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Cytokinetics and JI XING Announce Expansion of Collaboration to Include Licensing of Omecamtiv Mecarbil in China; RTW to Add to Its Investment in Cytokinetics
12/20/2021
Cytokinetics, Incorporated (Nasdaq: CYTK) and Ji Xing Pharmaceuticals Limited today announced an expansion of their collaboration by entering into an exclusive license and collaboration agreement to develop and commercialize omecamtiv mecarbil for the proposed treatment of heart failure with reduced ejection fraction (HFrEF) in Greater China.
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Can-Fite Announces Exercise of Warrants for Cash Proceeds of $10 Million
12/20/2021
Can-Fite BioPharma Ltd. announced the agreement by an healthcare-focused institutional investor to exercise certain warrants to purchase up to an aggregate of 150,000,000 ordinary shares represented by 5,000,000 American Depositary Shares having an exercise price of $2.00 per ADS issued by Can-Fite in August 2021, at an exercise price of $2.00 per ADSs.
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KemPharm, Inc. Announces Authorization of $50 Million Share Repurchase Program
12/20/2021
KemPharm, Inc. announced today its Board of Directors has authorized a program to repurchase up to $50 million of the Company’s outstanding stock.
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Crystallographic Discoveries Bring New Clarity to Pharmaceutical Psilocybin Polymorph Characterization
12/20/2021
Breakthrough research has now revealed the true crystal forms of pharmaceutical psilocybin. A new study overcomes experimental challenges to solve the crystallographic puzzle and brings clarity to the unique crystalline arrangements, called polymorphs, that naturally arise from the production of synthetic psilocybin.
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European Commission Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine
12/20/2021
Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that the European Commission has granted Novavax conditional marketing authorization for Nuvaxovid™ COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
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Aptose Provides Update on APTO-253 Program
12/20/2021
Aptose Biosciences Inc. (“Aptose”) (NASDAQ: APTO, TSX: APS) today announced its decision to discontinue further clinical development of APTO-253.
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Cara Therapeutics Announces CMS Grants TDAPA to KORSUVA™ (difelikefalin) Injection
12/20/2021
Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted Transitional Drug Add-On Payment Adjustment (TDAPA) to KORSUVA™ (difelikefalin) injection in the anti-pruritic functional category.
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Stealth BioTherapeutics Reports Positive Pre-IND Meeting for Duchenne Muscular Dystrophy
12/20/2021
Stealth BioTherapeutics Corp today reported an update on its pre-IND meeting with the FDA's Division of Cardiology and Nephrology (DCN) regarding its Duchenne muscular dystrophy (DMD) development program, including reaching alignment on Stealth's proposal to assess the progression of myocardial fibrosis as a surrogate endpoint for its planned clinical trial.
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Opiant Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - Dec 20, 2021
12/20/2021
Opiant Pharmaceuticals, Inc. announced the Compensation Committee of the Company’s Board of Directors has approved the grant of restricted stock units covering an aggregate of 31,500 shares of common stock to six hired employees, pursuant to the Company’s 2021 Inducement Equity Incentive Plan.
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MediWound Announces Positive Initial Data from its U.S. Phase 2 Pharmacology Study of EscharEx Showing Effective and Rapid Debridement in Chronic and Hard to Heal Wounds
12/20/2021
MediWound Ltd. (Nasdaq: MDWD) (the “Company”), today announced positive initial data from seven of the maximum fifteen patients in its ongoing open-label, phase 2 pharmacology study of EscharEx®, the company’s next-generation enzymatic debridement agent under development for chronic and hard-to-heal wounds.
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Coherus Announces U.S. FDA Approval of YUSIMRY™ (adalimumab-aqvh)
12/20/2021
Coherus BioSciences, Inc. (Nasdaq: “CHRS”, “the Company”, “Coherus”) announced that the United States Food and Drug Administration (“FDA”) approved YUSIMRY™ (adalimumab-aqvh), formerly CHS-1420, a Humira® (adalimumab) biosimilar product.
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Provention Bio Announces Leadership Team Expansion
12/20/2021
Provention Bio, Inc. today announced that the Company has appointed Christina Yi as Chief Operations Officer, responsible for manufacturing, supply chain and human resources, and Benedict Osorio as Chief Quality Officer, responsible for all aspects of quality.
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Zynex Monitoring Announces First Enrollment in a Hemodialysis Clinical Trial for its Fluid Monitoring System
12/20/2021
Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation and patient monitoring, today reported it has started enrollments in a hemodialysis clinical trial with its fluid monitoring system, CM-1500.
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Progenity Completes Exit from Laboratory Business with Sale of Affiliate LabTransaction Adds Cash to Balance Sheet and Further Reduces Operating Expenses
12/20/2021
Progenity, Inc., a biotechnology company innovating in the field of oral biotherapeutics for gastrointestinal health and beyond, announced it has successfully closed the business divestiture of its affiliate Avero Diagnostics through an asset sale to Northwest Pathology.
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Helsinn and Xediton sign exclusive license and distribution agreement for TRUSELTIQ™ (infigratinib) in Canada
12/20/2021
Helsinn Group (Helsinn), and Xediton Pharmaceuticals Inc. (Xediton), announced today the signing of an exclusive license and distribution agreement in Canada for TRUSELTIQ™.
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Henlius' anti-PD-1 mAb MRCT achieved 15.38 months OS in first-line treatment of SCLC, reducing the risk of death by 38% of the overall population
12/20/2021
Shanghai Henlius Biotech, Inc. (2696.HK) successfully held its Global R&D Day themed "H-evolution: From Biotech to Biopharma", and released its interim analysis results of Phase 3 clinical study (ASTRUM-005) in previously untreated patients with extensive-stage small cell lung cancer (ES-SCLC) of serplulimab (novel anti-PD-1 mAb).
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Galecto Provides Enrollment Update on Phase 2a MYLOX-1 Trial and Reiterates Expected Timing of Multiple Data Readouts in 2022
12/20/2021
Galecto, Inc. (NASDAQ: GLTO), a publicly listed company focused on the development of novel treatments for fibrosis and cancer, today announced it has enrolled 10 of the anticipated 16 patients in its Phase 2a trial of its oral LOXL2 inhibitor GB2064 in myelofibrosis.
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scPharmaceuticals to Participate in Two Upcoming Investor Conferences - Dec 20, 2021
12/20/2021
scPharmaceuticals Inc. announced that John Tucker, president & chief executive officer, will participate virtually in two upcoming investor conferences.
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World Health Organization Grants Second Emergency Use Listing for Novavax COVID-19 Vaccine
12/20/2021
Novavax, Inc. announced that the World Health Organization has granted a second Emergency Use Listing for NVX-CoV2373, Novavax' recombinant protein nanoparticle COVID-19 vaccine with Matrix-M™ adjuvant, for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
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EDWARDS RECEIVES FDA APPROVAL FOR SAPIEN 3 WITH ALTERRA PRESTENT FOR TRANSCATHETER PULMONIC VALVE REPLACEMENT
12/20/2021
Edwards Lifesciences (NYSE: EW) today announced it received approval from the U.S. Food and Drug Administration (FDA) for the use of the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (SAPIEN 3 with Alterra) for patients with severe pulmonary regurgitation.