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...
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
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...
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
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
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.
