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Home » Authors » Marie Powers

Articles by Marie Powers

Astrazeneca’s pain is Relypsa’s gain as FDA stings HK drug ZS-9 with CRL

May 31, 2016
By Marie Powers
Astrazeneca plc acknowledged receipt of a complete response letter (CRL) from the FDA on its new drug application (NDA) for sodium zirconium cyclosilicate, an oral suspension designed to treat hyperkalemia (HK). The candidate, better known as ZS-9, was the prize in Astrazeneca’s 2015 acquisition of ZS Pharma Inc. for $2.7 billion.
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Ionis sinks as company, investors fret over meaning of platelet signal

May 27, 2016
By Marie Powers
Shares of Ionis Pharmaceuticals Inc. (NASDAQ:IONS) were pummeled Thursday, sinking to a three-year low of $21.09, after the company clarified that “less than a handful of patients” enrolled in its phase III NEURO-TTR study evaluating IONIS-TTRRx in transthyretin (TTR) familial amyloid polyneuropathy (FAP) experienced a serious decline in platelets. The small number of events, in seriously ill patients often taking other medications, might have been a minor blip on the radar screen except that partner Glaxosmithkline plc (GSK), which holds an option to license IONIS-TTRRx exclusively, decided to postpone a phase III cardiovascular study, CARDIO-TTR, that was planned to evaluate IONIS-TTRRx in patients with TTR amyloid cardiomyopathy.
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Zenith lands dough for bro, moves lead cancer program into clinic

May 18, 2016
By Marie Powers
Zenith Epigenetics Corp. closed a $24.56 million private placement with its lead investor, Eastern Capital Ltd., by pricing 24.56 million common shares at $1 apiece. For starters, the funds will finance a phase I trial of the company's pan selective BET (bromodomain and extraterminal domain) inhibitor, ZEN-3694, in the lead indication of metastatic castrate-resistant prostate cancer (mCRPC).
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Biostage preclinical esophageal findings support regeneration

May 16, 2016
By Marie Powers

Pedal to the metal: Cancer drug prices outpace inflation years after launch

May 16, 2016
By Marie Powers
Pricing of prescription drugs has emerged as a cause célèbre in the U.S., especially in the vortex of a contentious presidential race, and an analysis of changes over time in the prices of two dozen approved oral cancer drugs could fan the flames.
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Biostage 'HARTs' preclinical esophageal findings in Mayo regenmed collaboration

May 13, 2016
By Marie Powers
Biostage Inc., formerly Harvard Apparatus Regenerative Technology Inc., or HART, said preclinical data from a collaborative large animal study with the Mayo Clinic showed complete regeneration of a segment of the esophagus using its Cellspan organ implants.
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Nacellins 'Encycle' across cell membranes to target IBD, fibrosis

May 12, 2016
By Marie Powers
After years of taking a back seat to research efforts in indications such as cardiovascular disease, cancer and pulmonary disease, the gastrointestinal space is hot.
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Epirus pares pipeline, slashes jobs in a biosimilars shake-up

May 11, 2016
By Marie Powers
Epirus Biopharmaceuticals Inc. is learning the hard way that developers of biosimilars are not immune from the market vagaries affecting the biopharma industry as a whole.
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Eylea generates cash for Regeneron, but Praluent plodding

May 6, 2016
By Marie Powers
Analysts and investors found plenty to like in first quarter earnings from Regeneron Pharmaceuticals Inc., which beat consensus revenue forecasts with approximately $1.2 billion in global sales, including a 44 percent increase in U.S. and global net sales of Eylea (aflibercept).
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Kynamro dealt to newco Kastle Therapeutics for potential $95M

May 4, 2016
By Marie Powers
Eight years after Ionis Pharmaceuticals Inc. selected then-independent Genzyme Corp. as the partner for its phase III lipid-lowering drug, mipomersen, in a potential $1.9 billion deal, the Carlsbad, Calif.-based company dealt the commercial asset, Kynamro, to start-up Kastle Therapeutics LLC for peanuts.
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