Pharmaceuticals

Everest Medicines' Partner Venatorx Receives FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI)

SHANGHAI, Aug. 15, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK)'s partner Venatorx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase in...

2023-08-15 20:19 1725

OnCusp Therapeutics Receives FDA Clearance for the Phase 1 Clinical Trial of CUSP06, Targeting Ovarian Cancer and Other Advanced Solid Tumors

NEW YORK, Aug. 15, 2023 /PRNewswire/ -- OnCusp Therapeutics, a biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients worldwide, announced today the clearance of its Investigational New Drug (IND) Applicatio...

2023-08-15 20:00 1050

TB Alliance Announces Partnership with Remington Pharmaceuticals to Commercialize New Therapy for Drug-Resistant Forms of TB in Pakistan

Non-profit drug developer partners with leading manufacturer of medicine in Pakistan NEW YORK, Aug. 14, 2023 /PRNewswire/ -- Non-profit drug developer TB Alliance has granted Remington Pharmaceutical Industries (Pvt.) Ltd. a non-royalty bearing license to market the anti-tuberculosis (TB) medici...

2023-08-14 21:30 1670

Kelun-Biotech announces that a Phase III clinical trial of core product SKB264 (MK-2870, TROP2-ADC) in patients with unresectable locally advanced, recurrent or metastatic TNBC who have failed second-line or above prior standard of care has met its primary endpoint

CHENGDU, China, Aug. 14, 2023 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. ("Kelun-Biotech", HKEX: 6990.HK) announced today that its innovative TROP2-ADC (SKB264, also known as MK-2870) met the primary endpoint in the randomized, controlled, open-label, multi-center Phase III ...

2023-08-14 12:50 3118

Streamlining Generic Drug Immunogenicity Evaluation: EpiVax's "PANDA" Approach

PROVIDENCE, R.I., Aug. 11, 2023 /PRNewswire/ -- EpiVax Inc. announces the publication of results from a research collaboration with the Food and Drug Administration aimed at streamlining generic drug evaluations. The research, initiated in 2018 with a$1M contract spanning two years (HHSF223018186...

2023-08-11 21:14 3041

Asieris Announces Positive Phase III Bridging Trial of Hexvix®, a Diagnostic Drug for Bladder Cancer

SHANGHAI, Aug. 11, 2023 /PRNewswire/ -- Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced that the Phase III bridging clinical tr...

2023-08-11 17:00 3770

First Patient Dosed in Pivotal Phase III Study of TLX591-CDx (Illuccix®) for Prostate Cancer Imaging in Chinese Patients

MELBOURNE, Australia, Aug. 11, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that a first patient has been dosed inChina in the pivotal Phase III registration study of TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11),[1] for the i...

2023-08-11 11:14 1738

WuXi XDC and Boostimmune Sign MOU for Integrated Services

SHANGHAI, Aug. 10, 2023 /PRNewswire/ -- WuXi XDC, a leading global Contract Research, Development and Manufacturing Organization (CRDMO) focused on the ADC and broader bioconjugate market, and Boostimmune, a biotech company dedicated to developing next-generation anti-cancer therapies modulating ...

2023-08-11 08:30 1312

Antengene Enters into Commercialization Partnership with Hansoh Pharma for First/Only-in-Class XPO1 Inhibitor XPOVIO®(selinexor) in the Mainland of China

-      Antengene and Hansoh Pharma to enter into collaboration agreement involving commercialization of XPOVIO® in the mainland of China, broadening coverage and improving access of the drug to patients in the mainland ofChina -      Antengene to receive up to RMB200 million in upfront payments,...

2023-08-11 08:00 2537

First Patient Dosed in Pivotal Phase III Study of TLX591-CDx (Illuccix®) for Prostate Cancer Imaging in Chinese Patients

MELBOURNE, Australia, Aug. 11, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that a first patient has been dosed inChina in the pivotal Phase III registration study of TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11),[1] for the i...

