Clinical Trials (Phase III)

Found 17,274 articles

• Dr. Reddy’s Receives Approval to Conduct Phase 3 Clinical Trial for Sputnik V Vaccine in India

  1/15/2021

  Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) announced today that it has received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine in India. The phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India. Earlie

• TOXINS 2021: New analyses of pivotal Phase III trial data highlight long duration of response for Dysport® (abobotulinumtoxinA) in five therapeutic indications

  1/15/2021

  Analyses of pivotal study data of Dysport® reveal a large proportion of study patients did not require retreatment for at least 12 weeks

• Organogenesis Enrolls First Patient in Pivotal Phase 3 Clinical Trial of RMAT-Designated ReNu® for Knee Osteoarthritis

  1/14/2021

  Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today announced that the first patient has been enrolled in its pivotal Phase 3 clinical trial evaluating the safety and efficacy of ReNu®, a cryopreserved amniotic suspension allograft (ASA), for the managem

• Lexicon Pharmaceuticals Provides Regulatory Update on Sotagliflozin in Heart Failure

  1/14/2021

  Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that it has received U.S. Food and Drug Administration (FDA) regulatory feedback that the results of its SOLOIST and SCORED Phase 3 clinical studies can support a new drug application (NDA) submission for an indication to reduce the risk of cardiovascular death, hospitalization for heart failure,

• NewAmsterdam Pharma Completes $196M (€160M) Series A Funding for Comprehensive Phase 3 Development Program

  1/14/2021

  Founding investor Forbion joined by co-lead investors, Morningside Ventures and Ascendant BioCapital, and other leaders in global biopharmaceutical investment

• Kintara Announces Initiation of Patient Recruitment for VAL-083's Study Arm in the GBM AGILE Trial

  1/13/2021

  Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that patient recruitment has commenced in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma (GBM). 

• Arcutis Initiates Pivotal Phase 3 Clinical Trials Evaluating Topical Roflumilast Cream (ARQ-151) as a Potential Treatment for Atopic Dermatitis

  1/13/2021

  Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that it has commenced pivotal Phase 3 clinical trials evaluating topical roflumilast cream (ARQ-151) as a potential treatment for atopic dermatitis (AD)

• Alexion Provides Update on Phase 3 Study of ULTOMIRIS® (ravulizumab-cwvz) in Hospitalized Patients with Severe COVID-19

  1/13/2021

  Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the decision to pause further enrollment in the global Phase 3 study of ULTOMIRIS® (ravulizumab-cwvz) in adults with severe COVID-19 requiring mechanical ventilation. This decision is based on the recommendation of an independent data monitoring committee (IDMC), following their review of data from a pre-specified interim analysis.

• Rockwell Medical Announces Dosing of First Patient in Pivotal Triferic® Phase 3 Trial by Partner, Wanbang Biopharmaceuticals, in ChinaChina is a sizable and growing market, with more than 600,000 patients receiving hemodialysis annually

  1/13/2021

  Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced that its partner in China, Wanbang Biopharmaceuticals, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., enrolled the first patient in a pivotal Phase 3 trial for Triferic Dialysate

• Marinus Pharmaceuticals Receives Positive Response from FDA on Sufficiency of One Phase 3 Clinical Trial for Filing of New Drug Application (NDA) for the Use of Ganaxolone in CDKL5 Deficiency Disorder (CDD)

  1/13/2021

  Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced it has received a positive response from the U.S. Food and Drug Administration (FDA) that the efficacy and safety data resulting from the company’s pivotal Phase 3 Marigold Study on the use of oral ganaxolone

• Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59

  1/13/2021

  CT-P59 (40mg/kg) treated patients reported reduced progression rates to severe COVID-19 by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and over

• GenSight Biologics Announces Publication of Results from LUMEVOQ® RESCUE Pivotal Phase III Trial in AAO journal Ophthalmology®

  1/13/2021

  GenSight Biologics announced that the journal of the American Academy of Ophthalmology, Ophthalmology®, has published results from the RESCUE pivotal Phase III clinical trial of LUMEVOQ® gene therapy in ND4 Leber Hereditary Optic Neuropathy subjects.

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  2021 Biopharma Update on the Novel Coronavirus: January 12

  1/12/2021

  Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 12, 2021.

• Blue Earth Diagnostics Announces Dosing of Initial Patient in Phase 3 REVELATE Clinical Trial of 18F-Fluciclovine PET Imaging for Detection of Recurrent Brain Metastases

  1/12/2021

  Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced that the first patient has been dosed in its Phase 3 REVELATE clinical trial of 18F-fluciclovine, a positron emission tomography (PET) imaging radiopharmaceutical being studied for potential use in detecting recurrent brain metastases.

• Bayer Announces U.S. FDA Accepts New Drug Application and Grants Priority Review for Investigational Drug Finerenone for Patients with Chronic Kidney Disease and Type 2 Diabetes

  1/12/2021

  Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted Priority Review for finerenone, an investigational drug for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). This regulatory submission was based on Phase III FIDELIO-DKD trial data, which were recently presented at the American Society of Nephrology’s (ASN) Kidney Week Reimagined 2020,

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  Clinical Catch-Up: January 4-8

  1/11/2021

  The new year began with a fairly low level of clinical trial news. Here’s a look.

• Gamida Cell to Present Full Data from Phase 3 Study of Omidubicel at TCT, the Combined Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR

  1/11/2021

  Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the full results of the Phase 3 clinical trial of omidubicel will be presented for the first time at the TCT Meetings, the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blo

• Mesoblast Presents Heart Failure Phase 3 Trial Results at Investor Healthcare Conference

  1/11/2021

  Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced that its Chief Executive Officer, Dr Silviu Itescu, today presented additional data from the landmark DREAM-HF Phase 3 trial in patients with chronic heart failure. The presentation materials have been lodged with the ASX, and Mesoblast’s presentation at the H.C. Wainwright Virtual BioConnect 2021 Conference can be accessed at

• CureVac's COVID-19 Vaccine Candidate, CVnCoV, Demonstrated Efficient Protection of Non-Human Primates During SARS-CoV-2 Challenge Infection

  1/11/2021

  Data provided further evidence on immunogenicity and protective efficacy of CVnCoV Induction of robust antibody and T cell responses at lower dose than tested in Phase 3 trial Full lung protection of CVnCoV-vaccinated animals during SARS-CoV-2 challenge infection

• Pivotal phase III clinical trial IND submission of the original innovative anticancer drug Chiauranib for the treatment of small cell lung cancer was accepted by the Center of Drug Evaluation of the NMPA.

  1/11/2021

  On January 8, 2021, Shenzhen Chipscreen Biosciences Co., Ltd. submitted its pivotal phase III clinical trial application of national class I innovative drug Chiauranib to NMPA, for the treatment of Small Cell Lung Cancer as a single agent for the patients after 2nd-line systemic chemotherapy and recurrence afterwards.