Featuring latest Drug Developments and Treatment Protocols and also Updates about the Pharmaceutical Industry , both in Thailand and abroad, latest USFDA and Thai FDA approvals and also Corporate News with regards to various Pharma companies.
In a latest development, the European Commission (EC) has approved Johnson & Johnson subsidiary Janssen’s Spravato (esketamine) nasal spray for treatment-resistant major depressive disorder.
Spravato or Esketamine is an antagonist of the N-methyl-D-aspartate (NMDA) glutamate receptor and is similar in composition to illegal drug ketamine; Janssen has a risk management plan related to ...
Combined analysis of three phase 1 and 2 clinical trials published online ahead of print in the journal Lancet Oncology show that the drug entrectinib is effective and well-tolerated against advanced ROS1 and NTRK fusion-positive non-small cell lung cancers (NSCLC). Results of the trials STARTRK-1 (NCT02097810), STARTRK-2 (NCT02568267), and ALKA, show 77 percent response rate to entrectinib in 53 ...
A new research by pediatrics and migraine specialists from the University of Medical Sciences, Tehran show that Cinnarizine and Sodium Valproate are effective as the preventive agents of pediatric migraine in young children and teenagers.
The study article entitled "Cinnarizine and sodium valproate as the preventive agents of pediatric migraine: A randomized double-blind placebo-controlled t...
Pharma Conglomerate, AstraZeneca announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC).
Small Cell Lung Cancer is an aggressive, fast-growing form of lung cancer that r...
The US FDA (Food and Drug Administration) has approved South Korean company SK Chemicals’ patch-type Alzheimer’s drug, SID710.
The drug which has already secured approval in the European Union in 2013, is the generic version of Novartis’ Exelon Patch for the treatment of dementia symptoms associated with Alzheimer’s disease.
The approval marks the first time...
Thailand Pharma News
The US FDA has granted supplemental approval to acalabrutinib (Calquence, AstraZeneca) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).1
The Project Orbis, a collaboration between the United States, Australia, and Canada, provides a framework for concurrent submission and review of oncology pharmaceutical ap...
The US FDA (Food and Drug Administration ) has approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options.
Dr John Farley, acting director of the Office of Infecti...
The US Food and Drug Administration approved Novartis AG's Adakveo (crizanlizumab) as new medicine that can help reduce extremely painful sickle cell disease flare-ups for patients 16 and older. The monthly infusion, which halves occurrences of sickle cell pain episodes, will carry a list price of roughly US$82,000 to US$114,000 per year, depending on dosing.
Unfortunately, sickle cell dise...
The US FDA approved a record-breaking 59 novel drugs in 2018 for a range of diseases, bringing hope to scores of health sufferers around the world. This number was a more than twofold increase from a decade prior, which saw only 24 new drug approvals. And while this rise in the production and dissemination of new biological agents and products is good news for the advancement of global h...
The U.S. Food and Drug Administration has granted approval for Reblozyl (luspatercept-aamt) to be used for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
Dr Richard Pazdur, M.D., director of the US FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in th...
New findings from the LIBERTY ASTHMA QUEST trial show that add-on dupilumab (Dupixent) showed symptomatic benefit for patients with both early-onset and later-onset uncontrolled asthma.
In trial data published in the Chest Journal, the interleukin 4 and 13 (IL-4; IL-13) targeting monoclonal antibody showed an associated reduction of severe exacerbations and improved lung function in patien...
The US FDA has approved a new indication for the SGLT2 inhibitor canagliflozin made by Janssen Pharmaceuticals to reduce the risk for end-stage renal disease, worsening of kidney function, cardiovascular death and hospitalization for heart failure among adults with type 2 diabetes and diabetic kidney disease. Type 2 diabetes is the leading cause of kidney disease in the world, and the fifth fastes...
Trikafta (elexacaftor/ivacaftor/tezacaftor) from Vertex Pharmaceuticals is the first triple combination therapy to be approved by the US FDA and made available to treat patients with the most common cystic fibrosis mutation. Its list price is US$350,000 a year, same as one of the maker's earlier treatments for the genetic disease.
Trikafta has been approved for patients aged 12 an...
A study by the London School of Hygiene & Tropical Medicine has shown that Tranexamic Acid, a low cost and widely available drug could reduce deaths in traumatic brain injury patients by as much as 20%, depending on the severity of injury. The findings were published in the The Lancet. The researchers say that tranexamic acid, (TXA), a drug that prevents bleeding into the brain by inhibit...
.jpg)
