Akebia and Mitsubishi Tanabe Pharma Announce Collaboration to Develop and Commercialize Vadadustat in Asia

– Agreement Includes Total Upfront and Milestone Payments of up to $350 Million, Including $100 Million in Upfront and Development Payments, as well as Tiered Double Digit Royalties –
– Akebia to Host Conference Call at 8:30 AM Eastern Time Today –

CAMBRIDGE, Mass. & OSAKA, Japan -- Akebia Therapeutics, Inc. (AKBA), and Mitsubishi Tanabe Pharma Corporation (TSE:4508) (MTPC) announced today that they have entered into a development and commercialization agreement for vadadustat (formerly AKB-6548), an oral therapy for the treatment of anemia related to chronic kidney disease (CKD), in Japan and certain other countries in Asia.

Published: 14 December 2015
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NephroGenex Announces FDA Clearance of IND Application for Clinical Study of Intravenous Pyridorin in the Treatment of Acute Kidney Injury

RALEIGH, N.C.-- NephroGenex, Inc. (Nasdaq:NRX), a pharmaceutical company focused on the development of therapeutics to treat kidney disease, today announced that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug (IND) application for clinical studies with intravenous Pyridorin® for the treatment of acute kidney injury.

Acute kidney injury (AKI) is a serious medical condition characterized by an abrupt loss of kidney function. AKI is estimated to affect up to 18 percent of hospital inpatients and is responsible for approximately 2 million deaths annually worldwide.1, 2 In Company sponsored preclinical studies, I.V. Pyridorin ameliorated renal oxidative stress and injury, enhanced functional recovery and reduced post-injury fibrosis. Additionally, a recently completed preclinical toxicity study of intravenous Pyridorin did not show signs of toxicity or intolerance to the drug.

Published: 14 December 2015
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Otonomy Announces FDA Approval of OTIPRIO(TM) for the Treatment of Pediatric Patients Undergoing Tympanostomy Tube Placement Surgery

U.S. Commercial Launch Expected in the First Quarter of 2016
Webcast and Conference Call at 8:30 a.m. EST Today

SAN DIEGO, Dec. 11, 2015  -- Otonomy, Inc. (OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that the U.S. Food and Drug Administration (FDA) has approved OTIPRIO (ciprofloxacin otic suspension) for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. OTIPRIO is a single-dose, physician-administered antibacterial and the first product approved by the FDA for this indication.

Published: 11 December 2015
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Eagle Pharmaceuticals Achieves Milestone to Receive $15 Million Payment for Approval of BENDEKA

-The Company will receive a 20% royalty on net sales of BENDEKA-

WOODCLIFF LAKE, N.J.-- Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) (Nasdaq:EGRX) announced that it has achieved the milestone which entitles the Company to receive a $15 million payment from Teva Pharmaceuticals Industries Ltd. resulting from the U.S. Food and Drug Administration (“FDA”) approval of BENDEKA™, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine for the treatment of patients with chronic lymphocytic leukemia (“CLL”) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (“NHL”) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Published: 08 December 2015
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Onconova Presents Positive Data From Phase 2 Combination Trial of Oral Rigosertib and Azacitidine in Higher-Risk Myelodysplastic Syndromes at 2015 ASH Annual Meeting

--Combination Achieved 77% Overall Response Rate in all MDS Patients--
--Overall Response Rate of 84% in treatment-naïve MDS Patients--
--Response Rate of 64% in MDS Patients who had Previously Failed HMAs--
--Company to Provide Further Information on Next Steps for Combination Development Program at Investor Event in New York City on December 16th--

NEWTOWN, Pa., Dec. 07, 2015 - Onconova Therapeutics, Inc. (ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced the presentation of data from an ongoing Phase 1/2 clinical trial of oral rigosertib and azacitidine in higher-risk myelodysplastic syndromes (HR-MDS) at the 57th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.

Published: 08 December 2015
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