Wednesday, April 27, 2016

Study finds no beneficial effect of cancer medication on Alzheimer's disease

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Bexarotene (brand name: Targretin) is an antineoplastic (anti-cancer) agent approved by the U.S.Food and Drug Administration (FDA) (in late 1999) and the European Medicines Agency (EMA) (early 2001) for use as a treatment for cutaneous T cell lymphoma (CTCL). It is a third-generation retinoid.



Study finds no beneficial effect of cancer medication on Alzheimer's disease: The cancer medication bexarotene, aka Targretin, made headlines when researchers reported that it quickly lowered Aβ in the brain, reduced amyloid plaques, and improved learning and memory in mice that mimic salient features of Alzheimer's disease (AD).

Tuesday, April 26, 2016

Impax Receives Approval of Emverm (mebendazole) Chewable Tablets

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the United States Food and Drug Administration (FDA) has approved the Company's supplemental new drug application (sNDA) for Emverm (mebendazole) 100 mg chewable tablets.



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Impax Receives Approval of Emverm (mebendazole) Chewable Tablets

Monday, April 25, 2016

Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for Dalvance (dalbavancin)

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In continuation of my update on Dalbavancin

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved the company's supplemental new drug application (sNDA) to update the label for Dalvance (dalbavancin) for injection. The expanded label will include a single dose administered as a 30-minute intravenous (IV) infusion of Dalvance for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible Gram-positive bacteria in adults, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA).

Thursday, April 21, 2016

Adzenys XR-ODT (amphetamine) FDA Approval History

Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company with a late‐stage pipeline of innovative extended-release (XR) product candidates for the treatment of attention-deficit/hyperactivity disorder (ADHD), today announced that the U.S. Food and Drug Administration (FDA) approved Adzenys XR-ODT for the treatment of ADHD in patients six years and older. With this approval, Adzenys XR-ODT is the first and only extended-release orally disintegrating tablet (ODT) for the treatment of ADHD.

“The novel features of an extended-release orally disintegrating tablet, which is dosed once daily and disintegrates in the mouth, make Adzenys XR-ODT attractive for use in both children (six years and older) and adults,” said Dr. Alice Mao, Medical Director, Memorial Park Psychiatry in Houston, TX.
Adzenys XR-ODT was approved by the FDA via the 505(b)(2) regulatory pathway. The clinical program demonstrated that Adzenys XR-ODT is bioequivalent to a previously approved mixed amphetamine salts extended-release capsule (Adderall XR1), one of the most commonly prescribed medications for the treatment of ADHD. Adzenys XR-ODT will be available in six dosage strengths, equivalent to the Adderall XR1 dosage strengths, thus allowing healthcare providers to individualize the dose.

FDA Approves Halaven (eribulin mesylate) for the Treatment of Liposarcoma

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The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.
“Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug.”

FDA Approves Halaven (eribulin mesylate) for the Treatment of Liposarcoma

Wednesday, April 20, 2016

FDA Approves Onzetra Xsail (sumatriptan nasal powder) for the Acute Treatment of Migraine

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Sumatriptan is a medication used for the treatment of migraine headaches.It is a synthetic drug belonging to the triptan class. Structurally, it is an analog of the naturally occurring neuro-active alkaloidsdimethyltryptamine (DMT), bufotenine, and 5-methoxy-dimethyltryptamine, with an N-methyl sulfonamidomethyl- group at position C-5 on theindole ring.
Sumatriptan is produced and marketed by various drug manufacturers with many different trade names such as ImitrexImigran, and Treximetas a combination product with naproxen.
Avanir Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Onzetra Xsail (sumatriptan nasal powder), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults. Onzetra Xsail is an intranasal medication delivery system consisting of a low-dose (22mg) of sumatriptan powder that is delivered utilizing the novel Xsail™ Breath Powered Delivery Device. Onzetra Xsail is a fast-acting dry powder formulation of sumatriptan, the most commonly prescribed migraine medication.
“While there are many acute migraine treatment options available, more than 70% of patients are not fully satisfied with their current migraine treatment. Given this high dissatisfaction, there remains an unmet need to provide patients with fast-acting, well tolerated therapies that deliver consistent relief,” said Stewart Tepper, M.D., professor of neurology at the Geisel School of Medicine at Dartmouth.
“Onzetra Xsail provides a new and much needed treatment option for what can be a debilitating condition for millions of people,” said Roger K. Cady, M.D., director of the Headache Care Center and associate executive chairman of the National Headache Foundation. “The Xsail Breath Powered Delivery Device allows the medication to be deposited deep into the nose, an area that is rich with blood vessels. By delivering the medication here, Onzetra Xsail provides targeted and efficient delivery with the potential for fast, consistent relief, while also limiting the amount of medicine that goes down the back of the throat.”
“We are excited about this major milestone for Avanir as the approval of Onzetra Xsail represents our second approved product. We expect to make Onzetra Xsail available to patients in the coming months,” said Rohan Palekar, president and CEO of Avanir. “We continue to be focused on building a leading CNS biopharmaceutical company and the addition of Onzetra Xsail to our product portfolio takes us closer to achieving that goal.”

