Polaris Group Initiates Rolling Submission of Biologic License Application (BLA) for ADI-PEG 20 with U.S. FDA to Treat Malignant Pleural Mesothelioma
By Dr. Matthew Watson
TAIPEI, Taiwan and SAN DIGEO, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Polaris Group (The Company, TWSE:6550), today announced that the Company has initiated the rolling submission of its Biologic License Application (BLA) for ADI-PEG 20 to the U.S. Food and Drug Administration (FDA) for the systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology, in combination with a platinum agent and pemetrexed. This submission is based on the results of the successful phase 3 trial of ADI-PEG 20 in combination with a platinum agent and pemetrexed which met both its primary and secondary objectives for progression free survival and overall survival. The rolling submission process allows for the submission of individual modules of the BLA as they are completed, which can streamline the regulatory review process and may expedite the potential approval timeline.
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Polaris Group Initiates Rolling Submission of Biologic License Application (BLA) for ADI-PEG 20 with U.S. FDA to Treat Malignant Pleural Mesothelioma
Verona Pharma’s President and CEO David Zaccardelli Wins Executive of the Year SCRIP Award
By Dr. Matthew Watson
LONDON and RALEIGH, N.C., Nov. 17, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces its President and CEO, David Zaccardelli, has won ‘Executive of the Year 2023’ at the SCRIP Awards in recognition of his exemplary leadership.
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Verona Pharma’s President and CEO David Zaccardelli Wins Executive of the Year SCRIP Award
First Product Incorporating Arecor’s Arestat Technology, At220, Launched in Europe
By Dr. Matthew Watson
Arecor Therapeutics plc(“Arecor” or the “Group”)
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First Product Incorporating Arecor’s Arestat Technology, At220, Launched in Europe
Mendus Announces Nomination Committee for the 2024 Annual General Meeting
By Dr. Matthew Watson
Press Release
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Mendus Announces Nomination Committee for the 2024 Annual General Meeting
Medicenna Announces Compelling Survival Benefit from Phase 2b Study of Bizaxofusp in Recurrent Glioblastoma at the 28th Annual Meeting of the Society…
By Dr. Matthew Watson
Single treatment of bizaxofusp doubled mOS (14.5 months vs. 7.2 months) irrespective of IL4R expression (high or low) compared to patients treated in the external control arm
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Medicenna Announces Compelling Survival Benefit from Phase 2b Study of Bizaxofusp in Recurrent Glioblastoma at the 28th Annual Meeting of the Society...
Day One Announces Tovorafenib FIREFLY-1 Data Published in Nature Medicine
By Dr. Matthew Watson
Data subsets to be shared today in plenary oral presentations at the 2023 Society for Neuro-Oncology Annual Meeting Data subsets to be shared today in plenary oral presentations at the 2023 Society for Neuro-Oncology Annual Meeting
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Day One Announces Tovorafenib FIREFLY-1 Data Published in Nature Medicine
Adlai Nortye Announces Completion of Patient Enrollment in Global Phase III Clinical Trial of Buparlisib (AN2025) in Combination with Paclitaxel for…
By Dr. Matthew Watson
SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, Nov. 17, 2023 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced the Completion of Patient Enrollment in Global Phase III Clinical Trial (BURAN) of Buparlisib (AN2025) in Combination with Paclitaxel for the Treatment of Recurrent or Metastatic HNSCC in more than 180 sites around the world, spanning over 18 markets in North America, Europe, Asia, and South America.
Humacyte Announces Two Presentations at the VEITHsymposium® of Positive Clinical Results of the Human Acellular Vessel™ (HAV™) in the Treatment…
By Dr. Matthew Watson
– Presentations included results from Phase 2/3 clinical trial and outcomes of real-world use of the HAV under a humanitarian aid program to treat wartime injuries in Ukraine –
Parexel Named “Best Contract Research Organization” at 19th Annual Scrip Awards
By Dr. Matthew Watson
Company recognized with prestigious industry award by a distinguished panel of life science industry executives Company recognized with prestigious industry award by a distinguished panel of life science industry executives
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Parexel Named “Best Contract Research Organization” at 19th Annual Scrip Awards
PaxMedica Inc. Featured in Syndicated Broadcast Highlighting FDA Type-B Meeting to Review PAX-101 Pivotal Trial Data
By Dr. Matthew Watson
LOS ANGELES, Nov. 17, 2023 (GLOBE NEWSWIRE) -- via IBN –PaxMedica, Inc. (NASDAQ: PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, today announces that it has been featured in a broadcast via NetworkNewsAudio (“NNA”), a solution that delivers additional visibility, recognition and brand awareness in the investment community via distribution to thousands of syndication points. The audio news release covers PaxMedica’s recent announcement of the completion of a type-B meeting with the FDA. During the live meeting, the company discussed the positive results of the recent data from its PAX-HAT-301 study of suramin in Stage One Human African Sleeping Sickness caused by Trypanosoma brucei rhodesiense, a rare and fatal parasitic disease if left untreated.
