FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection

In continuation of my update on sofosbuvir

Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved Olysio (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination withsofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.

FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection

New treatment regimen for hepatitis C in transplant patients produces promising results

The investigational three-drug regimen, which produced hepatitis C cure rates of 97 percent, is an oral interferon-free therapy. Previously, the typical treatment for hepatitis C after a liver transplant was an interferon-based therapy, usually given for 48 weeks. It had a much lower response rate, had a risk of organ rejection and was poorly tolerated because of the immunosuppressants required to prevent rejection. The new oral regimen -- ABT-450, ombitasvir and dasabuvir (with or without ribavirin) -- produces significantly fewer side effects and is prescribed for 24 weeks.

New treatment regimen for hepatitis C in transplant patients produces promising results

Study reports anti-cancer activity in mice treated with experimental drug TAK-733

Study reports anti-cancer activity in mice treated with experimental drug TAK-733

TAK-733 is a potent and selective MEK allosteric site inhibitor for MEK1 with IC50 of 3.2 nM, inactive to Abl1, AKT3, c-RAF, CamK1, CDK2, c-Met, etc.

Ref: http://www.heemd.com/news/?md=1510006/
http://www.medchemexpress.com/TAK-733.html

Eribulin drug has minor added benefit in one patient group, indication of lesser benefit in others

In continuation of my update on Eribulin

Eribulin (trade name: Halaven) is approved for women with locally advanced or metastatic breast cancer in whom the disease has progressed despite prior drug therapy. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether the drug offers an added benefit over the appropriate comparator therapy in these patient groups.

According to the findings, there are both positive and negative effects. There is proof of minor added benefit for one group of patients. For other groups, there are hints or indications of lesser benefit.

Second assessment of eribulin

IQWiG already presented a dossier assessment of eribulin in February 2012. The subsequent decision on the added benefit made by the Federal Joint Committee (G-BA) was limited until April 2014. In addition, the drug manufacturer meanwhile obtained approval for an expanded therapeutic indication: In March 2011 eribulin was only available for patients who have progressed further after at least two chemotherapeutic regimens. Since June 2014, however, the drug can already be used after one unsuccessful treatment attempt. Hence there were two reasons ─ independent from each other ─ for the reassessment of eribulin.

G-BA specified appropriate comparator therapies

When the G-BA specified the appropriate comparator therapy, it distinguished between several treatment situations: The first one refers to patients who are not eligible for further chemotherapy with a taxane or an anthracycline. In this situation, eribulin was to be compared with individual chemotherapy containing the drugs capecitabine or vinorelbine.

In patients for whom taxanes or anthracyclines are principally still an option, eribulin was to be compared with an individual chemotherapy containing a taxane or an anthracycline.

Eribulin drug has minor added benefit in one patient group, indication of lesser benefit in others

FDA Approves Dual-Chamber Syringe for Abilify Maintena (aripiprazole) for Schizophrenia

In continuation of my update on aripiprazole

We know that, Aripiprazole (brand names: Abilify, Aripiprex) is a atypical antipsychotic. It is primarily used in the treatment of schizophrenia, bipolar disorder, major depressive disorder (as an add on to other treatment),tic disorders, and irritability associated with autism. 

It was approved by the U.S. Food and Drug Administration (FDA) for schizophrenia on November 15, 2002 and the European Medicines Agency on 4 June 2004; for acute manic and mixed episodes associated with bipolar disorder on October 1, 2004; as an adjunct for major depressive disorder on November 20, 2007; and to treat irritability in children with autism on 20 November 2009.  Likewise it was approved for use as a treatment for schizophrenia by the TGA of Australia in May 2003.  It is a partial dopamine agonist

Aripiprazole was developed by Otsuka in Japan, and in the United States, Otsuka America markets it jointly with Bristol-Myers Squibb.

FDA Approves Dual-Chamber Syringe for Abilify Maintena (aripiprazole) for Schizophrenia

FDA Approves Ofev (nintedanib) for Idiopathic Pulmonary Fibrosis

In continuation of update on nintedanib

The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.

FDA Approves Ofev (nintedanib) for Idiopathic Pulmonary Fibrosis

FDA Approves Revised Indication for Ozurdex for the Treatment of Diabetic Macular Edema

In continuation of my update on dexamethasone

Allergan, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved Ozurdex (dexamethasone intravitreal implant) 0.7 mg, a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema (DME). Ozurdex was originally approved in June as a treatment for DME in adult patients who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic). Based on ongoing review of clinical data demonstrating efficacy and safety, the FDA has now approved Ozurdex for use in the general DME patient population.

FDA Approves Revised Indication for Ozurdex for the Treatment of Diabetic Macular Edema

FDA Approves Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis

Pirfenidone is a drug developed by several companies worldwide, including InterMune Inc. (now part of Roche), Shionogi Ltd., and GNI Group Ltd., for the treatment of idiopathic pulmonary fibrosis (IPF). In 2008, it was first approved in Japan for the treatment of IPF after clinical trials, under the trade name of Pirespa by Shionogi & Co. In October 2010, the Indian Company Cipla launched it as Pirfenex. In 2011, it was approved for use in Europe for IPF under the trade name Esbriet.  was approved in Canada in 2012 under the trade name Esbriet; and was approved in the United States in October 2014 under the same name. In September 2011, the Chinese State Food and Drug Administration provided GNI Group Ltd with new drug approval of pirfenidone in China,^[3] and later manufacture approval in 2013 under the trade name of Etuary. 

In continuation of my update on pirfenidone

FDA Approves Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis

FDA Approves Ofev (nintedanib) for Idiopathic Pulmonary Fibrosis

In continuation of update on nintedanib

The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.

FDA Approves Ofev (nintedanib) for Idiopathic Pulmonary Fibrosis

An apple a day could keep obesity away

Sientists at Washington State University have concluded that non digestible compounds in apples -- specifically, Granny Smith apples  may help prevent disorders associated with obesity. The study, thought to be the first to assess these compounds in apple cultivars grown in the Pacific Northwest, appears in October's print edition of the journal Food Chemistry.

"We know that, in general, apples are a good source of these nondigestible compounds but there are differences in varieties," said food scientist Giuliana Noratto, the study's lead researcher. "Results from this study will help consumers to discriminate between apple varieties that can aid in the fight against obesity."

The tart green Granny Smith apples benefit the growth of friendly bacteria in the colon due to their high content of non-digestible compounds, including dietary fiber and polyphenols, and low content of available carbohydrates. Despite being subjected to chewing, stomach acid and digestive enzymes, these compounds remain intact when they reach the colon. Once there, they are fermented by bacteria in the colon, which benefits the growth of friendly bacteria in the gut.

The study showed that Granny Smith apples surpass Braeburn, Fuji, Gala, Golden Delicious, McIntosh and Red Delicious in the amount of nondigestible compounds they contain.

"The nondigestible compounds in the Granny Smith apples actually changed the proportions of fecal bacteria from obese mice to be similar to that of lean mice," Noratto said.

An apple a day could keep obesity away