2023-08-11 07:18 1775

YS Biopharma to Report First Quarter Fiscal Year 2024 Financial Results on August 15, 2023

GAITHERSBURG, Md., Aug. 10, 2023 /PRNewswire/ -- YS Biopharma Co., Ltd. (NASDAQ: YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious disea...

2023-08-11 04:30 4595

Standigm and Nashville Biosciences join to revolutionize early drug discovery

Companies will identify novel therapeutic targets using Standigm's explainable AI and Nashville Biosciences' datasets SEOUL, South Korea, Aug. 10, 2023 /PRNewswire/ -- Standigm , a company using artificial intelligence (AI) technology for drug discovery and develop...

2023-08-10 21:07 1266

Oricell OriCAR-017 CAR-T Therapy Clears IND Hurdle, Paving the Way for Global Impact

SHANGHAI, Aug. 10, 2023 /PRNewswire/ -- August 10, 2023, in a groundbreaking development, Oricell Therapeutics Co., Ltd. ("Oricell") has received the green light for its Investigational New Drug (IND) application of OriCAR-017, a cutting-edge CAR-T cell therapy targeting GPRC5D to combat relapsed...

2023-08-10 21:00 2016

AffaMed Therapeutics Announces Partner Vistagen Reports Positive Top-Line Results from Phase 3 PALISADE-2 Trial of Fasedienol (PH94B) Nasal Spray in Social Anxiety Disorder

First positive U.S. Phase 3 study of an investigational therapy for social anxiety disorder in over 15 years Statistically significant rapid-onset reduction in patient-reported Subjective Units of Distress Scale (SUDS) score compared to placebo in a public speaking challenge (primary endpoint, p...

2023-08-10 15:49 3997

Pfizer's Pneumococcal 20-Valent Conjugate Vaccine is Now Available in Hong Kong, For Adults Aged 18 Years or Older[1]

* First pneumococcal conjugate vaccine that fights against 20 serotypes leading to most of the invasive pneumococcal diseases and pneumonia[2],[3] — one of the leading causes of death inHong Kong[4] — has been approved by Hong Kong Department of Health inApril 2023 and is now available in Hong ...

2023-08-10 14:15 1566

Pharming announces first patient enrolled in Phase III clinical trial of leniolisib for the treatment of APDS in Japan

Single-arm Phase III study in Japan evaluating leniolisib in patients aged 12 years and older with APDS, a rare primary immunodeficiency LEIDEN, The Netherlands, Aug. 9, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that...

2023-08-09 13:00 2622

Everest Medicines to Announce First Half 2023 Financial Results on August 24, 2023

SHANGHAI, Aug. 9, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, today announced that it will report financial results for the fir...

2023-08-09 08:06 1789

Lynk Pharmaceuticals Announced Positive Topline Data from Phase II Clinical Trial of LNK01001 in the Treatment of Atopic Dermatitis

HANGZHOU, China, Aug. 9, 2023 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as 'Lynk Pharmaceuticals'), an innovative clinical stage company, announced positive topline data from a Phase II clinical trial of LNK01001 for the treatment of atopic dermatitis. The study was...

2023-08-09 08:00 2612

Race Strategic Update August 2023

SYDNEY, Aug. 9, 2023 /PRNewswire/ -- Race Oncology Limited ("Race") is pleased to provide a strategic update, including an overview of revisions to corporate strategy, designed to optimise use of existing resources, while driving bisantrene's commercial partnering and collaboration potential. Ev...

2023-08-09 07:30 2308

Neuragenex Expands to Open New Illinois Location, Giving More People Access to its Innovative Approach to Chronic Pain Management

CHICAGO, Aug. 8, 2023 /PRNewswire/ -- Neuragenex, a trailblazing pain management practice at the forefront of pain management solutions, is delighted to announce the opening of four new locations inIllinois. With its groundbreaking approach to chronic pain management that is drug-free and non-in...

2023-08-09 00:14 1184
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