NEW YORK, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the European Committee for Medicinal Products for Human use (“CHMP”) has adopted a negative opinion recommending a refusal of the marketing authorization for omburtamab for the treatment of CNS/leptomeningeal metastasis from neuroblastoma in Europe.

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The CHMP has Adopted a Negative Opinion for Omburtamab for the Treatment of CNS/LM Metastasis from Neuroblastoma in Europe

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, has received notification from the Nasdaq Stock Market LLC Listing Qualifications Department that it was not in compliance with the minimum bid price requirement set forth in Nasdaq Rule 5450(a)(1) since the closing bid price for the Company's common shares listed on Nasdaq was below US$1.00 for 30 consecutive business days. Nasdaq Rule 5450(a)(1) requires the shares to maintain a minimum bid price of US$1.00 per share, and Nasdaq Rule 5810(c)(3)(A) provides that failure to meet such a requirement exists when the bid price of the shares is below US$1.00 for a period of 30 consecutive business days. These notifications do not impact the Company’s listing on the Nasdaq Global Market at this time. In accordance with Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of notification, or until June 12, 2023, to regain compliance with the minimum bid price requirement, during which time the shares will continue to trade on the Nasdaq Global Market. If at any time during the 180-calendar day period, the bid price of the shares closes at or above US$1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that the Company has achieved compliance with the minimum bid price requirement and will consider such deficiency matters closed.

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CENTOGENE Receives Nasdaq Non-Compliance Notice

Chair of the Board of Directors, Sean P. Nolan, appointed Chief Executive Officer

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Taysha Gene Therapies Announces Executive Leadership Changes

1. Stem Cell Technologies and Applications Market Report 2022-2032  Yahoo Finance
2. Stem Cell Therapy Market is expected to generate a revenue of USD 296.14 Million by 2028, Globally, at 10.97% CAGR: Verified Market Research  PR Newswire
3. The Stem Cell Technologies and Applications market is projected to grow at a CAGR of 8.9% by 2032: Visiongain Reports Ltd  GlobeNewswire
4. Global Stem Cell Therapy Market Survey Insights,Outlook and Forecast 2023-2030 PRIZM News  PRIZM News
5. View Full Coverage on Google News

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Stem Cell Technologies and Applications Market Report 2022-2032 - Yahoo Finance

Fred Hutch at ASH: Global insights on AML outcomes, COVID-19 and cancer, CD19 CAR T-cell therapy updates, latest on precision oncology and more  Newswise

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Fred Hutch at ASH: Global insights on AML outcomes, COVID-19 and cancer, CD19 CAR T-cell therapy updates, latest on precision oncology and more -...

VANCOUVER, British Columbia, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Canary Medical, a medical data company focused on the development and commercialization of its patented implantable sensor technology and complementary data and analytics ecosystem, today announced the introduction of its first orthopedic analytic module, Canary Quantiles™ Recovery Curves. Recovery curves utilize movement data measured by Canary Medical’s proprietary implantable canturio™te tibial extension sensor technology integrated with Zimmer Biomet’s Persona IQ® - The Smart Knee®.

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Canary Medical Announces Introduction of Groundbreaking Orthopedic Analytic Platform

Media Release

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Immutep Successfully Achieves Commercial Scale in Manufacturing of Eftilagimod Alpha

ATLANTA, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians, and partners concerned with retinal health and maintaining better vision longer, today announced that it has agreed to an amendment to its existing loan and security agreement with its debt facility partner, SLR Investment Corp (“SLR”) to extend the interest-only period through March 31, 2023 with the possibility of extending to July 1, 2023.

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Alimera Sciences Announces Agreement to Extend Amortization Date and Interest-Only Period on Loan Agreement

MALVERN, Pa., Dec. 08, 2022 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX) a pharmaceutical company focused on innovative products for hospital and related settings, today announced the initiation of a clinical study evaluating the safety, tolerability profile, and intubation conditions of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery.

