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MicroBiome Therapeutics to present clinical trial data of NM504 in type 2 diabetes, prediabetes at ICE/ENDO 2014

MicroBiome Therapeutics LLC, today announced that data from the company's clinical trial of microbiome modulator NM504 in development for type 2 diabetes and prediabetes has been accepted for a Poster Preview Presentation at ICE/ENDO 2014, the joint meeting of the International Society of Endocrinology and The Endocrine Society.

8 Apr 2014

Alkermes announces results from phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia

Alkermes plc today announced positive topline results from a randomized, double-blind, placebo-controlled phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. Patients treated once monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at week 12, compared to placebo (p<0.001 aripiprazole lauroxil 441 mg, p<0.001 aripiprazole lauroxil 882 mg), which was the prespecified primary endpoint in the study. Based on the positive results from this phase 3 study, Alkermes plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2014.

8 Apr 2014

Bristol-Myers Squibb submits NDAs to FDA for treatment of genotype 1b hepatitis C

Bristol-Myers Squibb Company (NYSE:BMY) announced today that they have submitted new drug applications (NDAs) with the U.S. Food and Drug Administration (FDA) for the investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor.

8 Apr 2014

Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. DVT and PE are collectively referred to as venous thromboembolism (VTE).

8 Apr 2014

Rare case of tuberculous otitis media described

South Korean researchers have reported a rare case of tuberculous otitis media and say that ear tuberculosis should be considered in patients presenting with otitis media complicated by facial paralysis.

7 Apr 2014

Eli Lilly presents early-stage data from several targeted cancer therapies at AACR 2014

Eli Lilly and Company will present early-stage data from several targeted cancer therapies – including bemaciclib "beh meh sye' klib" (LY2835219), its oral, cell-cycle inhibitor of CDK4/6 – that make up its diverse clinical oncology pipeline during the American Association for Cancer Research (AACR) Annual Meeting 2014 held in San Diego, Calif. from April 5 – 9.

7 Apr 2014

6 months of hormonal treatment in addition to radiotherapy improves outcome for prostate cancer

Vienna, Austria: Men with prostate cancer that is small and confined to the prostate gland but that is at risk of growing and spreading, do better if they are treated with radiotherapy combined with androgen deprivation therapy, which lowers their levels of the male hormone, testosterone, according to new research.

7 Apr 2014

Adolescents in Sweden are at increased risk for type 1 diabetes than previously thought

New research published in Diabetologia (the journal of the European Association for the Study of Diabetes) suggests that Sweden-the country already thought to have the second highest prevalence of type 1 diabetes in the world-could have 2-3 times more adolescents and young adults with type 1 diabetes than previously estimated.

7 Apr 2014

Sanford-Burnham to present new cancer research data at AACR 2014

Sanford-Burnham Medical Research Institute will present a wide range of new research data at the annual American Association for Cancer Research Meeting in San Diego starting Saturday, April 5, at the San Diego Convention Center. The presentations will cover a variety of topics including breast, melanoma, and prostate cancer, as well as novel methods of delivering drugs to tumors.

4 Apr 2014

Patients' risk of stroke increases following shingles, but antiviral drugs appear to offer protection

Patients' risk of stroke significantly increased following the first signs of shingles, but antiviral drugs appeared to offer some protection, according to a new study in Clinical Infectious Diseases, now available online.

3 Apr 2014

Gilead reports topline results from sofosbuvir Phase 3 trial in Japan for treatment of HCV infection

Gilead Sciences, Inc. today announced topline results from a Phase 3 clinical trial (Study GS-US-334-0118) in Japan evaluating the once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin (RBV) for the treatment of genotype 2 chronic hepatitis C virus (HCV) infection.

3 Apr 2014

BronchoGen genomic test meets primary endpoint in AEGIS-2 clinical trial

Allegro Diagnostics Corp. today announced that the AEGIS-2 clinical trial has met its primary endpoint, demonstrating that the BronchoGen genomic test improves the accuracy of lung cancer diagnosis when used in combination with bronchoscopy.

