Research Triangle Park, NC - May 1, 2015 – Envisia Therapeutics today announced that eight posters have been selected for presentation at the Association for Research in Vision and Ophthalmology’s (ARVO) Annual Meeting being held May 3 – 7, 2015 in Denver, Colorado. ARVO is the largest gathering of eye and vision researchers in the world, attracting over 11,000 attendees from more than 75 countries. The theme of the ARVO 2015 Annual Meeting is Powerful Connections: Vision Research and Online Networking.
Envisia Therapeutics to Present at ARVO 2015 Annual Meeting
IlluminOss Medical Appoints Amy Orlick Berman as Vice President of Clinical Affairs
EAST PROVIDENCE, RI, Apr 21, 2015 – IlluminOss Medical, a commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced the appointment of Amy Orlick Berman as the company's vice president of clinical affairs. Berman brings almost two decades of clinical affairs experience and has extensive expertise leading global research programs from inception through product approval. In her new position, she will be responsible for the global clinical trial program at IlluminOss, including the U.S. Lightfix trial towards securing approval for the treatment of impeding and actual fractures of the humerus in patients with metastatic bone disease.
Prior to joining IlluminOss, Berman was at Cordis, Johnson & Johnson for nearly 10 years where she held roles of increasing responsibility and oversaw a number of high-profile clinical research programs in the U.S., Europe and Japan.
CoLucid Pharmaceuticals Announces Initiation of First Phase 3 Pivotal Trial of Lasmiditan in Migraine
First Patient Randomized in SAMURAI STUDY Trial Being Conducted Under Special Protocol Assessment Agreement with FDA
BURLINGTON, Mass., April 28, 2015 – CoLucid Pharmaceuticals, Inc., a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches in adults, announced today that the first patient has been randomized in its SAMURAI study, the Company’s first Phase 3 pivotal trial of lasmiditan.
The objective of SAMURAI is to evaluate the safety and efficacy of lasmiditan (100 mg and 200 mg) in comparison to placebo two hours after dosing on freedom from migraine headache pain, which is our primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia), which is our secondary endpoint. SAMURAI is a randomized, double-blind, placebo-controlled parallel group study. The study is expected to treat up to 1,483 migraine patients with lasmiditan at approximately 70 U.S. sites for approximately 12 months. We expect patients will include those with migraine who also have cardiovascular risk factors or cardiovascular disease. SAMURAI is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.
Envisia Therapeutics Names Dr. Rhett Schiffman Chief Medical Officer
RESEARCH TRIANGLE PARK, NC – April 14, 2015 – Envisia Therapeutics today announced that it has named Rhett M. Schiffman M.D., M.S., M.H.S.A as Chief Medical Officer and Senior Vice President of Development. Prior to Envisia, Dr. Schiffman was the Chief Medical Officer at Neurotech Pharmaceuticals where he led the company’s NT-503 program, a cell-based therapy for wet age-related macular degeneration (AMD), through its phase 1/2 studies. He brings with him more than 20 years of expertise and achievements in ophthalmology.
Thrasos Secures $21 Million to Complete Phase 2 Study of THR-184 in the Prevention of Acute Kidney Injury and Expand the Company's Renal Portfolio
With these funds Thrasos will accelerate the development of its technology for Chronic Kidney Disease and position THR-184 for the next step in clinical development
MONTREAL, March 31, 2015 –Thrasos Therapeutics, a biotherapeutics company focused on delivering new solutions for kidney disease, today announced that it has completed a $21M Series D financing led by BDC Capital and SR One with participation by all current investors. Thrasos' Board of Directors will be expanded with the addition of Ela Borenstein, Managing Partner at BDC Capital Healthcare Venture Fund.
Syndax and Merck to Collaborate on Immuno-Oncology Study Evaluating Entinostat in Combination with KEYTRUDA® (pembrolizumab) in Lung Cancer and Melanoma
WALTHAM, Mass. and KENILWORTH, N.J., March 31, 2015 – Syndax Pharmaceuticals, Inc., and Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that they have entered into a clinical trial collaboration to evaluate the safety and efficacy of combining Syndax’s entinostat, an investigational epigenetic therapy, with Merck’s KEYTRUDA® (pembrolizumab), the first anti-PD-1 therapy approved in the United States. The Phase 1b/2 study will evaluate this novel combination regimen in patients with either advanced non-small cell lung cancer (NSCLC) or melanoma. The study is expected to begin enrolling patients in the second half of 2015.
IlluminOss Medical Announces the Enrollment of First Patient in Proximal Humerus Fracture Repair Trial at Albert Schweitzer Hospital
Light Fix Proximal Humerus Trial Led by Dr. Paul Vegt to Apply IlluminOss’ PatientConforming Implant Technology to Fragility Fractures; First use of New Latitude Radiopaque Markings
East Providence, RI/Dordrecht, Netherlands, (March 24, 2015) – IlluminOss Medical, a commercial stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that the first patient has been enrolled at Albert Schweitzer Hospital in the Netherlands as part of its EU Light fix Proximal Humerus Fracture Repair Trial for the treatment of osteoporotic and fragility fractures. The trial at Albert Schweitzer Hospital is being led by Dr. Paul Vegt, M.D., Ph.D, and is an expansion of IlluminOss’ technology in to the treatment of osteoporotic and fragility fractures most common in the elderly.
A drug that could raise IQ - Balance Therapeutics raises $18M, conducting Down Syndrome trials
MedCity News, March 19, 2015 - Stanford spinout Balance Therapeutics just raised $18 million for its therapy that could raise the IQ of people with intellectual disability. It’s using a small molecule drug that has been around for decades – GABA-A antagonists – but rationalizes the approach by delving deeper into the molecular underpinnings of what causes diseases like Down Syndrome and dementia.
And it could improve the IQ of a person with Down Syndrome 10 to 20 percent.
Anthera Announces $3 Million Research Award from Cystic Fibrosis Foundation Therapeutics for Development of Sollpura - a Novel Enzyme Therapy
HAYWARD, Calif., March 19, 2015 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) today announced it has received an award from Cystic Fibrosis Foundation Therapeutics Inc. of up to $3 million to support the manufacturing and clinical development of Anthera's novel pancreatic enzyme replacement therapy, Sollpura™ (liprotamase). Cystic Fibrosis Foundation Therapeutics is a non-profit affiliate of the Cystic Fibrosis Foundation.
Liprotamase is an investigational soluble, stable and non-porcine enzyme therapy intended for people with low digestive enzyme levels, or Exocrine Pancreatic Insufficiency (EPI) due to Cystic Fibrosis and other diseases. EPI is characterized by low absorption of fat and other nutrients due to a reduction in digestive enzymes produced by the pancreas. According to the Cystic Fibrosis Foundation, about 90 percent of people with cystic fibrosis have pancreatic insufficiency and need to take pancreatic enzymes with every meal and most snacks in order to absorb vital nutrients.
Anthera Pharmaceuticals Announces Completion of Interim Analysis from Phase 3 Trial with Blisibimod for IgA Nephropathy
-BRIGHT-SC study passes futility analysis and will continue to completion
-Primary efficacy analysis data expected in second half of 2016
-Feedback from European Medicines Agency incorporated into final study design
HAYWARD, Calif., March 16, 2015 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH), in collaboration with its partner Zenyaku Kogyo Co., Ltd. today announced that the BRIGHT-SC study of blisibimod in patients with IgA nephropathy (IgAN) should continue to completion as planned. This follows the successful completion of an interim futility analysis, conducted by an independent statistician, which evaluated several important biomarkers of renal disease in patients who had completed at least 8 weeks of treatment.
