-
Intra-Cellular Therapies Discloses New Drug Candidate For Dementia Related Episodes
2021 Feb 24, 10:42am | 289Read More...Intra-Cellular Therapies Inc (NASDAQ: ITCI) expands its pipeline with a new molecular entity, ITI-1284, a sublingually delivered deuterated form of lumateperone. ITI-1284 has been developed in collaboration with Catalent Inc (NYSE: CTLT), using its...
-
Johnson & Johnson's Single-Dose Coronavirus Shot Gets Favorable FDA Review Ahead Of Adcom Meeting
2021 Feb 24, 10:14am | 516Read More...Johnson & Johnson (NYSE: JNJ) shares were advancing Wednesday following the release of the FDA briefing document meant for the Friday Adcom meeting to discuss the company's coronavirus vaccine candidate. What Happened: Johnson & Johnson's single-shot vaccine —...
-
ElectroCore Concludes Enrollment In COVID-19 Study Evaluating Vagus Nerve Stimulation
2021 Feb 24, 9:39am | 195Read More...ElectroCore Inc (NASDAQ: ECOR) and the Hospital Clínico Universitario de Valencia in Spain have completed the enrollment in the SAVIOR-1 study. This study was supported in part by electroCore. The randomized, controlled study evaluates the effect of non-invasive...
-
Benitec Biopharma's Gene Therapy For Rare Muscle Disorder Shows Encouraging Action In Animal Studies
2021 Feb 24, 9:26am | 354Read More...Benitec Biopharma Inc (NASDAQ: BNTC) reports an interim analysis of the BB-301 Pilot Dosing study conducted in large animal subjects. BB-301 a genetic medicine directly injected into the pharyngeal muscles. It employs the proprietary platform, which allows for a "Silence...
-
Fortress Biotech's Partner Offloads CUTX-101 To Sentynl Therapeutics
2021 Feb 24, 9:20am | 238Read More...Fortress Biotech Inc's (NASDAQ: FBIO) partner company, Cyprium Therapeutics Inc, has agreed to sell CUTX-101 to Sentynl Therapeutics Inc. CUTX-101 is a copper histidinate product candidate for the treatment of Menkes disease. The condition is characterized by...
-
Kura Oncology Receives FDA Breakthrough Therapy Tag For Tipifarnib In Head & Neck Cancer
2021 Feb 24, 9:12am | 177Read More...The FDA has designated Breakthrough Therapy status to Kura Oncology Inc's (NASDAQ: KURA) tipifarnib, an orally bioavailable inhibitor of farnesyl transferase for head and neck cancer. The status covers recurrent or metastatic HRAS mutant head and neck squamous cell...
-
The Daily Biotech Pulse: Bausch Calls Truce With Icahn, Pfizer's Brain Inflammation Vaccine Gets Priority Review, BriaCell IPO
2021 Feb 24, 7:30am | 2350Read More...Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Feb. 23) AxoGen, Inc (NASDAQ: AXGN) (reacted to its fourth-quarter results) Gemini Therapeutics Inc (NASDAQ: GMTX) Orthofix Medical Inc (NASDAQ: OFIX)...
-
Qiagen, Inovio In Development Pact For VGX-3100 Companion Diagnostics
2021 Feb 24, 7:26am | 344Read More...Qiagen NV (NYSE: QGEN) and Inovio Pharmaceuticals Inc (NASDAQ: INO) expanded their partnership with a new master collaboration agreement to develop liquid biopsy-based companion diagnostic products using next-generation sequencing technology to complement Inovio...
-
Opthea Outlines OPT-302 Pivotal Study Designs In Chronic Eye Disorder
2021 Feb 24, 7:21am | 221Read More...Following consultations with FDA and European Medical Agency, Opthea NASDAQ: OPT) has finalized trial designs for two Phase 3 clinical trials to assess 2 mg OPT-302, administered 4-weekly or 8-weekly in wet age-related macular degeneration (AMD). Each trial will enroll around...
-
Karyopharm's Partner Antengene Receives Priority Review For Selinexor Application In China
2021 Feb 24, 7:09am | 179Read More...Karyopharm Therapeutics Inc's (NASDAQ: KPTI) collaborating partner Antengene Corporation Limited has received priority review from China's National Medical Products Administration (NMPA) for ATG-010 (selinexor, XPOVIO). It is a first-in-class selective...
-
Pfizer's Tick-Borne Encephalitis Vaccine Gets Priority Review Tag In US
2021 Feb 24, 6:31am | 166Read More...The FDA has accepted Pfizer Inc's (NYSE: PFE) marketing application seeking approval for TicoVac under priority review status. TicoVac is the tick-borne encephalitis (TBE) vaccine for active immunization in individuals aged one and older. The anticipated action date is expected...
-
Takeda Doses First Participant In Novavax COVID-19 Vaccine Study In Japan
2021 Feb 24, 6:21am | 438Read More...Takeda Pharmaceutical Co Ltd (NYSE: TAK) said that the first patient had been dosed with Novavax Inc's (NASDAQ: NVAX) COVID-19 vaccine candidate (dubbed as TAK-019) in a Japanese clinical trial. The first volunteer was given a Novavax shot in a Phase 1/2...
-
Akers Biosciences' Proposed Partner MyMD's Lead Candidate Inhibits Fibrotic Diseases-Associated Biomarkers
2021 Feb 23, 1:25pm | 220Read More...Akers Biosciences Inc (NASDAQ: AKER) and its proposed merger partner MyMD Pharmaceuticals Inc have announced new data for MYMD-1 from the Eurofins Discovery Phenotypic Center of Excellence study. MYMD-1 is being evaluated for autoimmune and age-related diseases. The...
-
Biocept Inks Research Pact With Protean BioDiagnostics For Target Selector Kit Advantages In Lung Cancer
2021 Feb 23, 12:35pm | 211Read More...Biocept Inc (NASDAQ: BIOC) will collaborate with Protean BioDiagnostics Inc to research Biocept's Target Selector molecular assay's ability to determine EGFR status in non-small cell lung cancer (NSCLC) patients. The research will be conducted in an independent...
-
Sanofi/Regeneron's DUPIXENT Wins Canada Approval For Atopic Dermatitis In Children Aged 6-11
2021 Feb 23, 11:33am | 246Read More...Health Canada has approved Sanofi’s SA (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc (NASDAQ: REGN) DUPIXENT (dupilumab injection) for the treatment of moderate-to-severe atopic dermatitis in children aged six to 11 years whose disease is not adequately...
