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Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron KP.2-adapted COVID-19 Vaccine in the European Union

Bagsværd, Denmark, 20 September 2024 – Novo Nordisk today announced headline results from a phase 2a clinical trial with monlunabant, a small molecule oral cannabinoid receptor 1 (CB1) inverse agonist. Monlunabant, formerly INV-202, was part of the acquisition of Inversago Pharmaceuticals Inc. announced in August 2023 [Link].

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Novo Nordisk A/S: Monlunabant phase 2a trial in obesity successfully completed

PARIS, FRANCE, 20 September 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the European Commission has conditionally approved Iqirvo® (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. Iqirvo is a first-in-class, oral, peroxisome proliferator-activated receptor (PPAR) agonist, that exerts an effect on the proteins PPAR? and PPAR?, thought to be key regulators of bile acid, inflammation and fibrosis.

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Ipsen’s Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade

TORONTO, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly,” “we,” or the “Company”) (NASDAQ: AIFF), an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, today announced advancing its artificial intelligence-powered Brain Network Analytics (BNA™) technology after successful research collaborations with Takeda Pharmaceutical Company Limited (“Takeda”) and Novartis, two global leaders in pharmaceutical R&D, illustrating the value of Firefly’s AI-based technology in providing objective measures in neuroscience drug development.

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Firefly Neuroscience Advances AI-Driven BNA™ Technology in Neuroscience Drug Development after Completing Successful Research Collaborations with...

LEXINGTON, Mass., Sept. 20, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has successfully defended against an opposition filed against a key patent for its direct-from-whole blood detection method in the European Union.

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T2 Biosystems Achieves Successful Defense of Patent for Direct-From-Whole Blood Pathogen Detection Method in the European Union

CARLSBAD, Calif., Sept. 20, 2024 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (the “Company”) today announced that on September 11, 2024, the Company received a notice from Nasdaq indicating that the Nasdaq Hearings Panel (“Panel”) has granted an extension for the continued listing of the Company, subject to the Company evidencing compliance with all applicable criteria for continued listing on The Nasdaq Capital Market by November 19, 2024. The Company is diligently working to fulfill the requirements set forth by the Panel to ensure the Company’s continued listing on Nasdaq.

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Qualigen Therapeutics, Inc. Received Extension from Nasdaq Hearings Panel

Hamilton, Bermuda, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Altamira Therapeutics Ltd. ("Altamira" or the "Company") (Nasdaq: CYTO), a company providing nanoparticle-based technology for efficient RNA delivery to extrahepatic targets, today announced that it will host its First Half 2024 Financial Results and Business Update Call on Tuesday, September 24, 2024. Founder, Chairman, and CEO Thomas Meyer and COO Covadonga Pañeda will deliver prepared remarks followed by a Q&A session where they will address questions from investors and analysts.

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Altamira Therapeutics to Host First Half 2024 Financial Results and Business Update Call on September 24, 2024

PsyLabs develops and produces certified pharmaceutical-grade natural psychedelics for applications in mental health and well-being PsyLabs develops and produces certified pharmaceutical-grade natural psychedelics for applications in mental health and well-being

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Psyence Group Enters into Agreement to Dispose of Stake in PsyLabs

CINCINNATI, Ohio, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Onconetix, Inc. (NASDAQ: ONCO) (“Onconetix” or the “Company”), a commercial-stage biotechnology company focused on the research, development, and commercialization of innovative solutions for men’s health and oncology, today announced that the Company’s stockholders have approved all proposals voted on at the Company’s 2024 annual meeting of stockholders (the “Annual Meeting”) held on September 5, 2024, and that its Board of Directors (the “Board of Directors” or “Board”) approved a 1-for-40 reverse stock split of its outstanding shares of common stock, to be effective as of 12:01 a.m. Eastern Time on Tuesday, September 24, 2024.

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Onconetix, Inc. Announces 1-for-40 Reverse Stock Split and Results of the Annual Meeting of Stockholders

SOUTH SAN FRANCISCO, Calif., Sept. 20, 2024 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody-drug conjugates (ADCs), today announced that on September 16, 2024, the Compensation Committee of Sutro’s Board of Directors granted 60,000 restricted stock units (RSUs) of Sutro common stock to a new employee. The grant was made as an inducement material to the employee’s acceptance of employment with Sutro and was approved by the Compensation Committee of Sutro’s Board of Directors in accordance with Nasdaq Listing Rule 5635(c)(4).

