Tolera Therapeutics Granted Orphan Drug Designation for Organ Transplant Rejection Drug
KALAMAZOO, Mich., April 9 /PRNewswire/ -- Tolera Therapeutics, Inc., was granted orphan drug status by the United States Food and Drug Administration (FDA) for its initial lead candidate, TOL101, for prophylaxis of acute rejection of solid organ transplantation. TOL101 is a biologic protein that...Ikaria(R) Acquires North American Rights to LUCASSIN(R) From Orphan Therapeutics
- No Currently Approved Drugs to Treat Hepatorenal Syndrome Type 1 in U.S. - CLINTON, N.J. and LEBANON, N.J., Sept. 2 /PRNewswire/ -- Ikaria Holdings, Inc. and Orphan Therapeutics, LLC announced today that they have entered into an agreement under which Ikaria ...Biotest Pharmaceuticals Corporation Responds to Orphan Drug Act Announcement
BOCA RATON, Fla., March 27 /PRNewswire/ -- Biotest Pharmaceuticals Corporation, a leading developer of immunology biotherapeutic products, today responded to an announcement that a Hepatitis B Immune Globulin Intravenous (Human) product manufactured by another company has received Orphan Drug ...Ocera Therapeutics Receives Orphan Drug Status for AST-120 for Pouchitis
Company to Present at 26th Annual JP Morgan Healthcare Conference SAN DIEGO, Jan. 7 /PRNewswire/ -- Ocera Therapeutics, Inc., a privately-held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat gastrointestinal and liver diseases, an...Isis Announces ISIS 333611 Granted Orphan Drug Status for Treatment of ALS
CARLSBAD, Calif., Dec. 13 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS ) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug status to ISIS 333611 for the treatment of an inherited form of amyotrophic lateral sclerosis (ALS), commonly...ViroPharma Receives European Orphan Drug Designation for CAMVIA(TM)
EXTON, Pa., Nov. 12 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM ) today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) has granted orphan drug designation for CAMVIA for the prevention of cytomegalovirus (CMV) dise...FDA Grants Kiadis Pharma Lead Product ATIR Orphan Drug Designation
AMSTERDAM, The Netherlands, Nov. 6 /PRNewswire/ -- Kiadis Pharma announced today that its lead product ATIR has been granted orphan drug designation by the US Food and Drug Administration (FDA) as a therapy for immune reconstitution and prevention of Graft versus Host Disease (GvHD) following ...Lexicon's Drug Candidate LX1032 for Carcinoid Syndrome Receives Orphan Drug Designation From EMEA
THE WOODLANDS, Texas, July 21 /PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX ), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it has received orphan d...Cystic Fibrosis - Liposomal Tobramycin Receives Second Orphan Drug Designation Within Weeks
ZURICH, July 16 /PRNewswire/ -- An innovative treatment for infections of the respiratory tract in cystic fibrosis patients has received a second orphan drug designation in the US only weeks after a first designation was granted. The recent designation relates to Burkholderia cepacia pathogens...AIMSPRO is Awarded TGA Orphan Status for the Treatment of Amyotrophic Lateral Sclerosis
LONDON, June 1 /PRNewswire/ -- Privately owned UK biotech company Daval International Limited ( http://www.davalinternational.com ) has been informed by Australia's Therapeutic Goods Administration (TGA) that its innovative anti-inflammatory agent AIMSPRO(R) has been awarded Orphan Status for ...AMT Receives EMEA Orphan Drug Designation for Acute Intermittent Porphyria
AMSTERDAM, May 28 /PRNewswire-FirstCall/ -- Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, announced today that the European Medicines Agency has granted Orphan Drug Designation to AMT's gene therapy product AMT-021 for the treatment of acute int...Oasmia: FDA Grants Paclical(R) Orphan Drug Designation for Ovarian Cancer in the USA
UPPSALA, Sweden, April 14 /PRNewswire-FirstCall/ -- Oasmia Pharmaceutical, Uppsala, Sweden, has been granted Orphan Drug designation by the USA FDA of Paclical(R) for the treatment of ovarian cancer. Orphan Drug designation can entail additional assistance from FDA to expedite and optimize dru...Kiadis Pharma Receives Two Orphan Drug Designations for Reviroc(TM) From the FDA
AMSTERDAM, December 8 /PRNewswire/ -- Biopharmaceutical company Kiadis Pharma announces today that the U.S. Food and Drug Administration (FDA) has granted its product Reviroc(TM) Orphan Drug Designations (ODD) for the treatment of two types of Non-Hodgkin Lymphoma (NHL). One ODD has been granted f...A to Z Drug Facts, 6th Edition
Features:... Rx, OTC, orphan, and investigational drugs A searchable index of Canadian drugs by Trade name Indications for labeled, unlabeled and orphan uses Side effects organized by body system Route/Dosage section organized by age, route and specific disease state or medical condition Precautions...Sequella receives US and EU orphan drug status for SQ109 for the treatment of TB
