China Biologic Products

XPHOZAH® (tenapanor) Granted Orphan Drug Designation by U.S. FDA for the Treatment of Pediatric Hyperphosphatemia

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星期三, 十一月 15, 2023
Chronic kidney disease, Hyperphosphatemia, China Biologic Products, Orphan, Patient, Dialysis, Food, CKD, FDA, Pharmaceutical industry

WALTHAM, Mass., Nov. 15, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XPHOZAH® (tenapanor) for the treatment of pediatric hyperphosphatemia.

Key Points: 
  • WALTHAM, Mass., Nov. 15, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XPHOZAH® (tenapanor) for the treatment of pediatric hyperphosphatemia.
  • XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.
  • “We are pleased that the FDA has recognized the important need among pediatric patients with hyperphosphatemia for treatment options,” said Mike Raab, president and chief executive officer of Ardelyx.
  • In October, XPHOZAH was approved by the FDA to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

Federal Court Enters Consent Decree Against Pharmasol for Distributing Adulterated Drugs

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星期四, 十二月 14, 2023
China Biologic Products, Safety, Heated tobacco product, Anesthetic, Justice, Complaint, Risk, Patient, Multimedia, Research, FDA, Animal, Vaccine, Health, Cosmetics, District court, Human services, Dietary supplement, Food, Failure, FD, Public, Pharmaceutical industry, Medical device, Badia

According to the complaint, which was filed along with the consent decree by the U.S. Department of Justice, Pharmasol and Badia unlawfully distributed adulterated drugs, meaning they do not comply with manufacturing quality requirements within the U.S. marketplace.

Key Points: 
  • According to the complaint, which was filed along with the consent decree by the U.S. Department of Justice, Pharmasol and Badia unlawfully distributed adulterated drugs, meaning they do not comply with manufacturing quality requirements within the U.S. marketplace.
  • In this case, the defendant's company distributed adulterated, poor-quality drugs without regard for patients and consumers," said Jill Furman, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research.
  • Pharmasol manufactures and distributes over-the-counter drugs, as well as human and animal prescription drugs such as topical corticosteroids and inhalant anesthetics.
  • According to the complaint, the defendants violated federal law under the FD&C Act by introducing drugs into interstate commerce that fail to comply with current good manufacturing practice requirements; therefore, these drugs are adulterated.

Study published in Antiviral Research supports promise of Scinai Immunotherapeutics' coronavirus NanoAb as aerosolized prophylactic and therapeutic drug

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星期一, 十二月 11, 2023
China Biologic Products, VHH, Aerosol, CDMO, Psoriasis, Antiviral Research, University Medical Center, Inflammation, Inhalation, COVID-19, Omicron, Infection, Antiviral drug, SARS-CoV-2, Max Planck Society, I&I, Single-domain antibody, Coronavirus, Arthritis, Weight loss, UMG, Vaccine, Pharmaceutical industry

JERUSALEM, Dec. 11, 2023 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI), a biopharmaceutical company focused on development of inflammation and immunology (I&I) biological products, is pleased to announce the publication following peer-review of an article titled "Nanobodies to multiple spike variants and inhalation of nanobody-containing aerosols neutralize SARS-CoV-2 in cell culture and hamsters" in the prestigious scientific journal Antiviral Research.

Key Points: 
  • The Antiviral Research paper covers several aspects of the NanoAbs, including their structure, mechanism of action, neutralization of a wide range of SARS-CoV-2 variants including Omicron, production in yeast, and formulation into aerosols.
  • "Our next pipeline project is an anti-IL-17 NanoAb for the treatment of autoimmune diseases such as plaque psoriasis and psoriasis arthritis.
  • Amir Reichman, CEO of Scinai, added "The publication of this prestigious journal article comes at an auspicious time for our company.
  • It is currently undergoing copyediting and typesetting and will soon be updated with the final version at this same link.

FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease

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星期五, 十二月 8, 2023
Malignancy, VOC, DNA, Sickle cell disease, Abdominal pain, Headache, Patient, Research, Hemoglobin A, Cas9, CRISPR, Oxygen, Volatile organic compound, Recurrence, Fever, Mutation, Priority review, DSM-IV codes, Vomiting, Bone marrow, Hematology, China Biologic Products, Safety, Food, Multimedia, Rejection, HBF, Ronas Voe, Health, Person, Nausea, Throat, Mouth, Hispanic and Latino Americans, Public, Adolescence, Stomatitis, Risk, Tissue, Febrile neutropenia, History, End organ damage, Fetal hemoglobin, Animal, Pain, SCD, B cell, Regenerative medicine, Heated tobacco product, Disease, FDA, African Americans, Mouth ulcer, Vaccine, Cosmetics, Blood, Human services, Dietary supplement, Freedom, Pharmaceutical industry

Sickle cell disease is a group of inherited blood disorders affecting approximately 100,000 people in the U.S.

