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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.
Source: Thailand Medical News Jan 03, 2020 3 months 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 4 months 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 4 months 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 4 months 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 4 months 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 5 months 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 5 months 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 5 months 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 5 months 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 5 months 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 6 months 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 6 months 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 6 months 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 6 months 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 6 months 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 6 months 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 7 months 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 7 months 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 7 months 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 8 months 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 8 months 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 9 months 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 10 months 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 11 months 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 12 months 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 12 months 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 1 year 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 1 year 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 1 year 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 1 year 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 1 year 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...
Source: National Multiple Sclerosis Society Jan 10, 2019 1 year ago
An immune system drug may help prevent or slow complications in a type of multiple sclerosis known as secondary progressive MS, a new study finds.
The medication is called rituximab (Rituxan). It's used to treat a number of conditions, including certain blood cell cancers and the autoimmune condition rheumatoid arthritis.
The new Swiss study found that MS patients taking the drug reported ...
Source: Rutgers Robert Wood Johnson Medical School. Jan 08, 2019 1 year ago
Women with chronic pain or discomfort around the vulva showed improved sexual function with an oral nerve pain medication used to treat pain caused by a previous herpes infection as well as fibromyalgia, according to a Rutgers study.
The study, which was the first to analyze sexual function in women with vulva pain treated with Gabapentin, appeared in the American Journal of Obstetri...
Source: Louisiana State University Health Sciences Center Jan 01, 2019 1 year ago
An investigational oral antibiotic called zoliflodacin was well-tolerated and successfully cured most cases of uncomplicated gonorrhea when tested in a Phase 2 multicenter clinical trial, according to findings published in the New England Journal of Medicine. The National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, sponsored the ...
Source: University of Rhode Island College of Pharmacy (Kingston) Nov 18, 2018 1 year ago
Antiepileptic drugs were found to be linked with almost ninefold increased odds for two adverse skin reactions, Steven‐Johnson syndrome and toxic epidermal necrolysis, compared with non-AED medication classes in an analysis of adverse-event data from the Food and Drug Administration Adverse Event Reporting System.
Researchers at the University of Rhode Island College of Pharmacy in Kingston, wh...
The US Food and Drug Administration has approved cemiplimab (Libtayo) for use in patients with locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC). This agent is the first to be approved for advanced cSCC and is intended for those who are not eligible for curative surgery or radiation.
Researchers reported on the efficacy of cemiplimab in expansion cohorts of a phase I...
Source: American Heart Association Nov 14, 2018 1 year ago
Low-dose rivaroxaban (Xarelto) added to antiplatelet therapy was associated with reduced risk of thromboembolic events in heart failure patients, researchers reported here.
In post hoc analysis of the COMMANDER HF trial, rivaroxaban (2.5 mg twice daily) led to a lower composite of thromboembolic events (13.1% vs 15.5%, HR 0.83, 95% CI 0.72-0.96) compared with placebo, reported Barry Green...
A drug therapy used for patients with chronic heart failure also improves markers of poor prognosis in individuals who are hospitalized with acute heart failure, new Yale-led research shows. The findings suggest that the drug can improve outcomes for acutely ill heart patients and potentially become the new standard of care for treating this serious condition, the researchers said.
The study wa...
Results from a phase 2 randomised trial suggest that a new investigational antibiotic is as effective as the current standard-of-care antibiotic for the treatment of complicated urinary tract infections (UTIs) caused by several multidrug resistant Gram-negative bacteria.
The findings, published in The Lancet Infectious Diseases, indicated that patients treated with the siderophore-based drug...
Roche announced that the US Food and Drug Administration (FDA) has approved Xofluza™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. Xofluza is a first-in-class, single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication. [1-2...
Source: University of Eastern Finland Oct 01, 2018 2 years ago
Antibiotics have saved many lives by rescuing patients with bacterial or fungal infections, but these valuable drugs also have a dark side. As most medical drugs, also many antibiotics can have undesired effects on the body's metabolism, causing more or less severe symptoms.
The group of fluoroquinolones with its most famous member ciprofloxacin is such a case: Fluoroquinolones are some of t...
Peptilogics, a development stage company utilizing its innovative peptide platform to treat multidrug-resistant bacterial infections, today announced it recently held a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for the development of PLG0206 for the treatment of prosthetic joint infections (PJI). PJI is one of ...
Source: European Molecular Biology Laboratory Aug 08, 2018 2 years ago
The effectiveness of antibiotics can be altered by combining them with each other, non-antibiotic drugs or even with food additives. Depending on the bacterial species, some combinations stop antibiotics from working to their full potential whilst others begin to defeat antibiotic resistance.
Combining antibiotics changes their effectiveness.
In the first large-scale screening of its kin...
The U.S. Food and Drug Administration has approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon.
“To address the risk of bio...
An FDA advisory committee voted to recommend approval of single-dose tafenoquine (GlaxoSmithKline) in patients 16 and older for the "radical cure" (prevention of relapse) of malaria, finding both substantial evidence for efficacy and adequate evidence for safety.
The vote on the evidence for efficacy was unanimous (13-0), while the evidence for adequate safety also sailed through (12-...
Source: AbbVie Pharmaceuticals Jul 12, 2018 2 years ago
AbbVie and Johnson & Johnson’s Imbruvica has failed to meet its key target in a late stage study assessing its use in patients with treatment-naïve diffuse large B-cell lymphoma.
The Phase III DBL3001 study did not show additional efficacy when adding Imbruvica (ibrutinib) to the existing standard of first-line care – a regimen of rituximab, cyclophosphamide, doxorubi...
Source: WHO (World Health Organisation) Jul 11, 2018 2 years ago
The World Health Organization said Tuesday it was awaiting formal approval from the Democratic Republic of Congo to send in unlicenced Ebola medication to help rein in an outbreak of the deadly virus.
The UN health agency and DRC authorities are rushing to contain the outbreakthat has sickened 54 people in recent weeks, including 25 who have died.
A "major innovation in t...
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