Med News category - Thailand Medical News

Med News

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.

US FDA Approves Supplemental NDAs For Delstrigo And Pifeltro For HIV Treatment

Source: Thailand Medical News Sep 21, 2019 5 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...

Study Shows Ticagrelor Reduced Heart Attacks And Strokes In Diabetics

Source: Thailand Medical News Sep 02, 2019 5 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...

Pretomanid Approved By US FDA For Newly Emerging Extensively Drug Resistant Tuberculosis

Source: Thailand Medical News Aug 16, 2019 5 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 ...

Self-Administration Nucala For Eosinophilic Asthma Gets EU Approval

Source: Thailand Medical News Aug 03, 2019 5 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...

US FDA Approves Selinexor (Xpovio) For Treatment of Relapsed Or Refractory Multiple Myeloma.

Source: Thailand Medical News Jul 04, 2019 6 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...

Vascepa Set To Steal Market Share From Statins.

Source: Thailand Medical News Jun 01, 2019 6 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...

Piqray (Alpelisib),The First PI3K inhibitor Approved By US FDA For Breast Cancer

Source: US FDA May 29, 2019 6 years ago

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...

Pzifer’s Fragmin Drug Gets US FDA’s Approval For Treatment Of Pediatric Venous Thromboembolism (VTE)

Source: Thailand Medical News May 19, 2019 6 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) ...

FDA approves Benlysta for pediatric patients with lupus

Source: US FDA May 01, 2019 6 years ago

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...

Anti-skin cancer drug approved in EU

Source: Sanofi Apr 27, 2019 6 years ago

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...

Study shows Metformin help patients maintain weight loss long-term

Source: American College of Physicians Apr 24, 2019 6 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...

Drug, Canagliflozin reduces risk of kidney failure in people with diabetes

Source: Stanford Medicine Apr 16, 2019 6 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...

US FDA approves Cimzia injections for patients with a type of inflammatory arthritis

Source: US FDA Apr 02, 2019 6 years ago

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...

Cancer prevention drug Eflornithine, also disables H. pylori bacterium

Source: Vanderbilt University Medical Center Mar 29, 2019 6 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...

Atorvastatin, Drug used to control cholesterol found effective against cancer-associated cachexia

Source: University Of Massachusetts Mar 21, 2019 6 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...

Olaparib (Lynparza) successful in pancreatic cancer phase 3 trial

Source: AstraZeneca Mar 03, 2019 6 years ago

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...

Latest study links Celebrex to Heart Valve Calcification after earlier research declared drug safe

Source: Vanderbilt University Feb 24, 2019 6 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...

Antidepressant drug, Fluvoxamine stops deadly Sepsis

Source: University of Virginia Feb 15, 2019 6 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...

Breaking News: High Drug Concentrations Lead to Voluntary Recall of Infants’ Ibuprofen worldwide

Thailand Medical News Feb 05, 2019 6 years ago

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...

Hetero Pharmaceuticals launches generic lapatinib in India

Source: Thailand Medical News Feb 03, 2019 6 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. ...

Dsuvia which is 10 times stronger than Fentanyl and 1000 times stronger than Morphine, approved by US FDA and EU.

Thailand Medical News Jan 19, 2019 6 years ago

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...

FDA approves Ultomiris (Ravulizumab) as new treatment for adult patients with PNH.

Source: US FDA Jan 13, 2019 6 years ago

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...

Rituximab (Rituxan) May Delay Secondary Progressive Multiple Sclerosis.

Source: National Multiple Sclerosis Society Jan 10, 2019 6 years 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 ...

Painful Intercourse in Women Improved with Gabapentin, an oral nerve pain drug

Source: Rutgers Robert Wood Johnson Medical School. Jan 08, 2019 6 years 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...

Zoliflodacin, A Novel antibiotic shows promise in treatment of Gonorrhea

Source: Louisiana State University Health Sciences Center Jan 01, 2019 6 years 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 ...

Antiepileptic Drugs (AEDs) linked to rare serious skin reactions.

Source: University of Rhode Island College of Pharmacy (Kingston) Nov 18, 2018 6 years 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...

US FDA Approves Cemiplimab for Advanced cSCC

Source: US FDA Nov 17, 2018 6 years ago

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...

Xarelto or Rivaroxaban Reduces Thromboembolic Risk in HF Patients

Source: American Heart Association Nov 14, 2018 6 years 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...

Newly FDA Approved Drug: Sacubitril-Valsartan improves outcomes for patients with acute heart illness.

Source: Yale University Nov 12, 2018 6 years ago

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...

Cefiderocol : New antibiotic effective against drug-resistant bacteria in phase 2 trial

Source: Lancet Nov 01, 2018 6 years ago

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...

US FDA approves Roche's Xofluza (baloxavir marboxil) for influenza

Source: Roche Oct 25, 2018 6 years ago

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...

Ciprofloxacin has detrimental effects on mitochondrial genome

Source: University of Eastern Finland Oct 01, 2018 6 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 held pre-IND meeting with FDA to develop PLG0206 for treating prosthetic joint infections

Source: Peptilogics, US Aug 28, 2018 6 years ago

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 ...

Combining antibiotics changes their effectiveness

Source: European Molecular Biology Laboratory Aug 08, 2018 6 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...

