China Biologic Products

FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes

Retrieved on: 
Wednesday, June 28, 2023
Vaccine, China Biologic Products, Seizure, Injection, Insulin, Hyperglycemia, Angels Unawares, Education, Diabetes, Diarrhea, Office of Inspector General, U.S. Department of Health and Human Services, Human services, Public, Center for Biologics Evaluation and Research, Food, Cosmetics, Multimedia, Abdominal pain, Animal, Fatigue, Blood, Hypoglycemia, Dietary supplement, Patient, Anemia, Nausea, Heated tobacco product, Research, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Consciousness, Safety, Injury, Medical device, Pharmaceutical industry

"Today's approval, the first-ever cell therapy to treat patients with type 1 diabetes, provides individuals living with type 1 diabetes and recurrent severe hypoglycemia an additional treatment option to help achieve target blood glucose levels."

Key Points: 
  • "Today's approval, the first-ever cell therapy to treat patients with type 1 diabetes, provides individuals living with type 1 diabetes and recurrent severe hypoglycemia an additional treatment option to help achieve target blood glucose levels."
  • People with type 1 diabetes also perform blood glucose checks several times a day to guide the management of their diabetes.
  • Some people with type 1 diabetes have trouble managing the amount of insulin needed every day to prevent hyperglycemia (high blood sugar) without causing hypoglycemia.
  • Lantidra is approved with patient-directed labeling to inform patients with type 1 diabetes about benefits and risks of Lantidra.

The FDA Inspires Confidence in Decentralized Clinical Trials With New Guidance for Future Success

Retrieved on: 
Tuesday, June 27, 2023
Cloud, China Biologic Products, Pharma, COVID-19, Clinical trial, Risk assessment, Research, COVID, DCT, DCTS, HCP, Tablet, IPS, Patient, Risk, Informatics, Rare, FDA, Caregiver, Software, Medical device, Pharmaceutical industry, Vaccine

TYSONS CORNER, Va., June 27, 2023 /PRNewswire-PRWeb/ -- As of June 2023, there are 455,756 active clinical trials in all 50 U.S. states and 221 countries worldwide.(1) Unfortunately, studies indicate that the overall success rate of clinical trials is only 7.9%, meaning that, statistically speaking, over 90% of those trials will be unsuccessful.(2) Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, explains, "The exceedingly high failure rate of clinical trials is not necessarily due to the lack of efficacy of the treatment being studied, but it's often the lack of efficacy of the study itself." It appears that the FDA is aligned with this view, given its recent guidance for the industry that encourages it to further modernize its approach to clinical trials to help boost outcomes and lower costs.

Key Points: 
  • The FDA has released new guidance for decentralized clinical trials (DCTs) for drugs, biological products, and medical devices to improve DCT implementation.
  • (1) Unfortunately, studies indicate that the overall success rate of clinical trials is only 7.9%, meaning that, statistically speaking, over 90% of those trials will be unsuccessful.
  • One trend in the clinical trial space that is helping to tackle the problem is the evolution of Hybrid and Decentralized Clinical Trials.
  • With the FDA's continued support and guidance, decentralized and hybrid clinical trials can continue to gain momentum and cement their role in the future of clinical research."

ADAMA 2022 ESG Report Highlights Significant Progress in Portfolio and Operational Sustainability

Retrieved on: 
Tuesday, June 27, 2023
China Biologic Products, Learning, Carbon footprint, CSO, Farmer, Carbon, Social Security Government Pension Offset, DE, TEL, Running, Sustainability accounting, Outline, GRI, Soil, Water, Sustainability Accounting Standards Board, ESG, Copper, SZSE, Social, Health, Environment, Agriculture, Nursing

TEL AVIV, Israel, June 27, 2023 /PRNewswire/ -- ADAMA Ltd. (SZSE 000553), a leading global crop protection company, today published its 2022 Environmental, Social and Governance (ESG) Report, further embedding sustainability into its business activities. The report details the company's commitment to transparency, incorporating several key standards from the Sustainability Accounting Standards Board (SASB) and the Global Reporting Initiative (GRI). In the report, ADAMA commits to the target of reducing scope 1 and 2 carbon emissions by 5% on average every year until 2030.

