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BREAKING 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.
Thailand Medical News  Feb 05, 2019  3 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...
Source: Thailand Medical News  Feb 03, 2019  3 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. ...
Thailand Medical News  Jan 19, 2019  3 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...
Source: US FDA  Jan 13, 2019  3 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...
Source: National Multiple Sclerosis Society  Jan 10, 2019  3 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 ...
Source: Rutgers Robert Wood Johnson Medical School.  Jan 08, 2019  3 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...
Source: Louisiana State University Health Sciences Center   Jan 01, 2019  3 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 ...
Source: University of Rhode Island College of Pharmacy (Kingston)  Nov 18, 2018  3 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...
Source: US FDA  Nov 17, 2018  3 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...
Source: American Heart Association  Nov 14, 2018  3 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...
Source: Yale University  Nov 12, 2018  3 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...
Source: Lancet  Nov 01, 2018  3 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...
Source: Roche  Oct 25, 2018  3 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...
Source: University of Eastern Finland  Oct 01, 2018  3 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...
Source: Peptilogics, US  Aug 28, 2018  3 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 ...
Source: European Molecular Biology Laboratory  Aug 08, 2018  3 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...
Source: US FDA  Jul 16, 2018  3 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...
Source: USFDA  Jul 13, 2018  3 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-...
Source: AbbVie Pharmaceuticals  Jul 12, 2018  3 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  3 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...
Staff Writer, TMN  Jul 01, 2018  3 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...
Staff Writer, TMN  Jul 02, 2018  3 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...
Staff Writer, TMN  Jul 03, 2018  3 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...
Staff Writer, TMN  Jul 04, 2018  3 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...
Staff Writer, TMN  Jul 05, 2018  3 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...
Staff Writer, TMN  Jul 06, 2018  3 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  ...
Staff Writer, TMN  Jul 07, 2018  3 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...
Staff Writer, TMN  Jul 08, 2018  3 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...
Source: uniqure.com  Jul 09, 2018  3 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...
Staff Writer, TMN  Jul 07, 2018  3 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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