Drug Quality and Security Act

Shineco, Inc. Attends MEDICA 2022 Düsseldorf Germany

Retrieved on: 
Tuesday, November 29, 2022
Marketing, COVID-19, Monkeypox virus, Attention, CBP, Drug Quality and Security Act, Textile, Security (finance), MEDICA, News, SISI, Medical device

MEDICA 2022 is one of the world's largest medical trade fair held annually for medical technology, electromedical equipment, laboratory equipment, diagnostics and pharmaceuticals.

Key Points: 
  • MEDICA 2022 is one of the world's largest medical trade fair held annually for medical technology, electromedical equipment, laboratory equipment, diagnostics and pharmaceuticals.
  • With an exhibition area of more than 108,000 square meters, the trade fair attracts visitors and exhibitors from approximately 70 countries worldwide.
  • The CBP team demonstrated its competitive strengths to experts, scholars, and partners in the field of medical testing globally.
  • Utilizing modern engineering technologies and biotechnologies, Shineco produces, among other products, Chinese herbal medicines, organic agricultural produce, and specialized textiles.

Medical Marijuana, Inc. Subsidiary Kannaway Expands Leadership Team With Appointment of Industry Veterans to Roles of Executive Vice President and Vice President of Information Technology

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Tuesday, November 29, 2022
SAN, Safe harbor, OTC, CNBC, Nature, Organization, Information technology, Food, Life, Natural Resources, Medical Marijuana, Inc., Drug Quality and Security Act, Textile, Disease, GMP, Agriculture, Information, CBD, The O.C., Food and Drug Administration, Building material, Medical cannabis, Safety, Drug, Management, Dietary supplement

SAN DIEGO, CA, Nov. 29, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – Medical Marijuana, Inc. (OTC: MJNA) (the “Company”), the first-ever publicly traded cannabis company in the United States that launched the world’s first-ever cannabis-derived nutraceutical products, brands, and supply chain, announced today that its subsidiary Kannaway, has appointed two industry veterans to leadership roles within the organization; Mike Randolph as Executive Vice President and Mike Kolinski as Vice President of Information Technology.

Key Points: 
  • Mr. Randolph is a 31-year veteran of the industry bringing a combination of entrepreneurial spirit and a diverse professional background with him to Kannaway.
  • Newly appointed Vice President of Information Technology Mike Kolinski brings 25 years of industry experience, having worked in both sales and customer support roles, before taking on a leadership role in information technology where he has held the Vice President title for nearly two decades.
  • Medical Marijuana, Inc.'s headquarters is in San Diego, California, and additional information is available at OTCMarkets.com or by visiting www.medicalmarijuanainc.com .
  • Medical Marijuana, Inc. does not sell or distribute any products that are in violation of the United States Controlled Substances Act.

Zymeworks Announces Expiration of Hart-Scott-Rodino Waiting Period for Zanidatamab License Agreement with Jazz Pharmaceuticals

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Tuesday, November 29, 2022
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, COVID-19, HER2, Inc., Jazz Pharmaceuticals, Engineering, Patient, Legislation, Drug Quality and Security Act, Conjugation, Drug development, HSR, Security (finance), NYSE, Zymeworks, Hart–Scott–Rodino Antitrust Improvements Act, Research, Safety, Pharmaceutical industry, Jazz

The expiration or termination of the HSR waiting period was a condition to Zymeworks receipt of a $50.0 million non-refundable upfront payment from Jazz as part of the agreement.

Key Points: 
  • The expiration or termination of the HSR waiting period was a condition to Zymeworks receipt of a $50.0 million non-refundable upfront payment from Jazz as part of the agreement.
  • Zymeworks anticipates providing Jazz top-line clinical data from Zymeworks HERIZON-BTC-01 study before the end of 2022.
  • Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics.
  • Zymeworks suite of therapeutic platforms and its fully integrated drug development engine enable precise engineering of highly differentiated product candidates.

Allakos Announces Publication of AK006 Mechanism of Action Manuscript in Communications Biology

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Tuesday, November 29, 2022
EOE, Skin, SAN, KIT, Nature Communications, Allergy, Myelocyte, Macrophage, Antibody, Lirentelimab, Food, Cell, IND, Safety, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, AK002, EOD, Neoplasm, Drug Quality and Security Act, Annual report, CD47, ADCP, Inflammation, Immunoglobulin E, CD24, Gastrointestinal tract, Cancer, B cell, Eosinophilic esophagitis, Therapy, Tams, DC, EG, C5a, MRGPRX2, Atopic dermatitis, Eosinophil, Vaccine, Pharmaceutical industry

SAN CARLOS, Calif., Nov. 29, 2022 (GLOBE NEWSWIRE) -- Allakos Inc. (Nasdaq: ALLK), a clinical-stage biotechnology company developing therapeutics which target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases, today announced the publication of “Discovery of an agonistic Siglec-6 antibody that inhibits and reduces human mast cells,” in Communications Biology. The publication describes the generation of Siglec-6 agonist monoclonal antibodies optimized for mast cell inhibition and their ability to suppress mast cell activity in pre-clinical models.

