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Chemistry World
February 16, 2015
Phillip Broadwith
Teva wins generic esomeprazole race The copycat version will be marketed by Ivax Pharmaceuticals, a subsidiary of Israeli generic behemoth Teva. mark for My Articles similar articles
The Motley Fool
September 18, 2008
Brian Orelli
Ranbaxy's Troubles Won't Help Competitors The FDA will block the importing of more than 30 drugs and ingredients until Ranbaxy's problems at two Indian manufacturing plants are resolved. mark for My Articles similar articles
Chemistry World
September 18, 2008
James Mitchell Crow
Ranbaxy hit by US drug ban The US Food and Drug Administration (FDA) has banned the import of more than 30 drugs made by Ranbaxy, India's largest drugmaker. mark for My Articles similar articles
Chemistry World
January 27, 2014
Phillip Broadwith
US blocks imports from fourth Ranbaxy plant The US Food and Drug Administration has banned Indian drugmaker Ranbaxy from importing active pharmaceutical ingredients produced at its plant at Toansa, India, into the US. mark for My Articles similar articles
Chemistry World
July 16, 2015
Rebecca Trager
US import ban imposed on Indian pharma firm The US Food and Drug Administration has prohibited India's Emcure Pharmaceuticals from importing drugs manufactured at its Maharashtra-based facility into the US owing to concerns over its manufacturing practices. mark for My Articles similar articles
Chemistry World
April 9, 2014
Andy Extance
Sun set on Ranbaxy rescue India's Sun Pharma will acquire its compatriot Ranbaxy in a $3.2 billion all-share deal that will create the world's fourth largest generic drugs producer. mark for My Articles similar articles
Chemistry World
May 23, 2013
Phillip Broadwith
$500m fine over generics fraud for Ranbaxy A long-running investigation by the US Department of Justice and Food and Drug Administration has ended with a $500 million fine for generic drugmaker Ranbaxy. mark for My Articles similar articles
Chemistry World
August 20, 2012
Generic Actos Approved Three generics manufacturers - Mylan, Ranbaxy and Teva - have won US marketing approval for their generic versions of Actos diabetes tablets. mark for My Articles similar articles
Chemistry World
April 1, 2015
Sanjay Kumar
Sun Pharma snares Ranbaxy in $4bn deal Sun Pharma is now the fifth largest generics drug company in the world. mark for My Articles similar articles
The Motley Fool
February 26, 2009
Brian Orelli
Ranbaxy Spoils It for Everyone The Food and Drug Administration claims that generic-drug maker Ranbaxy falsified data that it submitted to the agency. Other innocent drug companies may suffer from guilt by association. mark for My Articles similar articles
Pharmaceutical Executive
October 1, 2011
30 Years of Pharma: Perspective in Numbers, Part 3 Top 10 generics companies. mark for My Articles similar articles
The Motley Fool
October 8, 2007
Brian Orelli
New FDA Regulations for Drugmakers To deal with a growing backlog of pending applications, the FDA plans to stop its first-come, first-served system. mark for My Articles similar articles
Chemistry World
July 28, 2008
Rebecca Trager
Ranbaxy troubles place FDA under fire Indian drug firm Ranbaxy is facing scrutiny by American federal agencies and lawmakers over allegations that the company falsified scientific evidence to gain US approval for its products. mark for My Articles similar articles
BusinessWeek
July 14, 2003
Einhorn & Kripalani
In India a Little Lab Work and Lots of Lawyers Ranbaxy, a maker of generic drugs, must win lawsuits to grow mark for My Articles similar articles
Managed Care
February 2008
Martin Sipkoff
FDA Approach to Generics May Be a Mixed Blessing A recently announced initiative is supposed to speed approval of generic drugs, but does it address some fundamental flaws in the approval process? mark for My Articles similar articles
The Motley Fool
January 8, 2010
Brian Orelli
Heartburn Relieved ... for Now AstraZeneca settles its patent dispute with Teva. mark for My Articles similar articles
The Motley Fool
May 15, 2008
Brian Orelli