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Sutro Biopharma Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

JI’AN, Jiangxi, China, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Universe Pharmaceuticals INC (the “Company,” “we,” “our” and “us”) (Nasdaq: UPC), a pharmaceutical producer and distributor in China, today announced its unaudited financial results for the first six months of fiscal year 2024 ended March 31, 2024.

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Universe Pharmaceuticals INC Reports Financial Results for The First Six Months of Fiscal Year 2024

Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma not eligible for transplant

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Press Release: Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly...

TEL AVIV, Israel and PARSIPPANY, N.J., Sept. 21, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today presented data informing clinical strategies for switching patients to UZEDY®, an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults, from a once-monthly subcutaneous injection of Perseris® (RBP-7000). The results were presented during the 37th Annual European College of Neuropsychopharmacology (ECNP) Congress taking place between September 21-24, 2024, in Milan, Italy.

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New Data Provide Treatment Insights into Options for Switching Adult Patients Diagnosed with Schizophrenia to UZEDY® (risperidone) Extended-Release...

TEL AVIV, Israel & PARSIPPANY, N.J., Sept. 21, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new positive efficacy, safety and tolerability results for Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) trial evaluating TEV-‘749 in adult patients diagnosed with schizophrenia. In the study, TEV-‘749 met the primary endpoint, demonstrating significant improvements in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 8, as well as key secondary endpoints with improvements in both the Clinical Global Impression-Severity (CGI-S) scale and the Personal and Social Performance (PSP) scale score, compared to placebo at week 8. Additionally, SOLARIS (Period 1) and Phase 1 safety results demonstrated no incidence of post-injection delirium/sedation syndrome (PDSS) in participants taking TEV-‘749 to date.1 The overall safety profile was consistent with other oral acting olanzapine options. These data were presented during the 37th Annual European College of Neuropsychopharmacology (ECNP) Congress taking place between September 21-24, 2024, in Milan, Italy.

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Teva Presents New Phase 3 Efficacy, Safety and Tolerability Data from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous...

Webcast to be held Monday, September 23, at 8:00 a.m. ET

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Black Diamond Therapeutics to Host Webcast Presentation of Initial Phase 2 BDTX-1535 Data in Patients With Recurrent EGFRm NSCLC

Basel, 23 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has included dual-stain cytology testing in its cervical cancer prevention guideline.1 The Roche CINtec® PLUS Cytology test is the only FDA-approved and CE-marked dual-stain test that helps identify human papillomavirus (HPV)-positive individuals who are most at risk of developing cervical precancer and cancer.

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WHO endorses dual-stain cytology (CINtec PLUS) testing in its cervical cancer prevention guidelines, advancing patient care and underlining Roche’s...

TEL AVIV, Israel, Sept. 23, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that a new analysis from the European cohort of the RIM-TD open-label extension (OLE) study revealed that deutetrabenazine treatment of patients with Tardive Dyskinesia (TD) was associated with long term improvement of TD symptoms. The improvement in symptoms was sustained throughout the three-year study, and deutetrabenazine was well tolerated.1 The data were presented at the European College of Neuropsychopharmacology (ECNP) annual congress in Milan.

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Teva Announces Long Term Efficacy and Safety of Deutetrabenazine in European Patients with Debilitating Movement Disorder Tardive Dyskinesia

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), September 23, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that the European Commission has conditionally approved Iqirvo®1 (elafibranor) 80mg tablets for the treatment of Primary Biliary Cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. This follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on July 26, 2024 and the U.S. FDA Accelerated Approval on June, 10, 2024 .

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GENFIT: Ipsen’s Iqirvo® (Elafibranor) Receives EU Approval as a First-in-Class Treatment for Primary Biliary Cholangitis following U.S. FDA...

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Nicox and Glaukos Sign Exclusive NCX 1728 Research and Global Licensing Option Agreement

Brussels, 23 September 2024 – Synergia Medical, a leader in the development of optoelectronic medical devices, is pleased to announce the successful implantation of its groundbreaking NAO.VNS system in the first two patients as part of the AURORA study. These first-in-human implantations took place on September 6, 2024, at Cliniques Universitaires Saint-Luc and UZ Gent. Two weeks after surgery, both patients have fully recovered, allowing the initiation of stimulation therapy as planned.

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Synergia Medical Successfully Implants First Patients With NAO.VNS™