Key Points: 
  • Binding of AK006 to Siglec-6 activates the native inhibitory function of the receptor which in turn reduces mast cell activation.
  • In pre-clinical studies, AK006 inhibited multiple modes of mast cell activation, including IgE, IL-33, KIT, C5a, and MRGPRX2, resulting in the broad suppression of inflammation.
  • In addition to mast cell inhibition, AK006 reduced human tissue mast cells via antibody-dependent cellular phagocytosis (ADCP).
  • These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos forward-looking statements.

Evolva: Update on activities to boost Resveratrol

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Tuesday, November 29, 2022
Menopause, Public, Skin, Science, Solvent, International Flavors & Fragrances, Cosmetics, Nature, Flavor, Cognition, Human, Drug Quality and Security Act, Plant, Dietary supplement, Health, Research, Beauty, Oxidative stress, Woman, Resveratrol, Evolva

Reinach, 29 November 2022 Evolva (SIX: EVE), a pioneer in the field of natural molecules and industrial biotech, today provides an update on the ongoing activities to boost the commercial performance of Resveratrol sales under its umbrella brand Veri-teTM Resveratrol.

Key Points: 
  • Reinach, 29 November 2022 Evolva (SIX: EVE), a pioneer in the field of natural molecules and industrial biotech, today provides an update on the ongoing activities to boost the commercial performance of Resveratrol sales under its umbrella brand Veri-teTM Resveratrol.
  • Also, the approval of Veri-te Resveratrol in Brazil for animal nutrition and health significantly expands the respective addressable market.
  • The focus of current commercial efforts in Evolvas core Resveratrol business is on addressing the most dynamic and profitable health areas where Veri-teTM Resveratrol has the strongest value propositions.
  • With these first concrete actions and milestones achieved, we are building momentum to successfully boost the commercial performance of Resveratrol.

United Health Products Provides Update on FDA PMA Application

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Monday, November 28, 2022
Premarket tobacco application, SOP, NORC, Food, UHP, Drug Quality and Security Act, PMA, News, Food and Drug Administration, Emergency medicine, Documentation, FDA, Medical device

About United Health Products -- UHP develops, manufactures and markets HemoStyp™, a patented Neutralized Oxidized Regenerated Cellulose (NORC) hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and emergency medicine markets, and is focused on gaining approval to access the human surgical market. 

Key Points: 
  • Mesquite, NV, Nov. 28, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products, Inc. (OTCPK: UEEC), (UHP)today provides an update on the companys FDA Premarket Approval application.
  • Upon receipt and review of the sample analysis, the company expects to submit its full PMA application within a few days.
  • There can be no assurance that the companys PMA application will be approved.
  • About United Health Products -- UHP develops, manufactures and markets HemoStyp, a patented Neutralized Oxidized Regenerated Cellulose (NORC) hemostatic agent.

Tenaya Therapeutics Receives Orphan Drug Designation from the U.S. Food and Drug Administration for its Gene Therapy for Genetic Arrhythmogenic Right Ventricular Cardiomyopathy

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Monday, November 28, 2022
Marketing, COVID-19, SAN, Degenerative disease, Antibody, Food, University, Precision medicine, Gene, IND, ARVC, Heart Rhythm Society, Orphan Drug Act of 1983, American Society of Gene and Cell Therapy, Therapy, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PKP2, Drug Quality and Security Act, Gladstone Institutes, Muscle tissue, Arrhythmia, University of Texas Southwestern Medical Center, Disease, Society, Security (finance), HIV disease progression rates, Heart, HRS, Cardiomyopathy, Investigational New Drug, Cell, Clinical trial, AAV, FDA, Pharmaceutical industry, Tenaya

SOUTH SAN FRANCISCO, Calif., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for its second gene therapy product candidate, TN-401, for the treatment of arrhythmogenic right ventricular cardiomyopathy (ARVC).