Tuesday, April 19, 2016

FDA Approves Takeda's Dexilant SoluTab (dexlansoprazole)

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Dexlansoprazole (INN, trade names KapidexDexilant) is a proton pump inhibitor that is marketed by Takeda Pharmaceuticals for the treatment of erosive esophagitis and gastro-oesophageal reflux disease...

Takeda Pharmaceuticals U.S.A., Inc., (Takeda) (TSE: 4502) today announced that the United States (U.S.) Food and Drug Administration (FDA) approved Dexilant SoluTab delayed-release orally disintegrating tablets, a new formulation of dexlansoprazole that can be taken by allowing the tablet to melt in the patient's mouth. Dexilant SoluTab is a proton pump inhibitor (PPI) indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) and the maintenance of healed erosive esophagitis (EE) and relief of heartburn in adults 18 years and older. Dexilant SoluTab is a PPI with dual delayed release (DDR) technology that is designed to provide two separate releases of medication.


Monday, April 18, 2016

Promius Pharma Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray


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We know that Betamethasone dipropionate (see structure)  is a glucocorticoid steroid with anti-inflammatory and immunosuppressive abilities. It is applied as a topical cream, ointment, lotion or gel (Diprolene) to treat itching and other minor skin conditions such as eczema.
Brand names include Alphatrex, Beta-Val, Diprolene, Diprolene AF, Diprosone, and Luxiq.
Minor side effects include dry skin and mild, temporary stinging when applied.
Betamethasone dipropionate is a "super high potency" corticosteroid used to treat inflammatory skin conditions such as dermatitis, eczema andpsoriasis. It is a synthetic analog of the adrenal corticosteroids. Although its exact mechanism of action is not known, it is effective when applied topically to cortico-responsive inflammatory dermatoses...

Dr. Reddy’s announced today that its US subsidiary, Promius Pharma, LLC, U.S. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), has received approval for Sernivo (betamethasone dipropionate) Spray, 0.05% from the U.S. Food and Drug Administration (FDA). Sernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. The commercial launch of the product is planned for the coming quarter.

Friday, April 15, 2016

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C



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In continuation  of my update on Daclatasvir



Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is already available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. Sustained virologic response (SVR) rates are reduced in genotype 3 patients with cirrhosis receiving Daklinza and sofosbuvir for 12 weeks without ribavirin. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir with or without (+/-) ribavirin for 12 weeks..

“The expanded indication for Daklinza offers an additional treatment option for multiple subsets of patients who have genotype 1 or 3 chronic HCV,” said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb. “HCV/HIV-coinfected patients and patients with advanced cirrhosis or post-transplant recurrence of HCV still pose a treatment challenge to physicians. As part of our commitment to the HCV community, we have sought to make new treatment options available for these and other targeted populations that have not yet been able to fully benefit from currently available next-generation medicines.”

Thursday, April 14, 2016

Ambrisentan avoids sildenafil drug interaction in PAH patients

Sildenafil may be better given to pulmonary arterial hypertension patients in combination with ambrisentan than with bosentan, study findings suggest.

