By a News Reporter-Staff News Editor at Drug Week A patent application by the inventors Akula, Chandrashaker; Lomans, John; Tummidi, Madhukiran; Tatake, Prashant Anil, filed on September 12, 2016, was made available online on January 5, 2017, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent appl
Abeona Therapeutics Inc., a clinical-stage biopharmaceutical company focused on developing gene therapies for life-threatening rare diseases, announced today that the European Medicines Agency Committee for Orphan Medicinal Products has granted Orphan Drug Designation for Abeonas gene therapy program ABO-101 for children impacted by Sanfilippo...
-Adamis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration has accepted for review the Companys New Drug Application for its Epinephrine Pre-filled Syringe product candidate for the emergency treatment of anaphylaxis. Filed on December 15, 2016, the resubmission was intended to address the issues raised by the FD
Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today announced the results of additional data analyses related to cognitive function from its 12- week, randomized, double-blind, placebo-controlled Phase IIb clinical trial of MIN-101 as...
SAINT HELIER- AbbVie's blockbuster blood cancer drug Imbruvica has been approved by the FDA for yet another indication- this time, for the treatment of patients with relapsed/refractory marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20-based therapy. Adamis Pharmaceuticals Corp.' s resubmitted New Dr
By a News Reporter-Staff News Editor at Drug Week Gilead Sciences, Inc. announced that Alessandro Riva, MD, will join the company as Senior Vice President, Hematology and Oncology Therapeutic Area Head. Dr. Riva joins Gilead from Novartis Oncology, where he served as Head, Global Oncology Development. Prior to joining Novartis, Dr. Riva co-founde
By a News Reporter-Staff News Editor at Drug Week- Amorsa Therapeutics, Inc., a neuropharmaceutical company pioneering the development of breakthrough treatments for nervous system disorders has announced a research, option and license agreement with Janssen Pharmaceuticals, Inc. to develop and commercialize a novel small molecule drug candidate
Amplitude Surgical, a leading French player on the global surgical technology market for lower-limb orthopedics, today announces that it has received 510 regulatory clearance from the US Food and Drug Administration for its Anatomic implant, addressing degenerative knee disorders. Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says:
-Anavex Life Sciences Corp. and the International Rett Syndrome Foundation, doing business as Rettsyndrome.org today announced that Rettsyndrome.org has committed a financial grant of a minimum of $0.6 million to cover the majority of a planned U.S. multicenter Phase 2 clinical trial of ANAVEX 2-73 for the treatment of Rett syndrome.
ARMO BioSciences, Inc., a late-stage immuno-oncology company, presented new Phase 1 b clinical data on the Company's lead investigational immuno-oncology drug AM0010 at the 2017 Gastrointestinal Cancers Symposium, co-sponsored by the American Society of Clinical Oncology, taking place January 19-21, 2017 in San Francisco, CA.. "AM0010 induces th
Release date- 19012017- East Windsor, N.J.- Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Ziprasidone HCl Capsules, 20 mg, 40 mg, 60 mg and 80 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited's Ziprasidone HCl Capsules, 20 mg, 40 mg, 60 mg and 80 mg to be bioequivalent
Dr Weinberg will be based in Chicago, USA. Dr Weinberg joins Avillion from Halloran Consulting Group, a consulting firm that provides strategic guidance and development expertise to life science companies, where he was Chief Medical Officer and Managing Director. Prior to Astellas, Dr Weinberg held various positions of increasing responsibility at.
The global bioreactor market is segmented on the basis of scale range, usage, end-user, control, materials, suppliers, and region.Sarasota, FL 01/20/2017 Global Bioreactors Market: Overview. Bioreactor or fermenter is requisite equipment required for bioprocessing. Bioreactors are specifically constructed systems or vessels that can support a
By a News Reporter-Staff News Editor at Drug Week Bird Rock Bio, Inc., a clinical stage biopharmaceutical company, announced that it had received approval for the initiation of a 200 patient, Phase 2 rheumatoid arthritis clinical trial for gerilimzumab, a novel therapeutic antibody to the IL-6 cytokine, to be conducted solely in Brazil. Working c
The main focus of Catalyst Pharmaceuticals, Inc. is the development of a treatment for Lambert-Eaton Myasthenic Syndrome a rare, autoimmune, neuromuscular disorder characterized by muscle weakness and autonomic dysfunction. Catalyst Pharmaceuticals is currently developing amifampridine phosphate specifically for the treatment of LEMS and...
What: ChemoCentryx, Inc., a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered therapeutics that target the chemokine and chemoattractant systems in order to treat autoimmune diseases, inflammatory disorders and cancer, will visit the Nasdaq Entrepreneurial Center in San Francisco.
Concert Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has granted orphan drug designation for CTP-656, Concert s next generation CFTR potentiator being developed for the treatment of cystic fibrosis. In December 2016, Concert initiated a Phase 2 trial in the U.S. evaluating CTP-656 in cystic fibrosis patients w
By a News Reporter-Staff News Editor at Drug Week HYPERLINK " http://www.custopharm.com/"\ nCustopharm, Inc., a U.S. leader in generic injectable products, announced that it has acquired two paragraph IV abbreviated new drug application products from HYPERLINK " http://www.perrigo.com/"\ nPerrigo Company plc. William Larkins, chief executive offi
Release date- 19012017- Tokyo, Japan and Parsippany, N.J.- Daiichi Sankyo Company, Limited announced today the initiation of a three-part open-label phase 1/ 2 study in Japan with U3-1402, a novel HER3-targeting antibody drug conjugate, in patients with HER3-positive metastatic or unresectable breast cancer who are refractory or intolerant to stand
-DaVita Clinical Research, a specialty contract research organization with services spanning the full spectrum of drug and device development, and Prism Clinical Research, a leader in providing fully integrated clinical research services to pharma/device companies and clinicians, today announced Verified Clinical Trials has been selected by both...
By a News Reporter-Staff News Editor at Drug Week Eagle Pharmaceuticals, Inc. announced that the 505 New Drug Application for its novel pemetrexed drug product has been submitted to the U.S. Food and Drug Administration. "We look forward to the FDA's decision on this NDA this year, and to continuing to work closely with the FDA through the revie
By a News Reporter-Staff News Editor at Drug Week- Allergan plc, a leading global pharmaceutical company, and Medicines360, a nonprofit global women's health pharmaceutical company, announced that the U.S. Food and Drug Administration has accepted for filing the company's supplemental New Drug Application to potentially extend the duration of use
By a News Reporter-Staff News Editor at Drug Week- Bayer announced that the U.S. Food and Drug Administration has granted priority review status for the supplemental New Drug Application for Stivarga tablets for the second-line systemic treatment of patients with hepatocellular carcinoma in the U.S. The FDA grants priority review to medicines
News: Catabasis' positive phase I data on Edasalonexent published in the Journal of Clinical Pharmacology. News: Leap Therapeutics Inc., with which Macrocure is merging, has reported promising biomarker data from a clinical study of DKN-01 in combination with Paclitaxel in esophageal cancer. Upon completion of the prospective merger, Macrocure will
FOSTER CITY- Gilead Sciences, Inc. announced Friday that the European Medicines Agency has validated its Marketing Authorization Application or MAA for Investigational Chronic Hepatitis C Therapy Sofosbuvir/Velpatasvir/Voxilaprevir. SOF/VEL/VOX for the treatment of HCV will be reviewed by the EMA under the centralized licensing procedure for all...