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.
Anthera Pharmaceuticals Announces Acquisition of Sollpura® (liprotamase) for Exocrine Pancreatic Insufficiency From Eli Lilly and Company
CardioDx Announces Aetna and Coventry Health Coverage for Corus® CAD Gene Expression Test
- 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.
Ultragenyx Announces Initiation of a Phase 2 Study of KRN23 for Pediatric X-Linked Hypophosphatemia in the US and EU
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.
Rotation Medical Completes $27.2 Million Series B Financing
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.
Ultragenyx Announces Results from Phase 1/2 Study of KRN23 in X-linked Hypophosphatemia in Adults
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.
Mirati Therapeutics Receives Orphan Drug Designation from U.S. Food & Drug Administration for Mocetinostat in Myelodysplastic Syndrome
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.
Thrasos Presents Preclinical Data Demonstrating THR-184 Prevents Loss of Kidney Function Following Acute Ischemic Injury
Results presented at the ERA-EDTA congress led to initiation of ongoing Phase 2 clinical study in patients undergoing cardiac surgery
MONTREAL, June 3, 2014 – Thrasos Therapeutics, a biotherapeutics company focused on delivering new solutions for kidney disease, today presented preclinical results showing that its lead development compound THR-184 can effectively protect against loss of kidney function following acute ischemic injury in rat. Results of the studies were presented at the 51st European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Congress taking place in Amsterdam, The Netherlands.
Plexxikon Announces Promising Preliminary PLX3397 Phase 1 Extension Data in Patients with Pigmented Villonodular Synovitis (PVNS)
79 Percent of Patients Achieved Partial Response; 21 Percent Had Stable Disease with Targeted Therapy PLX3397
BERKELEY, Calif., May 14, 2014 (BUSINESS WIRE) -- Plexxikon, a member of the Daiichi Sankyo Group, announced today promising, proof-of-concept Phase 1 extension clinical data with PLX3397 in pigmented villonodular synovitis (PVNS), a type of rare, often locally aggressive, musculoskeletal neoplasm that arises from the soft tissues of joints and tendons. Interim data from this ongoing trial show that all evaluable patients treated with PLX3397 achieved either partial responses or stable disease. PLX3397 is a novel, oral small molecule that potently and selectively inhibits CSF1R, KIT and oncogenic FLT3 kinases, which play important roles in cancer. CSF1R, in particular, has been shown to be a primary driver in PVNS. These data are being released today as part of the American Society of Clinical Oncology (ASCO) 50th Annual Meeting Press Program. More detailed data will be presented at the ASCO 50th Annual Meeting, being held May 31-June 3 in Chicago.
Shire adds to rare disease portfolio with acquisition of Lumena Pharmaceuticals, bringing late stage compounds for rare GI/hepatic conditions
- Acquisition of Lumena Pharmaceuticals, a biopharmaceutical company with late stage rare disease pipeline assets
- Adds to Shire's rare diseases portfolio and leverages this expertise, and is a perfect combination with Shire's already strong Gastrointestinal (GI) presence
- Adds LUM001 in Phase 2 development for four rare and devastating hepatic diseases, two pediatric and two adult with a potential 2016 approval and LUM002 a Phase 2-ready candidate for the treatment of non-alcoholic steatohepatitis (NASH)
- Very attractive opportunity to develop treatments for significant unmet need in rare cholestatic liver diseases as well as a treatment for non-alcoholic steatohepatitis (NASH)
- Shire will acquire Lumena Pharmaceuticals for an upfront payment of $260 million in cash, plus a payment for net cash at closing, and near-term contingent milestone payments related to ongoing clinical trials
- These two compounds, and Shire's full portfolio, will be discussed in more detail at an Investor Day later in 2014.
Dublin, Ireland and San Diego, U.S. – May 12th, 2014 – Shire plc (LSE: SHP, NASDAQ: SHPG) and Lumena Pharmaceuticals, Inc., a biopharmaceutical company with rare disease pipeline assets, announce the acquisition of Lumena Pharmaceuticals by Shire.
TESARO Announces Successful Achievement of Primary and All Secondary Endpoints in Third and Final Phase 3 Trial of Rolapitant
- Achieved Primary Endpoint of Complete Response (CR) in the Delayed Period (24 to 120 Hours) Following Initiation of Chemotherapy
- Achieved Key Secondary Endpoints of CR in the Acute and Overall Periods
- Achieved All Secondary Endpoints, Including No Significant Nausea
- Adverse Event Profile Consistent with Earlier Clinical Trials
- New Drug Application (NDA) Submission to U.S. FDA On Track for Mid-2014
WALTHAM, Mass., May 12, 2014 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced positive top-line results from the third and final Phase 3 trial of rolapitant, an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The rolapitant arm in this trial, which enrolled patients receiving cisplatin-based, highly emetogenic chemotherapy (HEC), successfully achieved statistical significance over the standard therapy arm for the primary and all secondary endpoints. The adverse event profile for rolapitant remains consistent with that seen in previous clinical studies.
