TESARO Announces Submission of Rolapitant New Drug Application (NDA) to U.S. Food and Drug Administration
WALTHAM, Mass., Sept. 8, 2014 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced that it has submitted the New Drug Application (NDA) for oral rolapitant to the U.S. Food and Drug Administration (FDA). Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist developed for the prevention of chemotherapy-induced nausea and vomiting (CINV).
SAN DIEGO, Aug. 11, 2014 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX) today announced that the U.S. FDA has granted Orphan Drug Designation to mocetinostat, a spectrum selective HDAC inhibitor, for diffuse large B-cell lymphoma (DLBCL). In June, mocetinostat was granted Orphan Drug Designation as a treatment for myelodysplastic syndrome (MDS). Orphan drug designation is also being sought for bladder cancer patients with specific genetic alterations.
New Patent Also Issued With Composition Claims for Triheptanoin
NOVATO, Calif., Aug. 5, 2014 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced a license agreement with UniQuest Pty Limited for intellectual property related to the treatment of refractory epilepsy and other seizure-related and neurologic disorders with triheptanoin (UX007). The intellectual property originated from research on epilepsy and other neurologic models conducted at The University of Queensland.
Three Abstracts Presented at 2014 World Transplant Congress
DURHAM, N.C., July 31, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, presented new data on its investigational antiviral, brincidofovir (BCV, CMX001), at the 2014 World Transplant Congress (WTC) in San Francisco.
Data presented at WTC support brincidofovir's antiviral activity and safety profile in hematopoietic cell transplant (HCT) and solid organ transplant recipients who were treated for viral infections including adenovirus (AdV), cytomegalovirus (CMV), BK virus, Epstein-Barr virus (EBV) and varicella zoster virus (VZV).
Anthera to Form a New Subsidiary, Alkira Therapeutics, to Assume All Development Activities and Registration Activities as a Subsidiary of Anthera
HAYWARD, Calif., July 14, 2014 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) today announced that it has acquired Sollpura (liprotamase), a novel investigational Pancreatic Enzyme Replacement Therapy ("PERT") from Eli Lilly and Company. Sollpura is a soluble, stable and non-porcine enzyme product intended for the treatment of patients with low digestive enzyme levels, or Exocrine Pancreatic Insufficiency (EPI), due to cystic fibrosis, and potentially other diseases. EPI is characterized by low absorption of fat and other nutrients due to a reduction in digestive enzymes produced by the pancreas.
- Blood-Based Test Has Potential to Improve Quality of Care and Lower Costs of Evaluation of Obstructive Coronary Artery Disease -
REDWOOD CITY, Calif. – [July 7, 2014] - CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, confirmed today that Aetna has established a clinical policy for the company’s Corus® CAD gene expression test. With this decision, the Corus CAD gene expression test is eligible for coverage among Aetna and Coventry Health members. Aetna considers the Corus CAD gene expression test medically necessary for evaluation of non-diabetic adults with chest pain or anginal equivalent symptoms who have no history of obstructive coronary artery disease.
NOVATO, CA – July 1, 2014 – Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, announced the first patient screened and enrolled in the Phase 2 study of the human monoclonal anti-FGF23 antibody KRN23 (UX023) in pediatric patients with X-linked hypophosphatemia (XLH). XLH is an inherited metabolic bone disease characterized by short stature, skeletal deformities, bone pain, fractures, and muscle weakness.
Funds to Support Commercial Launch and Post-Market Clinical Studies of Rotator Cuff System with Bioinductive Implant for Treating Rotator Cuff Disease
PLYMOUTH, MINN. — July 1, 2014 - Rotation Medical, a medical device company focused on developing new technologies to treat rotator cuff disease, today announced that it has secured $27.2 million in an oversubscribed Series B financing. Life Sciences Partners (LSP), a new investor, and New Enterprise Associates (NEA) co-led the financing, which also included new investor Pappas Ventures and others. Fouad Azzam, Ph.D., from LSP and Scott Weiner from Pappas Ventures will join the Rotation Medical Board of Directors. The funding will support the commercial launch and post-market clinical studies of the Rotation Medical rotator cuff system.
Treatment with KRN23 induces a sustained increase in serum phosphorus and increases in bone remodeling markers
Novato, CA— June 24, 2014 — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the presentation of results from a multiple-dose study, conducted by Kyowa Hakko Kirin Pharma, Inc (KKP), of the investigational anti-FGF23 monoclonal antibody KRN23 (UX023) in adult patients with X-linked hypophosphatemia (XLH). XLH is an inherited metabolic bone disease characterized by short stature, skeletal deformities, bone pain, fractures, and muscle weakness. The data was presented at the 2014 ICE/ENDO joint meeting of The Endocrine Society and The International Congress of Endocrinology in Chicago.
SAN DIEGO, June 17, 2014 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX) announced that mocetinostat, the company's spectrum selective HDAC inhibitor, has been granted Orphan Drug Designation by the U.S. Food & Drug Administrationas a treatment for myelodysplastic syndrome (MDS). Mocetinostat is being developed in Phase 2 clinical studies in combination with Vidaza as a treatment for intermediate and high-risk MDS, as well as a single agent treatment in patients with diffuse large B-cell lymphoma (DLBCL) and bladder cancer targeting specific genetic mutations in histone acetylation that increase the likelihood of response in tumor cells.
