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ProQR Doses First LCA 10 Patient in Clinical Trial of QR-110, ProQR’s Lead Program for Genetic Blindness
11/13/2017
The first patient has received the first dose of QR-110 in the Phase 1/2 safety & efficacy clinical trial in children and adults with Leber’s congenital amaurosis 10.
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NousCom's Neoantigen-based Vaccine Synergizes With NKTR-214 to Cure Established Tumors in Preclinical Model
11/13/2017
Nouscom, an oncology company developing next generation cancer vaccines based on its Exovax platform, today announced preclinical data of its neoantigen-based cancer vaccine in combination with Nektar Therapeutics' NKTR-214, a CD122-biased cytokine agonist which is currently in clinical trials.
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NANOBIOTIX Presented New Clinical and Pre-Clinical Data Confirming NBTXR3's Significant Potential Role in Immuno-Oncology at SITC Annual Meeting
11/13/2017
Nanobiotix's lead product, NBTXR3, has a universal physical mode of action which is designed for the local destruction of tumors.
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C4X Discovery C4XD Presents Data on its Lead Addiction Programme: Orexin-1 Antagonist
11/13/2017
C4X Discovery presented new pre-clinical data on its Orexin-1 antagonist programme at Neuroscience 2017 on 11th November 2017 in Washington, DC.
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eFFECTOR Therapeutics Presents Preclinical Data for eFT508 that Demonstrates Beneficial Immunological Effects
11/13/2017
In vitro and in vivo preclinical models demonstrate eFT508 selectively downregulates key immune checkpoint proteins without compromising T cell activation or viability.
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Cytori Announces New U.S. Investigator Trial for Hip Osteonecrosis
11/13/2017
Details of the trial can be assessed at https://clinicaltrials.gov/ct2/show/NCT03269409.
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Arbutus’ LNP Licensee Alnylam Receives Accelerated Assessment of Patisiran from European Medicines Agency (EMA)
11/13/2017
Accelerated assessment may provide a reduced review timeline from 210 to 150 days once the marketing authorization application (MAA) is filed and validated, which Alnylam intends to file by year-end 2017.
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Vanda Receives Negative Opinion for Marketing Authorization From the European Medicines Agency on Fanaptum for the Treatment of Schizophrenia
11/13/2017
After considering the grounds for this request, the CHMP re-examined the opinion and confirmed the refusal of the Fanaptum MAA on November 9, 2017.
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ASLAN Pharma Received IND Approval in Singapore to Initiate Phase II Study of ASLAN003 in Acute Myeloid Leukaemia
11/13/2017
The phase II trial is a dose optimisation study, and the primary outcome is to determine the optimum monotherapy dose of ASLAN003 including efficacy evaluated by OCRR.
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Merck Receives Positive CHMP Opinion for PREVYMIS (letermovir) in the European Union
11/13/2017
Merk announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of PREVYMIS (letermovir).
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Protalix BioTherapeutics Receives Positive Opinion for Orphan Designation for PRX-102 for the Treatment of Fabry Disease in the European Union
11/13/2017
In its official opinion letter, the COMP explained that Protalix has established that although satisfactory methods of treatment of Fabry disease have been authorized in the European Union, PRX-102 will be of significant benefit to those affected by Fabry disease.
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AmerisourceBergen Urges Policymakers to Support Regulator and Industry Data Transparency to More Effectively Combat Opioid Abuse
11/13/2017
The Company is committed to working collaboratively to help mitigate controlled substance abuse, a complex national crisis, and has urged Congress to take action to enable stronger oversight of opioid ordering and distribution practices.
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Biolog Granted Patent on Novel Treatment for Clostridium Difficile Infection - Seeks Commercial Partner
11/13/2017
The patent describes the discovery by Biolog scientists that cationic compounds can rapidly inactivate the toxin produced by this bacterium.
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BriaCell Announces Advancement of its Small Molecule Program and Patent Allowance
11/13/2017
The company disclosed the allowance by the USPTO and also the EPO of two patent applications related to protein kinase C delta (PKCδ) inhibitor technology,
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Evonik Industries: Launches New Sterile and Ultra-Low-Metal Content Bioresorbable Polymers
11/13/2017
Evonik , a global leader in biomaterials, is expanding its RESOMER portfolio of bioresorbable polymers for controlled-release parenteral drug formulations.
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Avista Pharma Solutions Doubles API Manufacturing Capacity at Colorado Facility
11/13/2017
During this expansion, the site’s three existing GMP drug substance manufacturing suites were upgraded, and a fourth GMP suite was added.
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Cycle Pharmaceuticals Launches Free Trial of NITYR in the US and Partners With Cambrooke Therapeutics to Support HT-1 Patients’ Dietary Needs
11/13/2017
Cycle Pharmaceuticals launches of a new program in the US to offer patients with hereditary tyrosinemia type 1 (HT-1) the opportunity to experience NITYR (nitisinone) tablets for free for three weeks.
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CRISPR Therapeutics Highlights New Additions to Portfolio of Allogeneic CRISPR-based CAR-T Therapies at SITC Annual Meeting
11/13/2017
CRISPR believes that its CAR-T cells therapies may have distinct advantages over the current generation of autologous cell therapies.
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New Treatments to Solve Global Antibiotic Crisis Have Potential to Reach the Market as Early as 2020
11/13/2017
Helperby have developed a novel answer to the clear and present danger of antimicrobial resistance - Antibiotic Resistance Breakers.
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Replikins Release: H5N8 'Bird Flu' Pandemic, Now Disruptive in South Africa, Might Have Been Controlled by Specific Replikins Vaccines and Blockers, Available Since 2013
11/13/2017
Replikins' Dr. Samuel Bogoch spoke this week on the H5N8 current pandemic 'bird flu' H5N8 at the 3rd annual Chernack Conference at Boston University School of Medicine on Crisis & Emergency Management.