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PaxMedica Inc. Featured in Syndicated Broadcast Highlighting FDA Type-B Meeting to Review PAX-101 Pivotal Trial Data
Serina Therapeutics Announces POZ Polymer Technology License Agreement with Pfizer
By Dr. Matthew Watson
HUNTSVILLE, AL, Nov. 17, 2023 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (Serina), a privately held, clinical stage biotechnology company focused on developing its proprietary POZ Platform TM drug delivery technology, including POZ lipid nanoparticle (LNP) delivery systems for RNA-based therapeutics, today announced Serina has entered into a License Agreement under which Pfizer Inc. will license, on a non-exclusive basis, Serina’s POZ polymer technology.
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Serina Therapeutics Announces POZ Polymer Technology License Agreement with Pfizer
Rezolute to Participate in BTIG’s 3rd Annual Ophthalmology Day
By Dr. Matthew Watson
REDWOOD CITY, Calif., Nov. 17, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that the management team will participate in BTIG’s 3rd Annual Ophthalmology Day, taking place virtually on November 27th.
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Rezolute to Participate in BTIG’s 3rd Annual Ophthalmology Day
Fresh Tracks Therapeutics Announces Adjournment of Special Meeting of Stockholders
By Dr. Matthew Watson
Meeting adjourned to November 30, 2023 at 10 a.m. MT
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Fresh Tracks Therapeutics Announces Adjournment of Special Meeting of Stockholders
Benitec Biopharma to Participate in a Fireside Chat at the 35th Annual Piper Sandler Healthcare Conference
By Dr. Matthew Watson
HAYWARD, Calif., Nov. 17, 2023 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary DNA-directed RNA interference (“ddRNAi”) platform, today announced that Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec, will participate in a Fireside Chat at the 35th Annual Piper Sandler Healthcare Conference on Thursday, November 30th, 2023 at 10:00 am ET.
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Benitec Biopharma to Participate in a Fireside Chat at the 35th Annual Piper Sandler Healthcare Conference
Tenax Therapeutics Announces Professor Javed Butler, M.D., M.P.H, M.B.A., joins PH-HFpEF Scientific Advisory Board
By Dr. Matthew Watson
CHAPEL HILL, N.C., Nov. 17, 2023 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced the appointment of Javed Butler, M.D., M.P.H, M.B.A., to the Company’s PH-HFpEF Scientific Advisory Board (SAB).
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Tenax Therapeutics Announces Professor Javed Butler, M.D., M.P.H, M.B.A., joins PH-HFpEF Scientific Advisory Board
Scilex Holding Company Announces Issuance of a Second New Patent in the U.S. for Its Lead Commercial Product ZTlido® (lidocaine topical system) for a…
By Dr. Matthew Watson
PALO ALTO, Calif., Nov. 17, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that the U.S. Patent and Trademark Office has issued a second new patent, No. 11,786,455 (the ”Patent”), further strengthening the Company’s intellectual property position and coverage for its lead commercial product, ZTlido® (lidocaine topical system) 1.8%, which will expire in 2031. The Patent, titled “Non-aqueous Patch,” covers a non-aqueous lidocaine patch with certain specifications, as well as a method of relieving pain through the application of a non-aqueous lidocaine-containing patch.
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Scilex Holding Company Announces Issuance of a Second New Patent in the U.S. for Its Lead Commercial Product ZTlido® (lidocaine topical system) for a...
Uppsala University Hospital and Sana Biotechnology Announce Authorization of the First-in-Human Clinical Trial Application for a Primary Islet Cell…
By Dr. Matthew Watson
Goal is to report UP421 proof of concept data in 2023 and 2024
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Uppsala University Hospital and Sana Biotechnology Announce Authorization of the First-in-Human Clinical Trial Application for a Primary Islet Cell...
Altamira Therapeutics Announces Partial Spin-Off of Bentrio® Business
By Dr. Matthew Watson
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Altamira Therapeutics Announces Partial Spin-Off of Bentrio® Business
Clearmind Medicine Announces Receipt of Nasdaq Delisting Notice and Plan for Immediate Recompliance
By Dr. Matthew Watson
As part of the Company’s plan for recompliance, the Company’s shareholders approved a reverse stock split on November 14, 2023.
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Clearmind Medicine Announces Receipt of Nasdaq Delisting Notice and Plan for Immediate Recompliance
Cellectis’ Shareholders Meeting to be Held on December 22, 2023
By Dr. Matthew Watson
NEW YORK, Nov. 17, 2023 (GLOBE NEWSWIRE) -- Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, announced today that it will hold a general meeting on December 22, 2023 at 2:30 p.m. CET at the Biopark auditorium, 11 rue Watt, 4th floor, 75013 Paris, France.
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Cellectis’ Shareholders Meeting to be Held on December 22, 2023