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.
Cancer Drugs: Pembrolizumab, an immunotherapy drug has been recently approved by the U.S. FDA as a first-line treatment for patients with certain types of advanced colorectal cancer. This is the 9th FDA approval supported by Stand Up To Cancer® (SU2C) research.
Individuals newly diagnosed with advanced or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (d...
Pharma News: American biotech company that is linked to the corrupted Trump administration Regeneron, has another of its clinical trials halted over the weekend due to fatal adverse reactions to the monoclonal antibody drug garetosmab (REGN2477).
Only about 4 days ago, another clinical trial involving another monoclonal antibody drug to treat severe COVID-19 patients was also stopped due ...
Drugs News: A new study by researchers from the Universities of Edinburgh, Birmingham, Oxford and Nottingham have found the drug Gabapentin that is regularly used to treat chronic pelvic pain in women has been found to be no more effective than a placebo.
Chronic pelvic pain is estimated to affect 2–24% of women worldwide, and is associated with substantially reduced quality of life...
HIV Drug News: Researchers at the George Washington University in a new study have discovered that Fingolimod, a US FDA-approved immunosuppressive drug used to treat multiple sclerosis flare-ups, may be used to effectively block HIV infection and reduce the latent virus reservoir.
The research findings were published in the journal: PLOS Pathogens. https://journals.plos.org/plospathogens/...
TB Treatments: New protocols involving the drugs Bedaquiline and Delamanid for multidrug-resistant tuberculosis (MDR-TB) have shown early effectiveness in 85 percent of patients in a cohort that included many individuals with serious comorbidities that would have excluded them from clinical trials, according to the results of a new international study.
The clinical trial results, based on...
Source: Diabetes And Canagliflozin Aug 09, 2020 9 months ago
Diabetes And Canagliflozin: A serious drug interaction between canagliflozin (Invokana) and rosuvastatin (Crestor) was thought to cause liver and muscle toxicity (myotoxoicty) in a female patient in Canada, according to a new published case report.
The case report was published in the medical journal: Annals of Internal Medicine as reported by Dr David Juurlink, MD, PhD, of Sunnybrook Health Sc...
Source: Multiple Sclerosis: Aug 06, 2020 9 months ago
Multiple Sclerosis: A recently completed phase 3, multicenter clinical trial has found that an immune-modulating drug can silence inflammatory disease activity in a large majority of patients with relapsing multiple sclerosis (RMS), the most common form of the illness, in which symptoms wax and wane.
Multiple Sclerosis or MS is an autoimmune disease in which the body's immu...
Head Lice: A novel prescription head lice treatment, developed by University of Melbourne Associate Professor Dr Vern Bowles, has been given Food and Drug Administration (FDA) approval, allowing it to be sold in the U.S.
The new treatment, Xeglyze, was developed by Hatchtech, an Australian pharmaceutical company and will be commercialised by Dr. Reddy's Laboratories.
Hugh Alsop, ...
Source: Sports Medicine Aug 04, 2020 10 months ago
Sports Medicine: Researchers from Western Norway University of Applied Sciences and the Norwegian University of Sport and Physical Education have discovered that a type of asthma drug, known as ß2-agonists, can boost sprint and strength performance in athletes who don't have the respiratory condition.
Their research findings have been published in the British Journal of Spo...
Medicine Alert: Pennsylvania State University researchers along with scientists from La Jolla Institute for Immunology-California and Weill Cornell Medicine-Qatar, have found that in rats and human cells in vitro, LCCBs cause changes in blood vessels known as vascular remodeling that reduce blood flow and increase pressure and could potentially lead to heart failure.
The study finding...
Source: COVID-19 Warnings- Captopril Jul 07, 2020 10 months ago
COVID-19 Warnings: A US based study involving researchers from University of Missouri Kansas City School of Pharmacy, Kansas State University and North Carolina State University has found that the high blood pressure drug Captopril to be associated with a higher rate of pulmonary adverse reactions in patients with diabetes than that of other ACE inhibitors or angiotensin receptor blockers (ARBs).
