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Home » Authors » Catherine Shaffer

Articles by Catherine Shaffer

Protagonist’s Series B Draws New Investor, $4M for GI Pipeline

Sep. 20, 2013
By Catherine Shaffer
Protagonist Therapeutics Inc. added a new investor, Pharmstandard International SA, to its previously announced Series B financing, boosting its raise by $4 million, for a total of $18 million. The funds will support Protagonist’s pipeline of orally stable peptides for inflammatory bowel disease (IBD) and other gastrointestinal (GI) disorders.
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Sangamo Biosciences Prices its $65M Public Offering

Sep. 19, 2013
By Catherine Shaffer
Sangamo Biosciences Inc. will collect about $65 million in gross proceeds from a public offering of 6. 1 million shares of common stock in an underwritten public offering. The company will funnel the money into continued research and development of its engineered zinc finger DNA-binding proteins (ZFP).
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Regado Launches Phase III Trial Testing First-in-Class Clotbuster

Sep. 18, 2013
By Catherine Shaffer
Regado Biosciences Inc., of Basking Ridge, N.J., enrolled its first patient in the Phase III REGULATE-PCI trial of its antithrombotic drug, REG1, in patients undergoing percutaneous coronary intervention (PCI).
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Thermodox HEAT Study Subgroup Analysis Offers Hope

Sep. 17, 2013
By Catherine Shaffer
Following its dramatic primary endpoint miss in February, Celsion Corp.’s HEAT study offers some hope in a post-hoc analysis including positive overall survival results in a subgroup of participants.
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Galena Prices $35M Offering to fund Breast Cancer Drug

Sep. 16, 2013
By Catherine Shaffer
Galena Biopharma Inc. priced an underwritten public offering of 17.5 million units of stock at $2 per unit, for gross proceeds of $35 million. The funds will be used for commercialization of Abstral (fentanyl) sublingual tablets, and to support an ongoing Phase III trial of Neuvax.
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Perjeta Poised to Blaze a New Trail in Neoadjuvant Breast Cancer Therapy

Sep. 12, 2013
By Catherine Shaffer
The FDA’s Oncologic Drugs Advisory Committee voted 13 - 1 Thursday to support approval of Genentech Inc.’s supplemental biologics license application for Perjeta (pertuzumab) in neoadjuvant (preoperative) treatment of breast cancer. The application is the first for a neoadjuvant indication.
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Prometic Secures $10M for GMP Facility

Sep. 12, 2013
By Catherine Shaffer
Prometic Life Sciences Inc., of Laval, Quebec, will earmark a portion of the proceeds from a $10 million financing from Thomvest Seed Capital Inc. to commission its GMP facility for manufacture of plasma-derived orphan drugs.
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Ethics Questions Trouble Pediatric Ethics Committee

Sep. 11, 2013
By Catherine Shaffer
What if a child were playing on the train tracks? What if there were a nuclear accident on the coastline? What if a safe were falling from the sky? The Pediatric Ethics Subcommittee of the FDA spent a second day of meetings deliberating on the questions posed by the agency, informed by speaker presentations from the previous day.
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FDA Ethics Panel Tackles Pediatric MCM

Sep. 10, 2013
By Catherine Shaffer
The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee convened Monday morning for a two-day meeting to hammer out the difficult ethical issues related to development of pediatric medical countermeasures (MCM).
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Anoro Ellipta Briefing Docs Promising Ahead of PADAC Meeting

Sep. 9, 2013
By Catherine Shaffer
The FDA released briefing documents for Glaxosmithkline plc’s Anoro Ellipta (umeclidinium/vilanterol) inhaler product for chronic obstructive pulmonary disease (COPD) ahead of a scheduled advisory committee meeting on Sept. 10. The outlook for Anoro Ellipta appears to be smooth sailing, as the FDA’s clinical review found little to criticize in GSK’s submission.
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