U.S. FDA Clears MYCO-001 for Multi-Site Government Funded Trial in Smoking Cessation
By Dr. Matthew Watson
DENVER, June 17, 2022 (GLOBE NEWSWIRE) -- Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology aiming to transform the treatment of mental health and addiction disorders, today announced that the U.S. Food and Drug Administration (FDA) has cleared MYCO-001 in a recent Investigational New Drug (IND) application, marking the first clearance of the Company’s drug product.
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U.S. FDA Clears MYCO-001 for Multi-Site Government Funded Trial in Smoking Cessation
ObsEva Announces European Commission Marketing Authorization for Yselty® (linzagolix), an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids
By Dr. Matthew Watson
-Yselty® (linzagolix) is the first and only approved GnRH antagonist to provide flexible dosing options with and without hormonal add-back therapy-
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ObsEva Announces European Commission Marketing Authorization for Yselty® (linzagolix), an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids
Quotient Limited to Report Fourth Quarter and Full Year 2022 Financial Results and Host Conference Call on June 22nd
By Dr. Matthew Watson
JERSEY, Channel Islands, June 17, 2022 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ: QTNT), a commercial-stage diagnostics company, today announced that financial results for its fiscal fourth quarter and full year ended March 31, 2022 will be released before market open on Wednesday, June 22, 2022.
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Quotient Limited to Report Fourth Quarter and Full Year 2022 Financial Results and Host Conference Call on June 22nd
Altimmune Announces Oral Presentation of Pemvidutide Clinical Data at Upcoming EASL International Liver Congress™ on June 25, 2022
By Dr. Matthew Watson
Presentation to be highlighted in the Best of International Liver Congress Presentation to be highlighted in the Best of International Liver Congress
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Altimmune Announces Oral Presentation of Pemvidutide Clinical Data at Upcoming EASL International Liver Congress™ on June 25, 2022
VYNE Therapeutics Completes Enrollment in Phase 2a Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis
By Dr. Matthew Watson
Top-line Efficacy Results Expected in Approximately 6 to 8 Weeks Top-line Efficacy Results Expected in Approximately 6 to 8 Weeks
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VYNE Therapeutics Completes Enrollment in Phase 2a Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis
Cyclerion Therapeutics Announces CY6463 Data Demonstrating Improved Cellular Energetics in Preclinical Models of Mitochondrial Disease
By Dr. Matthew Watson
CY6463 alleviated mitochondrial dysfunction and reduced inflammation in preclinical models of mitochondrial complex 1 deficiency
Codexis Announces the Publication of Research Demonstrating Proof of Concept for Chemoenzymatic Site-Selective Bioconjugation of Native Peptides
By Dr. Matthew Watson
Collaboration with Merck published in Science magazine
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Codexis Announces the Publication of Research Demonstrating Proof of Concept for Chemoenzymatic Site-Selective Bioconjugation of Native Peptides
Capricor Therapeutics to Present One-Year Efficacy Results from its Ongoing HOPE-2 Open Label Extension Study at 2022 Parent Project Muscular…
By Dr. Matthew Watson
Results to be Presented in Late-Breaking Session Results to be Presented in Late-Breaking Session
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Capricor Therapeutics to Present One-Year Efficacy Results from its Ongoing HOPE-2 Open Label Extension Study at 2022 Parent Project Muscular...
ExCellThera announces submission of Drug Master File for UM171
By Dr. Matthew Watson
MONTRÉAL, June 17, 2022 (GLOBE NEWSWIRE) -- ExCellThera Inc. (ExCellThera), an advanced clinical-stage biotechnology company delivering molecules and bioengineering solutions to expand and engineer various cell lines for use in next generation cell and gene therapies, announced today that it has submitted a Type II Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for UM171, a proprietary molecule being studied for use in the expansion and rejuvenation of hematopoietic stem cells.
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ExCellThera announces submission of Drug Master File for UM171
Sana Biotechnology Presents Data at ISSCR 2022 Annual Meeting Showing Survival of Transplanted Hypoimmune iPSC-Derived Differentiated Cell Types…
By Dr. Matthew Watson
First demonstration of the survival of allogeneic islet cells, cardiomyocytes, and retinal pigment epithelium cells transplanted into an immunocompetent non-human primate model without any immune suppression
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Sana Biotechnology Presents Data at ISSCR 2022 Annual Meeting Showing Survival of Transplanted Hypoimmune iPSC-Derived Differentiated Cell Types...
BioCorRx Featured on LiveNOW from FOX
By Dr. Matthew Watson
ANAHEIM, CA, June 17, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance abuse and related disorders, today announced that Tom Welch, Executive Vice President of BioCorRx Inc., was featured on LiveNOW from FOX. Mr. Welch discussed BioCorRx’s pilot program with 2B3D, a virtual, augmented, and mixed reality technology company, a first-of-its-kind post-traumatic stress disorder (PTSD) and addiction treatment solutions program for veterans in the metaverse setting.
