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FDA approves Lannett's ANDA for Diazepam Oral Solution

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application (ANDA) for Diazepam Oral Solution (Concentrate), 5 mg/mL, a Schedule C-IV controlled drug.

15 Apr 2014

Johnson & Johnson's sales increase 3.5% to $18.1 billion in first quarter 2014

Johnson & Johnson today announced sales of $18.1 billion for the first quarter of 2014, an increase of 3.5% as compared to the first quarter of 2013. Operational results increased 5.3% and the negative impact of currency was 1.8%. Domestic sales increased 2.2%. International sales increased 4.5%, reflecting operational growth of 7.9% and a negative currency impact of 3.4%.

15 Apr 2014

Prestige Brands Holdings signs agreement for acquisition of Hydralyte

Prestige Brands Holdings, Inc. today announced the signing of a purchase agreement for the acquisition of Hydralyte in Australia and New Zealand from The Hydration Pharmaceuticals Trust of Victoria, Australia. The acquisition is expected to close, subject to customary closing conditions, during the first quarter of fiscal 2015, which began on April 1, 2014.

15 Apr 2014

Antibiotics present a safe option for treating children with uncomplicated acute appendicitis

Using antibiotics alone to treat children with uncomplicated acute appendicitis is a reasonable alternative to surgery that leads to less pain and fewer missed school days, according to a pilot study.

15 Apr 2014

New drug combination proves effective in treating patients with HCV genotype 1

Treatment options for the 170 million people worldwide with chronic Hepatitis C Virus (HCV) are evolving rapidly, although the available regimens often come with significant side effects. Two multi-center clinical trials led by Beth Israel Deaconess Medical Center show promise for a new option that could help lead to both an increase in patients cured with a much more simple and tolerable all oral therapy.

15 Apr 2014

Oral therapy cures hepatitis C infection in more than 90% of patients with liver cirrhosis

Twelve weeks of an investigational oral therapy cured hepatitis C infection in more than 90 percent of patients with liver cirrhosis and was well tolerated by these patients, according to an international study that included researchers from UT Medicine San Antonio and the Texas Liver Institute.

15 Apr 2014

Radiation plus hormones offers best outcomes for localised prostate cancer

The combination of radiotherapy and androgen deprivation therapy is more effective than radiotherapy alone for preventing disease recurrence in men with localised prostate cancer, according to research findings presented at the European Society for Radiotherapy and Oncology 33rd annual congress in Vienna, Austria.

14 Apr 2014

Study shows link between overuse injury rates in young athletes and their socioeconomic status

A Loyola University Medical Center study is reporting for the first time a link between overuse injury rates in young athletes and their socioeconomic status.

11 Apr 2014

Loyola study reports link between overuse injury rates and socioeconomic status in young athletes

A Loyola University Medical Center study is reporting for the first time a link between overuse injury rates in young athletes and their socioeconomic status.

11 Apr 2014

Inserm plays key role in developing European research

The French National Institute of Health and Medical Research (Inserm) is currently the leading biomedical research organisation in Europe, and plays a key role in developing European research. To mark its 50th anniversary, Inserm wanted to assess the perceptions of Europeans regarding biomedical research.

10 Apr 2014

Experts and entrepreneurs to gather at 2014 Biotech China on 14-16 May

With just one month until 2014 Biotech China, experts, entrepreneurs and decision-makers from the international biotechnology industry will gather at the heart of the Chinese biotechnology industry on May 14-16th, 09:00 AM-06:00 PM in Nanjing China.

10 Apr 2014

Researchers find that cancer gene require copper to promote tumor growth

Drugs used to block copper absorption for a rare genetic condition may find an additional use as a treatment for certain types of cancer, researchers at Duke Medicine report.

10 Apr 2014

Gilead Sciences announces positive results from LDV/SOF phase 2 studies on HCV infection

Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from two Phase 2 studies evaluating investigational all-oral regimens containing the nucleotide analog polymerase inhibitor sofosbuvir (SOF) for the treatment of chronic hepatitis C virus (HCV) infection.

10 Apr 2014

Millennium Medical Devices inks another network selling agreement

Millennium HealthCare Inc. today announced that its subsidiary, Millennium Medical Devices LLC, has signed yet another network selling agreement. This agreement was signed with a US based healthcare organization for the use of Millennium's medical devices in 400 of the organization's locations. This agreement includes an average monthly minimum use of 350 units per device, per location.

9 Apr 2014

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc.

8 Apr 2014

Access provides update on new formulation of anti-inflammatory drug amlexanox

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) provided an update on a new formulation of the anti-inflammatory drug amlexanox, called LexaGard™, for the treatment of inflammatory and ulcerative conditions of the esophagus.

8 Apr 2014

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

Oral News and Research

FDA approves Lannett's ANDA for Diazepam Oral Solution

Johnson & Johnson's sales increase 3.5% to $18.1 billion in first quarter 2014

Prestige Brands Holdings signs agreement for acquisition of Hydralyte

Antibiotics present a safe option for treating children with uncomplicated acute appendicitis

New drug combination proves effective in treating patients with HCV genotype 1

Oral therapy cures hepatitis C infection in more than 90% of patients with liver cirrhosis

Radiation plus hormones offers best outcomes for localised prostate cancer

Study shows link between overuse injury rates in young athletes and their socioeconomic status

Loyola study reports link between overuse injury rates and socioeconomic status in young athletes

Inserm plays key role in developing European research

Experts and entrepreneurs to gather at 2014 Biotech China on 14-16 May

Researchers find that cancer gene require copper to promote tumor growth

Gilead Sciences announces positive results from LDV/SOF phase 2 studies on HCV infection

Millennium Medical Devices inks another network selling agreement

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Access provides update on new formulation of anti-inflammatory drug amlexanox

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

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