- FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on the BLA -
SHANGHAI, China, Dec. 26, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, today announces a new exclusive licensing and commercialization agreement with Hikma Pharmaceuticals PLC (Hikma), a multinational pharmaceutical company, for toripalimab in the Middle East and North Africa (MENA). Under the terms of the agreement, Hikma is granted an exclusive license to develop and commercialize toripalimab injection in all its MENA markets. In addition, Junshi Biosciences will grant the right of first negotiation to Hikma for the future commercialization of three under development drugs in MENA.
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Junshi Biosciences and Hikma Sign Exclusive Licensing Agreement for Cancer Treatment Drug Toripalimab for the Middle East and North Africa Region
TORONTO, Dec. 26, 2022 (GLOBE NEWSWIRE) -- Acerus Pharmaceuticals Corporation (the “Company” or “Acerus”) (TSX: ASP; OTCQB: ASPCF) today announced that Mr. Scott Leckie has resigned from the board of directors of the Company, effective immediately.
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Acerus Announces Resignation of Director
PARIS and CAMBRIDGE, Mass., Dec. 27, 2022 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced the first patient in the United States has been randomized in NANORAY-312, a global Phase 3 registrational trial evaluating NBTXR3 for the treatment of elderly patients with locally advanced head and neck squamous cell carcinoma (“LA-HNSCC”) who are ineligible for platinum-based chemotherapy. NBTXR3 activated by radiotherapy will be evaluated alone or in combination with cetuximab. NBTXR3 is a potentially first-in-class radioenhancer with broad application across solid tumors, with prioritized focus in head and neck cancer.
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NANOBIOTIX Announces First Patient Randomized in the United States in Global Phase 3 Pivotal Trial Evaluating Radioenhancer NBTXR3 in Head and Neck...
STAMFORD, Conn., Dec. 27, 2022 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, announced today that the Company has completed the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for nirogacestat, an investigational gamma secretase inhibitor, for the treatment of adults with desmoid tumors.
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SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Nirogacestat for the Treatment of Adults with Desmoid Tumors
NEW YORK, Dec. 27, 2022 (GLOBE NEWSWIRE) -- LifeMD, Inc. (NASDAQ: LFMD/LFMDP), a leading direct-to-patient telehealth company, today announced that its Board of Directors has authorized a cash dividend to holders of the Company’s 8.875% Series A Cumulative Perpetual Preferred Stock (Nasdaq: LFMDP) equal to $0.5546875 per share.
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LifeMD Declares Quarterly Dividend on Series A Cumulative Perpetual Preferred Stock
Acquires F351, a Phase 3 Drug to Treat Fibrosis
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Catalyst Biosciences Completes First Steps in Reverse Merger Plan
Initial $3.5M Funding Maintains Cash Runway of Mid-2023 Initial $3.5M Funding Maintains Cash Runway of Mid-2023
New FDA-approved formulation for patients living with urea cycle disorders
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Acer Therapeutics and Relief Therapeutics Announce U.S. FDA Approval of OLPRUVA™ for Patients with Urea Cycle Disorders
Company announcement no. 31 - 2227 December 2022
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Transactions in connection with share buy-back program
PRESS RELEASE
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Masitinib receives orphan drug status for the treatment of amyotrophic lateral sclerosis in Switzerland
-- On-track to initiate Phase 2b trial in 1Q 2023; Topline data expected in 1Q 2024 -- -- Received remaining $25 million investment under previously announced private placement financing --ARLINGTON, Mass., Dec. 27, 2022 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare diseases of the eye, today announced that the U.S. Food and Drug Administration (FDA) has accepted an investigational new drug (IND) application for the company’s lead product candidate, KPI-012, a human mesenchymal stem cell secretome (MSC-S), initially in development for the treatment of persistent corneal epithelial defect (PCED).
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Kala Pharmaceuticals Announces FDA Acceptance of IND Application for KPI-012 for the Treatment of PCED
SALT LAKE CITY, Dec. 27, 2022 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company today announced topline study results from its Phase 2 investigational trial with CNM-ZnAg, an ionic solution of zinc and silver, for the treatment of non-hospitalized acutely symptomatic participants infected with COVID-19.
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Clene Nanomedicine Reports Topline Results of Phase 2 COVID-19 Study of CNM-ZnAg
REDWOOD CITY, Calif., Dec. 27, 2022 (GLOBE NEWSWIRE) -- Seer, Inc. (Nasdaq: SEER), a life sciences company commercializing a disruptive new platform for proteomics, today announced that the company will be participating in the upcoming 41st Annual J.P. Morgan Healthcare Conference.
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Seer to Present at the J.P. Morgan 41st Annual Health Care Conference
SEATTLE, Dec. 27, 2022 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (“Adaptive Biotechnologies”) (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced it will be participating in the upcoming 41st Annual J.P. Morgan Healthcare Conference in San Francisco, CA.
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Adaptive Biotechnologies to Present at the 41st Annual J.P. Morgan Healthcare Conference
-- Agreement Covers Buyout of Remaining Financial Obligations for Anti-CCR8 Antibody in Development as a Potential Treatment for Solid Tumors -- -- Agreement Covers Buyout of Remaining Financial Obligations for Anti-CCR8 Antibody in Development as a Potential Treatment for Solid Tumors --
Advancing pipeline of next generation therapeutics and diagnostics for oncology and immune diseases of high unmet need Advancing pipeline of next generation therapeutics and diagnostics for oncology and immune diseases of high unmet need
-Wouter Joustra Elected to the Board of Directors -Wouter Joustra Elected to the Board of Directors
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VectivBio Announces Results of Extraordinary General Meeting
BASKING RIDGE, NJ, Dec. 09, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced that the Company has received formal notice from The NYSE American LLC (“NYSE American”) stating that the Company has regained compliance with the NYSE American’s continued listing standards.
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Timber Pharmaceuticals Regains Compliance with NYSE American Continued Listing Standards
FT819 Off-the-Shelf CAR T-cell Product Candidate Derived from Clonal Engineered Master iPSC Line with Novel CD19-specific 1XX CAR Integrated into TRAC Locus