Key Points: 
  • Sickle cell disease is a group of inherited blood disorders affecting approximately 100,000 people in the U.S.
  • The primary problem in sickle cell disease is a mutation in hemoglobin, a protein found in red blood cells that delivers oxygen to the body's tissues.
  • Casgevy, a cell-based gene therapy, is approved for the treatment of sickle cell disease in patients 12 years of age and older with recurrent vaso-occlusive crises.
  • In patients with sickle cell disease, increased levels of HbF prevent the sickling of red blood cells.

Scinai Immunotherapeutics Regains Compliance with Nasdaq's Stockholders' Equity Rule

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星期一, 十一月 20, 2023
Classification, China Biologic Products, Special-purpose acquisition company, CDMO, Bank statement, USD, American depositary receipt, BofA Securities, Infection, Documentation, GAAP, EIB, European Investment Bank, NPV, I&I, Letter, Autoimmunity, WACC, Cryptocurrency

JERUSALEM, Nov. 20, 2023 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) today announced today the receipt of formal notification from the Nasdaq Stock Market ("Nasdaq") that the Company has regained compliance with Nasdaq listing rules regarding minimum stockholders' equity.

Key Points: 
  • JERUSALEM, Nov. 20, 2023 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) today announced today the receipt of formal notification from the Nasdaq Stock Market ("Nasdaq") that the Company has regained compliance with Nasdaq listing rules regarding minimum stockholders' equity.
  • Nasdaq indicated that their determination that the Company complies with Listing Rule 5550(b)(1), which requires listed companies to maintain a minimum $2.5 million in stockholders' equity, is based on the content of the Company's Form 6-K dated November 13, 2023.
  • This change impacted the classification of most of the current and future warrants as equity and not as liabilities, as per GAAP accounting rules.
  • The Company expects this new WACC to be incorporated in the Company's financial statements for the year ending December 31, 2023.

Federal Judge Enters Consent Decrees Against Utah-Based Dietary Supplement Distributor and Manufacturer of Balance of Nature Products

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星期四, 十一月 16, 2023
CGMP, China Biologic Products, Safety, Heated tobacco product, Regulatory affairs, Food, Justice, Justice minister, Risk, Multimedia, FDA, Animal, Vaccine, Balance, Cirrhosis, COVID-19, Health, Cosmetics, District court, Human services, Dietary supplement, Cancer, Balance of nature, Diabetes, Walmart, Asthma, Public, Amazon

Balance of Nature products are marketed as dietary supplements, with labeling that rendered them unapproved new drugs and misbranded drugs.

Key Points: 
  • Balance of Nature products are marketed as dietary supplements, with labeling that rendered them unapproved new drugs and misbranded drugs.
  • In addition, Evig LLC violated current good manufacturing practice (CGMP) requirements, which rendered its products adulterated dietary supplements.
  • Evig distributes Balance of Nature dietary supplement products through Amazon, Walmart, and its own online store at www.balanceofnature.com .
  • The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

FDA Announces Federal Court Enters Consent Decree Against Arizona-Based Company for Distribution of Unapproved Contraceptive Drugs

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星期三, 十一月 15, 2023
China Biologic Products, Safety, Heated tobacco product, Justice, Complaint, Choice, Multimedia, Research, FDA, Animal, Vaccine, Social media, Cosmetics, District court, Human services, Dietary supplement, Person, Food, FD, Public, Pharmaceutical industry

According to the complaint, which was filed with the consent decree by the U.S. Department of Justice, Smart Women's Choice and Richard unlawfully distributed unapproved new drugs within the U.S. marketplace.

Key Points: 
  • According to the complaint, which was filed with the consent decree by the U.S. Department of Justice, Smart Women's Choice and Richard unlawfully distributed unapproved new drugs within the U.S. marketplace.
  • "The FDA remains fully committed to taking enforcement action against companies and executives responsible for marketing unapproved drugs in violation of federal law."
  • The FDA has not approved Smart Women's Choice's drug, a vaginal cream the company has marketed as a safe and effective contraceptive.
  • Smart Women's Choice has disseminated these claims on its website and social media accounts, among other sources.

Regenerative Medicine and Stem Cell Therapies Fuel Cell Line Development Market Growth to US$4.6 Billion by 2033 | Future Market Insights, Inc.