Ambrisentan structure.svg (Ambrisentan)  Sildenafil.svg (Sildenafil)


Sildenafil may be better given to pulmonary arterial hypertension (PAH) patients in combination with ambrisentan than with bosentan, study findings suggest.Researcher Keiichi Odagiri (Hamamatsu University School of Medicine, Japan) and team found that patients’ plasma concentration of sildenafil was significantly lower if given with bosentan, compared with ambrisentan.

They say this is because bosentan induces the expression of cytochrome P450 3A4, thus interfering with the pharmacokinetics of sildenafil. Ambrisentan has no such effect, so when the seven study patients, who were all taking sildenafil, were switched from bosentan to ambrisentan, their plasma concentrations of sildenafil were significantly higher.

The patients attained maximum sildenafil concentration in 1.0 hours when they took it with ambrisentan, compared with 0.5 hours with bosentan, and their respective maximum plasma concentrations were 120.2 versus 58.3 ng/mL.And the corresponding areas under the plasma concentration–time curve, representing plasma concentrations across 8 hours, were 396.8 versus 165.8 ng/h per mL.

The team notes that the patients received bosentan 62.5 mg twice daily, rather than the usually recommended 125.0 mg twice daily. They explain that Japanese physicians often use this dose “because of concerns about dose-dependent hepatic toxicity, even though the pharmacokinetics of bosentan and its metabolites are broadly comparable in Japanese and Caucasian individuals.”

Patients’ exercise tolerance improved in line with the higher sildenafil levels achieved with ambrisentan versus bosentan, the researchers report in Clinical and Translational Science.
The median distance achieved in the externally paced 10-metre shuttle walking test was significantly greater during 4–5 weeks of ambrisentan treatment than during the equivalent time on bosentan, at 340 versus 280 metres. The corresponding median 6-minute walking distances were not significantly different, at 503.0 versus 454.0 metres, but peak oxygen consumption and oxygen consumption at anaerobic threshold were significantly greater during the ambrisentan versus bosentan treatment periods.

The researchers caution, however, that they did not use invasive haemodynamic measures to definitively measure treatment response.


Tuesday, April 12, 2016

Positive data on ability of MyoKardia’s MYK-461 to prevent development of HCM


MyoKardia, Inc., a clinical stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, today announced the publication of an article in the leading medical journal Science. The article demonstrates the ability of MYK-461, the company’s lead drug candidate, to prevent and reverse development of disease in multiple genetic mouse models of hypertrophic cardiomyopathy (HCM). The published research represents the product of collaboration among scientists from MyoKardia, Harvard Medical School, the University of Colorado and Stanford University. These data add to a growing body of laboratory and clinical research demonstrating the potential of MYK-461 as an important and novel approach to treating HCM.

The study, titled “A Small-Molecule Inhibitor of Sarcomere Contractility Suppresses Hypertrophic Cardiomyopathy in Mice,” will be published in the Feb. 5 issue of the journal Science.

“I am encouraged by these data that illustrate MYK-461’s ability to effectively reduce the consequences of HCM mutations at the biochemical, cellular and whole animal levels,” said Jonathan Fox, M.D., Ph.D., chief medical officer of MyoKardia. “Translation of these findings from mouse to human could offer great potential to improve the lives of patients living with this devastating disease.”

Monday, April 11, 2016

Bosutinib shows 'low' vascular, cardiac event risk profile

Bosutinib2DACS.svg In continuation of my update on Bosutinib


Third-generation tyrosine kinase inhibitor (TKI) study findings suggest that bosutinib is associated with a low risk of vascular and cardiac events in patients undergoing first-line or subsequent treatment for chronic myeloid leukaemia (CML).

"The results of this analysis suggest that the vascular and cardiac toxicity profile of bosutinib is distinct relative to other TKIs", write Jorge Cortes, from University of Texas MD Anderson Cancer Center in Houston, USA, and co-authors in the American Journal of Hematology
.
The team collated information on treatment-emergent adverse events (TEAEs) in 570 patients who received second-, third- or fourth-line bosutinib treatment for Philadelphia chromosome-positive CML as part of a phase I/II study.

In addition, the researchers determined the incidence of TEAEs in a phase III study comparing first-line bosutinib in 248 patients with first-line imatinib in 251 patients.

