Kaye to its medical advisory board in mid-2006, expanding a panel that guides work on its C-Pulse heart failure treatment.
Melbourne biotech Hatchtech received two $10,000 Australian commercialisation prizes and had recently drawn down extra funding to sit alongside its $2.4 million government grant for its head lice treatment.
Sunshine Heart says co-founder Crispin Marsh will swap his executive corporate affairs role for a non-executive board seat from mid-2006, as the medical device maker brings in senior staff including a new COO.