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- Read more about Adverse effect of Afatinib can reduce with dosage monitoring, says Clinical Trial
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.
- Read more about Biogen to present new research from MS patients at ECTRIMS congress
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.
- Read more about Raptor Pharma presents positive results from Quinsair study at ERS congress
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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- Read more about HSRx Biopharma's HSRx 431 tests effective against Zika virus
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.
- Read more about FDA clears icometrix’ image quantification software
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.
- Read more about Glucose changes a traditional Chinese medicine into powerful anticancer medicine
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.
- Read more about Indoor dust with antibacterial components could lead to antibiotic resistance
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.
- Read more about Neutron crystallography aids in drug design
Neutron crystallography is an important complementary technique to X-ray crystallography since it provides details of the hydrogen atom and proton positions in biological molecules. Furthermore, as neutrons are a non-destructive probe, the resulting structures are free from radiation damage even at room temperature.
- Read more about Evoke Pharma present Positive Non-Clinical Pre-NDA Meeting with FDA for Gimoti
Evoke Pharma, Inc. announced that it has completed a pre New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, Gimoti™, its patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The focus of this pre-NDA meeting with the FDA was the content of the regulatory, chemistry, manufacturing, and control (CMC), and non-clinical sections of the Company's planned 505(b)(2) NDA for Gimoti.
- Read more about FDA Accepts sBLA, Assigns Priority Review and Grants Breakthrough Therapy Designation to Merck’s KEYTRUDA
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, with a PDUFA, or target action, date of Dec. 24, 2016. Additionally, the FDA granted Breakthrough Therapy Designation for this indication. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency for this indication.