Wanted: FDA Approval -- Pronto Teva and Amphastar have the courts on their side, but the FDA still stands in the way of a generic-drug launch. mark for My Articles similar articles
BusinessWeek
February 27, 2006
Einhorn & Kripalani
In India, Selling Generics Used To Be So Easy Suddenly, Indian drugmakers Dr. Reddy's and Ranbaxy have a host of copycat rivals. mark for My Articles similar articles
The Motley Fool
June 25, 2007
Brian Orelli
Leading the Pack of Follow-On Drug Makers Generic drug maker Dr. Reddy's Laboratories is taking a huge risk to get ahead of the pack, but it's well worth the rewards of being in front of its competitors. Investors, take note. mark for My Articles similar articles
Pharmaceutical Executive
November 1, 2008
Patrick Clinton
Over There Is it the FDA's responsibility to be in charge of inspections at foreign pharmaceutical plants? mark for My Articles similar articles
Chemistry World
October 17, 2014
Dinsa Sachan
Indian manufacturers hit back over quality claims The Indian pharmaceutical industry has asked its government to sue authors of a study published by the US National Bureau of Economic Research in early September. mark for My Articles similar articles
Chemistry World
June 10, 2013
Phillip Broadwith
Sandoz manufacturing woes continue Sandoz, the generic drugs arm of Swiss firm Novartis, has had an official warning from the US Food and Drug Administration over failings at one of its manufacturing plants. mark for My Articles similar articles
The Motley Fool
October 29, 2007
Brian Orelli
The Extended Release That Wasn't The FDA is investigating Teva's generic version of Wellbutrin XL. Investors, take note. mark for My Articles similar articles
Chemistry World
October 23, 2013
Sarah Houlton
Pharma manufacturing woes dog industry Many problems arise from quality control failures, according to Nicholson Price from Harvard Law School's Petrie-Flom center for health law policy, biotechnology and bioethics, this is not the only problem -- regulatory constraints can prevent process improvements being made. mark for My Articles similar articles
Managed Care
September 2007
Martin Sipkoff
Patent Law Rulings Work in Favor of Generics Thanks to recent Supreme Court rulings, manufacturers of generic drugs are in a good position to continue expansion of their market share. mark for My Articles similar articles
The Motley Fool
July 1, 2008
Brian Orelli
As the FDA Generics Office Turns The FDA reluctantly gives Teva a 180-day exclusive period to sell generic Risperdal. mark for My Articles similar articles
The Motley Fool
January 31, 2007
Brian Lawler
FDA Says Hurray for More Drug Safety The FDA outlines its proposal to increase drug safety. Whatever the FDA does, pharmaceutical investors should hope that its renewed interest in drug safety doesn't make the already lengthy process of bringing drugs to market any longer. mark for My Articles similar articles
The Motley Fool
October 16, 2006
Brian Lawler
The Coming Generic Drug Boom Generic drugmakers are poised to profit from several key factors. Investors, take note. mark for My Articles similar articles
The Motley Fool
February 22, 2011
Brian Orelli
A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S. mark for My Articles similar articles
The Motley Fool
January 20, 2006
Rich Duprey
Generics Give Originators Heartburn Eisai, the Japanese manufacturer of an acid reflux remedy, sees a generic maker win FDA approval. What does this mean for investors? mark for My Articles similar articles
The Motley Fool
October 5, 2011
Brian Orelli
1 Sure Sign of an FDA Approval Transcept Pharmaceuticals shoots up 34% after announcing that the FDA had classified its resubmission as a class 1 response. mark for My Articles similar articles
The Motley Fool
May 11, 2006
Brian Lawler
Encysive Evasive About Thelin The pharmaceutical stays tight-lipped about FDA approval of its new drug. Investors should keep an eye on Encysive's cash-burn rate in the coming months. mark for My Articles similar articles
The Motley Fool
March 23, 2010
Brian Orelli
No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma. mark for My Articles similar articles
Chemistry World
February 14, 2012
Rebecca Trager