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Baudax Bio Initiates Phase II Clinical Trial Evaluating BX1000 in Patients Undergoing Surgery

Company also announces that Julia Haller, MD, is stepping down from its Board of Directors Company also announces that Julia Haller, MD, is stepping down from its Board of Directors

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Eyenovia Announces Promotion of Bren Kern to Chief Operating Officer and Corporate Vice President

The Company will Provide an Overview of its Immune Checkpoint Enhancer (ICE) Platform

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AltruBio Hosting Research & Development Update on Immune Checkpoint Enhancer Platform for T Cell Mediated Immunological Diseases

Intranasal administration of Ampligen demonstrated to be well-tolerated

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AIM ImmunoTech Reports Positive Safety, Tolerability and Biological Activity Data for Intranasal Ampligen® (Rintatolimod) in Healthy Subjects

Expands Commercialization Efforts in Areas with High Unmet Needs Expands Commercialization Efforts in Areas with High Unmet Needs

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Biomerica Receives KFDA and Ministry of Health Approval for Colorectal Screening and Breast Screening Tests in Saudi Arabia and UAE

LEXINGTON, Mass., Dec. 08, 2022 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistant genes, today announced the publication of a peer-reviewed article published by Oxford University Press on behalf of the Infectious Diseases Society of America.

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T2 Biosystems Highlights Peer-Reviewed Article Linking COVID-19 and Sepsis and Underscoring CDC Call for Adoption of Early and Accurate Microbial...

NEW YORK, Dec. 08, 2022 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the Independent Data Monitoring Committee (IDMC) for its Phase 3 REGAL study for galinpepimut-S (GPS) in acute myeloid leukemia (AML) performed its initial prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. The charter for the IDMC provides for periodic reviews by the IDMC for safety, efficacy and futility in addition to the interim and final analyses.

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SELLAS Life Sciences’ Independent Data Monitoring Committee Recommends Galinpepimut-S REGAL Trial to Continue as Planned

VANCOUVER, British Columbia, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (“Sirona”) is pleased to announce that the clinical trial, for novel anti-aging compound TFC-1326, started on December 5th, 2022.

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Sirona Biochem Announces Start of Clinical Trial for Anti-Aging Compound TFC-1326

NEW YORK, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the National Medical Products Administration (“NMPA”) in China has granted DANYELZA (naxitamab-gqgk) 40mg/10ml conditional approval. DANYELZA will be marketed in China by Y-mAbs’ partner SciClone Pharmaceuticals (Holdings) Limited (“SciClone Pharmaceuticals”).

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Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma Approved in China

NEW YORK and MAINZ, GERMANY, DECEMBER 8, 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 their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age. Children in this age group can receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 Vaccine followed by a third 3-µg dose of the bivalent vaccine to complete the primary series. Vaccine doses can be delivered immediately upon receipt of a recommendation from the U.S. Centers for Disease Control and Prevention ("CDC").

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Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years

COPENHAGEN, Denmark, December 8, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that the Board of Directors has decided to issue warrants to members of the Executive Management and selected employees in the Bavarian Nordic Group. As a new initiative, vesting of the warrants for members of the Executive Management will be based on successful achievement of relevant Key Performance Indicators (KPI's). The decision is made in accordance with the shareholder authorizations for the Board of Directors adopted as Articles 5b and 5c of the Articles of Association and the Remuneration Policy.

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New Incentive Program Established for Members of Executive Management and Selected Employees in Bavarian Nordic

SAN DIEGO, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced acceptance of two abstracts presenting patient data on its targeted therapeutics delivery system for presentation at the Crohn’s & Colitis Congress, which will take place January 19-21, 2023, in Denver, Colorado. This annual conference, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association, is focused on bringing together a multidisciplinary community of health care practitioners and researchers to transform inflammatory bowel disease care.

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Biora Therapeutics Announces Two Poster Presentations at the Crohn’s & Colitis Congress