VANCOUVER, British Columbia, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Qu Biologics Inc., a private clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies designed to restore innate immune function, is pleased to announce it is receiving advisory services and research and development funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to quickly move forward the potential application of Qu’s lung-directed SSI, QBKPN, to prevent and treat infection with SARS-CoV-2, the virus causing COVID-19. Unlike traditional vaccines that direct the host adaptive immune response to a very specific antigen, Qu’s immunotherapy platform engages and trains the innate arm of the immune system that is responsible for providing the body’s first line of defense. Optimal innate immune defenses can efficiently contain and clear infection before it spreads and plays an essential role in also directing the adaptive immune response against new infections. By training the innate immune system to protect the lungs, QBKPN is designed to protect the lungs not only against COVID-19, but also against a wide range of other bacterial and viral respiratory infections, like influenza. Importantly, since QBKPN activates innate immunity, the immune protection it provides would not lose efficacy if SARS-CoV-2 mutates, which is a risk with traditional vaccines that rely on antigen specificity.

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Qu Biologics Receives Funding for COVID-19 Prevention/Treatment Research with Qu’s Novel Immunotherapy Platform

The Company’s Proposed Pharma Grade Version of Tauri-Gum™ is Being Developed Specifically to Target: Patients Subjected to Ongoing Chemotherapy Treatment (the “Indication”)

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Tauriga Sciences Inc. Enters into Master Services Agreement with CSTI to Resume the Clinical Development of its Anti-Nausea Pharmaceutical Grade...

MENLO PARK, Calif., Dec. 18, 2020 (GLOBE NEWSWIRE) -- Pacific Biosciences of California, Inc. (NASDAQ: PACB) (“Pacific Biosciences” or the “Company”), a leading provider of high-quality sequencing of genomes, transcriptomes, and epigenomes, today announced that the Compensation Committee of the Company’s Board of Directors granted non-qualified stock options covering an aggregate of 100,000 shares of Pacific Biosciences common stock and restricted stock units (“RSU”) covering 50,000 shares of Pacific Biosciences common stock to a recently hired non-executive officer employee under the Pacific Biosciences 2020 Inducement Equity Incentive Plan on December 14, 2020 (the “Effective Date”).

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Pacific Biosciences Grants Equity Incentive Award to New Employee

BASEL, Switzerland, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that the U.S. Food and Drug Administration (FDA) has approved ORGOVYX™ (relugolix) for the treatment of adult patients with advanced prostate cancer. ORGOVYX, which was granted Priority Review by the FDA, is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer. The approval is based on efficacy and safety data from the Phase 3 HERO study of ORGOVYX in men with advanced prostate cancer. ORGOVYX is expected to be available in January 2021.

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Myovant Sciences Announces FDA Approval of ORGOVYX™ (relugolix), the First and Only Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist...

Basel, December 18, 2020 — The U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for inclisiran, a potential treatment for hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. The FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action date of December 23, 2020, due to unresolved facility inspection-related conditions. The conditions will be conveyed to the European manufacturing facility within 10 business days. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the Novartis NDA may be approved. No onsite inspection was conducted. If it is determined that a facility inspection is needed to approve the application, the FDA will define an approach for scheduling once safe travel may resume based on public health need and other factors.

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Novartis receives complete response letter from U.S. FDA for inclisiran

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Hiya Vitamins Reviews - Best Vitamins Supplement for your Kids? - Product Review by Mike Vaughn

SAN FRANCISCO, Dec. 18, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period of the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD) by three months. The updated Prescription Drug User Fee Act (PDUFA) action date is March 20, 2021.

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FibroGen Provides Regulatory Update on Roxadustat

AUSTIN, TX and DURHAM, NC, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today announced that it will be added to the Russell 2000® and 3000® Indexes effective December 21, 2020, following Russell’s quarterly additions of select initial public offerings.

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Shattuck Labs Added to Russell 2000® and 3000® Indexes

MALVERN, Pa., Dec. 18, 2020 (GLOBE NEWSWIRE) -- Recro (Nasdaq:REPH), a leading contract development and manufacturing organization (CDMO), with integrated solutions for formulation, analytical services, regulatory support, manufacturing and packaging of both commercial and development stage oral solid dose drug products, today announced that it granted an inducement award to its newly-appointed President and Chief Executive Officer, David Enloe.

