*PAREXEL

It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process. It is the second ... "Drugs trial men 'seriously ill'". BBC News. March 15, 2006. "When drug trials go horribly wrong". The International Herald ... The drug had been tested on animals but this was the first test on humans. PAREXEL became the target of legal proceedings from ... announced it would acquire its competitor PAREXEL for $612.7 million in stock and combine the two drug research and development ...

*Biotechnology in pharmaceutical manufacturing

Prior to the development and FDA approval of a means to produce human blood clotting factors using recombinant DNA technologies ... "Sanofi launches malaria drug production , Chemistry World". Rsc.org. Retrieved 2013-12-17. ... page 343 Kaufman, pages 9622-3 Kaufman, page 9623 Kaufman, page 9626 United States Food and Drug Administration: "The licensing ...

*Pirfenidone

In September 2011, the Chinese State Food and Drug Administration provided GNI Group Ltd with new drug approval of pirfenidone ... The drug is around 60% bound to plasma proteins, especially to albumin. Up to 50% of the drug is metabolized by hepatic CYP1A2 ... The drug is contraindicated in patients who have severe hepatic impairment. Dizziness and fatigue have been reported in ... Most drug interactions are mediated by various cytochrome P450 (CYP) enzymes. Since Pirfenidone is metabolised through the ...

*Amphotericin B

"Drug Approval Package". www.accessdata.fda.gov. Archived from the original on 2015-11-17. Retrieved 2015-11-03. "Untitled ... 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 ... "Drugs@FDA: FDA Approved Drug Products". www.accessdata.fda.gov. Archived from the original on 2014-09-05. Retrieved 2015-11-03 ... However, recently novel nanoparticulate drug delivery systems such as AmbiOnp, nanosuspensions, lipid-based drug delivery ...

*Cancer immunotherapy

"Opdivo Drug Approval History". James JS, Dubs G (December 1997). "FDA approves new kind of lymphoma treatment. Food and Drug ... Demko S, Summers J, Keegan P, Pazdur R (February 2008). "FDA drug approval summary: alemtuzumab as single-agent treatment for B ... Cameron F, Whiteside G, Perry C (May 2011). "Ipilimumab: first global approval". Drugs. 71 (8): 1093-104. doi:10.2165/11594010- ... Research, Center for Drug Evaluation and. "Approved Drugs - Durvalumab (Imfinzi)". www.fda.gov. Retrieved 2017-05-06. Byrd JC, ...

*Raltegravir

"Isentress Drug Approval Package". U.S. Food and Drug Administration (FDA). February 22, 2008. Retrieved 2009-11-15. "UPDATE 2- ... The drug is metabolized away via glucuronidation. It is the first integrase inhibitors, to receive approval in the United ... HIV Antiretroviral Agents in Development "FDA approval of Isentress (raltegravir)". U.S. Food and Drug Administration (FDA). ... Stephenson J (2007). "Researchers buoyed by novel HIV drugs: will expand drug arsenal against resistant virus". JAMA. 297 (14 ...

*Urate oxidase

"Pegloticase Drug Approval Package". US FDA. Retrieved 15 May 2017. Nguyen T, Zelechowska M, Foster V, Bergmann H, Verma DP ( ... Urate oxidase is formulated as a protein drug (rasburicase) for the treatment of acute hyperuricemia in patients receiving ...

*Etelcalcetide

"Parsabiv New FDA Drug Approval , CenterWatch". www.centerwatch.com. Retrieved 2017-10-30. Blair, Hannah A. (2016-12-01). " ... announced its submission of a new drug application to the Food and Drug Administration for etelcalcetide. The European ... "Etelcalcetide: First Global Approval". Drugs. 76 (18): 1787-1792. doi:10.1007/s40265-016-0671-3. ISSN 0012-6667. "Parsabiv: ... Due to the lower iPTH levels achieved by the use of this drug, it is possible that adynamic bone disease could occur at levels ...

*Dinutuximab

No company had offered by that time to get FDA approval and commercialize the drug, so the NCI kept manufacturing it and making ... "Unituxin New FDA Drug Approval". CenterWatch. Retrieved 28 January 2018. "Unituxin: Withdrawal of the marketing authorisation ... Dinutuximab received marketing approval in the US and in Europe in March 2015; the marketing approval was withdrawn in 2017. ... In the meantime in Europe, oncologists and patient advocates wanted to have the drug available in Europe, and made efforts to ...

*Valdecoxib

U.S. FDA Drug Approval." Last accessed June 8, 2007. "Information for Healthcare Professionals: Valdecoxib (marketed as Bextra ... Company as an anti-inflammatory arthritis drug. It was approved by the United States Food and Drug Administration on November ... Mandal U, Jayakumar M, Ganesan M, Nandi S, Pal T K, Chakraborty M K, Roy Chowdhary A. and Chattoraj T K, Indian Drugs, 2004, 41 ... Pharmacia and Upjohn, a Pfizer subsidiary, violated the United States Food, Drug and Cosmetic Act for misbranding Bextra "with ...