Trial participants were all followed up for at least 2 years and the overall incidence of vascular TEAEs was low, with all-grade and grade 3 or more severe side effects affecting 6.8% and 3.7% of patients given bosutinib, respectively.

First-line bosutinib was associated with a lower rate of vascular TEAEs than second-line or subsequent bosutinib therapy, affecting 4.8% versus 7.7%. First-line imatinib had comparable incidence of both overall and grade 3 and more severe vascular TEAEs to that of first-line bosutinib.

Cerebrovascular TEAEs were reported in 1.8% of patients given bosutinib, again being less common in those given primary bosutinib relative to second-line or later treatment (0.8 vs 2.3%). All-grade and grade 3 or more severe cardiovascular TEAEs occurred in 3.7% and 2.3% of bosutinib-treated patients, occurring at a lower rate in first-line than later treated patients (2.4 vs 4.2%).

Serious vascular TEAEs were reported in 4.2% of bosutinib-treated patients, with grade 3 or more severe events occurring in 3.1%, most commonly coronary artery disease (0.9%) and acute myocardial infarction (0.6%).

Events were less common in newly diagnosed patients than those with refractory or relapsed disease (2.0 vs 5.1%), and there was no significant difference in the incidence or exposure-adjusted rate between the first-line bosutinib and imatinib groups.

Ref : http://onlinelibrary.wiley.com/doi/10.1002/ajh.24360/abstract


Bosutinib shows 'low' vascular, cardiac event risk profile: Third-generation tyrosine kinase inhibitor study findings suggest that bosutinib is associated with a low risk of vascular and cardiac events in patients undergoing first-line or subsequent treatment for chronic myeloid leukaemia.

EC approves expanded use of Daklinza (daclatasvir) for patients with chronic HCV and HIV co-infection



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Daclatasvir formerly BMS-790052, trade name Daklinza) is a drug for the treatment of hepatitis C (HCV). It was developed by Bristol-Myers Squibb and was approved in Europe on 22 August 2014. Daklinza gained its FDA approval on July 24, 2015 in the United States; it is approved for Hepatitis C genotype 3 infections.  
A generic version of daclatasvir is expected to be approved in India before the end of 2015. 
Daclatasvir inhibits the HCV nonstructural protein NS5A.  Recent research suggests that it targets two steps of the viral replication process, enabling rapid decline of HCV RNA. Daclatasvir has been tested in combination regimens with pegylated interferon and ribavirin,  as well as with other direct-acting antiviral agents including asunaprevir and sofosbuvir....
Now....


EC approves expanded use of Daklinza (daclatasvir) for patients with chronic HCV and HIV co-infection: Bristol-Myers Squibb today announced that the European Commission has approved the expanded use of Daklinza, a first-in-class oral, once-a-day pill used in combination with other treatments as an option for adult patients with chronic hepatitis C virus infection who are co-infected with HIV or who have had a prior liver transplant.

Friday, April 8, 2016

FDA-approved blood pressure drug reduces cell damage linked to Alzheimer's disease

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In laboratory neuronal cultures, an FDA-approved drug used to treat high blood pressure reduced cell damage often linked to Alzheimer's disease, say researchers at Georgetown University Medical Center (GUMC) and the National Institutes of Health.

They say their work, published online Jan. 28 in the journal Alzheimer's Research and Therapy, provides information supporting the potential effect of the drug candesartan -- as well as other Angiotensin receptor blockers (ARBs) for the early treatment of Alzheimer's disease.

"Our findings make sense in many ways," says the study's senior author Juan M. Saavedra, MD, from GUMC's Department of Pharmacology and Physiology. "Hypertension reduces blood flow throughout the body and brain and is a risk factor of Alzheimer's disease. Previous epidemiological studies found that Alzheimer's progression is delayed in hypertensive patients treated with ARBs."

Using neuronal cultures, the researchers explored the action of candesartan on the neurotoxic effects of exposure to excessive glutamate, a demonstrated injury factor in the early stages of Alzheimer's disease.

The scientists found that candesartan prevented glutamate-induced neuronal death. They conducted in-depth gene analyses of the laboratory results, demonstrating that candesartan prevented neuronal inflammation and many other pathological processes, including alterations in amyloid metabolism, a hallmark of Alzheimer's disease.

