Hypoalbuminemia

PharmAbcine Publishes Study in Science Advances Demonstrating the Potential of PMC-403 in Preclinical Models of Idiopathic Systemic Capillary Leak Syndrome

Retrieved on: 
Thursday, November 23, 2023
Lung, Hypotension, ODD, Tissue, Clinical trial, Protein, Mortality, Mouse, Edema, Therapy, Blood, Systemic, NIH, Survival, Histamine, Hypertelorism, KOSDAQ, Pharmaceutical industry, Vaccine, TEK tyrosine kinase, Science Advances, Hypoalbuminemia

Study reveals a promising avenue for addressing Idiopathic Systemic Capillary Leak Syndrome (ISCLS, a.k.a.

Key Points: 
  • Study reveals a promising avenue for addressing Idiopathic Systemic Capillary Leak Syndrome (ISCLS, a.k.a.
  • The results underscore the novel mechanism of action, demonstrating the ability of PMC-403 to reduce vascular leakage associated with ISCLS in the preclinical models.
  • In February 2023, the US FDA granted Orphan Drug Designation (ODD) for PMC-403 for the treatment of Systemic Capillary Leak Syndrome.
  • Dr. Kirk Druey's team shared enthusiasm for the potential breakthrough, underscoring their strong determination to advance into clinical trial.

VANFLYTA® Now Available in U.S. for Patients with Newly Diagnosed FLT3-ITD Positive AML

Retrieved on: 
Wednesday, August 9, 2023
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Neutropenia, REMS, Maintenance, Hypermagnesemia, Cardiac arrest, Febrile neutropenia, Hypophosphatemia, Magnesium, Diarrhea, Mitigation, Hypocalcemia, Pharmacy, Food, QT interval, Indigestion, ECG, HSCT, Abdominal pain, QT, Sepsis, Acute myeloid leukemia, Alkaline phosphatase, Vomiting, Insomnia, AML, Lymphocytopenia, Patient, NE, Physician, Risk, Hypokalemia, Daiichi Sankyo, Anemia, HR, CR, Mucositis, Nausea, Hypernatremia, FLT3, Fungal infection, Upper respiratory tract infection, Lancet, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Death, Safety, Headache, Thrombocytopenia, Nosebleed, Hyperkalemia, TSE, Disease, Pharmaceutical industry, Hypoalbuminemia

VANFLYTA was approved by the FDA on July 20, 2023 in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive as detected by an FDA-approved test.

Key Points: 
  • VANFLYTA was approved by the FDA on July 20, 2023 in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive as detected by an FDA-approved test.
  • The results of QuANTUM-First were published in The Lancet .1
    The safety of VANFLYTA was evaluated in 265 patients with newly diagnosed FLT3-ITD positive AML who received VANFLYTA once daily (35.4 mg with chemotherapy, 26.5 to 53 mg as maintenance) in the QuANTUM-First trial.
  • Daiichi Sankyo is committed to ensuring that patients in the U.S. who are prescribed VANFLYTA can access the medication and receive appropriate financial support.
  • Provider and patient support and information regarding distribution, access, and reimbursement are now available through Daiichi Sankyo Access Central by visiting www.DSIAccessCentral.com or calling 1-866-4-DSI-NOW (1-866-437-4669).

VANFLYTA® First FLT3 Inhibitor Approved in the U.S. Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML

Retrieved on: 
Thursday, July 20, 2023
Oncology, Health, FDA, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Magnesium, QT interval, Doctor of Philosophy, Alkaline phosphatase, Patient, Division, Risk, Daiichi Sankyo, HR, Leukemia, Nosebleed, Thrombocytopenia, REMS, Maintenance, Febrile neutropenia, Diarrhea, Pharmacy, Duke Cancer Institute, Sepsis, Vomiting, FLT3, Fungal infection, Lancet, Death, Headache, Safety, Neutropenia, Cardiac arrest, Indigestion, ECG, Abdominal pain, Acute myeloid leukemia, Insomnia, Lymphocytopenia, Anemia, CR, Mucositis, Hypermagnesemia, Hyperkalemia, Hypophosphatemia, Mitigation, Hypocalcemia, HSCT, QT, Bone marrow, AML, NE, Hypokalemia, Nausea, Hypernatremia, Upper respiratory tract infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, TSE, Pharmaceutical industry, Nursing, MD, Hypoalbuminemia

VANFLYTA will be available by prescription in the U.S. in the coming weeks.

