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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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
Pharmaceutical Executive October 1, 2011 |
30 Years of Pharma: Perspective in Numbers, Part 3 Top 10 generics companies. |
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. |
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. |
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 |
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? |
The Motley Fool January 8, 2010 Brian Orelli |
Heartburn Relieved ... for Now AstraZeneca settles its patent dispute with Teva. |
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. |
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. |
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. |
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? |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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? |
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. |
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. |
The Motley Fool March 23, 2010 Brian Orelli |
No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma. |
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. |
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. |
The Motley Fool December 3, 2007 Brian Orelli |
Nebivolol's Almost Approvable Letter Forest and Mylan get an approvable letter for Nebivolol. |
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. |
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. |
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. |
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. |
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. |
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? |
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. |
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. |
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. |
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? |
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. |
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. |
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. |
The Motley Fool April 1, 2004 Charly Travers |
Atrix Batting 1.000 Atrix Laboratories' drugs have breezed past the Food and Drug Administration. |