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 The leading web portal for pharmacy resources, news, education and careers December 18, 2018
Pharmacy Choice - News - Pharmaceutical Development - December 18, 2018

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
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12/18/18 - AChristmas message from Follicum
The company has had a very intensive autumn and has finalized a number of important activities that have generated much attention. The key milestones are the successful completion of a new phase II study for stimulating hair growth, and at the same time, new preclinical data has been generated in the diabetes project. The results from the clinical
12/18/18 - AbbVie licences BioArctics Parkinsons disease portfolio [Syrian Arab News Agency]
Swedish biopharma company BioArctic has secured clearance from US Federal Trade Commission to out-licence its alpha-synuclein antibody portfolio to AbbVie. AbbVie decided to licence the therapeutics under an option that is part of the research, development, option and license agreement signed with BioArctic in September 2016. Under the partnership,
12/18/18 - Asarina Pharma Scientific Advisory Board gives full backing to Menstrual Migraine Phase IIA trial
On December 17 Asarina Pharma's Scientific Advisory Board gave its full backing to the company's upcoming trial of a new preventive treatment for Menstrual Migraine. Sepranolone, the new therapy from Asarina Pharma, aims to prevent Menstrual Migraine from occurring. Asarina Pharma's SAB has now given its input and full backing on the proposed proto
12/18/18 - Astellas buys Potenza Therapeutics for up to $405m [Tehran Times (Iran)]
Japanese pharmaceutical company Astellas Pharma has acquired US-based Potenza Therapeutics for a total consideration of up to $405 m. Astellas made an upfront payment of $164.6 m; Potenza will be eligible for additional payment of up to $240.1 m dependent on the progress of different programmes in clinical development. Following the completion of t
12/18/18 - BeiGene Initiates Two Global Phase 3 Front-Line Clinical Trials of Tislelizumab, in Patients with Gastric Cancer and in Patients with Esophageal Cancer [T-break Tech (Middle East)]
BeiGene, Ltd., a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the first patients have been enrolled in two global Phase 3 clinical trials of its investigational anti-PD-1 antibody, tislelizumab.
12/18/18 - Bridge Biotherapeutics Announces FDA Clearance of IND for its BBT-877, an Autotaxin Inhibitor for IPF [Sport360]
Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, South Korea and a tenant company of JLABS@ TMC in Houston, Texas, announced that the Investigational New Drug application for BBT-877, a potent best-in-class drug candidate for Idiopathic Pulmonary Fibrosis, has been cleared by the US Food and Drug Administrati
12/18/18 - Celltrion/Tevas Herceptin biosimilar approved in US [Syrian Arab News Agency]
The FDA has approved Celltrion and Tevas biosimilar of Roches breast cancer drug Herceptin, the second potential competitor to the cancer blockbuster in the US. All three are threatened by biosimilar competition, although Mylan and Celltrion will be unable to launch Herceptin in the US until the patent expires. Celltrion and Teva began an exclusive
12/18/18 - ExCellThera receives FDA orphan drug designation for ECT-001 for the prevention of graft-versus-host disease [Sport360]
ExCellThera Inc., a biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, announced today that the U.S. Food and Drug Administration has granted the ExCellTheras lead solution, ECT-001, orphan drug designation for the prevention of graft-versus-host-disease.
12/18/18 - GC Pharma wins nod to carry out clinical trials on hemophilia drug [T-break Tech (Middle East)]
GC Pharma announced on Dec. 17 it has won approval from the local public health authority to carry out clinical tests on a drug that can be used to treat hemophilia. The drug company, also known as Green Cross, said the Ministry of Food and Drug Safety has granted approval for testing of the MG1113 on people. It marks the first time for a locally m
12/18/18 - Global Personalized Medicine Market Set for Rapid Growth to Reach Around $3466 Mn by 2024: Global personalized medicine market expected to generate revenue of around USD 3466 million by 2024, growing at a CAGR of around 11.9% between 2018 and 2024. P
Sarasota, FL 12/18/2018 Zion Market Research has published a new report titled "Personalized Medicine Market by Therapeutic Area, by Application, by End-User, and by Technology: Global Industry Perspective, Comprehensive Analysis, and Forecast, 2017 2024". According to the report, the global personalized medicine market was valued at appro
12/18/18 - I-Mab and CSPC Pharma Announce Strategic Partnership for Long-acting GLP-1 Fc Program [Syrian Arab News Agency]
I-Mab Biopharma, a China- based clinical stage biopharmaceutical company focused on the development of innovative biologics in immuno-oncology and autoimmune diseases and CSPC Pharmaceutical Group Co., Ltd., a leading pharmaceutical group in China, jointly announced a strategic partnership between the two companies. Under the partnership, I-Mab`s w
12/18/18 - Idorsia's P2Y12 receptor antagonist - selatogrel - Phase 2 clinical studies meet their objective
Idorsia Pharmaceuticals Ltd./ Idorsia's P2Y12 receptor antagonist- selatogrel- Phase 2 clinical studies meet their objective. Allschwil, Switzerland- December 18, 2018 Idorsia Ltd today announced that Phase 2 clinical studies with selatogrel, Idorsia's P2Y12 receptor antagonist, in patients with stable coronary artery disease and patients with acut
12/18/18 - Neurotrope Announces Publication of Phase 2 Study of Bryostatin-1 in Moderate to Severe Alzheimer`s Disease in the Journal of Alzheimer`s Disease [Syrian Arab News Agency]
Neurotrope Inc., a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer`s disease, today announced that data from its Phase 2, multidose, exploratory trial evaluating Bryostatin-1 as a treatment of cognitive deficits in moderate to severe Alzheimer`s disease were published...