*Miltefosine

"Impavido New FDA Drug Approval , CenterWatch". www.centerwatch.com. Archived from the original on 2016-11-04. Retrieved 2016-11 ... "Drugs.com - Miltefosine Side Effects". Archived from the original on 2016-11-17. S.D. Seth (2008). "Drug therapy of ... "Miltefosine Side Effects in Detail - Drugs.com". www.drugs.com. Archived from the original on 2016-11-17. Retrieved 2016-11-16 ... "New FDA Pregnancy Categories Explained - Drugs.com". www.drugs.com. Archived from the original on 2016-11-16. Retrieved 2016-11 ...

*Indeloxazine

ISBN 978-0-412-46630-4. Hayashi, K; Hashimoto, K; Yanagi, M; Umeda, T; Hama, R (8 August 1998). "Drug approval in Japan ... Index nominum, international drug ... - Google Books. 2000. ISBN 978-3-88763-075-1. r Ganellin, C; j Triggle, D; MacDonald, F ... The drug has been found to possess nootropic, neuroprotective, anticonvulsant, and antidepressant-like effects in animal models ... Kaneko S, Sugimura M, Inoue T, Satoh M (June 1991). "Effects of several cerebroprotective drugs on NMDA channel function: ...

*Nepafenac

"Drug Approval Package: Nevanac (Nepafenac) NDA #021862". FDA. FDA. Retrieved October 27, 2017. "Ilevro Approval Package" (PDF ... "Drug Approval Package: Nepafenac NDA #203491". FDA. FDA. Retrieved October 27, 2017. "About Us". Novartis. Novartis. Retrieved ... Average price for both drugs is similar. Generic formulations are not yet available for either drug. Alcon faced declining ... "Generic Nevanac Availability". Drugs.com. Retrieved October 31, 2017. "Generic Ilevro Availability". Drugs.com. Retrieved ...

*Joan Miller

"Drug Approval Package: Visudyne (Verteporfin) Injection". U.S. Food and Drug Administration (FDA). Retrieved 28 June 2016. ... On April 12, 2000, verteporfin became the first drug approved by the Food and Drug Administration (FDA) for treating AMD. In ... Helzner, Jerry (September 1, 2005). "Inside Genentech's Lucentis Strategy: The company had no experience in ophthalmic drugs, ... and a laser specifically activates the drug in the choroidal vessels, blocking vessel leakage and preventing further vessel ...

*Pemetrexed

Hazarika M, White RM, Johnson JR, Pazdur R (2004). "FDA drug approval summaries: pemetrexed (Alimta)". Oncologist. 9 (5): 482-8 ... National Cancer Institute: FDA Approval for Pemetrexed Disodium Cohen MH, Justice R, Pazdur R (September 2009). "Approval ... In addition to the brand name Alimta, this drug is also marketed in India by Abbott Healthcare as Pleumet and by Cadila ... Pemetrexed (brand name Alimta) is a chemotherapy drug manufactured and marketed by Eli Lilly and Company. Its indications are ...

*Mesoblast

"FDA Drug Approval Process Infographic (Horizontal)". "Free SEC Filings Email Alerts - SECFilings.com". secfilings.com. ... Conditional approval does not mean that the regulatory approval process is over. It simply allows the therapy to be made ... Mesoblast announced in its 2014 results and corporate strategy that the Food and Drug Administration granted approval to ... Conditional approval would last seven years. In March 2014, Circulation Journal published results of a clinical trial using ...

*Genta (company)

"Anticancer drug, created at Penn, nears approval, The drug, made by Genta, could bring tens of millions a year in royalties for ... "Genta falls as drug approval delayed". The Scotsman. 4 June 2002. Retrieved 10 January 2010. Chang, Althea (December 15, 2006 ... Food and Drug Administration (FDA) approved drug, is a gallium nitrate injection for treatment of cancer-related hypercalcaemia ... Feuerstein, Adam (October 29, 2009). "Genta Melanoma Drug Study Disappoints: BioBuzz". TheStreet.com. Retrieved 10 January 2010 ...

*Ceftaroline fosamil

Ceftaroline has received approval from the U.S. Food and Drug Administration for the treatment of community-acquired bacterial ... "New Drug Approvals". 2010-10-29. Retrieved 2010-11-08. "FDA approves Teflaro for treatment of bacterial infections". 30 Oct ... No clinical drug-drug interaction studies have been conducted with ceftaroline fosamil. In vitro studies in human liver ... If anemia develops during or after treatment with ceftaroline, drug-induced hemolytic anemia should be considered. If drug- ...

