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FDA Grants Orphan Drug Designation To RGX181 Gene Therapy For The Treatment Of CLN2 Form Of Batten Disease

Thursday, November 15, 2018

REGENXBIO Inc a leading clinicalstage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV Technology Platform today announced the US Food and Drug Administration FDA granted Orphan Drug Designation to RGX181 a onetime treatment c..

Fervent Pharmaceuticals Completes Clinical Trial For Promising New PostMenopausal Therapy Treating Vasomotor Symptoms

Thursday, November 15, 2018

Fervent Pharmaceuticals of Greenville NC has successfully completed its Phase 2A clinical trial for FP101 a new therapy developed to treat the vasomotor symptoms associated with menopause like hot flashes and night sweats The twomonth clinical trial included 112 women in North Carolina South Caro..

Lonzas Global Subject Matter Expert for Endotoxin Detection Appointed Chair of ASMFC Horseshoe Crab Advisory Panel

Thursday, November 15, 2018

Today Lonza announced the appointment of Allen Burgenson Global Subject Matter Expert for Endotoxin Detection at Lonza as Chair of the Horseshoe Crab Advisory Panel of the Atlantic States Marine Fisheries Commission ASMFC Burgenson was elected by his peers to this esteemed position on 26 September 2..

Ardelyx Announces FDA Acceptance of the Filing of its New Drug Application for Tenapanor for the Treatment of Patients with IBSC

Wednesday, November 14, 2018

Ardelyx Inc today announced that the US Food and Drug Administration FDA has accepted for review the New Drug Application NDA for tenapanor for the treatment of patients with irritable bowel syndrome with constipation IBSC Tenapanor Ardelyx39s lead product candidate is a minimallysystemic small mole..

NeuroRx Receives FDA Breakthrough Therapy Designation for NRX101 First Oral Drug Targeting Suicidal Bipolar Depression

Wednesday, November 14, 2018

NeuroRx a clinical stage biopharma company focused on the development of Rapid Acting Antidepressants RAADs that target the brains NMDA receptor has been granted Breakthrough Therapy Designation by the US Food and Drug Administration FDA for development of NRX101 The designation is for treatment of ..

NMPA Accepts Biosimilar New Drug Application for IBI303 a Biosimilar Candidate to HumiraR adalimumab

Tuesday, November 13, 2018

Innovent Biologics Inc Innovent a worldclass Chinabased biopharmaceutical company that develops and commercializes high quality drugs announced today that National Medical Products Administration NMPA successor to CFDA has accepted its new drug application NDA for adalimumab biosimilar candidate IBI..

Theravance Biopharma Highlights Expanded COPD Indication for Trelegy Ellipta in Europe

Tuesday, November 13, 2018

Theravance Biopharma Inc Theravance Biopharma today highlighted that the European Commission authorized an expanded label for oncedaily Trelegy Ellipta fluticasone furoateumeclidiniumvilanterol 39FFUMECVI39 recognizing the product39s effect on exacerbations and making it the first singleinhaler trip..

Generon Receives Investigative New Drug IND Approval from China SFDA for A319 to Treat Patients with B Cell Malignancies

Monday, November 12, 2018

Generon Corporation a leading biopharmaceutical company in China today announced it received approval for the Companys Investigational New Drug IND application from the State Food and Drug Administration SFDA of the Peoples Republic of China to initiate a Phase I clinical trial for A319 in patients ..

T3 Pharmaceuticals Wins Prestigious Falling Walls Venture Award for Its Bacterial Cancer Therapy

Monday, November 12, 2018

T3 Pharmaceuticals a biotech company with a focus on immunooncology today announced it has been named 2018 Science StartUp of the Year by Falling Walls Venture The award honors emerging scientistentrepreneurs for their breakthrough business models The Falling Walls Conference in Berlin Germany an..

RetiPharma Secures Funding to Develop Treatments of Degenerative Eye Disorders

Monday, November 12, 2018

RetiPharma focusing on the development of products for the treatment of degenerative eye disorders based on an in vivo platform for translation from in vivo models to humans is pleased to announce that it has secured funding from the Novo Nordisk Foundations BioInnovation Institute BII The funding w..