3 Apr 2014

FDA grants Fast Track designations for IV and oral formulations of Tetraphase's eravacycline

Tetraphase Pharmaceuticals, Inc. today announced that the U.S. Food & Drug Administration has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company's lead antibiotic candidate, eravacycline.

3 Apr 2014

Actavis opens new regional headquarters in Singapore

Actavis plc (NYSE: ACT), a leading global specialty pharmaceutical company, today announced the official opening of its new regional office in Singapore that will serve as the headquarters for the Company's Asia Pacific and Africa (APACA) region.

3 Apr 2014

FDA approves ORALAIR sublingual allergy immunotherapy tablet

GREER Laboratories, Inc., a leading developer and provider of allergy immunotherapy products and services, today announced that the U.S. Food and Drug Administration has approved ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) sublingual allergy immunotherapy tablet.

2 Apr 2014

Bayer’s Adempas now available in the UK to treat patients with CTEPH

Adempas (riociguat) is available in the UK today as the first drug treatment for CTEPH, to treat adult patients with WHO Functional Class (FC) II to III with inoperable or persistent disease to improve exercise capacity.

1 Apr 2014

New device simulates gastro-intestinal tract

A breakthrough in drug testing developed by a University of Huddersfield lecturer could lead to cheaper, more effective medicines. Dr Hamid Merchant is a member of the team that has created a device which accurately simulates the gastro-intestinal tract and how it absorbs medication.

1 Apr 2014

Enrollment commences for Daiichi Sankyo's ENSURE-AF multinational phase 3 study in NVAF patients

Daiichi Sankyo Company, Limited today announced that it has started enrolling patients into the ENSURE-AF multinational phase 3 study, which will evaluate the efficacy and safety of its investigational oral, once-daily direct factor Xa-inhibitor edoxaban compared to enoxaparin/warfarin for the prevention of stroke and other blood clot complications in patients with non-valvular atrial fibrillation (NVAF) undergoing electrical cardioversion (low-energy shocks to trigger normal heart rhythm).

31 Mar 2014

NeuroVive presents clinical data of NVP018 for treatment of chronic hepatitis B infections at EASL

NeuroVive's anti-viral preclinical program, with compound designated NVP018, has generated significant data indicating that NVP018 has the potential to become an effective alternative or addition to current drugs for treating chronic hepatitis B infections.

29 Mar 2014

Dental associations promote National Facial Protection Month, raise awareness on sports-related injuries

Five of the nation's top dental associations want to remind young athletes to play it safe by wearing a mouth guard during recreational and organized sports this spring. Research estimates that about 2 percent of all children or adolescents who participate in sports eventually will suffer a facial injury severe enough to require medical attention.

29 Mar 2014

Oral News and Research

MicroBiome Therapeutics to present clinical trial data of NM504 in type 2 diabetes, prediabetes at ICE/ENDO 2014

Alkermes announces results from phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia

Bristol-Myers Squibb submits NDAs to FDA for treatment of genotype 1b hepatitis C

Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Rare case of tuberculous otitis media described

Eli Lilly presents early-stage data from several targeted cancer therapies at AACR 2014

6 months of hormonal treatment in addition to radiotherapy improves outcome for prostate cancer

Adolescents in Sweden are at increased risk for type 1 diabetes than previously thought

Sanford-Burnham to present new cancer research data at AACR 2014

Patients' risk of stroke increases following shingles, but antiviral drugs appear to offer protection

Gilead reports topline results from sofosbuvir Phase 3 trial in Japan for treatment of HCV infection

BronchoGen genomic test meets primary endpoint in AEGIS-2 clinical trial

FDA grants Fast Track designations for IV and oral formulations of Tetraphase's eravacycline

Actavis opens new regional headquarters in Singapore

FDA approves ORALAIR sublingual allergy immunotherapy tablet

Bayer’s Adempas now available in the UK to treat patients with CTEPH

New device simulates gastro-intestinal tract

Enrollment commences for Daiichi Sankyo's ENSURE-AF multinational phase 3 study in NVAF patients

NeuroVive presents clinical data of NVP018 for treatment of chronic hepatitis B infections at EASL

Dental associations promote National Facial Protection Month, raise awareness on sports-related injuries

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