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BioCorRx Featured on LiveNOW from FOX
Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age
By Dr. Matthew Watson
NEW YORK and MAINZ, GERMANY, June 17, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series for children 6 months through 4 years of age (also referred to as 6 months to less than 5 years of age). The 3-µg dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity data.
BioStem Technologies® CEO to Appear on the Benzinga All Access Show on June 17,2022
By Dr. Matthew Watson
POMPANO BEACH, FLORIDA, June 17, 2022 (GLOBE NEWSWIRE) -- BioStem Technologies® (OTC: BSEM), a leading, innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies will be hosted on Benzinga’s All Access show, which airs on Benzinga TV and Benzinga’s YouTube channel on June 17 2022, at 10:20 AM EST.
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BioStem Technologies® CEO to Appear on the Benzinga All Access Show on June 17,2022
Genmab Announces Initiation of Share Buy-Back Program
By Dr. Matthew Watson
Company Announcement
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Genmab Announces Initiation of Share Buy-Back Program
Tiziana Life Sciences Ltd. Receives Nasdaq Deficiency Notice
By Dr. Matthew Watson
NEW YORK, June 17, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company enabling breakthrough immunotherapies via novel routes of monoclonal antibody delivery, today disclosed the receipt of a notice (the “Notice”) on June 14, 2022 from the Nasdaq Stock Market LLC (“Nasdaq”) that the Company is not currently in compliance with the $1.00 minimum bid price requirement for continued listing of the Company’s common shares on the Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Requirement”). The Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 days, or until December 12, 2022 (the “Compliance Deadline”), to regain compliance with the Minimum Bid Price Requirement by having the closing bid price of the Company’s common shares meet or exceed $1.00 for at least ten consecutive business days.
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Tiziana Life Sciences Ltd. Receives Nasdaq Deficiency Notice
Connect Biopharma Announces Receipt of NASDAQ Deficiency Notice Regarding Minimum Bid Price Requirement
By Dr. Matthew Watson
SAN DIEGO, CA and TAICANG, SUZHOU, China, June 17, 2022 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) ("Connect Biopharma" or the “Company”) announced on June 16, 2022, Connect Biopharma Holdings Limited (the “Company”) received a letter from the Listings Qualifications Department of the Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty consecutive business days, the bid price for the Company’s American Depositary Shares (“ADSs”) had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Global Market under Nasdaq Listing Rule 5550(a)(2).
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Connect Biopharma Announces Receipt of NASDAQ Deficiency Notice Regarding Minimum Bid Price Requirement
Neurona Therapeutics to Present Preclinical Data Supporting Regenerative Cell Therapy, NRTX-1001, in Clinical Development for Chronic Focal Epilepsy,…
By Dr. Matthew Watson
Oral presentation will outline design of first ever Phase 1/2 clinical trial of regenerative human cell therapy in epilepsy
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Neurona Therapeutics to Present Preclinical Data Supporting Regenerative Cell Therapy, NRTX-1001, in Clinical Development for Chronic Focal Epilepsy,...
Entera Bio Announces Departure of Dr. Phillip Schwartz, the Company’s President of Research & Development to Pursue Outside Opportunities
By Dr. Matthew Watson
BOSTON and JERUSALEM, June 17, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered peptides and therapeutic proteins, today announced that Dr. Phillip Schwartz, the Company’s President of Research & Development and Founder, will resign from his current role effective July 21, 2022 to pursue other opportunities. Dr. Schwartz also stepped down from the Company’s Board of Directors, effective June 15, 2022. Dr. Schwartz’s resignation was not a result of any disagreement with the Company and Dr. Schwartz will remain as a consultant to the Company.
Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15
By Dr. Matthew Watson
Saint-Herblain (France) and New York, June 20, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today announced that they have entered into an Equity Subscription Agreement and have updated the terms of their Collaboration and License Agreement for Lyme disease vaccine candidate VLA15. As previously announced on April 26, 2022, Pfizer plans to initiate the Phase 3 study of VLA15 in the third quarter of 2022.
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Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15
Clover Appoints Donna Ambrosino, M.D., and Ralf Clemens, M.D., Ph.D., to Board of Directors
By Dr. Matthew Watson
SHANGHAI, China, June 20, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced the appointment of Donna Ambrosino, M.D., and Ralf Clemens, M.D., Ph.D., to the company’s Board of Directors.
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Clover Appoints Donna Ambrosino, M.D., and Ralf Clemens, M.D., Ph.D., to Board of Directors