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Recro Grants Inducement Award to New Chief Executive Officer

VANCOUVER, British Columbia, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Haltain Developments Corp. (“Haltain” or the “Company”) announces that its previously announced non-binding letter of intent with ScreenPro Security Ltd. has terminated and that the transactions contemplated thereby will not proceed. For more information on the letter of intent and the transactions contemplated thereby, please see the Company's news release dated June 25, 2020.

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Haltain Announces Termination of LOI with ScreenPro Security Ltd.

COLUMBUS, Ohio, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Green Growth Brands Inc. (CSE: GGB) (OTCQB: GGBXF) (“GGB” or the “Company”) and certain of its direct and indirect wholly owned subsidiaries (collectively, the “Applicants”) today provided an update on their insolvency proceedings under the Companies’ Creditors Arrangement Act (Canada) (“CCAA”).

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Green Growth Brands Provides CCAA and Other Updates

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Neck Relax Reviews – Best Neck Massager around? – Product Review by Mike Vaughn

CAMBRIDGE, Mass., Dec. 17, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced the appointment of Satyavrat “Sath” Shukla, CFA, as Chief Financial Officer, effective as of January 4, 2021.

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Spero Therapeutics Announces Appointment of Sath Shukla as Chief Financial Officer

LA JOLLA, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) -- CalciMedica Inc. (“CalciMedica” or the “Company), a clinical-stage biotechnology company targeting calcium release-activated calcium (“CRAC”) channels for the treatment of severe acute and chronic inflammatory diseases, today announced that the trial evaluating Auxora™ in patients with severe COVID-19 pneumonia has received a recommendation to continue, following a pre-scheduled safety review by an Independent Data Monitoring Committee (IDMC). The IDMC recommendation that the trial continue is based on an unblinded analysis of safety data from over 50 patients. The company expects to have more than 100 patients enrolled by the end of December.

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CalciMedica Announces IDMC Recommendation to Continue with Trial Evaluating Auxora™ in Patients with Severe COVID-19 Pneumonia

- Proceeds Received from Registered Direct Offering, Warrant Exercises and Upfront Fee from China Out-licensing -

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SELLAS Strengthens Year-End Balance Sheet with Addition of Approximately $30.5 Million

NEW YORK, Dec. 17, 2020 (GLOBE NEWSWIRE) -- via InvestorWire — Cybin Inc. (NEO: CYBN) today announces its placement in an editorial published by NetworkNewsWire ("NNW"), one of 50+ trusted brands within the InvestorBrandNetwork (“IBN”), a multifaceted financial news and publishing company for private and public entities.

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Cybin Inc. (NEO: CYBN) Acquisition, Three-Pillar Approach Reason for Optimistic MDD Outlook

SAN CARLOS, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) -- BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the Phase III pivotal CardiAMP™ Heart Failure Trial. The DSMB based its review on all available data for the 86 patients enrolled in the trial, including 60 randomized patients who have reached their one-year follow-up. The DSMB performed a risk-benefit assessment, indicated no safety concerns, and recommended that the study continue as designed.

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BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Heart Failure Study as Designed

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Acer Therapeutics Announces Publication of Vascular Ehlers-Danlos Syndrome (vEDS) Patient Registry Data from Sweden

TEL-AVIV, Israel, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Tarsier Pharma (doing business as Tarsius Pharma Ltd.), a late clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients with blinding ocular diseases, today announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), and received important feedback on its trial design and program for its TRS01 Phase 3 program in uveitis, including feedback on its nonclinical and CMC plans supporting submission of a New Drug Application (NDA) in the U.S.  TRS01, the Company’s first clinical development candidate, is a novel immunomodulator drug for treating Active Anterior Non-Infectious Uveitis.

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Tarsier Pharma's Positive End-of-Phase 2 Meeting with the U.S. FDA Sets Stage for TRS01 Phase III Program in Uveitis

Additional agreement that expands Intrivo’s family of authorized distributors will ensure broad access to rapid testing solutions across US Additional agreement that expands Intrivo’s family of authorized distributors will ensure broad access to rapid testing solutions across US

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Intrivo Diagnostics Secures National Distribution Agreement with McKesson Medical-Surgical for Access Bio CareStart™ COVID-19 Tests