Key Points: 
  • VANFLYTA will be available by prescription in the U.S. in the coming weeks.
  • VANFLYTA is approved with a Boxed WARNING for QT prolongation, torsades de pointes and cardiac arrest.
  • The FDA concurrently approved a companion diagnostic test to detect FLT3-ITD mutations in patients with newly diagnosed AML.
  • Daiichi Sankyo is committed to ensuring that patients in the U.S. who are prescribed VANFLYTA can access the medication and receive appropriate financial support.

Takeda Delivers Strong Revenue and Profit Growth in FY2022; Updated Capital Allocation Policy Reflects Deleveraging Progress and Confidence in Growth Outlook

Retrieved on: 
Thursday, May 11, 2023
Research, Pharmaceutical, Oncology, Infectious Diseases, Genetics, Clinical Trials, Science, Biotechnology, Neurology, FDA, Health, Diabetes, CD, Civil service commission, CER, Takeda, Hypovolemia, Hereditary angioedema, ADHD, PDT, Neuroscience, ADCETRIS, Multifocal motor neuropathy, Lung cancer, Ulcerative colitis, Lymphoma, Inflammatory bowel disease, HAE, Emerging market, Acquisition, UC, Investment, Patient, EGFR, Growth, PP, Primary immunodeficiency, Immunology, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, European Commission, PP&E, Pharmaceutical industry, Hypoalbuminemia

Rare Diseases, with 723.4 billion yen in reported revenue, grew 4.8% on a CER basis.

Key Points: 
  • Rare Diseases, with 723.4 billion yen in reported revenue, grew 4.8% on a CER basis.
  • Plasma-Derived Therapies (PDT) Immunology, with 678.4 billion yen in reported revenue, delivered outstanding growth of 15.3% on a CER basis.
  • ALUNBRIG® (for non-small cell lung cancer) also grew 35% on a CER basis with strong demand in Europe, China, and Growth & Emerging Markets.
  • This approval marks the first approval of QDENGA in Latin America as Takeda continues to progress additional regulatory filings in other dengue-endemic countries.

Libtayo® (cemiplimab) in Combination with Chemotherapy Receives Positive CHMP Opinion for the Treatment of Advanced PD-L1 Positive Non-small Cell Lung Cancer (NSCLC)

Retrieved on: 
Friday, February 24, 2023
CHMP, Death, Safety, Insomnia, Survival, CSCC, European, European Commission, ALK, Committee, Chemoradiotherapy, European Medicines Agency, Lung cancer, Vomiting, Risk, Regeneron Pharmaceuticals, FDA, PD-L1, Regulation of tobacco by the U.S. Food and Drug Administration, Patient, Anemia, OS, ROS1, Hyperglycemia, Nausea, Committee for Medicinal Products for Human Use, NSCLC, EMA, Neutropenia, BCC, Diarrhea, Fatigue, Hair, Peripheral neuropathy, Committee on Herbal Medicinal Products, Thrombocytopenia, Periodic breathing, Food, Constipation, Neoplasm, Cervical cancer, DSM-IV codes, Rash, Physician, Pharmaceutical industry, Birth control, Hypoalbuminemia, Cemiplimab, EU

Specifically, the CHMP recommended the Libtayo combination be approved in the European Union (EU) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression.

Key Points: 
  • Specifically, the CHMP recommended the Libtayo combination be approved in the European Union (EU) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression.
  • This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.
  • In November 2022, the Libtayo combination was approved by the U.S. Food and Drug Administration (FDA) for advanced NSCLC regardless of PD-L1 expression.
  • Libtayo is currently approved in the EU and other countries for the treatment of certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), advanced NSCLC and advanced cervical cancer.

