Clinical Trials (Phase III)
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Veru Inc. has announced the publication of positive Phase III results from its COVID-19 antiviral therapeutics that could lead to potential Emergency Use Authorization.
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Eisai and Biogen's BLA for lecanemab for Alzheimer's disease received FDA Priority Review with a target action date of January 6, 2023, while Roche's lymphoma drug scored the same designation.
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Eyenovia Strategic Partner Arctic Vision Enrolls First Patient in Phase III Clinical Trial of ARVN003 (MicroLine) for Presbyopia in China
7/6/2022
Eyenovia, Inc. today announced that its strategic partner, Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, enrolled the first patient in its Phase 3 clinical trial of ARVN003 (MicroLine) for presbyopia.
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Veru Announces New England Journal of Medicine Evidence Publication of Phase 3 Clinical Trial Results Demonstrating that Sabizabulin Treatment Significantly Reduced Deaths in High-Risk Hospitalized COVID-19 Patients
7/6/2022
Veru Inc. today announced the publication of the results from a Phase 3 COVID-19 study evaluating the efficacy and safety of oral sabizabulin.
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Amylyx Pharmaceuticals to Announce Plans for an Open Label Extension (OLE) Phase for Global PHOENIX Trial of AMX0035 in ALS at the 17th International Congress on Neuromuscular Diseases
7/6/2022
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced a poster on the ongoing international Phase 3 PHOENIX trial (study A35-004, NCT05021536) of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) in people living with amyotrophic lateral sclerosis (ALS) will be presented on Saturday, July 9, at the 17th International Congress on Neuromuscular Diseases (ICNMD 2022) in Brussels, Belgium.
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Seagen announced positive data from its Phase II trial in colorectal cancer, and the FDA provided positive feedback supporting a Phase IIIb trial for ANeuroTech’s MDD drug.
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Otsuka and Lunbeck report positive Phase III results in agitation in Alzheimer's, Acer's vEDS program hits Phase III and BridgeBio's primary hyperoxaluria type 1 program progresses.
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Ayala Pharmaceuticals Announces Interim Data from Part A of the Phase 2/3 RINGSIDE Trial of AL102 in Desmoid Tumors
7/5/2022
Ayala Pharmaceuticals, Inc. today announced positive interim results from Part A of the ongoing RINGSIDE Pivotal Phase 2/3 clinical trial evaluating AL102 in desmoid tumors. AL102 is a potent, selective, oral gamma-secretase inhibitor (GSI).
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ANeuroTech receives positive feedback from the FDA for its pivotal Phase IIIb development programme for ANT-01 as an adjunctive anti-depression drug for Major Depressive Disorder
7/5/2022
ANeuroTech announces that following a successful pre-IND meeting, the US Food and Drug Administration has given positive feedback on its pivotal Phase IIIb development programme of ANT-01 as an adjunctive anti-depression drug for Major Depressive Disorder.
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Arctic Vision Announces First Patient Enrolled in Phase III Clinical Trial of ARVN003 for Presbyopia
7/4/2022
Arctic Vision announced that the first patient has been enrolled in a Phase III clinical study evaluating ARVN003, a proprietary pilocarpine formulation leveraging its micro dosing platform Optejet®, as a treatment to temporarily improve vision in adults with presbyopia in China.
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AstraZeneca Shares Data at EASL and ESMO World GI for IMFINZI® (durvalumab) Combinations in Patients With Liver and Biliary Tract Cancers
7/1/2022
AstraZeneca presented data for IMFINZI® (durvalumab) combinations from the HIMALAYA and TOPAZ-1 Phase III trials at the European Association for the Study of the Liver's International Liver Congress 2022 (EASL 2022) and the European Society for Medical Oncology’s World Congress on Gastrointestinal Cancer (ESMO World GI 2022).
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The FDA's decision came after researchers found cases of drug-induced liver injury in some patients. Tolebrutinib is being evaluated for relapsing types of MS, MG, nrSPMS, and PPMS.
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Capping off the first half of the year is a flurry of clinical trial wins. BioSpace takes a look at some of the most exciting ones:
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Italfarmaco is making headway against DMD as it announced positive results from a Phase III study, Clover's homologous booster against Omicron increases antibodies, and much more.
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Takeda’s TAKHZYRO® (lanadelumab) Demonstrated Positive Results in the Prevention of HAE Attacks in First and Only Open-Label Phase 3 Trial in Children Ages 2 to <12 Years
6/30/2022
Takeda (TSE:4502/NYSE:TAK) today announced late-breaking data from the Phase 3 SPRING study (NCT04070326) presented at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2022, demonstrating positive results of TAKHZYRO® (lanadelumab) for preventing hereditary angioedema (HAE) attacks in patients 2 to <12 years of age, which were consistent with earlier studies in adult and adolescent patients.
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9 Meters Biopharma Announces Debt Facility to Support Phase 3 Study of Vurolenatide for Short Bowel Syndrome
6/30/2022
9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage company pioneering novel treatments for people with rare or debilitating digestive diseases, today announced it has entered into a senior secured convertible notes facility with a single lender for up to $70 million that is part of an overall financing strategy.
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IMFINZI® (durvalumab) Plus Chemotherapy Significantly Improved Pathologic Complete Response in AEGEAN Phase III Trial in Resectable Non-Small Cell Lung Cancer
6/30/2022
IMFINZI ® (durvalumab) Plus Chemotherapy Significantly Improved Pathologic Complete Response in AEGEAN Phase III Trial in Resectable Non-Small Cell Lung Cancer.
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CanariaBio Announces Milestone achievement of 50% patient enrollment in its Phase III FLORA-5 clinical study of its lead product oregovomab in front-line advanced ovarian cancer treatment
6/30/2022
CanariaBio Inc. announces that it has reached 50% of target enrollment of 602 patients for its pivotal Phase III clinical study of its lead product oregovomab, in combination with standard of care chemotherapy for the treatment of front-line advanced ovarian cancer patients.
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BioNTech announced it is partnering with Pfizer to begin testing a next-generation universal vaccine against coronaviruses, including SARS-CoV-2, the coronavirus that causes COVID-19.
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Axsome hosted an investor day event to provide an update on plans for Sunosi and other developmental assets, including MDD treatment AXS-05.