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 The leading web portal for pharmacy resources, news, education and careers October 15, 2018
Pharmacy Choice - News - Pharmaceutical Development - October 15, 2018

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
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10/15/18 - 35 Stocks Moving In Monday's Mid-Day Session
Gainers XTL Biopharmaceuticals Ltd. climbed 24.6 percent to $2.99. Krystal Biotech, Inc. shares climbed 19.7 percent to $18.77 after the company's Phase 1/ 2 trial of KB103 for dystrophic epidermolysis bullosa met all primary efficacy and safety endpoints. Cambium Learning Group, Inc. climbed 19.3 percent to $14.395 after the company agreed to be a
10/15/18 - ACACIA PHARMA PROVIDES FURTHER UPDATE ON FDA REGULATORY REVIEW OF BARHEMSYS(TM)
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation No 596/ 2014. Cambridge, UK and Indianapolis, US- 15 October 2018: Acacia Pharma Group plc provides an update following receipt of a Complete Response Letter from the US Food and Drug Administration in respect of its New Drug Application for B
10/15/18 - Advicenne Receives Health Canada Clearance to Extend its Pivotal Phase III Trial of ADV7103 in Canada
Advicenne, a specialty pharmaceutical company focused on the development of pediatric-friendly therapeutics for the treatment of orphan renal and neurological diseases, announced today that it has received a No Objection Letter to extend its ARENA-2 pivotal Phase III trial for the treatment of distal Renal Tubular Acidosis in Canada from Health Can
10/15/18 - Aevi Genomic Medicine Announces Completion of Enrollment for Part B of the ASCEND Trial
Aevi Genomic Medicine, Inc. today announced that it has reached full enrollment of Part B of its Phase 2 ASCEND clinical trial. Part A completed enrollment in August 2018. The accelerated enrollment in Part B will allow the Company to provide complete top line data for both Parts A and B of the ASCEND trial in January 2019. Individual and pooled
10/15/18 - Aimmune Therapeutics Announces Initiation of Phase 2 Study With Regeneron and Sanofi of AR101
Aimmune Therapeutics a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced the initiation of a phase 2 study, with Regeneron and Sanofi, of AR101 with adjunctive dupilumab in peanut-allergic patients. As quoted in the press release:. We are delighted to have Regeneron and Sanofi join u
10/15/18 - Aimmune Therapeutics Announces Initiation of Phase 2 Study With Regeneron and Sanofi of AR101 With Adjunctive Dupilumab in Peanut-Allergic Patients
Aimmune Therapeutics, Inc., a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced the initiation of a phase 2 study, with Regeneron and Sanofi, of AR101 with adjunctive dupilumab in peanut-allergic patients. We are delighted to have Regeneron and Sanofi join us in our commitment to imp
10/15/18 - Alnylam Announces Plan to Initiate Rolling Submission of a New Drug Application
Alnylam Pharmaceuticals, the leading RNAi therapeutics company, today announced that in consultation with the U.S. Food and Drug Administration, the Company plans to pursue a full approval based on the complete results of the ENVISION Phase 3 study of givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 for the...
10/15/18 - Alnylam Announces Plan to Initiate Rolling Submission of a New Drug Application and Pursue Full Approval for Givosiran
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, today announced that in consultation with the U.S. Food and Drug Administration, the Company plans to pursue a full approval based on the complete results of the ENVISION Phase 3 study of givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 for
10/15/18 - Alnylam Plans To Pursue Full Approval Of Givosiran, Rolling Submission Of NDA
WASHINGTON- Alnylam Pharmaceuticals Inc., an RNAi therapeutics company, said that in consultation with the U.S. Food and Drug Administration, it plans to pursue a full approval of givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 or ALAS1 for the treatment of acute hepatic porphyria or AHP. Based on our positiv
10/15/18 - Applied Therapeutics to Present New Data on Novel Investigational Treatment for Galactosemia at 2018 NORD Summit
Applied Therapeutics Inc., a privately held biotechnology company focused on developing transformative drugs in areas of high unmet medical need, announced today that it will present data on AT-007, a novel investigational aldose reductase inhibitor, at the 2018 National Organization for Rare Disorders' Rare Diseases& Orphan Products Breakthrough
10/15/18 - Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1 Study of ARO-ANG3
Arrowhead Pharmaceuticals Inc. today announced that it has filed an application for approval to begin a Phase 1 clinical trial of ARO-ANG3, an RNAi-based investigational medicine targeting angiopoietin like protein 3 being developed for the treatment of dyslipidemias and metabolic diseases. Chris Anzalone, Ph.D., president and CEO of Arrowhead...
10/15/18 - Athenex and Xiangxue Life Sciences Announce Preliminary Results of Patients Receiving T-Cell Receptor Affinity Enhancing Specific T-Cell Therapy (TAEST) Showed Encouraging Positive Clinical Signals
Athenex, Inc., a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that preliminary results of pilot studies in China in which patients received T-cell receptor affinity enhancing specific T-cell therapy showed...