Ascendis Pharma Announces Formation of VISEN Pharmaceuticals to Develop and Commercialize TransCon Endocrinology Rare Disease Therapies in China

Friday, November 09, 2018

Ascendis Pharma AS a biopharmaceutical company that utilizes its innovative TransCon technology to address significant unmet medical needs today announced the formation of VISEN Pharmaceuticals Visen a joint venture with an investor syndicate led by Vivo Capital to develop manufacture and commercial..

Voyageur Minerals Signs Joint Venture with Chief Medical Supply to Begin Manufacturing Barium Contrast Pharmaceutical Products

Friday, November 09, 2018

Voyageur Minerals Ltd is pleased to announce that it has signed a joint venture agreement with Chief Medical Supply Ltd CM of Calgary Alberta The joint venture will engage in the development marketing and commercialization of human and animal radiographic contrast agents and related pharmaceutical p..

Orchard Therapeutics Strengthens Global Commercial Leadership Team with Appointments of Heads of US and EMEA Region Commercial Operations

Friday, November 09, 2018

Orchard Therapeutics a leading commercialstage biotech company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies today announced two additions to its global commercial leadership team appointing Robin Kenselaar as senior vice president and general m..

Rocket Pharmaceuticals Announces FDA Clearance of IND Application for RPL102 Gene Therapy for Fanconi Anemia

Thursday, November 08, 2018

Rocket Pharmaceuticals Inc a leading USbased multiplatform gene therapy company announces the clearance of the Companys Investigational New Drug IND application for RPL102 the Companys lentiviral vector LVVbased gene therapy for the treatment of Fanconi Anemia FA by the US Food and Drug Administrati..

Verastem Oncology Announces Collaboration with The Leukemia Lymphoma Society to Accelerate Development of Duvelisib for the Treatment of Peripheral TCell Lymphoma

Thursday, November 08, 2018

Verastem Inc focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients today announced a collaboration with The Leukemia Lymphoma Society LLS to accelerate the development of duvelisib for the treatment of patients with peripheral Tcell lymph..

FDA Approves First Drug Using the Recombinant Factor C Assay for Endotoxin Testing

Thursday, November 08, 2018

Lonza announced today that the recombinant Factor C rFC Assay has been used for endotoxin testing of Eli Lillys Emgality galcanezumab the first drug approved by the US Food and Drug Administration FDA to have been released using this method instead of traditional Limulus Amebocyte Lysate LAL ba..

Merck introduces BioContinuum platform for advanced process optimization

Tuesday, November 06, 2018

Merck the vibrant science and technology company today announced the launch of its new BioContinuum platform to enhance biotherapeutics manufacturing through greater efficiency simplified process flows and improved quality and consistency The company introduced its new product offering in this ye..

zPREDICTA Collaborates With Science Exchange to Offer Unique PatientDerived 3D Cell Culture Services to Drug Development Researchers

Tuesday, November 06, 2018

Science Exchange the worlds leading marketplace for outsourced RD has announced that it is working with zPREDICTA to offer online access to its predictive cancer drug development and testing services zPREDICTA is a Californiabased biotechnology company with expertise in creating human diseasespec..

ProBioGen Announces Successful Bispecific GlymaxX Development Project for Zymeworks

Tuesday, November 06, 2018

ProBioGen AG a premier service technology provider for complex therapeutic antibodies and glycoproteins announced today that it has completed a cell line development project for one of Zymeworks Incs bispecific antibody program which exceeded expectations ProBioGen achieved the desired titers in cl..

Xellia Pharmaceuticals Announces the Launch of First US Market Product Vancomycin Hydrochloride for Injection USP

Monday, November 05, 2018

Xellia Pharmaceuticals a global leader in the manufacturing of specialty antiinfective treatments announced today it has launched Vancomycin Hydrochloride for Injection USP within the United States market Today marks an important milestone for our US market strategy and represents a significant s..