...
Source: Octreotide and Acromegaly Jun 27, 2020 11 months ago
Octreotide and Acromegaly: The American Food and drug administration has approved the first and only oral form of somatostatin analog octreotide ( tradename: Mycapssa) as a long-term maintenance therapy for individuals with acromegaly.
The drug Octreotide by Chiasma pharmaceuticals is the first product approved by the FDA using Chiasma's Transient Permeability Enhancer (TPE) tec...
Source: Multiple Sclerosis Jun 18, 2020 11 months ago
Multiple Sclerosis: Medical researchers from the Kessler Foundation recently conducted a comprehensive review of pharmacologic agents used in the treatment of multiple sclerosis, seeking evidence for efficacy for the cognitive dysfunction experienced by more than half of affected individuals and found that most of the prescribed drugs do not work.
The research findings were published in the...
Source: Vildagliptin Versus Metformin Jun 17, 2020 11 months ago
Vildagliptin an oral anti-hyperglycemic agent that goes by the trade name Galvus showed similar protective effects as metformin on the beta-cell function, reduced insulin resistance, and blood sugar levels in newly diagnosed Asian Indians with type 2 diabetes (T2D), according to a recent study.
The research trial further found that there was an improved insulin sensitivity in patients treated wi...
Source: Pharmaceuticals Jun 12, 2020 11 months ago
Pharmaceuticals: The US Food and Drug Administration has approved nivolumab (OPDIVO) by Bristol-Myers Squibb for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
Proof for efficacy was investigated in ATTRACTION-3 (NCT02569242), a multicenter, randomized (1:1), active-controlled,...
Source: Metformin and Diabetes May 30, 2020 12 months ago
Metformin: The US FDA has issued warnings that many brands and versions of the drug Metformin that is used by diabetics in the US and around the world have been found to be contaminated with a carcinogenic compound called N-Nitrosodimethylamine.
The U.S. health regulators have started telling five drugmakers to recall their versions of a widely used diabetes medication after laboratory te...
Source: Thailand Medical News Jan 03, 2020 1 year ago
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 ...
Source: Thailand Medical News Dec 14, 2019 1 year ago
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 ...
Source: Thailand Medical News Dec 11, 2019 1 year ago
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...
Source: Thailand Medical News Dec 02, 2019 1 year ago
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...
Source: Thailand Medical News Nov 29, 2019 1 year ago
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...
Source: Thailand Medical News Nov 22, 2019 2 years ago
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...
Source: Thailand Medical News Nov 20, 2019 2 years ago
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...
Source: Thailand Medical News Nov 16, 2019 2 years ago
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...
Source: Thailand Medical News Nov 10, 2019 2 years ago
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...
Source: Thailand Medical News Nov 09, 2019 2 years ago
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...
Source: Thailand Medical News Oct 26, 2019 2 years ago
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...
Source: Thailand Medical News Oct 25, 2019 2 years ago
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...
Source: Thailand Medical News Oct 23, 2019 2 years ago
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...
Source: Thailand Medical News Oct 22, 2019 2 years ago
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...
Source: Thailand Medical News Oct 20, 2019 2 years ago
A new flu drug by Genentech, Xofluza (baloxavir marboxil) has been granted US Food and Drug Administration (FDA) approval for a supplemental New Drug Application (NDA).
The US FDA approval has been given for the indication of acute, uncomplicated influenza, or flu, in individuals aged 12 and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-rela...
Source: Thailand Medical News Oct 14, 2019 2 years ago
New study shows that ranitidine is an unstable molecule that breaks down under different conditions into the carcinogen N-nitrosodimethylamine (NDMA).
Online pharmacy Valisure is claiming that the Zantac is carcinogenic with N-nitrosodimethylamine (NDMA); that is a byproduct of the breakdown of the ranitidine molecule. The company, which performs its own testing on drugs it carries,...