Key Points: 
  • TEL AVIV, Israel, June 27, 2023 /PRNewswire/ -- ADAMA Ltd. (SZSE 000553), a leading global crop protection company, today published its 2022 Environmental, Social and Governance (ESG) Report, further embedding sustainability into its business activities.
  • The report details the company's commitment to transparency, incorporating several key standards from the Sustainability Accounting Standards Board (SASB) and the Global Reporting Initiative (GRI).
  • In the report, ADAMA commits to the target of reducing scope 1 and 2 carbon emissions by 5% on average every year until 2030.
  • Juan Valero, Chief Sustainability Officer (CSO) at ADAMA, said: "The progress we outline in the report demonstrates ADAMA's practical and focused approach to sustainability.

Amarin Announces Vascepa® (Icosapent Ethyl) Approved to Reduce Cardiovascular Risk in the Kingdom of Saudi Arabia (KSA)

Retrieved on: 
Wednesday, June 21, 2023
China Biologic Products, Intellectual property, Research and development, Diabetes, Dyslipidemia, CV, Marketing, Saudi Food and Drug Authority, Cardiovascular disease, SHC, KSA, SFDA, TG, Amarin, Professional corporation, IPE, Development, Capsule, Publication, Patient, Risk, NHC, Kingdom, United Arab Emirates, Pharmaceutical industry

DUBLIN, Ireland and BRIDGEWATER, N.J., June 21, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) and its commercialization partner Biologix FZco, a company based in the United Arab Emirates and a pioneer in the distribution of pharmaceutical and biological products in the Middle East and North Africa, today announced that the Kingdom of Saudi Arabia’s (KSA) Saudi Food and Drug Authority (SFDA) has approved a new indication and label expansion for VASCEPA® (icosapent ethyl) capsules. VASCEPA is now the first and only drug approved by SFDA as an adjunct to statin therapy in adult patients with elevated triglycerides (TG) levels (≥150 mg/dL) who are at high-risk of cardiovascular (CV) events due to established cardiovascular disease or diabetes mellitus and at least one other risk factor for cardiovascular disease.

Key Points: 
  • VASCEPA is now the first and only drug approved by SFDA as an adjunct to statin therapy in adult patients with elevated triglycerides (TG) levels (≥150 mg/dL) who are at high-risk of cardiovascular (CV) events due to established cardiovascular disease or diabetes mellitus and at least one other risk factor for cardiovascular disease.
  • “We are excited that patients in KSA will now have the opportunity to benefit from the proven cardiovascular risk reduction with VASCEPA following the approval by the SFDA,” said Steven Ketchum, PhD., President, Research & Development and Chief Scientific Officer, Amarin.
  • “Today’s approval also marks an important step in our strategy to expand the global footprint where VASCEPA/VAZKEPA is indicated for cardiovascular risk reduction, built from the results seen in the REDUCE-IT outcomes trial.
  • Amarin is responsible for providing regulatory assistance, supply and maintaining intellectual property in the region.

FDA Proposes New, Easy-to-Read Medication Guide for Patients, Patient Medication Information

Retrieved on: 
Tuesday, May 30, 2023
Vaccine, Medical Information Technology, China Biologic Products, Disulfiram-like drug, Office of Inspector General, U.S. Department of Health and Human Services, Medication, Human services, Public, MACC, Intelligence, Food, Cosmetics, Multimedia, Animal, Plasma protein binding, Death, Dietary supplement, Patient, Blood, Translation, Heated tobacco product, Research, Health, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Pharmaceutical industry, Medical device

SILVER SPRING, Md., May 30, 2023 /PRNewswire/ -- Providing people with accurate and timely information to help them take their prescription medications safely and effectively is an important priority for the U.S. Food and Drug Administration. Evidence suggests that more easy-to-read information can help patients reduce preventable adverse drug reactions and improve health outcomes.

