Acquisition Enhances Company’s Decentralized Solutions Offering by Strengthening Patient Focus Acquisition Enhances Company’s Decentralized Solutions Offering by Strengthening Patient Focus
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Syneos Health Acquires Illingworth Research Group, a Leading Provider of Clinical Research Home Health Services
CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG) (“CENTOGENE” or the “Company”), a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians and pharmaceutical companies, today announced the voting results of the Company’s Extraordinary General Meeting. The shareholders of the Company voted in favor of all proposals, which included the appointments of Dr. Andrin Oswald as Managing Director and Dr. Jonathan Sheldon as Supervisory Director, the reappointment of Mr. Richard Stoffelen as Managing Director, and adjustments to the compensation of the Supervisory Board.
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CENTOGENE Announces Voting Results of Extraordinary General Meeting
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
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
