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Pukar M.M.,General Surgery | Hajare A.L.,Glenmark Pharmaceuticals | Krishnaprasad K.,Glenmark Pharmaceuticals | Bhargava A.I.,Glenmark Pharmaceuticals
Journal of Clinical and Diagnostic Research | Year: 2014

Skin and soft tissue infections represent a continuum of symptoms that range from uncomplicated cellulitis to the potentially lethal entity necrotizing fasciitis that is often considered to be microbial invasions of the epidermis, dermis and subcutaneous tissues. Garenoxacin, a newer oral des-fluoroquinolone having potent antimicrobial activity against wide variety of common pathogens involved in skin and skin structure infections (SSTIs), including the resistant strains offer the advantage of broad spectrum of coverage including gram positive, gram negative and anaerobic organisms. This case study indicates the utility of garenoxacin in treating skin and soft tissue infections caused by road traffic accidents.


Molfino N.A.,Drug Development Consultant | Kuna P.,Medical University of Lódz | Leff J.A.,InterMune Inc. | Oh C.K.,Glenmark Pharmaceuticals | And 4 more authors.
BMJ Open | Year: 2016

Objectives: We wished to evaluate the effects of an antigranulocyte-macrophage colony-stimulating factor monoclonal antibody (KB003) on forced expiratory volume in 1 s (FEV1), asthma control and asthma exacerbations in adult asthmatics inadequately controlled by long-acting bronchodilators and inhaled/ oral corticosteroids. Settings: 47 ambulatory asthma care centres globally. Primary outcome measures: Change in FEV1 at week 24. Participants: 311 were screened, 160 were randomised and 129 completed the study. Interventions: 7 intravenous infusions of either 400 mg KB003 or placebo at baseline and weeks 2, 4, 8, 12, 16 and 20. Primary and secondary outcome measures: FEV1 at week 24, asthma control, exacerbation rates and safety in all participants as well as prespecified subgroups. Main results: In the KB003 treated group, FEV1 at week 24 improved to 118 mL compared with 54 mL in the placebo group (p=0.224). However, FEV1 improved to 253 vs 26 mL at week 24 (p=0.02) in eosinophilic asthmatics (defined as >300 peripheral blood eosinophils/mL at baseline) and comparable improvements were seen at weeks 20 (p=0.034) and 24 (p=0.077) in patients with FEV1 reversibility .20% at baseline and at weeks 4 ( p=0.029), 16 (p=0.018) and 20 (p=0.006) in patients with prebronchodilator FEV1 .50% predicted at baseline. There were no effects on asthma control or exacerbation rates. The most frequent adverse events in the KB003 group were rhinosinusitis and headache. There was no significant difference in antidrug antibody response between placebo and treated groups. There were no excess infections or changes in biomarkers known to be associated with the development of pulmonary alveolar proteinosis. Conclusions: Higher doses and/or further asthma phenotyping may be required in future studies with KB003. Trial registration number: NCT01603277; Results.


Mohan J.C.,Fortis Hospital | Jain R.,Glenmark Pharmaceuticals | Chamle V.,Glenmark Pharmaceuticals | Bhargava A.,Glenmark Pharmaceuticals
Journal of Clinical and Diagnostic Research | Year: 2015

Objective: To assess the short term safety and tolerability of a fixed dose combination (FDC) of olmesartan, amlodipine and hydrochlorothiazide (OAH) in real-world clinical setting in India. Materials and Methods: Physicians were requested to provide eight weeks observational clinical event data of the patients prescribed with FDC of Olmesartan (20/40mg), Amlodipine (5mg) and hydrochlorothiazide (12.5mg) in the prescription event monitoring (PEM) forms. Data on patients’ demographics, indication for FDC, concomitant medication and other relevant history was also collected and was analysed with descriptive statistics. Results: Two hundred thirty eight physicians provided data of 4763 patients. Mean age of the population was 55±7 years and males were 59.3%. The commonest indication for the FDC was uncontrolled hypertension (60.7%). Diabetes and dyslipidemia were present in 37.9% and 35.1% respectively.Concomitant medications included statins (42.3%), oral anti-diabetic (33.7%) and antiplatelet agents (24.7%). Pedal oedema (0.29%) was the most common adverse event (AE) reported followed by headache (0.16%), giddiness (0.15%), light headedness (0.15) and stroke (0.15%). Other less common (0.04%) reported AEs were tiredness, dizziness, gastritis, hypersomnia, hypoglycaemia, lower respiratory tract infection (LRTI), weakness, diarrhea, labyrinthitis, urinary tract infection, hyponatremia and hypotension.Occurrence of AEs was more common in patients with uncontrolled hypertension (60.74%). Conclusion: The FDC of olmesartan, amlodipine and hydrochlorothiazide prescribed most frequently for patients with uncontrolled hypertension and co-morbidities was found to be safe and well tolerated over a short period of observation. © 2015, Journal of Clinical and Diagnostic Research. All Rights Reserved.