Key Points: 
  • Evidence suggests that more easy-to-read information can help patients reduce preventable adverse drug reactions and improve health outcomes.
  • Currently, patients may receive one or more types of written information for prescription drugs and certain biological products, depending on the medication they are prescribed.
  • Studies have found that the current system for written information for prescription drugs and certain biological products can be confusing, conflicting, incomplete, or repetitive.
  • We encourage public comments for the Medication Guide: Patient Medication Information proposed rule during the public comment period.

FDA Clears New Insulin Pump and Algorithm-Based Software to Support Enhanced Automatic Insulin Delivery

Retrieved on: 
Friday, May 19, 2023
Vaccine, China Biologic Products, Maintenance, AID, Insulin, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Diabetes, Human services, Public, Office of Inspector General, U.S. Department of Health and Human Services, Pancreas, FDA Center for Devices and Radiological Health, Quality of life, Food, Cosmetics, Multimedia, Animal, Dietary supplement, Patient, Medicine, GlySens ICGM, Conditional sentence, Heated tobacco product, Device, Health, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Pharmaceutical industry, Medical device

SILVER SPRING, Md., May 19, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices, along with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), will form a new system called the iLet Bionic Pancreas. This new automated insulin dosing (AID) system uses an algorithm to determine and command insulin delivery.

Key Points: 
  • This new automated insulin dosing (AID) system uses an algorithm to determine and command insulin delivery.
  • The human pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin.
  • The FDA reviewed the iLet ACE Pump and iLet Dosing Decision Software through the 510(k) premarket clearance pathway .
  • The FDA granted clearance of the iLet ACE Pump and iLet Dosing Decision Software to Beta Bionics Inc.

Syngenta Group Reports Solid Q1 2023 Results

Retrieved on: 
Thursday, April 27, 2023
Science, Other Science, Agriculture, Natural Resources, Chemicals, Plastics, Technology, Manufacturing, Other Technology, Farm, China Biologic Products, Chlorantraniliprole, Nutrition, Seed, Farmer, Crop protection, Syngenta, Growth, Crop, MAP, Legume

Syngenta Crop Protection sales grew 2 percent to $4.3 billion in the first quarter 2023.

Key Points: 
  • Syngenta Crop Protection sales grew 2 percent to $4.3 billion in the first quarter 2023.
  • Syngenta Crop Protection received regulatory approval for its PLINAZOLIN® technology in five countries including Brazil and India, providing farmers with cutting-edge insect control and addressing urgent resistance challenges.
  • Syngenta Seeds sales grew 12 percent to $1.5 billion in the first quarter 2023, as price increases covered higher costs.
  • Syngenta Group China, consisting of the Group’s Seeds, Crop Protection, Crop Nutrition, MAP and digital activities in China, achieved sales of $3.0 billion, up 26 percent, in the first quarter 2023.

FDA Approves First Orally Administered Fecal Microbiota Product for the Prevention of Recurrence of Clostridioides difficile Infection

Retrieved on: 
Wednesday, April 26, 2023
Vaccine, Infection, China Biologic Products, Clostridioides difficile infection, Priority review, CDI, Office of Inspector General, U.S. Department of Health and Human Services, Diarrhea, Hospital, Chills, Human services, Public, Fever, Center for Biologics Evaluation and Research, Constipation, Food, Cosmetics, Multimedia, Risk, History, Abdominal pain, Bloating, Animal, Trial of the century, Death, Clostridioides difficile, Capsule, Dietary supplement, Patient, Immune system, Pelvic floor dysfunction, Heated tobacco product, Research, FDA, Recurrence, Health, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Fungal infection, Therapy, Safety, Fatigue, Disease, Pharmaceutical industry

SILVER SPRING, Md., April 26, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Vowst, the first fecal microbiota product that is taken orally.