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星期二, 十一月 14, 2023
Associate, China Biologic Products, Price analysis, Thermo Fisher Scientific, Research, Conditional sentence, Gene editing, Toxicity, Incidence, Competitive landscape, Regenerative medicine, Vaccine, Immunotherapy, Tissue engineering, Immortalised cell line, DSM-IV codes, Library, Cas9, Drug discovery, GPCR, Growth, Merck Group, A-DNA, HIV disease progression rates, Drug development, FMI, Research report, Fine chemical, Pharmaceutical industry, Video game, Retail

, Nov. 14, 2023 /PRNewswire/ -- Global Cell Line Development Market by Immunotherapy and GPCR Cell Lines, Growth Opportunities and Revenue Forecast 2023 to 2033

Key Points: 
  • , Nov. 14, 2023 /PRNewswire/ -- Global Cell Line Development Market by Immunotherapy and GPCR Cell Lines, Growth Opportunities and Revenue Forecast 2023 to 2033
    The global cell line development market value is expected to rise from US$ 3,124.4 million in 2023 to US$ 4,674.8 million by 2033.
  • Several factors are expected to provide impetus for the growth of the cell line development market .
  • Gene-edited cell lines for disease modeling have emerged as a growing and transformative trend in the cell line development market.
  • "The increasing focus on regenerative medicine and stem cell-based therapies is expected to open growth windows for the cell line development market.

Regenerative Medicine and Stem Cell Therapies Fuel Cell Line Development Market Growth to US$4.6 Billion by 2033 | Future Market Insights, Inc.

Retrieved on: 
星期二, 十一月 14, 2023
Associate, China Biologic Products, Price analysis, Thermo Fisher Scientific, Research, Conditional sentence, Gene editing, Toxicity, Incidence, Competitive landscape, Regenerative medicine, Vaccine, Immunotherapy, Tissue engineering, Immortalised cell line, DSM-IV codes, Library, Cas9, Drug discovery, GPCR, Growth, Merck Group, A-DNA, HIV disease progression rates, Drug development, FMI, Research report, Fine chemical, Pharmaceutical industry, Video game, Retail

NEWARK, Del., Nov. 14, 2023 /PRNewswire/ -- Global Cell Line Development Market by Immunotherapy and GPCR Cell Lines, Growth Opportunities and Revenue Forecast 2023 to 2033

Key Points: 
  • NEWARK, Del., Nov. 14, 2023 /PRNewswire/ -- Global Cell Line Development Market by Immunotherapy and GPCR Cell Lines, Growth Opportunities and Revenue Forecast 2023 to 2033
    The global cell line development market value is expected to rise from US$ 3,124.4 million in 2023 to US$ 4,674.8 million by 2033.
  • Several factors are expected to provide impetus for the growth of the cell line development market .
  • Gene-edited cell lines for disease modeling have emerged as a growing and transformative trend in the cell line development market.
  • "The increasing focus on regenerative medicine and stem cell-based therapies is expected to open growth windows for the cell line development market.

Sarah McGarry, M.D., Senior FDA Official in CDER and CBER, Joins Greenleaf Health

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星期三, 十一月 8, 2023
FDA, COVID-19, Public Policy, Consulting, Pharmaceutical, Professional Services, Medical Devices, Infectious Diseases, Government, Science, Biotechnology, AIDS, Other Science, Health, Research, Georgetown University School of Medicine, Bioinformatics, CBER, Center for Biologics Evaluation and Research, Policy, Food, Infection, Duke University, SARS-CoV-2, Center for Drug Evaluation and Research, OND, HIV, CDER, Ritonavir, Senior, Marketing, Internal medicine, China Biologic Products, Associate, Food and Drug Administration, Pharmaceutical industry

Greenleaf Health, Inc. (Greenleaf), a leading consulting firm for companies regulated by the Food and Drug Administration (FDA), is pleased to announce that Sarah McGarry, M.D., has joined as Senior Vice President, Drug and Biological Products.

Key Points: 
  • Greenleaf Health, Inc. (Greenleaf), a leading consulting firm for companies regulated by the Food and Drug Administration (FDA), is pleased to announce that Sarah McGarry, M.D., has joined as Senior Vice President, Drug and Biological Products.
  • Throughout her 18-year FDA service, Sarah held multiple leadership, review, and advisory positions within the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
  • Her knowledge of the FDA review process and regulatory policy will enrich the strategic and scientific guidance that Greenleaf provides to clients.
  • from Georgetown University Medical School and completed a residency in internal medicine and a fellowship in infectious diseases at Duke University.