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Although pediatrics represent around two-fifths of the global population the market for pediatric medicines remains relatively small (accounting for<10% of global pharmaceutical sales). Until pediatric legislation was introduced in the US (1997) and EU (2007) there has been little incentive for the pharma industry to evaluate drugs in children due to the low medical need of chronic illnesses and the high off-label use of generic drugs (Milne & Bruss, 2008).

Adaptive Licensing (AL) is a flexible approach to drug development and regulation, with two live pilot schemes accepted by the European Medicines Agency (EMA). The system acknowledges that levels of uncertainty will always surround innovative treatments. An initial license is granted at an earlier stage than possible under the traditional system, with less clinical information from Randomized Controlled Trials (RCTs). After the initial license is granted, the entry to market is heavily restricted, and the patient population is carefully monitored through observational studies, electronic devices and registries. Data from ongoing RCTs, and the more robust data from post-license surveillance studies are used to determine full license permission. By improving the alignment of stakeholder needs in a fluid system, overall costs and patient access times can be reduced. However, uncertainty still exists around the approach, and it is clear that cultural and political changes will be necessary to realize the full potential of AL.

GlobalData's clinical trial report, "Neonatal Respiratory Distress Syndrome Global Clinical Trials Review, H2, 2014" provides data on the Neonatal Respiratory Distress Syndrome clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Neonatal Respiratory Distress Syndrome. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Neonatal Respiratory Distress Syndrome. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.

Global Markets Direct's, 'Alopecia - Pipeline Review, H2 2014', provides an overview of the Alopecia's therapeutic pipeline.

The biosimilars market is undergoing rapid change with developments such as the recent approvals of infliximab and trastuzumab heralding a new era. In order to keep up with the pace of change in the marketplace, regulatory agencies have been developing updated guidance around the development and approval of biosimilars, but there is still a lack of consistency, particularly between the two leading agencies - the FDA and EMA.

Antibacterial drugs are chemical compounds used to kill or inhibit the growth of bacteria. The term "antibiotic" is often used synonymously with antibacterial; however, the term "antibiotic" was originally coined to refer to the antibacterial compounds of microbial origin. Antibacterial acts via various mechanisms such as the inhibition of cell wall synthesis, the inhibition of nucleic acid synthesis, the disruption of the cell membrane, and the inhibition of protein synthesis. It can be bacteriostatic or bactericidal in nature. Antibiotics are medicines that are used to treat infections caused by bacteria (e.g., respiratory tract infections). Antibiotics work against microorganisms such as bacteria, fungi, and parasites but are not effective against viruses. Antibiotics either block vital processes in bacteria, kill the bacteria, or halt them from growing. Antibiotics that affect a wide range of bacteria are called broad spectrum antibiotics (e.g., amoxicillin and gentamicin). Antibiotics that affect only a few types of bacteria are called narrow spectrum antibiotics (e.g., penicillin).

Global Markets Direct's, 'Ventilator Associated Pneumonia (VAP) - Pipeline Review, H2 2014', provides an overview of the Ventilator Associated Pneumonia (VAP)'s therapeutic pipeline.

Netscribes' latest market research report titled OTC Drug Market in India 2014 highlights the analysis of the drivers and explains the factors for growth of the industry. Increasing self-medicated patient population, growing confidence in OTC drugs, and change of prescription drugs to OTC drugs are the key drivers of this market. The various segments of OTC drugs such as Vitamins & Minerals, Gastrointestinal, and Cough Cold & Allergy etc. are the major reasons for the popularity of the OTC drug market.

Global Markets Direct's, 'BioArctic Neuroscience AB - Product Pipeline Review - 2014', provides an overview of the BioArctic Neuroscience AB's pharmaceutical research and development focus.

Global Markets Direct's, 'Atopic Dermatitis - Pipeline Review, H2 2014', provides an overview of the Atopic Dermatitis's therapeutic pipeline.