PubMed | Chiltern International, Medical University of Lódz, Glenmark Pharmaceuticals, University of Manchester and 2 more.
Type: Clinical Trial, Phase II | Journal: BMJ open | Year: 2016

We wished to evaluate the effects of an antigranulocyte-macrophage colony-stimulating factor monoclonal antibody (KB003) on forced expiratory volume in 1 s (FEV1), asthma control and asthma exacerbations in adult asthmatics inadequately controlled by long-acting bronchodilators and inhaled/oral corticosteroids.47 ambulatory asthma care centres globally.Change in FEV1 at week 24.311 were screened, 160 were randomised and 129 completed the study.7 intravenous infusions of either 400 mg KB003 or placebo at baseline and weeks 2, 4, 8, 12, 16 and 20.FEV1 at week 24, asthma control, exacerbation rates and safety in all participants as well as prespecified subgroups.In the KB003 treated group, FEV1 at week 24 improved to 118 mL compared with 54 mL in the placebo group (p=0.224). However, FEV1 improved to 253 vs 26 mL at week 24 (p=0.02) in eosinophilic asthmatics (defined as >300 peripheral blood eosinophils/mL at baseline) and comparable improvements were seen at weeks 20 (p=0.034) and 24 (p=0.077) in patients with FEV1 reversibility 20% at baseline and at weeks 4 (p=0.029), 16 (p=0.018) and 20 (p=0.006) in patients with prebronchodilator FEV1 50% predicted at baseline. There were no effects on asthma control or exacerbation rates. The most frequent adverse events in the KB003 group were rhinosinusitis and headache. There was no significant difference in antidrug antibody response between placebo and treated groups. There were no excess infections or changes in biomarkers known to be associated with the development of pulmonary alveolar proteinosis.Higher doses and/or further asthma phenotyping may be required in future studies with KB003.NCT01603277; Results.


MAHWAH, N.J., Nov. 4, 2016 /PRNewswire/ -- Glenmark Pharmaceuticals, a global pharmaceutical company, today announced preclinical findings suggesting that GBR 1302 is efficient at eliminating tumor cells and has potential for a  large therapeutic window. Unlike current HER-2 targeting ther...


News Article | December 12, 2016
Site: www.prnewswire.com

DUBLIN, Dec. 12, 2016 /PRNewswire/ -- Endo International plc (NASDAQ / TSX: ENDP) announced today that one of its operating companies, Par Pharmaceutical, has begun shipping ezetimibe 10 mg tablets, the generic version of Merck's ZETIA®. Par Pharmaceutical is the marketer and distributor...


MAHWAH, N.J., March 1, 2017 /PRNewswire/ -- Glenmark Pharmaceuticals Inc., USA, and Evestra, Inc. have completed a strategic development, license and commercialization agreement to develop and market a generic version of Merck's & Co.'s NuvaRing® product – etonogestrel/ethinyl...


News Article | December 12, 2016
Site: www.prnewswire.co.uk

DUBLIN, Dec. 12, 2016 /PRNewswire/ -- Endo International plc (NASDAQ / TSX: ENDP) announced today that one of its operating companies, Par Pharmaceutical, has begun shipping ezetimibe 10 mg tablets, the generic version of Merck's ZETIA®. Par Pharmaceutical is the marketer and distributor of the product in the U.S., and is entitled to Hatch-Waxman generic marketing exclusivity based on the first-to-file ANDA status of its licensing partners, Glenmark Pharmaceuticals, Inc., USA, with whom Par will share profits. "We, along with our partners at Glenmark, are proud to be able to offer patients managing their cholesterol levels the first generic version of ZETIA®," said Tony Pera, President of Par Pharmaceutical. "Par remains committed to providing patients access to high quality and affordable medicines." "Glenmark has a deep heritage of bringing safe, effective and affordable medicines to patients around the world," said Robert Matsuk, President of North America and Global API. "Our partnership with Endo to bring the first generic version of ZETIA® to market only underscores our joint commitment to bridging the gap between patients and the medicines they need most." ZETIA® is indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia. According to IMS Health data, U.S. sales of ZETIA® are approximately $2.614 billion for the 12 months ended September 30, 2016. Important Safety Information ZETIA is a prescription medicine and should not be taken by people who are allergic to any of its ingredients. ZETIA can be taken alone or with a statin. Statins should not be taken by women who are nursing or pregnant or who may become pregnant, or by anyone with liver problems. If you have ever had liver problems or are pregnant or nursing, your doctor will decide if ZETIA alone is right for you. Your doctor may do blood tests to check your liver before you start taking ZETIA with a statin and during treatment. Unexplained muscle pain or weakness could be a sign of a rare but serious side effect and should be reported to your doctor right away. In clinical studies, patients reported few side effects while taking ZETIA. These included diarrhea, joint pains, and tiredness. About Endo International plc Endo International plc (NASDAQ / TSX: ENDP) is a global specialty pharmaceutical company focused on improving patients' lives while creating shareholder value. Endo develops, manufactures, markets and distributes quality branded and generic pharmaceutical products as well as over-the-counter medications though its operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com. About Glenmark Pharmaceuticals Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with operations in more than 80 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development primarily focused in the areas of respiratory disease, oncology and immunology. Headquartered in Mumbai, India, with U.S. Headquarters in Mahwah, NJ.  Glenmark has improved the lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information visit www.glenmarkpharma.com/usa. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Although Endo believes that these forward-looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward-looking statements or information in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo with the Securities and Exchange Commission ("SEC") and with securities regulators in Canada on the System for Electronic Document Analysis and Retrieval ("SEDAR), and as otherwise enumerated herein or therein, could affect Endo's future financial results and could cause Endo's actual results to differ materially from those expressed in this communication. The forward-looking statements in this press release are qualified by these risk factors. Endo does not assume any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws.

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