FDA proposes biosimilars approval pathway The US Food and Drug Administration has released its long awaited guidance to assist in the development and approval of so-called 'biosimilars' - biological drugs that are very similar to licensed ones. mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2005
Jill Wechsler
Washington Report: Big Production Drug manufacturing costs too much and is cumbersome to regulate. FDA's answer: Quality by design, which shifts the emphasis from testing the final product to building quality into the manufacturing process from the beginning. mark for My Articles similar articles
The Motley Fool
December 3, 2007
Brian Orelli
Nebivolol's Almost Approvable Letter Forest and Mylan get an approvable letter for Nebivolol. mark for My Articles similar articles
The Motley Fool
November 8, 2007
Charly Travers
BioMarin Tips Its Hand BioMarin Pharmaceutical awaits an FDA decision on its drug Kuvan for the treatment of phenylketonuria. The company's recent conference call implies approval is imminent. mark for My Articles similar articles
The Motley Fool
August 24, 2009
Brian Orelli
J&J Would Rather Not Say Drug delayed, reason unknown. Should shareholders be worried? It's hard to tell. mark for My Articles similar articles
Chemistry World
July 25, 2012
Pharma Industry May Suffer as India Looks to Generics India plans to provide free generic drugs to half its population. mark for My Articles similar articles
The Motley Fool
December 31, 2007
Brian Lawler
The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency. mark for My Articles similar articles
The Motley Fool
October 25, 2007
Brian Orelli
Reddy for a Rollercoaster Ride In their quarterly results Dr. Reddy's Laboratories sees a dip in revenue from the loss of authorized generics. mark for My Articles similar articles
The Motley Fool
August 12, 2008
Brian Lawler
The FDA Stands Up Cardiome What does the approvable letter mean for Cardiome and other drug developers? mark for My Articles similar articles
The Motley Fool
November 14, 2007
Brian Lawler
Is the FDA Still Approving New Drugs? Lately the FDA seems more reluctant to approve new drugs than it once was. Let's take a look at the actual numbers from the past eight years. mark for My Articles similar articles
Chemistry World
June 13, 2008
Sarah Houlton
Daiichi Sankyo makes bid for Ranbaxy The combination of the two companies - one focused on research and the other predominantly on generics - bucks the trend for research-based companies selling off or spinning out their generics businesses. mark for My Articles similar articles
The Motley Fool
August 17, 2007
Brian Orelli
Fewer Drug Approvals? Buy! Stricter standards at the FDA could create a buying opportunity. Drug approvals are down one third this year, creating a lot of value in pharmaceutical and biotech companies. Just choose your medicines carefully. mark for My Articles similar articles
The Motley Fool
July 28, 2010
Brian Orelli
Fighting Hard to Keep a Blockbuster Sanofi is suing the FDA to take back approval of a competing generic drug. Did you expect something different? mark for My Articles similar articles
The Motley Fool
February 23, 2007
Rich Duprey
Foolish Forecast: Barr Labs Resets Bar The pharmaceutical is set to release fourth-quarter 2006 financial results. Investors, here is what you can expect to see. mark for My Articles similar articles
The Motley Fool
August 28, 2007
Brian Orelli
Teva Gets a Two-For Even for a maker of generic drugs, getting two FDA drug approvals in as many business days is a feat not often seen. Teva Pharmaceuticals managed to do it, though. Investors, take note. mark for My Articles similar articles
Chemistry World
May 14, 2015
Rebecca Trager
FDA accused of violating drug company's freedom of speech The US Food and Drug Administration is under pressure to reconsider its policy prohibiting pharmaceutical companies from promoting 'off-label' uses of their products. mark for My Articles similar articles
The Motley Fool
April 1, 2004
Charly Travers
Atrix Batting 1.000 Atrix Laboratories' drugs have breezed past the Food and Drug Administration. mark for My Articles similar articles