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  • patients
  • The company and GlaxoSmithKline plc recently reported that the FDA has accepted its New Drug Application for ANORO ELLIPTA for patients with chronic obstructive pulmonary disease. (yahoo.com)
  • review
  • The PDUFA "has provided critical resources for improving the quality and timeliness of premarket review of drugs," said FDA spokeswoman, Sandy Walsh. (yahoo.com)
  • Treatments
  • A 2017 review update studying the effects of anti-VEGF drugs on diabetic macular edema found that while all three studied treatments have advantages over laser therapy, there was moderate evidence that aflibercept is significantly favored in all measured efficacy outcomes over ranibizumab and bevacizumab, after one year. (wikipedia.org)
  • The early part of his career (1976-90) was spent establishing and leading the Pharmacology and New Drug Development Laboratory at the Medical Research Council's Clinical Oncology Unit at the University of Cambridge, where he developed new treatments to exploit hypoxic cells in solid tumours and elucidated the enzymes involved in the activation of hypoxia-targeted drugs. (wikipedia.org)
  • Halozyme has many ongoing and completed clinical trials testing the safety and efficacy of its primary investigational drug, PEGPH20, in combination with other therapies, with the goal of finding new treatments for pancreatic cancer, NSCLC, gastric cancer, breast cancer, and others. (wikipedia.org)
  • Pharmaceuticals
  • Aflibercept is a biopharmaceutical drug invented by Regeneron Pharmaceuticals, approved in the United States and Europe for the treatment of wet macular degeneration under the trade name Eylea, and for metastatic colorectal cancer as Zaltrap. (wikipedia.org)
  • In 1993 Workman joined Zeneca Pharmaceuticals (now AstraZeneca) where he was responsible for the Cancer Bioscience Section , establishing new drug discovery projects and leading the kinase research collaboration with Sugen Work in this role led to the development of one of the first targeted medicines gefitinib (Iressaâ„¢), which was later approved for use in non-small cell lung cancer in 2003. (wikipedia.org)
  • Therapeutics
  • In August 2015 United Therapeutics sold the United States Food and Drug Administration voucher they were awarded in March 2015 for Unituxin, the new treatment for high-risk neuroblastoma in pediatric patients, to AbbVie for $350 million. (wikipedia.org)
  • In early 2006, scientists studying the Ebola hemorrhagic fever virus at USAMRIID announced a 75% recovery rate after infecting four rhesus monkeys and then treating them with an antisense Morpholino drug developed by Sarepta Therapeutics (formerly named AVI BioPharma), a U.S. biotechnology firm. (wikipedia.org)
  • Prostate cancer drug abiraterone, which was approved for use in the US and Europe in 2011, was developed by Workman's Cancer Therapeutics Unit. (wikipedia.org)
  • Halozyme Therapeutics is a U.S. biotechnology company that develops novel oncology therapies designed to target the tumor microenvironment and licenses a novel drug delivery technology through corporate partnerships. (wikipedia.org)
  • Lilly
  • Pemetrexed (brand name Alimta) is a chemotherapy drug manufactured and marketed by Eli Lilly and Company. (wikipedia.org)
  • The molecular structure of pemetrexed was developed by Edward C. Taylor at Princeton University and clinically developed by Indianapolis-based drug maker, Eli Lilly and Company in 2004. (wikipedia.org)
  • dose
  • See drug label for appropriate dose modifications. (centerwatch.com)
  • The recommended initial dose of the drug for subjects not receiving erythropoiesis-stimulating agents (ESAs) is .6 mcg/kg body weight administered as a single IV or SC injection once every two weeks. (centerwatch.com)
  • The recommended initial dose of the drug is 200 mg (two 100 mg tablets) taken twice daily following a meal. (centerwatch.com)
  • The recommended regimen of treatment is a loading dose of 20 mg of the drug delivered via 30 minute infusion, followed by an additional infusion of 20 mg continuously over 24 hours. (centerwatch.com)
  • Pfizer
  • On September 2, 2009, the United States Department of Justice fined Pfizer $2.3 billion after one of its subsidiaries, Pharmacia & UpJohn Company, pleaded guilty to marketing four drugs including Bextra "with the intent to defraud or mislead. (wikipedia.org)
  • placebo-controlled
  • Approval of Alora is supported by a double-blind, placebo-controlled trial involving 268 postmenopausal women who experienced an average of at least 60 moderate-to-severe hot flashes during the screening period. (centerwatch.com)
  • enzyme
  • co-administration drugs that inhibit this enzyme (including but not limited to ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir) may increase serum Vaprisol concentration and halflife, and should be avoided. (centerwatch.com)
  • PEGPH20: A PEGylated drug candidate based on Halozyme's proprietary rHuPH20 enzyme (a recombinant human hyaluronidase enzyme). (wikipedia.org)
  • antibody
  • 14 of 23 subjects treated for 2 years with the drug experienced some degree of anti-IGF-1 antibody formation, though no clinical consequences (allergic reaction or loss of efficacy) were observed. (centerwatch.com)
  • HTI-1511 Anti-EGFR ADC: An antibody-drug conjugate (ADC) with a strong cytotoxin, monomethyl auristatin E, designed to treat EGFR-positive tumors, including those with KRAS and BRAF mutations. (wikipedia.org)