ROCKVILLE, MD -- Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing products to treat diseases of epidemic potential, announced today that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) independently reviewed Sequella lead dr...Virulizin granted orphan drug status in Europe
Leading marine scientists for the first time have assessed dolphin and porpoise populations around the world which are severely threatened by entanglement in fishing gear and recommended nine urgent priorities for action in a report commissioned by the World Wildlife Fund. These nine projects highl...DuoCort: New chronotherapy for adrenal insufficiency
...en. DuoCort is developing an improved glucocorticoid replacement therapy for patients with adrenal insufficiency, a rare disease for which DuoCort has orphan drug designations in Europe and the USA. The new product, a once daily dual-release hydrocortisone oral tablet that comes in both 5 mg and 20 mg sizes...International collaboration by scientists culminates in novel ion channels database
...l and patho-physiological properties of human, rat and mouse genes encoding in excess of 354 non sensory G protein-coupled receptors (GPCRs) including orphan receptors, 71 LGIC and 141 VGIC subunits. This set of genes is known to encompass a third of current drug targets and a significant proportion of li...Duke, Harvard researchers to monitor bonobo reintroduction
...are and threatened bonobo ape will lead monitoring efforts after a group of orphan bonobos are returned to the wild in the Congo for the first time this month. On June 14 and 28, for the first time ever, a group of 18 orphan bonobos will be returned to the wild. "We'll be monitoring the social be...NIH announces new program to develop therapeutics for rare and neglected diseases
...esearch (ORDR). "While Congress has previously taken important steps to help these patients, such as providing incentives for drug companies under the orphan Drug Act, this is the first time it is providing support for specific preclinical research and product development known to be major barriers prevent...Master gene plays key role in blood sugar levels
...dies in O'Malley's laboratory in collaboration with researchers from Duke University Medical Center in Durham, N.C., revealed that SRC-2 works with an orphan nuclear receptor ROR alpha to affect the activity of the sugar-converting enzyme, glucose-6-phosphatase in the liver. The liver produces 90 percen...Avoiding Spleen Removal for Cooley's Anemia SufferersAvoiding spleen removal for Cooley's anemia suf
...progressive iron overload occurs from increased gastrointestinal iron absorption. Despite its prevalence, Cooley's anemia (beta-thalassemia) is an orphan disease, of which studies are rare and not well-funded. Current disease management includes prenatal diagnosis, transfusion therapy, iron chelation an...Berlin Heart Inc. Receives FDA Orphan Product Development Grant
THE WOODLANDS, Texas, June 17 /PRNewswire/ -- Berlin Heart Inc. today announced it has been awarded an Orphan Product Development Grant by the FDA, to support the ongoing Investigational Device Exemption (IDE) study of the EXCOR(R) Pediatric Ventricular Assist Device (VAD). Dr. Christopher Alm...Delcath Systems Granted Third Orphan Drug Designation
NEW YORK, June 2 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH ), a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced today that the United States Food and Drug Administration ("FDA") granted Delcath's a...Tolera Therapeutics Granted Orphan Drug Designation for Organ Transplant Rejection Drug
KALAMAZOO, Mich., April 9 /PRNewswire/ -- Tolera Therapeutics, Inc., was granted orphan drug status by the United States Food and Drug Administration (FDA) for its initial lead candidate, TOL101, for prophylaxis of acute rejection of solid organ transplantation. TOL101 is a biologic protein that...FDA Approves Orphan Drug Status for Revolutionary Cancer Drug for Children
LOS ANGELES, Oct. 20 /PRNewswire/ -- The Cure Our Children Foundation, a nonprofit charitable foundation dedicated to children, announced today that the U.S. Food and Drug Administration (FDA) has approved the Orphan Drug Designation of the foundation's unique drug product for children with Ew...EMEA Grants Kiadis Pharma Lead Product ATIR(TM) Orphan Drug Designation
AMSTERDAM, September 22 /PRNewswire/ -- Kiadis Pharma announced today that its lead product ATIR(TM) has been granted orphan drug designation (ODD) by the European Medicines Agency (EMEA) for the prevention of acute Graft versus Host Disease (GvHD) following an allogeneic bone marrow transplan...