Aldeyra Therapeutics Advances Investigational Oral RASP Modulator ADX‑629 Into New Phase 2 Systemic Disease Trials

Retrieved on: 
Thursday, February 16, 2023
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, Edema, Pharmacology, Syndrome, Safety, RASP, Metabolism, Proteinuria, Patient, Asthma, Clinical trial, Atopic dermatitis, Skin, Therapy, Plasma, Psoriasis Area and Severity Index, Part, Nephrotic syndrome, COVID-19, Quality of life, Psoriasis, Pharmaceutical industry, Hypoalbuminemia

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the initiation of Phase 2 clinical trials evaluating the safety and efficacy of ADX‑629, a novel, internally developed, investigational oral RASP modulator, for the treatment of minimal change disease and Sjögren-Larsson Syndrome.

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the initiation of Phase 2 clinical trials evaluating the safety and efficacy of ADX‑629, a novel, internally developed, investigational oral RASP modulator, for the treatment of minimal change disease and Sjögren-Larsson Syndrome.
  • Additionally, Aldeyra announced the initiation of a Phase 2 clinical trial of ADX‑629 in atopic dermatitis.
  • Moderate Alcohol-Associated Hepatitis: Aldeyra plans to support an investigator-sponsored Phase 2 clinical trial of ADX‑629 in moderate alcohol-associated hepatitis.
  • In a Phase 2 clinical trial announced last year, ADX-629 reduced dermal flushing and improved balance time following alcohol intoxication.

Takeda Reinforces Long-term Growth Through Pipeline Advancement and Two Targeted Acquisitions; Delivers Another Strong Quarter in FY2022 Q3

Retrieved on: 
Thursday, February 2, 2023
Research, Pharmaceutical, Oncology, Infectious Diseases, Genetics, Clinical Trials, Science, Biotechnology, Neurology, FDA, Health, Diabetes, CER, Arrowhead Pharmaceuticals, Lupus, Major depressive disorder, Safety, Acquisition, ADHD, Fibrosis, Lung cancer, National Medical Products Administration, Multiple myeloma, Psoriasis, Neuroscience, Psoriatic arthritis, PDT, Biologics license application, PP&E, Lymphoma, YTD, Takeda, Growth, Fever Dream, OPTIC, NMPA, Hypovolemia, European Commission, AURORA, VEGFR, Investment, Inflammatory bowel disease, Cytomegalovirus, Civil service commission, Patient, Hereditary angioedema, Therapy, Liver disease, EC, Infection, U.S. FDA, CMV, Primary immunodeficiency, TYK2, ADAMTS13, Hand, Ulcerative colitis, SEQUOIA, Emerging market, Toll, Narcolepsy, USD, Disease, PP, Pharmaceutical industry, Leukemia, Hypoalbuminemia, F4, EU

Growth in our key business areas in FY2022 Q3 YTD was driven largely by Growth & Launch Products1, which delivered reported revenue of 1,199.6 billion yen, marking a +20% increase on a CER basis.

Key Points: 
  • Growth in our key business areas in FY2022 Q3 YTD was driven largely by Growth & Launch Products1, which delivered reported revenue of 1,199.6 billion yen, marking a +20% increase on a CER basis.
  • Sales of TAKHZYRO® (for hereditary angioedema) grew +25% on a CER basis due to expansion of the prophylactic market, continued geographic expansion and strong patient uptake.
  • Plasma-Derived Therapies (PDT) Immunology, with 502.4 billion yen in reported revenue, delivered outstanding growth of +18% on a CER basis.
  • Takeda has continued to deliver on its ability to bring new therapies to patients and capitalize on momentum within its innovative pipeline.

