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Vanda’s HETLIOZ MAA for Non-24-Hour Sleep-Wake Disorder accepted for evaluation by the EMA

Vanda Pharmaceuticals Inc. announced today that its Marketing Authorization Application (MAA) for oral HETLIOZ™ (tasimelteon) capsules has been accepted for evaluation by the European Medicines Agency (EMA) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).

3 Jun 2014

Novartis LDE225 Phase II study for advanced basal cell carcinoma meets primary endpoint

Novartis announced today the results of a pivotal Phase II trial demonstrating that patients with locally advanced (laBCC) or metastatic basal cell carcinoma (mBCC) taking the investigational oral compound LDE225 (sonidegib) had marked and sustained tumor shrinkage after a median follow-up of 13.9 months.

2 Jun 2014

Women with elevated levels of liver enzyme prior to pregnancy twice as likely to develop gestational diabetes

Women with high levels of a common liver enzyme measured prior to pregnancy were twice as likely to subsequently develop gestational diabetes than those with the lowest levels, according to a Kaiser Permanente study published today in the journal Diabetes Care.

5 May 2014

Obeticholic acid meets primary composite endpoint in Phase III study

Results from an international Phase III study presented today at the International Liver CongressTM 2014 have shown obeticholic acid (OCA) given to patients suffering from Primary Biliary Cirrhosis (PBC) who previously had an inadequate response to, or have been unable to tolerate ursodeoxycholic acid (UDCA), produced meaningful biochemical and clinical improvements. UDCA is the only therapy currently approved to treat PBC.

15 Apr 2014

Ceritinib ‘highly active’ in advanced ALK-rearranged NSCLC

Phase I study findings suggest the investigational drug ceritinib is effective in patients with advanced non-small-cell lung cancer with anaplastic lymphoma kinase gene rearrangement, even in those who develop resistance to crizotinib.

14 Apr 2014

Novartis’ investigational compound achieves overall response rate of 58% in patients with ALK+ NSCLC

Novartis today announced that The New England Journal of Medicine (NEJM) published clinical trial results showing the investigational compound LDK378 (ceritinib) achieved an overall response rate (ORR, including complete response [CR] and partial response [PR]) of 58% and a median progression-free survival (PFS) of seven months in adults with advanced anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) who received 400 mg or higher of LDK378 per day.

28 Mar 2014

Nintedanib plus docetaxel shows second-line efficacy in recurrent NSCLC

Nintedanib plus docetaxel offers significant efficacy in patients with non-small-cell lung cancer who experience disease progression after first-line chemotherapy, phase III study results show.

19 Feb 2014

Vanda Pharmaceuticals announces FDA approval of HETLIOZ for Non-24 treatment

Vanda Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration has approved HETLIOZ (tasimelteon) 20mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). HETLIOZ is the first FDA approved medication for Non-24.

31 Jan 2014

Monitoring individuals with chronic HBV is cost-effective strategy for China

A novel study determined that monitoring inactive chronic hepatitis B (HBV) carriers is a cost-effective strategy for China. However, results published in Hepatology, a journal of the American Association for the Study of Liver Diseases, show that increasing treatment, monitoring and adherence to therapy are necessary to achieve significant health benefits at the population level.

16 Jan 2014

Probe mimics pathogen's amino acids, solving mystery behind Chlamydiae cell wall

Biochemical sleuthing by an Indiana University graduate student has ended a nearly 50-year-old search to find a megamolecule in bacterial cell walls commonly used as a target for antibiotics, but whose presence had never been identified in the bacterium responsible for the most commonly reported sexually transmitted disease in the United States.

12 Dec 2013

FOXO3 transcription factor may protect against alcohol-induced liver injury

New data suggest that the transcription factor FOXO3 may protect against alcohol-induced liver injury. Researchers determined that alcohol given to mice deficient in FOXO3 caused severe liver injury resembling human alcoholic hepatitis.

11 Nov 2013

Testosterone treatment in hypogonadal men may reduce cardiovascular disease risk

Research from Boston University School of Medicine suggests that testosterone treatment in hypogonadal (testosterone deficient) men restores normal lipid profiles and may reduce the risk of cardiovascular disease. These finding currently appear online in the International Journal of Clinical Practice.

24 Oct 2013

Oil spill exposure appears to play role in development of hematologic and hepatic toxicity

A new study reports that workers exposed to crude oil and dispersants used during the Gulf oil spill cleanup display significantly altered blood profiles, liver enzymes, and somatic symptoms compared to an unexposed control group.

17 Sep 2013

Blood biomarkers predict suicidality

Researchers have found possible blood biomarkers for suicidal behavior that could help identify psychiatric patients at risk.

29 Aug 2013

Scientists find new biomarker to accurately measure long-term sugar intake from blood or hair sample

FAIRBANKS, Alaska-Scientists at the University of Alaska Fairbanks identified a new tool that can dramatically improve the notoriously inaccurate surveys of what and how much an individual eats and drinks. Their research is published in the June 2013 issue of the Journal of Nutrition.

19 Jun 2013

Study provides new insight into how pyrazinamide works

Pyrazinamide (PZA)-a frontline tuberculosis drug-kills dormant persister bacteria and plays a critical role in shortening TB therapy. PZA is used for treating both drug susceptible and multi-drug resistant TB but resistance to PZA occurs frequently and can compromise treatment.

14 Jun 2013

Alanine News and Research

Vanda’s HETLIOZ MAA for Non-24-Hour Sleep-Wake Disorder accepted for evaluation by the EMA

Novartis LDE225 Phase II study for advanced basal cell carcinoma meets primary endpoint

Women with elevated levels of liver enzyme prior to pregnancy twice as likely to develop gestational diabetes

Obeticholic acid meets primary composite endpoint in Phase III study

Ceritinib ‘highly active’ in advanced ALK-rearranged NSCLC

Novartis’ investigational compound achieves overall response rate of 58% in patients with ALK+ NSCLC

Nintedanib plus docetaxel shows second-line efficacy in recurrent NSCLC

Vanda Pharmaceuticals announces FDA approval of HETLIOZ for Non-24 treatment

Monitoring individuals with chronic HBV is cost-effective strategy for China

Probe mimics pathogen's amino acids, solving mystery behind Chlamydiae cell wall

FOXO3 transcription factor may protect against alcohol-induced liver injury

Testosterone treatment in hypogonadal men may reduce cardiovascular disease risk

Oil spill exposure appears to play role in development of hematologic and hepatic toxicity

Blood biomarkers predict suicidality

Scientists find new biomarker to accurately measure long-term sugar intake from blood or hair sample

Study provides new insight into how pyrazinamide works

Physicists develop novel technique that can detect molecular variants

Early PBC prognosis advocated

Biomarkers could be antidote to overdose overtreatment

FDA approves Genzyme’s KYNAMRO to treat homozygous familial hypercholesterolemia

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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