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Boehringer Ingelheim announced that the European Commission (EC) and U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to nintedanib for the treatment of systemic sclerosis (SSc, also known as scleroderma), including the associated interstitial lung disease (SSc-ILD).
Novartis introduces a novel in office point of care diagnostic tool - the Niji System and Total IgE Test. This first test delivers quantitative total IgE (Immunoglobulin E) levels in about 12 minutes using only one to two droplets of finger stick blood, allowing for quick in-office diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings.
DCGI (Drugs Controller General of India) extends validity of approval of Bioavailability and Bioequivalence Centre from one year to three years to facilitate ease of working.
Results from a new post-hoc analysis of two large phase III trials (LUX-Lung 3 and LUX-Lung 6) assessing the impact of dose adjustments for Giotrif (afatinib) in patients with advanced non-small cell lung cancer (NSCLC) were published in Annals of Oncology. The analysis suggests specific dose reductions, as described in SmPC / prescribing information, led to decreases in the incidence and severity of treatment-related adverse events (AEs) in afatinib-treated patients without any apparent compromise in efficacy.
Biogen announced that the new research collected from more than 16,000 multiple sclerosis (MS) patients across Europe, in the largest study to capture the widespread impact of the disease, along with updated clinical findings from the company's broad portfolio of MS therapies will be presented at the 32nd congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in London, 14-17 September 2016.
Raptor Pharmaceutical Corp., a biopharmaceutical company developing and commercializing transformative treatments for rare diseases, presented results from a network meta-analysis comparing inhaled antibiotics for cystic fibrosis (CF) patients with lung infections involving Pseudomonas aeruginosa. The study showed that Quinsair, a levofloxacin inhalation solution, had efficacy comparable to three other inhalable antibiotics also approved for use in Europe. These data were presented at the European Respiratory Society (ERS) International Congress 2016 in London.
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HSRx Biopharmaceutical, a leading developer of polyfunctional-powered combination drugs for infectious and age-related chronic disease conditions, confirmed its orally administered broad-spectrum antiviral drug candidate, HSRx 431, is effective against the Zika virus. HSRx expects to begin human trials early in 2017 and will seek accelerated drug approval from the US Food & Drug Administration.
The health tech company icometrix obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their image quantification software. Outside the US, the software is already extensively used and offered via MSmetrix.
More than 20 years ago, a billboard in China piqued the interest of a chemical biologist. It endorsed an extract from the plant known as the "thunder god vine" as an immunosuppressant. A brief review of published research revealed that the extract's key ingredient, the small molecule triptolide, had been identified 20 years before that billboard ad, and it could stop cells from multiplying.
Antibiotic-resistant bacteria, known as superbugs, pose a major public health threat. Some officials have even warned of a post-antibiotic, and sicker, era. To better understand the problem, researchers have been piecing together its contributing factors.
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