  • laboratory
  • Once a drug has been developed in a laboratory, it moves on to the next step. (healthcentral.com)
  • Reddy received the Award for Excellence in Drug Research of the Central Drug Research Institute in 2013 and the Scientist of the Year Award of the National Chemical Laboratory the same year. (wikipedia.org)
  • Workman received the Royal Society of Chemistry 2012 Chemistry World Entrepreneur of the Year Award for his success at taking pioneering cancer drugs from the laboratory into commercial development. (wikipedia.org)
  • Company
  • No company had offered by that time to get FDA approval and commercialize the drug, so the NCI kept manufacturing it and making it available under compassionate use. (wikipedia.org)
  • response
  • Calquence was granted accelerated approval based on overall response rate. (centerwatch.com)
  • The drug was seen to produce a statistically significant response in 15.7% (n=14 of 89) of evaluable subjects in the Vidaza arm, and 12.8% (n=6 of 47) of the crossover group. (centerwatch.com)
  • The EMA did not change its labelling of the drug in response to the Cochrane study. (wikipedia.org)
  • adverse
  • Zaltrap has adverse effects typical of anti-cancer drugs, such as reduced blood cell count (leukopenia, neutropenia, thrombocytopenia), gastrointestinal disorders like diarrhoea and abdominal pain, and fatigue. (wikipedia.org)
  • lung cancer
  • Antisense oligonucleotides have been researched as potential drugs for diseases such as cancers (including lung cancer, colorectal carcinoma, pancreatic carcinoma, malignant glioma and malignant melanoma), diabetes, amyotrophic lateral sclerosis (ALS), Duchenne muscular dystrophy, spinal muscular atrophy, Ataxia-telangiectasia and diseases such as asthma, arthritis and pouchitis with an inflammatory component. (wikipedia.org)
  • severe
  • They were instructed to administer the drug when suffering from moderate to severe migraine pain. (centerwatch.com)
  • Morphine is administered prior to, during, and for two hours after infusion of dinutuximab and dinutuximab beta to manage the severe pain that this drug causes. (wikipedia.org)
  • Council
  • Member of EORTC Board and Council as Chairman of the EORTC New Drug Development Coordinating Committee. (wikipedia.org)
  • label
  • The FDA approval of Iclusig was based on a single-arm, open-label, international, multicenter trial in 449 subjects with CML and Ph+ALL whose disease was considered to be resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. (centerwatch.com)
  • The FDA approval of Myalept was based on an open-label, single-arm study in 48 subjects with congenital or acquired generalized lipodystrophy and diabetes mellitus, hypertriglyceridemia, and/or increased fasting insulin. (centerwatch.com)
  • potential
  • In other words, the FDA has 60 days to consider whether or not it is even interested in filing the drug for a potential review. (healthcentral.com)
  • Application
  • Now that all of the trials have been performed, it's time for the FDA to discuss the submission of a New Drug Application. (healthcentral.com)
  • The FDA has 60 days after receiving the New Drug Application to be reviewed. (healthcentral.com)
  • Submit an interim report including analyses of 12-week safety data and supportive efficacy data with the Safety Update submission for the traditional approval supplemental new drug application for etravirine. (centerwatch.com)
  • years
  • It has been a highly effective drug for over fifty years in large part because it has a low incidence of drug resistance in the pathogens it treats. (wikipedia.org)
  • found
  • If problems are found, the FDA may change the labeling, issue a public warning or pull the drug from the market entirely. (healthcentral.com)
  • The drug has been found to possess nootropic, neuroprotective, anticonvulsant, and antidepressant-like effects in animal models. (wikipedia.org)
  • bone
  • Due to the lower iPTH levels achieved by the use of this drug, it is possible that adynamic bone disease could occur at levels "below 100 pg/mL" The drug is of course contraindicated in people with blood serum calcium levels below the norm. (wikipedia.org)
  • side effects
  • As with most drugs, Evista was associated with some side effects, the majority of which were reported as mild. (centerwatch.com)
  • Because this list is not all-inclusive, please consult a physician to discuss any side effects and the individual appropriateness of the drug. (centerwatch.com)
  • class
  • Evista, the first in a class of new drugs called selective estrogen receptor modulators (SERMs) to be approved by the FDA for marketing for the prevention of osteoporosis, is being studied for its selective ability to act like estrogen in some tissues but not in others. (centerwatch.com)
  • Constipation Pemetrexed is chemically similar to folic acid and is in the class of chemotherapy drugs called folate antimetabolites. (wikipedia.org)
  • business
  • Monsanto was one of the first companies to apply the biotechnology industry business model to agriculture, using techniques developed by biotech drug companies. (wikipedia.org)
  • growth
  • Verteporfin, a light-sensitive dye, is injected systemically, and a laser specifically activates the drug in the choroidal vessels, blocking vessel leakage and preventing further vessel growth. (wikipedia.org)