The study's first author, Abdel G. Elkahloun, PhD, from the Comparative Genomics and Cancer Genetics Branch of the National Human Genome Research Institute, then compared gene expression in the neuronal cultures with published gene databases of autopsy samples from Alzheimer's disease patients. "The correlations were impressive -- the expression of 471 genes that were altered by excess glutamate in our cultures were also altered in brain autopsy samples from patients who suffered from Alzheimer's disease. Candesartan normalized expression of these genes in our cultures," Elkahloun says.

"We hypothesize that candesartan, or other members of the ARB group, may not only slow progression of Alzheimer's but also prevent or delay its development," Saavedra says.


FDA-approved blood pressure drug reduces cell damage linked to Alzheimer's disease: In laboratory neuronal cultures, an FDA-approved drug used to treat high blood pressure reduced cell damage often linked to Alzheimer's disease, say researchers at Georgetown University Medical Center and the National Institutes of Health.

Thursday, April 7, 2016

Cystic Fibrosis Drug Seems OK for Preschoolers: Study

The cystic fibrosis drug ivacaftorappears safe and effective for young children, a drug company-funded study suggests.

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Ivacaftor (trade name Kalydeco, developed as VX-770) is a drug approved for patients with a certain mutation of cystic fibrosis, which accounts for 4–5% cases of cystic fibrosis. Ivacaftor was developed by Vertex Pharmaceuticals in conjunction with the Cystic Fibrosis Foundation and is the first drug that treats the underlying cause rather than the symptoms of the disease. Called "the most important new drug of 2012", and "a wonder drug"  it is one of the most expensive drugs, costing over US$300,000 per year, which has led to criticism of Vertex for the high cost...

"This was a small trial, but we are thrilled to see these results," said study leader Jane Davies, from the National Heart and Lung Institute at Imperial College London in England. "Ivacaftor is a potential new treatment to offer children aged 2 years and older with cystic fibrosis and a [specific gene mutation linked to the disease]. This novel therapy could substantially impact these children's lives, potentially opening the way to even greater progress in years to come."
Cystic fibrosis is a life-threatening genetic disease that destroys the lungs and digestive system. More than 70,000 people worldwide have cystic fibrosis, the researchers said.
One expert explained that ivacaftor has been considered a big advance in the treatment of the disease.
"Ivacaftor, approved in 2012, was the first groundbreaking drug of its kind in that it works to correct the genetic defect in cystic fibrosis patients," explained Dr. Joan Decelie-Germana, director of the Cystic Fibrosis Center at Cohen Children's Medical Center in New Hyde Park, N.Y.
"For many older patients who have been taking it since 2012, they report feeling 'normal,' have no daily symptoms and lung function has stabilized or improved -- it has been a 'game changer,' " she said.
Prior studies found that ivacaftor was safe and effective in children 6 and older, as well as in teens and adults, the researchers said. However, this is the first study to assess the pill's effects in younger children, they added.
The clinical trial included 34 cystic fibrosis patients between the ages of 2 and 5. All of the youngsters had at least one copy of a mutation in a gene linked to cystic fibrosis called the CFTR gene. For six months, they took two daily doses -- 50 milligrams (mg) for children who weighed less than 14 kilograms (31 pounds) and 75 mg for those who weighed more.
The children showed improvement in several areas, including weight gain, pancreatic function and sweat chloride levels, which suggests an improvement in the body's ability to restore the balance of salt in and out of cells. When this process is defective, it leads to cystic fibrosis complications, the researchers said.
The drug was generally well-tolerated by the children, the study showed. The most common problems were coughing and vomiting. Five children had liver function abnormalities, leading one to stop treatment, the researchers said.
Funding for the study was provided by Vertex Pharmaceuticals Inc., maker of ivacaftor. The findings were published Jan. 20 in the journal Lancet Respiratory Medicine.
The study is "groundbreaking for cystic fibrosis care in children aged 2 to 5 years," wrote the authors of an accompanying editorial who are from University Children's Hospital Bern and University Children's Hospital Zurich, in Switzerland.