10/15/18 - Auburn vet school, UAB part of joint NIH study of glioma brain cancer [Sudan Tribune]
People and animals suffering from the deadliest form of brain cancer are undergoing similar treatment in an NIH- funded clinical trial through the University of Alabama at Birmingham, Auburn Universitys College of Veterinary Medicine and two other currently enrolled Southeastern veterinary programs. Renee Chambers, who holds a doctor of veterinary.
10/15/18 - Avadel Pharmaceuticals Presents Data for NOCTIVA at 2018 American Urogynecologic Society Annual Scientific Meeting
Avadel Pharmaceuticals plc, a company focused on providing innovative medicines for chronic urological, central nervous system, and sleep disorders, presented data from two abstracts from Phase 3 clinical trials of NOCTIVA? at the American Urogynecologic Society Annual Scientific Meeting, Pelvic Floor Disorder Week 2018 in Chicago, Illinois fro
10/15/18 - Chugai Presents Results from Phase III Study of Satralizumab in NMOSD at ECTRIMS 2018
Chugai Pharmaceutical Co., Ltd. announced that results from the phase III study of satralizumab, SAkuraSky Study, were presented at the Congress of European Committee for Treatment and Research in Multiple Sclerosis 2018 held in Berlin, Germany from October 10 to 12. Satralizumab is a humanized investigational recycling anti-IL-6 receptor monoclona
10/15/18 - Cinclus Pharma abstract selected Poster of Excellence at the UEGW conference
The Basel, Switzerland- based biotech company Cinclus Pharma AG today announced that its abstract P1152 was selected Poster of Excellence at the upcoming United European Gastroenterology Week, which is the largest annual meeting in Europe focused on GI-related diseases. The poster presentation will be given by Kjell Andersson, CEO at Cinclus Pharma
10/15/18 - CORRECTING and REPLACING Delcath Expands Rollout of Registration Trial in Metastatic Ocular Melanoma
In a release issued under the same headline earlier today by Delcath Systems, Inc., please note the first sentence of the first paragraph should read: " Delcath Systems, Inc., an interventional oncology company focused on the treatment of primary and metastatic cancer centers of the liver, announces the addition of six major cancer centers in the
10/15/18 - CTD Holdings Announces Plans to Broaden its Expanded Access Program for Trappsol Cyclo?
CTD Holdings, Inc., a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, announced today that the company will broaden its expanded access program for its investigational drug, Trappsol Cyclo?, currently being studied for Niemann Pick Disease Type C.
10/15/18 - Delcath Expands Rollout of Registration Trial in Metastatic Ocular Melanoma
Delcath Systems, Inc., an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announces the addition of six major cancers in the United States that have adopted the amended trial protocol for the company s registration trial in ocular melanoma liver metastases. Moffitt Cancer Center- Tampa,
10/15/18 - Diffusion Pharmaceuticals Chief Financial Officer William Bill Hornung to Present at 2018 BIO Investor Forum
Diffusion Pharmaceuticals Inc., a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body s ability to bring oxygen to the areas where it s needed most, announced today that Chief Financial Officer William Bill Hornung will join leaders from the world s top pharmace
10/15/18 - Dr Reddy's to market aspirin, anti-coagulant drug in US [New Indian Express (India)]
HYDERABAD: Dr Reddys Laboratories Ltd Monday announced it has received the approval of the US Food and Drug Administration to market aspirin and dipyridamole capsules in the USA. Aggrenox is a registered trademark of pharmaceutical major Boehringer Ingelheim, the release said. The Aggrenox brand and the generic drug registered sales of approximatel
10/15/18 - Dr. Reddy's Laboratories Receives Approval for Aspirin and Extended-Release Dipyridamole Capsules in the U.S. Market
HYDERABAD, India& PRINCETON, N.J. Dr. Reddy s Laboratories Ltd today announced receipt of approval for Aspirin and Extended-Release Dipyridamole Capsules, a therapeutic equivalent generic version of Aggrenox Capsules in the United States market from the U.S. Food and Drug Administration. The Aggrenox brand and generic had U.S. sales of appro
10/15/18 - Dr. Reddy's: Aspirin And Extended-Release Dipyridamole Capsules Approved In US
NEW DELHI- Dr. Reddy's Laboratories Ltd. announced Monday the receipt of approval for Aspirin and Extended-Release Dipyridamole Capsules, a therapeutic equivalent generic version of Aggrenox Capsules in the United States market from the U.S. Food and Drug Administration. The company said it is working towards launching the product. Aggrenox brand,
10/15/18 - EyePoint Pharmaceuticals Receives FDA Approval of YUTIQ? (fluocinolone acetonide intravitreal implant) 0.18 mg
EyePoint Pharmaceuticals, Inc., a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, announced today that the U. S. Food and Drug Administration has approved YUTIQ? for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The approval of YUTIQ
10/15/18 - F-star Appoints Dr Eliot Forster as Chief Executive Officer
Dr Forster succeeds former CEO Dr John Haurum. Most recently, he served as CEO of Immunocore where he successfully steered the company s strategy in immuno-oncology, raising a $320 M Series A and establishing clinical collaborations with global pharmaceutical companies including AstraZeneca, GSK and Roche. Prior to Immunocore, Eliot held senior
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