Source: Thailand Medical News Sep 23, 2019 2 years ago
Researchers at Skaggs School of Pharmacy and Pharmaceutical Sciences at University of California San Diego have discovered that Nilotinib (Tasigna), a drug used to treat chronic myeloid leukemia (CML) appears to be more effective at stopping a type of brain cancer called medulloblastoma in animal models than existing treatments for the deadly pediatric brain tumor.
Nilotinib is a type...
Source: Thailand Medical News Sep 21, 2019 2 years ago
The US FDA has approved supplemental new drug applications (NDAs) to expand the use of the drugs Pifeltro and Delstrigo as inclusions in the treatment of patients who are virologically suppressed on a stable ART regimen with no previous history of treatment failure. The approvals provide HIV patients with a wider option of drugs for their ART regiments.
The new approval is for adults curr...
Source: Thailand Medical News Sep 02, 2019 2 years ago
Researchers from Brigham Hospital and Greater Paris University Hospitals presented the results from The Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study (THEMIS), during the current European Society of Cardiology Congress 2019.The clinical trial evaluated whether adding ticagrelor to aspirin improves outcomes for patients with stable coronary art...
Source: Thailand Medical News Aug 16, 2019 2 years ago
The US FDA announced this week the approval of pretomanid tablets as part of a 3 drug combo protocol for the treatment regimen for the most deadly strain of tuberculosis which is fast spreading globally with increasing occurrence rates.
Pretomanid (PA-824) tablets were approved to be used as part of a three drug combination protocol along with bedaquiline and linezolid in patients with extensive ...
Source: Thailand Medical News Aug 03, 2019 2 years ago
The European Commission on Ist Of August had granted marketing authorisation for two new methods of administering Nucala (mepolizumab): a pre-filled pen and a pre-filled safety syringe. This is the only monthly dose anti-IL5 biologic approved in Europe that patients with severe eosinophilic asthma can self-after getting it prescribed by a pulmonologists. The original lyophilised version remains av...
Source: Thailand Medical News Jul 04, 2019 2 years ago
The US FDA has approved a new drug, Selinexor to treat patients with relapsed or refractory multiple myeloma, overruling a panel of external cancer experts who expressed concerns about its toxicity. The FDA approval was under an accelerated, or conditional, approval based on a single-arm clinical trial showing a 25% tumor response rate. The patients enrolled in the clinical trial...
Source: Thailand Medical News Jun 01, 2019 2 years ago
Vascepa ( Icosapent Ethyl) by Amarin Group Of Companies, (New Jersey, US) is the only EPA prescription Omega-3 clinically proven to lower very high triglycerides in adults by 33%, without raising bad cholesterol (LDL-C). Unlike VASCEPA, common Omega Oil and fish oil supplements are not pure EPA and most also contain DHA which can raise bad cholesterol.
The produc...
The U.S. FDA has approved Piqray (alpelisib) tablets, to be used in combination with the approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (only as detected by an FDA-approved test) following progression on or after an end...
Source: Thailand Medical News May 19, 2019 2 years ago
US FDA has approved the Dalteparin Sodium, (Fragmin) which is a low molecular weight heparin(LMWH) for the treatment of of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older.
Venous thromboembolism (VTE) is a condition in which a blood clot forms most often in the deep veins of the leg, groin or arm (known as deep vein thrombosis, DVT) ...
The U.S. Food and Drug Administration approved Benlysta (belimumab) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (SLE) - often referred to as simply "lupus" - a serious chronic disease that causes inflammation and damage to various body tissues and organs. This is the first time that the FDA has approved a treatment for pediatric patients with SLE...
French pharmaceutical giant Sanofi on Friday said the European Medicines Agency had conditionally approved its anti-cancer drug Libtayo, the first drug of its kind to be authorised for use in the EU. The drug, also known as CEMIPLIMAB-RWLC is used for for treatment of Advanced Cutaneous Squamous Cell Carcinoma
The tumour-reducing drug is aimed at patients with the second most common form of ski...