FDA approves the first drug with an indication for treatment of smallpox

Source: US FDA Jul 16, 2018 7 years ago

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...

Tafenoquine Approved by USDA for “Radical Cure” of Malaria

Source: USFDA Jul 13, 2018 7 years ago

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-...

Imbruvica fails to target in B-Cell lymphoma trial

Source: AbbVie Pharmaceuticals Jul 12, 2018 7 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...

Unlicenced Meds: ZMapp, Remdesivir (GS-5734), REGN3470-3471-3479, Favipiravir and mAb 114, could soon be used in to treat Ebola in Congo say WHO

Source: WHO (World Health Organisation) Jul 11, 2018 7 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...

Amgen and Novartis present new data demonstrating long-term efficacy, safety and tolerability of Aimovig TM (erenumab-aooe) in patients with chronic and episodic migraine

Staff Writer, TMN Jul 01, 2018 7 years ago

Amgen announced that the results of two open-label extension (OLE) studies of AimovigTM (erenumab-aooe) in patients with chronic and episodic migraine, respectively, will be presented at the 60th Annual Scientific Meeting of the American Headache Society (AHS) in San Francisco. Results from a one-year study in chronic migraine patients reinforced the established safety and efficacy profile of Aimo...

Overwhelming Demand For GlaxoSmithKline’s New Shingle’s Vaccine, Shingrix

Staff Writer, TMN Jul 02, 2018 7 years ago

Amid high demand for GlaxoSmithKline's new shingles vaccine, healthcare providers are running out. Even though the company worked up what it calls a "fair and equitable" process to ship Shingrix doses, two U.S. senators are not satisfied and are urging the drugmaker do more to boost inventory levels. Senators Amy Klobuchar, D-Minn., and Tina Smith, D-Minn., wrote&nbs...

China Causing Global Herceptin Shortage

Staff Writer, TMN Jul 03, 2018 7 years ago

When Roche got Herceptin onto China’s national insurance program, it didn’t expect demand to surge so quickly, overwhelming its production capacity there. Now, to cope with a nationwide shortage, it’s shifting to a different manufacturing site to amp up supplies of the cancer therapy. Roche applied to change Herceptin's existing production site for China to a high...

Keytruda, Tecentriq Labeling Updated to Limit Use in Urothelial Cancer

Staff Writer, TMN Jul 04, 2018 7 years ago

The US Food and Drug Administration (FDA) has approved updated labeling for Keytruda (pembrolizumab; Merck) and Tecentriq (atezolizumab; Genentech) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy. The USFDA is continuing to review Merck's Keytruda and Roche's Tecentriq in pr...

Study indicates potential breakthrough HIV drug

Staff Writer, TMN Jul 05, 2018 7 years ago

French biotech Abivax’s might be on the verge of HIV cure and prevention discovery, after achieving a significant reduction of viral load patients during the first 28 days of treatment. The company has announced results from the first group of patients in its most recent phase 2a trial testing the potential HIV cure treatment codenamed ABX464. The study aimed at acc...

Case Report Details Use of Buprenorphine for Treatment of Kratom Dependence

Staff Writer, TMN Jul 06, 2018 7 years ago

Kratom shares structural similarities with opioid analgesics Opioid-like dependence due to chronic kratom use can be successfully treated with buprenorphine, according to a recent case report published in the Journal of Addiction Medicine. Kratom, an herbal supplement that shares structural similarities with opioid analgesics, has recently grown in popularity in the West ...

Statins increase the risk of developing diabetes in at-risk people

Staff Writer, TMN Jul 07, 2018 7 years ago

Among susceptible individuals, statins — which are a common cholesterol-lowering medication — could increase the risk of type 2 diabetes by 30 percent. These new findings are sure to reignite debate. The relationship between statins and diabetes is investigated in a new study. Statins lower cholesterol by reducing its production in the liver. They do this...

US FDA Approves Zemdri

Staff Writer, TMN Jul 08, 2018 7 years ago

Zemdri (plazomicin) Approved by FDA for the Treatment of Adults with Complicated Urinary Tract Infections (cUTI) Achaogen, Inc., a biopharmaceutical company developing and commercializing innovative antibacterial agents to address multidrug resistant (MDR) gram-negative infections, announced that the U.S. Food and Drug Administration (FDA) has approved Zemdri (plazomicin) for adults with complic...

UniQure’s starts pivotal haemophilia B gene therapy trial

Source: uniqure.com Jul 09, 2018 7 years ago

The treatment could relieve haemophilia B patients from factor IX replacement drugs UniQure has enrolled the first patient in its registration trial of haemophilia B gene therapy candidate AMT-061 as it tries to keep ahead of a rival project from Spark Therapeutics/Pfizer. The subject is the first out of around 50 subjects that will be recruited into the open-label HOPE-B trial of AMT-061, an a...

Suffering IBS symptoms? THIS new pill has been scientifically proven to help

Staff Writer, TMN Jul 07, 2018 7 years ago

IRRITABLE BOWEL SYNDROME is a common condition which can cause bouts of stomach cramps, bloating, diarrhoea and constipation - but a probiotic pill has been scientifically proven to relieve symptoms. IBS is thought to affect up to one in five people at some point in their life, and while there are a host of over-the-counter and home remedies available, a new probiotic supplement has been proven i...

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