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
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,
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
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
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.
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
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
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.
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
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
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
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...
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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...
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
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...
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...
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
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
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
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
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
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
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