Global Markets Direct's, 'Post-Polycythemia Vera Myelofibrosis (PPV-MF) - Pipeline Review, H2 2014', provides an overview of the Post-Polycythemia Vera Myelofibrosis (PPV-MF)'s therapeutic pipeline.

Global Markets Direct's, 'Hemophilia B - Pipeline Review, H2 2014', provides an overview of the Hemophilia B's therapeutic pipeline.

Arterial Stiffness Global Clinical Trials Review, H2, 2014

TapImmune is a clinical-stage immunotherapy company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer and infectious disease. The company now has multiple clinical trials underway at the Mayo Clinic in Rochester, MN, as well as an infectious disease program also completing pre-clinical testing at Mayo for a novel smallpox vaccine. In addition to our own sponsored clinical trials, we recently announced that a new grant-funded breast and ovarian cancer trial was started by Mayo using the same Folate Alpha receptor peptides to which we have the exclusive rights. Our development pipeline is extremely strong and provides us the opportunity to continue to expand on collaborations with leading institutions and corporations.

Global Markets Direct's, 'Kidney Transplantation - Pipeline Review, H2 2014', provides an overview of the Kidney Transplantation's therapeutic pipeline.

Global Markets Direct's, 'Polio - Pipeline Review, H2 2014', provides an overview of the Polio's therapeutic pipeline.

Netscribes' latest market research report titled Clinical Trials Market in India 2014 analyses how India is a potential global hub for conducting clinical trials by Indian as well as global pharmaceutical companies. Clinical trials are conducted on humans to examine the efficacy and safety of new drugs, treatments, therapies and new medical devices before launching them in the market. It is a necessary and final step for the completion of the drug development process. The market is divided into four phases - Phase I, Phase II, Phase III and Phase IV. Contract Research Organizations (CROs) are responsible for designing, monitoring, and managing clinical trials. The market is dominated by private players and foreign pharmaceutical companies.

Global Markets Direct's, 'BiOrion Technologies B.V. - Product Pipeline Review - 2014', provides an overview of the BiOrion Technologies B.V.'s pharmaceutical research and development focus.

Global Markets Direct's, 'Dyskinesia - Pipeline Review, H2 2014', provides an overview of the Dyskinesia's therapeutic pipeline.

ACCESS PHARMACEUTICALS, INC., has signed an exclusive, global license agreement with Plasma Technologies LLC ("PlasmaTech") for the development and commercialization of its proprietary plasma fractionation process. Concurrently, the Company announced a new corporate management team and its intention to strategically refocus and rebrand the company as PlasmaTech Biopharmaceuticals, Inc., and its plans to pursue a national listing for its common shares.

Affimed Therapeutics AG - Product Pipeline Review - 2014

Global Markets Direct's, 'Mnemosyne Pharmaceuticals, Inc. - Product Pipeline Review - 2014', provides an overview of the Mnemosyne Pharmaceuticals, Inc.'s pharmaceutical research and development focus.

GBI Research has released the pharma report, "ADHD Therapeutics to 2020 - Broadened Diagnostic Criteria and Growing Adult Prevalence to Drive Market Growth despite Patent Expirations" Changes in diagnostic criteria have reduced the symptom threshold for diagnosis and finally bring the acceptance of adult ADHD to the clinical setting, enabling those previously unable to obtain a diagnosis to be diagnosed for ADHD treatment. In the case of adult ADHD, 4.1% of US adults are believed to suffer from ADHD, 41.3% of these cases are classified as severe and would be eligible for therapeutic intervention.

Global Markets Direct's, 'Sentinel Oncology Limited - Product Pipeline Review - 2014', provides an overview of the Sentinel Oncology Limited's pharmaceutical research and development focus.

Relmada Therapeutics, Inc., a clinical-stage company developing novel therapies for the treatment of chronic pain, announced today that it has appointed Mr. Christopher W. James to the position of Senior Director of Clinical Development.