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Home » Authors » Marie Powers

Articles by Marie Powers

As AAN abstracts drop, attention flies to Bluebird’s CCALD data

March 7, 2016
By Marie Powers
Abstracts from the 2016 annual meeting of the American Academy of Neurology (AAN) drew swift reaction from analysts, who zeroed in on prospects for success in Bluebird Bio Inc.’s ongoing phase II STARBEAM trial of Lenti-D in childhood cerebral adrenoleukodystrophy (CCALD), an ultra-rare and ultimately fatal disorder.
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Syndax slashes price, lowers its sights to raise $52.8M in IPO

March 4, 2016
By Marie Powers
Syndax Pharmaceuticals Inc. managed to squeak through the IPO window but not before slashing its price to $12, below its proposed range of $14 to $16, to collect $52.8 million – well below its initial target raise of approximately $81 million.
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Ipsen suits Exelixis in potential $855M ex-U.S. license agreement

March 2, 2016
By Marie Powers
Exelixis Inc. selected Ipsen SA as its traveling partner outside the U.S., Canada and Japan in an exclusive licensing deal to commercialize and develop lead oncology drug cabozantinib (cabo) in all indications.
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Astrazeneca monotherapy miss in mesothelioma raises the stakes on combination studies

March 1, 2016
By Marie Powers
Tremelimumab flopped, again, as monotherapy, this time with Astrazeneca plc. The drug failed to demonstrate effectiveness in overall survival (OS) compared to placebo in a randomized, double-blind phase IIb study in second- or third-line treatment of patients with unresectable pleural or peritoneal malignant mesothelioma.
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OA trials numerous but endpoints tricky as stakeholders search for another way

Feb. 29, 2016
By Marie Powers

Peregrine halts bavi SUNRISE in NSCLC, pauses chemotherapy combo studies

Feb. 29, 2016
By Marie Powers
Peregrine Pharmaceuticals Inc. turned out the lights on its lead candidate, bavituximab (bavi), in the lead program in non-small-cell lung cancer (NSCLC). The company said it is halting the phase III SUNRISE trial evaluating bavi plus docetaxel in patients with previously treated locally advanced or metastatic nonsquamous NSCLC compared to docetaxel alone after the study's independent data monitoring committee concluded the bavi group showed insufficient improvement in overall survival (OS) to warrant continuation of SUNRISE.
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Better biomarkers needed to assess OA therapies, but patient voice still missing

Feb. 26, 2016
By Marie Powers

OA trials numerous but endpoints tricky as stakeholders search for better way

Feb. 26, 2016
By Marie Powers
ATLANTA – Speakers at the second day of the Accelerating Osteoarthritis (OA) Clinical Trials Workshop co-sponsored by the Arthritis Foundation and the FDA pointed to a wealth of trials examining drug, surgical and other interventions to treat the disease, citing more than 500 studies in the U.S. and five dozen in Europe under the sponsorship of dozens of biopharmas and academic institutions.
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Better biomarkers needed to assess OA therapies, but patient voice still missing

Feb. 25, 2016
By Marie Powers
ATLANTA – "It takes a village" to develop biomarkers in osteoarthritis (OA), Chris Leptak, medical officer in the FDA Office of New Drugs, Guidance and Policy Team told participants at the Accelerating Osteoarthritis Clinical Trials Workshop co-sponsored by the Arthritis Foundation and the FDA.
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Safety data in hand, Oncbiomune plies prostate cancer immunotherapy

Feb. 24, 2016
By Marie Powers
Oncbiomune Pharmaceuticals Inc. is pressing ahead with a phase II trial of Proscavax, its therapeutic vaccine to treat prostate cancer, after preliminary data from a small phase I trial showed the treatment was safe and suggested initial indications of efficacy.
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