Key Points: 
  • SILVER SPRING, Md., April 26, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Vowst, the first fecal microbiota product that is taken orally.
  • Vowst is approved for the prevention of recurrence of Clostridioides difficile (C. difficile) infection (CDI) in individuals 18 years of age and older, following antibacterial treatment for recurrent CDI.
  • "The availability of a fecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening."
  • The administration of fecal microbiota is thought to facilitate restoration of the gut flora to prevent further episodes of CDI.

FDA Approves Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell Transplantation

Retrieved on: 
Monday, April 17, 2023
Vaccine, Infection, China Biologic Products, Priority review, Graft-versus-host disease, Night sweats, Radiation, Office of Inspector General, U.S. Department of Health and Human Services, Neutrophil, Human services, Public, Tumors of the hematopoietic and lymphoid tissues, Survival, Bone marrow, Weight loss, Cancer, Weakness, Fever, Center for Biologics Evaluation and Research, Food, Cosmetics, Multimedia, Haematopoietic system, Cell, Animal, Rash, Transplant, Incidence, Secondary malignant neoplasm, Hematopoietic stem cell transplantation, Dietary supplement, Patient, Risk, Blood, Immune system, Growth, Vein graft failure, Trial of the century, Fungal infection, Research, B cell, FDA, Heated tobacco product, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, DSM-IV codes, Safety, Fatigue, Pharmaceutical industry

"Today's approval is an important advance in cell therapy treatment in patients with blood cancers," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research.

Key Points: 
  • "Today's approval is an important advance in cell therapy treatment in patients with blood cancers," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research.
  • "Hastening the return of the body's white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation.
  • Blood cancers are a form of cancer caused by uncontrolled growth of cells in the blood, disrupting the ability of blood cells to perform their normal functions.
  • Blood cancers can be fatal, with varying survival rates based on multiple factors including the specific type of blood cancer diagnosed.

Global Filtration Market (Focus on Biologics Manufacturing) Report 2023: Featuring Asahi Kasei, Cobetter Filtration, Corning, Merck, Pall, Parker Hannifin, Sartorius, Thermo Fisher & More - ResearchAndMarkets.com

Retrieved on: 
Wednesday, April 5, 2023
Biotechnology, Pharmaceutical, Health, Vaccine, United States Pharmacopeia, China Biologic Products, GMP, Good, Maintenance, Prevalence, Clogging, CPC, Overalls, Parker Hannifin, Ultrafiltration, Research, Thermo Fisher Scientific, USP, Element, Antibody, Type, Government, Sterilization, Organization, Protein, Patent, Investment, Nature, Good manufacturing practice, Risk, Conditional sentence, Growth, Merck, Filtration, Bacteria, Geography, Virus, Sartorius, Green bridge (filtration system), Safety, Sewage treatment, Fine chemical, Marketing, Filter

A key advancement in this industry has been the introduction of novel filtration systems, such as depth filtration systems, tangential flow filtration systems, virus filtration systems and chromatography filtration systems.

Key Points: 
  • A key advancement in this industry has been the introduction of novel filtration systems, such as depth filtration systems, tangential flow filtration systems, virus filtration systems and chromatography filtration systems.
  • Driven by these benefits, the demand for efficient biopharmaceutical filtration systems is anticipated to increase, resulting in lucrative opportunities for developers.
  • It also presents information on the factors affecting sterile filtration, advantages of biopharmaceutical filtration systems, challenges associated with biopharmaceutical filtration systems and applications of biopharmaceutical filtration.
  • Answer: The various types of filtration systems used in biomanufacturing processes include depth filtration systems, tangential flow filtration systems, virus filtration systems, other membrane filtration systems and chromatography filtration systems.