*D. Srinivasa Reddy

New Drug Approvals. 2016. "D. Srinivasa Reddy". Various links. All For Drugs. 2016. "D. Srinivasa Reddy". Product links,Silico ... New Drug Approvals. 2016. "D. Srinivasa Reddy". Various links. One Organic Chemist One Day. 2016. ... Reddy received the Award for Excellence in Drug Research of the Central Drug Research Institute in 2013 and the Scientist of ... NASI-Reliance Industries Platinum Jubilee Award and the Drug Research Excellence Award of the Central Drug Research Institute. ...

*United Therapeutics

"Drug Approval Package: Remodulin (Treprostinil Sodium) Injection". FDA. 21 May 2002. Retrieved 19 November 2015. Nicole Gray ( ... drug company sues federal government to fend off competition from generics". Washington Post. Retrieved 2017-08-13. Moukheiber ... The voucher doesn't guarantee the FDA will approve the drug." In August 2015 United Therapeutics sold the United States Food ... Worstall, Tim (20 October 2015). "The Economic Proof That The FDA's Drug Regulation Makes Us All Poorer". Forbes. Retrieved 19 ...

*Carvedilol

"Coreg - Food and Drug Administration" (PDF). U.S. Patent 4503067 "Drug Approval Package". www.accessdata.fda.gov. Retrieved ... Expert Opinion on Drug Metabolism & Toxicology. 6 (2): 237-250. doi:10.1517/17425250903540220. PMID 20073998. Physicians Desk ...

*Aflibercept

FDA Drug Approvals Database. Food and Drug Administration. August 3, 2012. Retrieved 2013-10-16. FDA Professional Drug ... On 12 March 2015, aflibercept was one of a group of drugs delisted from the UK Cancer Drugs Fund. Fraser HM, Wilson H, ... A 2017 review update studying the effects of anti-VEGF drugs on diabetic macular edema found that while all three studied ... Oct 19, 2006 Bayer HealthCare Signs On to Help Develop Regeneron's VEGF Trap-Eye "Regeneron and Sanofi-Aventis Cancer Drug ...

*Biogen

Grant, Charley (2016-12-27). "Surprise Drug Approval Is Holiday Gift for Biogen". Wall Street Journal. ISSN 0099-9660. ... "Once-monthly MS drug from Biogen Idec, AbbVie clears Phase III hurdle". Fierce Biotech. Retrieved 2013-04-08. "Lingo: a ... "FDA Approval for Rituximab". National Cancer Institute. "UPDATE 1-Roche, Biogen end dispute over Rituxan follow-ons". Reuters. ... In May 2016 the company announced that it will spin off its hemophilia drug business (Eloctate and Alprolix) into a public ...

*Oseltamivir

In May 2009, Cipla won approval from the WHO certifying that its drug Antiflu was as effective as Tamiflu, and Antiflu is ... "Drug Approval Package: Tamiflu (Oseltamivir Phosphate) NDA# 021087". Archived from the original on 2014-04-16. Jackson, RJ; ... dead link FDA Medical Review Archived 2014-04-16 at the Wayback Machine., linked from Tamiflu Drug Approval Package Archived ... WIPO April 2006 Avian Flu Drugs: Patent Questions Archived 2009-12-08 at the Wayback Machine. "Drugs at FDA: Tamiflu". FDA. ...

*Antisense therapy

Grant, Charley (2016-12-27). "Surprise Drug Approval Is Holiday Gift for Biogen". Wall Street Journal. ISSN 0099-9660. ... Therefore, antisense drug candidate molecules are generally modified during the drug discovery phase of their development. ... As of 2016, several antisense drugs have been approved by the U.S. Food and Drug Administration (FDA): fomivirsen as a ... FDA approves new orphan drug Kynamro to treat inherited cholesterol disorder U.S. Food and Drug Administration, Retrieved 31 ...

*Classical Anatolia

A compromise was worked out with a Parthian on the Armenian throne subject to Roman approval. The Julio-Claudian dynasty ended ... central government in rome was often far from civil and military commanders in the field, and local ambitions often dragged ... Parthia had broken with previous agreements of choosing Armenian kings subject to approval of Rome. Trajan's policy was to ... Mithrodates then dragged his eastern neighbour Armenia into the fray, since Tigranes the Great (95-55 BC) was his son in law. ...

*Paul Workman (scientist)

"FDA Drug Approval Summary: Gefitinib (ZD1839) (Iressa®) Tablets". Theoncologist.alphamedpress.org. Retrieved 4 April 2012. " ... Prostate cancer drug abiraterone, which was approved for use in the US and Europe in 2011, was developed by Workman's Cancer ... "Cancer Drug Researcher Receives Royal Society of Chemistry Award - ICR Global Foundation". Icrgf.org. 4 June 2010. Retrieved 4 ... Member of EORTC Board and Council as Chairman of the EORTC New Drug Development Coordinating Committee. In 1993 Workman joined ...