12/18/18 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
Agency: " Food and Drug Administration, HHS." FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5689, These public documents may be seen in the office of the Dockets Management Staff, Food and Drug Administration
12/18/18 - Positive 30-month DSMB Recommendation for Continuation of Phase 3 RESOLVE-IT Study of Elafibranor in NASH [Sport360]
GENFIT, a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that the DSMB issued a new positive recommendation for the continuation of the RESOLVE-IT Phase 3 trial evaluating elafibranor in nonalcoholic...
12/18/18 - Protalix BioTherapeutics (PLX) Reports Complete Enrollment in Phase III BRIDGE Clinical Trial of pegunigalsidase alfa for Treatment of Fabry Disease [Sport360]
Protalix BioTherapeutics, Inc. today announced the completion of enrollment for the BRIDGE phase III clinical trial of pegunigalsidase alfa for the treatment of Fabry disease. In September 2018, we reported encouraging, positive interim results from the BRIDGE study and look forward to continue releasing additional data in 2019, commented Moshe Man
12/18/18 - Protalix BioTherapeutics Announces the Completion of Enrollment in the Phase III BRIDGE Clinical Trial of pegunigalsidase alfa for the Treatment of Fabry Disease [Sudan Tribune]
Protalix BioTherapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, today announced the completion of enrollment for the BRIDGE phase III clinical trial of pegunigalsidase alfa for the...
12/18/18 - Sol-Gel Technologies Initiates Pivotal Phase III Clinical Program of TWIN for the Treatment of Acne Vulgaris [Syrian Arab News Agency]
Sol-Gel Technologies Ltd., a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced dosing of the first subject in the pivotal Phase III clinical program evaluating the safety and efficacy of TWIN in subjects with acne...
12/18/18 - Sophiris Bio Provides Updates on Phase 2b Localized Prostate Cancer Trial [T-break Tech (Middle East)]
Sophiris Bio Inc., a biopharmaceutical company studying topsalysin, a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, today provides an update from its Phase 2 b study of topsalysin for localized prostate cancer, including top-line safety and biopsy results from the patient
12/17/18 - 4 Stocks Moving In Monday's After-Hours Session
Gainers Oncomed Pharmaceuticals Inc shares are up 18 percent after a 13 D filing shows Mereo BioPharma Group PLC holds a 10.7 percent stake in the company. Achillion Pharmaceuticals, Inc. shares are up 5 percent after reporting interim data for ACH-4471 Phase 2 trials and provided clinical development strategy update. Achillion expects a year-end 2
12/17/18 - Acer Therapeutics Appoints Salma Jutt as Chief Commercial Officer
Acer Therapeutics Inc., a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and ultra-rare diseases with critical unmet medical need, today announced that it has appointed Salma Jutt as Chief Commercial Officer. If EDSIVO? is approved by the FDA for the treatment of vascular Ehler
12/17/18 - Achillion Reports Positive Interim Data for ACH-4471 Phase 2 Trials and Provides Clinical Development Strategy Update
Achillion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients and families affected by complement mediated disorders, today reported interim results for the Company s Phase 2 trials of its first-generation oral factor D inhibitor, ACH-4471, as well as Phase 1 pharmacokinetics and po
12/17/18 - Aclaris Therapeutics Provides Update on Oral and Topical JAK 1/3 Inhibitor Clinical Trials
Aclaris Therapeutics, Inc., a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in dermatology, both aesthetic and medical, and immunology, today provided updated data from three clinical trials for ATI-502, an investigational topical Janus
12/17/18 - Alkahest Announces Positive Top-Line Data from Two Phase 2a Studies of AKST4290 in Individuals with Wet Age-Related Macular Degeneration
Alkahest Inc., a clinical-stage biotechnology company focused on developing transformative therapies to treat age-related diseases, today announced top-line data from two Phase 2 studies of AKST4290 for the treatment of wet age-related macular degeneration. AKST4290 was found to be safe and well tolerated, with gains in visual acuity for both tre
12/17/18 - Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis
DUBLIN and CAMBRIDGE, Mass., Dec. 17, 2018/ PRNewswire/ Alkermes plc and Biogen Inc. today announced that Alkermes has submitted a New Drug Application to the U.S. Food and Drug Administration for diroximel fumarate, a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis. Alkermes is seeking approval of di
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