Source: American College of Physicians Apr 24, 2019 2 years ago
In the Diabetes Prevention Program (DPP) clinical trial and its long-term follow-up study, among the persons who lost at least 5 percent of their body weight during the first year, long-term maintenance of weight loss was more likely if they had been assigned to treatment with metformin than with placebo or lifestyle intervention. Being older and losing a greater amount of weight in the first year...
Source: Stanford Medicine Apr 16, 2019 2 years ago
A new landmark clinical trial shows that a drug lowers the risk of kidney failure by a third in people with Type 2 diabetes and kidney disease.
"For the first time in 18 years, we have a therapy for patients with Type 2 diabetes and chronic kidney disease that decreases kidney failure," said Kenneth Mahaffey, MD, professor of medicine at the Stanford University School of Medicine and co...
The U.S. Food and Drug Administration has approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation. This is the first time that the FDA has approved a treatment for nr-axSpA.
"Today's approval of Cimzia fulfills an unmet need for pa...
Source: Vanderbilt University Medical Center Mar 29, 2019 2 years ago
A medicine currently being tested as a chemoprevention agent for multiple types of cancer has more than one trick in its bag when it comes to preventing stomach cancer, Vanderbilt researchers have discovered.
The investigators found that in addition to its known ability to block the production of cell growth compounds, the drug DFMO (difluoromethylornithine, known also as Eflornithine and...
Source: University Of Massachusetts Mar 21, 2019 2 years ago
Brazilian researchers have discovered that a drug regularly prescribed to control cholesterol can also be used to treat cachexia, or wasting syndrome, a condition characterized by rapid weight loss and muscle atrophy associated with extreme physical weakness. This condition is common among patients with chronic diseases such as cancer, heart failure and AIDS.
"Our goal is to underst...
AstraZeneca and MSD have announced positive results from the Phase III POLO trial, in which there was a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with Lynparza (olaparib) for pancreatic cancer, making it the first PARP inhibitor to demonstrate benefit in the disease.
The drug is a first-in-class PARP inhibitor, and the first targeted treat...
Source: Vanderbilt University Feb 24, 2019 2 years ago
A well-known, four-year study found popular arthritis drug Celebrex no more dangerous for the heart than older drugs in its same classification - commonly called NSAIDs. Now, a big-data analysis of patient records at Vanderbilt University has found a link specifically between Celebrex and heart valve calcification.
W. David Merryman, professor of biomedical engineering, and Ph.D. student Megan B...
Source: University of Virginia Feb 15, 2019 2 years ago
An antidepressant drug used to treat obsessive-compulsive disorder could save people from deadly sepsis, new research from the University of Virginia School of Medicine suggests.
Sepsis is a significant cause of death around the world. The federal Centers for Disease Control and Infection calls it "the body's extreme response to an infection." Essentially, the body's immune re...
Tris Pharma Inc. voluntarily recalled three lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to have potentially higher concentrations of ibuprofen than normal.
Images of packagings of recalled products
“There is a remote possibility that infants, who may be more susceptible to...
Source: Thailand Medical News Feb 03, 2019 2 years ago
Hetero, one of India’s leading generic pharmaceutical companies and world’s largest producer of anti-retroviral drugs, announces the launch of generic version of lapatinib (250 mg) tablets in India. The product is marketed and distributed under the brand name ‘Hertab’ by Hetero Healthcare Ltd. It is made available in two SKUs, each consisting of 30 tablets and 150 tablets.
...
The US FDA and EU has approved a new sublingual formulation of sufentanil, Dsuvia, for the management of acute pain in adults in medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. The drug is supplied in a 30 microgram tablet in a single-dose, prefilled applicator for administration by a healthcare professional, and it will not be availa...
The U.S. Food and Drug Administration today approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease.
“The approval of Ultomiris will change the way that patients with PNH are treated,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and...
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