Aimed at ushering in good pharmacovigilance practices in the country for drug safety, around 100 pharma companies have joined hands with Central Drugs Standard Control Organisation and Pharmaco-vigilance Programme of India to come up a set of exhaustive guidelines on par with the existing global guidelines. Pharmaco-vigilance programme of India had
Biomerica, Inc. shares surged 27.7 percent to $2.68. Neuroderm Ltd shares jumped 26.7 percent to $19.70 as the company disclosed that it will replace two Phase 3 clinical trials with small pharmacokinetic trials following the FDA meeting on ND0612 regulatory development. Stone Energy Corporation gained 23.7 percent to $8.55. Stone Energy shares hav
POXEL SA, a biopharmaceutical company focused on the development of innovative treatments for type 2 diabetes, today announced the presentation of preclinical data supporting Imeglimin s drug profile as a novel diabetes therapy. We are continuing to add further differentiating data to Imeglimin s exciting clinical results as we learn more
CAMBRIDGE, Mass.& SUMMIT, N.J. Acceleron Pharma Inc. and Celgene Corporation, today announced preliminary results from an ongoing investigator initiated Phase 2 study with investigational drug sotatercept in patients with myelofibrosis at the 58 th Annual Meeting of the American Society of Hematology in San Diego, California. Sotatercept is bei
By a News Reporter-Staff News Editor at Clinical Trials Week Acorda Therapeutics, Inc. announced that the MILESTONE clinical study did not show sufficient efficacy to support further development of dalfampridine to improve post-stroke walking difficulties. I want to express our gratitude to the study participants, their care partners and clinicia
Novelion Therapeutics Inc., a biopharmaceutical company dedicated to developing new standards of care for individuals living with rare diseases, today announced that on December 3, 2016, Aegerion Pharmaceuticals, an indirect, wholly-owned subsidiary of Novelion, entered into an agreement in principle to settle all claims in the class action shareho
Alembic Pharmaceuticals has received approval from the US health regulator for Zolmitriptan orally disintegrating tablets, used for the treatment of migraine, in the American market. The company has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Zolmitriptan Orally Disintegrating Tablets, 2.5
Alembic now has a total of 51 ANDA approvals from USFDA. Alembic Pharmaceuticals Limited announced that the company has received approval from the US Food& Drug Administration for its Abbreviated New Drug Application for Zolmitriptan Orally Disintegrating Tablets, 2.5 mg and 5 mg. Alembic Pharmaceuticals Ltd is currently trading at Rs 631.9, down b
Alembic Pharmaceuticals Limited announced that the company has received approval from the US Food& Drug Administration for its Abbreviated New Drug Application for Zolmitriptan Orally Disintegrating Tablets. Alembic Pharmaceuticals Ltd ended at Rs 624.45 down by Rs 7.80 or 1.23% from its previous closing of Rs 632.25 on the BSE. The scrip opened at
SAINT HELIER- Alnylam Pharmaceuticals Inc., on Sunday, reported positive interim clinical results of its investigational RNAi therapeutic Fitusiran from an ongoing phase II open label extension study in patients with Hemophilia A or B without inhibitors. Acceleron Pharma Inc. and Celgene Corp., on Sunday, announced encouraging preliminary results f
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, today presented new results from Part C of its Phase 1/ 2 clinical trial with ALN-CC5, a subcutaneously administered investigational RNAi therapeutic targeting complement component 5 for the treatment of complement-mediated diseases, in a poster presentation at the 58th Annual...
Alzheon to Present New Clinical Data and Analyses for ALZ-801, an Amyloid-Targeted Drug Candidate, and its Active Molecule Tramiprosate at the 9th Clinical Trials on Alzheimer's Disease Congress. By a News Reporter-Staff News Editor at Clinical Trials Week Alzheon, Inc., a clinical-stage biopharmaceutical company focused on developing new medicin
Research and Markets has announced the addition of the "Antibacterial Drug Resistance: Market Landscape, Challenges and Upcoming Opportunities, 2016-2026" report to their offering. The "Antibacterial Drug Resistance: Market Landscape, Challenges and Upcoming Opportunities, 2016-2026" report provides an extensive study of the current landscape and t
~Investor and analyst call to be held on Wednesday, December 7 at 4:00 p.m. Central European Time. CAMBRIDGE, Mass.& VIENNA ARIAD Pharmaceuticals, Inc., a rare cancer-focused innovative biotechnology company, today announced clinical data on brigatinib, its investigational anaplastic lymphoma kinase inhibitor, from the ongoing Phase 1/ 2 and pi
Release date- 26112016- Cambridge, UK- Astex Pharmaceuticals, a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that it has become a strategic investor in The Dementia Discovery Fund. Astex joins the DDF investor group whi
Aurinia Highlights Renal Function Data from Global Phase IIb AURA Study of Voclosporin for Lupus Nephritis at American Society of Nephrology Kidney Week 2016. By a News Reporter-Staff News Editor at Clinical Trials Week Aurinia Pharmaceuticals Inc., a clinical stage biopharmaceutical company focused on the global immunology market, announced...
Release date- 02122016- Basel, Switzerland- Basilea Pharmaceutica Ltd. announced today the expansion of its ongoing oncology drug candidate BAL101553 clinical phase 1/ 2 a oral formulation study. Achim Kaufhold, Basilea's Chief Medical Officer, commented:' We are excited to explore BAL101553 in a separate glioblastoma study arm to our ongoing phase
BeiGene, Ltd. a clinical-stage biopharmaceutical company developing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today presented updated clinical data from an ongoing Phase I study of BTK inhibitor BGB-3111 in patients with chronic lymphocytic leukemia and small lymphocytic leukemia at the 2016 American..
Bellicum Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for cancers and orphan inherited blood disorders, today announced the presentation of preclinical results on the Company s GoCAR-T and GoTCR technologies at the 58th American Society of Hematology Annual
Bellicum Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for cancers and orphan inherited blood disorders, presented a review of results to date from its multicenter BP-004 clinical trial of BPX-501 in the pediatric setting, and provided an update on the regulato
Leading oncology biopharmaceutical company BerGenBio AS, today presented clinical and biological data from a Phase I trial of its potent, highly selective, first-in-class Axl inhibitor BGB324 in acute myeloid leukaemia in an oral session at the 58th ASH Annual Meeting& Exposition in San Diego. The company regards the results as an important indicat
As of 2016, almost 30 million people in the U.S. and 350 million people worldwide suffer from rare ailments known as "Orphan Diseases. As per the official definition, rare diseases are classified as those that affect fewer than 200,000 in the United States and less than 5 in 10,000 in the EU. Nevertheless, the Scenario has changed after the Orphan
By a News Reporter-Staff News Editor at Clinical Trials Week- HYPERLINK " http://www.absorption.com/"\ nAbsorption Systems, a world leader in novel test systems for drug transporters, announces the renewal of a technology licensing deal with Biogen. Drug transporters such as P-gp have received increasing attention from drug regulatory bodies such
BioLineRx Ltd., a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, presents positive Phase 2 a correlative data, as well as detailed mechanism-of-action data, for BL-8040, the Company's leading oncology platform at the ongoing 58th American Society of Hematology Annual.
Biothera Pharmaceuticals, Inc. today announced an expansion of its research collaboration with Merck to include a Phase 2 clinical study investigating Biothera s Imprime PGG in combination with KEYTRUDA , Merck s anti-PD-1 therapy, in second- and third-line patients with head and neck squamous cell cancer. A previously announced agreement b