Transcenta Releases Encouraging Interim Safety and Efficacy Data of the TST001 (Osemitamab) and Chemotherapy Combination Expansion Cohort for First Line Claudin18.2 Positive Gastric Cancer at ESMO Congress 2022

Retrieved on: 
Tuesday, September 13, 2022
Therapy, Safety, HKEX, FDA, Stomach, ADCC, Hospital, Suzhou Industrial Park, Vomiting, Neoplasm, Nature, Poster, Capecitabine, Population, European Society for Medical Oncology, News, IHC, CAPOX, Headquarters, Environment, NK, Patient, Platelet, III, Oncology, CDC, ICB, Fucose, Process, China Media Group Headquarters, Research, Nausea, Trae tha Truth, Congress, Social conditioning, Health authority, Causality, Anemia, ESMO, Discovery, Pharmaceutical industry, Oxaliplatin, Hypoalbuminemia

Based on these encouraging data, the TST001 (Osemitamab) program is further accelerated and Health Authority consultations are being initiated.

Key Points: 
  • Based on these encouraging data, the TST001 (Osemitamab) program is further accelerated and Health Authority consultations are being initiated.
  • A global phase III clinical program of TST001 (Osemitamab) for the first line treatment of locally advanced or metastatic Claudin18.2 positive G/GEJ cancer is currently being planned.
  • These data suggest that TST001 (Osemitamab) in combination with CAPOX as the first line treatment of patients with Claudin18.2 positive G/GEJ cancer is well tolerated and encouraging anti-tumor activities have been observed.
  • "Chemotherapy is still the main treatment of advanced or metastatic G/GEJ cancer, however, it has limited efficacy.

The Worldwide Albumin Industry is Expected to Reach $8.9 Billion by 2030 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, July 20, 2022
Health, Pharmaceutical, People, Serum albumin, Antibody, Awareness, Degenerative disease, Fatality, Acute respiratory distress syndrome, Acute liver failure, Trauma, Health, Hypovolemia, Adoption, CAGR, Bleeding, Drug development, Chronic liver disease, Therapy, Growth, Shock, Burns, Prevalence, Albumin, Hypoalbuminemia

The "Albumin Market by Type and Application: Global Opportunity Analysis and Industry Forecast, 2021--2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Albumin Market by Type and Application: Global Opportunity Analysis and Industry Forecast, 2021--2030" report has been added to ResearchAndMarkets.com's offering.
  • The Albumin market was valued at $4,813.5 million in 2020, and is estimated to reach $8,956.07 million by 2030, growing at a CAGR of 6.4% from 2021 to 2030.
  • Albumin is obtained from plasma fractionation process where human serum albumin and bovine serum albumin is most widely used.
  • This has further encouraged many key players to enter emerging markets, thus offering a lucrative growth opportunity in the albumin market.

Transcenta Releases Phase I Clinical Data of TST001 in Combination with CAPOX as the First Line Treatment of Advanced and Metastatic G/GEJ Cancer at ASCO 2022

Retrieved on: 
Thursday, June 2, 2022
ADCC, CMO, Social conditioning, Research, China Media Group Headquarters, Nausea, Anemia, High Affinity K+ transporter HAK5, Neoplasm, III, NK, HKEX, EVP, ICB, Suzhou Industrial Park, Nature, News, ASCO, Orphan, Capecitabine, Environment, CDC, CAPOX, Therapy, Ministry of Education (Malaysia), Stomach, FDA, Patient, IMAB362, Fucose, Headquarters, AST, Process, Discovery, Vomiting, Clinical trial, CMC, Safety, Pharmaceutical industry, Vaccine, Hypoalbuminemia, Oxaliplatin

The data showed that TST001 in combination with CAPOX as the first line treatment of patients with advanced and metastatic G/GEJ cancer is well tolerated and encouraging preliminary anti-tumor activities have been observed.

Key Points: 
  • The data showed that TST001 in combination with CAPOX as the first line treatment of patients with advanced and metastatic G/GEJ cancer is well tolerated and encouraging preliminary anti-tumor activities have been observed.
  • The recruitment for the current cohort is ongoing, and the safety and efficacy of the combination of TST001+CAPOX as first line treatment for patients with advanced and metastatic G/GEJ cancer will be further evaluated.
  • We believe that TST001 in combination with chemotherapy could provide a novel option for the treatment of Claudin18.2 positive gastric cancer patients globally."
  • TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).