Key Points: 
  • TN-401 is an adeno-associated virus (AAV)-based gene therapy being developed for the treatment of genetic ARVC caused by Plakophilin-2 (PKP2) gene mutations.
  • Current treatments do not address the underlying genetic cause of disease and do not appear to affect disease progression.
  • Orphan designation qualifies Tenaya for various development incentives as part of the Orphan Drug Act, including tax credits for certain clinical trial expenses.
  • Tenaya expects to submit an Investigational New Drug (IND) application for the program to the FDA in 2023.

Cidara Therapeutics and Melinta Therapeutics Announce Publication of Data from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis in The Lancet

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Monday, November 28, 2022
Marketing, COVID-19, DFC (cipher), SAN, Mycosis, European Medicines Agency, MAA, Caspofungin, Minocycline, Food, EMA, Safety, Therapy, Physician, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mortality, CDTX, QIDP, Drug Quality and Security Act, Priority review, File, Meropenem, Security (finance), AstraZeneca, NDA, Fungemia, Injection, Restore, New Drug Application, Respect, PDUFA, FDA, Pharmaceutical industry, Lancet, Melinta Therapeutics, EU

SAN DIEGO and PARSIPPANY, N.J., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX) and Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed pivotal ReSTORE Phase 3 clinical trial evaluating the efficacy and safety of its once-weekly antifungal candidate rezafungin as a potential treatment for candidemia and invasive candidiasis. The data, published in The Lancet titled, “Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial,” demonstrate the statistical noninferiority of rezafungin dosed once-weekly, versus the current standard of care caspofungin, dosed once-daily.

Key Points: 
  • We believe that rezafungin could have a significant impact on the lives of patients battling difficult-to-treat and often deadly Candida infections.
  • Melinta announced earlier this year that it had acquired the exclusive rights to commercialize rezafungin in the U.S. from Cidara.
  • The FDA has accepted for filing and granted Priority Review to Cidaras NDA for rezafungin for the treatment of candidemia and invasive candidiasis.
  • Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis.

VISIONARY-MS Trial Results Featured in Platform Presentation at PACTRIMS 2022: CNM-Au8® Demonstrated Global Neurological Improvement in Stable MS Patients as Adjunct to Background Disease Modifying Therapies

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Monday, November 28, 2022
Marketing, Remyelination, LS, Cognition, Neuroprotection, Brain, Randomness, Biomarker, CNM, Research, Neurodegeneration, SAP, Preferred walking speed, Multiple sclerosis, Treatment, SALT, MS, Patient, COVID, Mitt, FDA, COVID-19, ITT, R, Drug Quality and Security Act, Annual report, MRI, Efficacy, DMTS, Safety, Neurophysiology, PIRA, Gold, Committee, MD, Multiple sclerosis functional composite, Catalytic Communities, Congress, MBBS, HIV disease progression rates, Medical imaging, Pharmaceutical industry, Medicine, Risk management

These data provided consistent supportive evidence from neurophysiology, retinal imaging, and novel MRI markers for the potential neuroprotective and remyelinating effects of CNM-Au8 treatment.

Key Points: 
  • These data provided consistent supportive evidence from neurophysiology, retinal imaging, and novel MRI markers for the potential neuroprotective and remyelinating effects of CNM-Au8 treatment.
  • Placebo treated patients generally worsened across clinical and paraclinical measures during the 48-week period.
  • Robert Glanzman, MD FAAN, Chief Medical Officer at Clene, added, CNM-Au8s demonstration of neurological improvement in stable MS patients is very encouraging.
  • The currently available MS disease-modifying therapies are very successful at limiting relapses but do not address disease progression independent of relapse activity.

Crinetics Pharmaceuticals Provides Update on CRN04777 Program

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Monday, November 28, 2022
Marketing, COVID-19, Drug discovery, Acromegaly, SAN, Communication, Clinical trial, ACTH, Șaeș, Carcinoid syndrome, Congenital adrenal hyperplasia, IND, Congenital hyperinsulinism, Drug Quality and Security Act, Degenerative disease, Wilms' tumor, Annual report, Research, Therapy, Intellectual property, Investigational New Drug, HI, Trial of the century, Form 10-K, FDA, SST2, Pharmaceutical industry

SAN DIEGO, Nov. 28, 2022 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today provided an update on its development program for CRN04777, an investigational, oral somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism (HI).

Key Points: 
  • SAN DIEGO, Nov. 28, 2022 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today provided an update on its development program for CRN04777, an investigational, oral somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism (HI).
  • Crinetics plans to engage with the FDA to understand the additional information or clarifications that may be required before the FDA will allow the study to proceed.
  • Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors.
  • Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.