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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
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
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
April 22, 2015
Phillip Broadwith
Daiichi Sankyo steps out after Sun-Ranbaxy merger Japanese firm Daiichi Sankyo has sold off its entire stake in India's Sun Pharmaceuticals, following Sun's takeover of Indian rival Ranbaxy, in which Daiichi was the controlling shareholder. mark for My Articles similar articles
Chemistry World
November 21, 2014
Rebecca Trager
Ranbaxy sues over withdrawn US approvals Ranbaxy -- India's largest generics manufacturer -- has sued the US Food and Drug Administration after the agency withdrew tentative approval for the company to sell generic versions of two blockbuster drugs mark for My Articles similar articles
Chemistry World
April 14, 2008
Rebecca Trager
FDA Under Pressure Over Bisphenol A The US Food and Drug Administration (FDA) has been accused by congressmen of cherry picking research to support its decision on the use of Bisphenol A (BPA) in baby bottles and other products for use by children. 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
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
Pharmaceutical Executive
September 1, 2008
Jill Wechsler
Foreign Affairs FDA missteps and global outsourcing are drawing Congressional scrutiny and prompting new oversight approaches. mark for My Articles similar articles
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
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
February 1, 2011
Jill Wechsler
Challenges, Changes, Commitments The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency 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
February 16, 2010
Brian Orelli
For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward. mark for My Articles similar articles
Chemistry World
April 24, 2008
James Mitchell Crow
FDA takes tough line on biologic drug The US Food and Drug Administration has rejected an application from biotechnology firm Genzyme to make its already-approved, protein-based drug Myozyme in larger batches. 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 31, 2007
Brian Lawler
Does Leadership Count at the FDA? Let's take a look at how drug approval rates have fared under different FDA commissioners. 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
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
The Motley Fool
July 30, 2010
Brian Orelli
A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs. 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
The Motley Fool
September 9, 2010
Brian Orelli
Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September. 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
Pharmaceutical Executive
January 1, 2009
Jill Wechsler
FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order? mark for My Articles similar articles
The Motley Fool
March 8, 2010
Brian Orelli
Really? A 59% Share Price Jump for That? Justified or not, InterMune skyrockets ahead of an FDA panel meeting. mark for My Articles similar articles
Chemistry World
May 3, 2012
Akshat Rathi
Ranbaxy launches new anti-malarial Synriam It is the first recently developed antimalarial that is not based on artemisinin, one of the most effective treatments for malaria, which has begun to suffer from problems with resistance in recent years. 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
The Motley Fool
March 3, 2009
Brian Orelli
A Tale of 2 Weeks It's been a busy two weeks at Genzyme as two nasty notes from the FDA follow two approvals. 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
December 31, 2010
Brian Orelli
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. mark for My Articles similar articles
The Motley Fool
February 26, 2011
Brian Orelli
FDA Applications and a Look Ahead It isn't pretty. 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
Chemistry World
April 18, 2008
Rebecca Trager
EPA probes its own dismissal of scientist The US Environmental Protection Agency (EPA) has launched an internal enquiry on its decision to remove toxicologist Deborah Rice from an internal review panel last summer, amid a congressional enquiry on the issue. mark for My Articles similar articles
The Motley Fool
June 29, 2010
Brian Orelli
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2006
Jill Wechsler
Pharm Exec Q&A: A Soft Spot for Whistleblowers FDA's most aggressive critic in Washington is Iowa Senator Charles Grassley. In this exclusive interview, he explains where the agency goes wrong and what he would do to fix it. mark for My Articles similar articles
The Motley Fool
January 14, 2008
Brian Lawler
Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure. mark for My Articles similar articles
Chemistry World
May 7, 2014
Phillip Broadwith
Insider trading allegations stall Sun -- Ranbaxy deal The merger deal that would create India's largest pharmaceutical company has been stalled by accusations of insider trading of shares in the lead-up to the takeover announcement. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2007
Jill Wechsler
Washington Report: A Full Plate It's going to be a busy year in Washington for the pharmaceutical industry. Drug safety, unapproved uses, e-data requirements, and a shift to personalized medicine are just a few of the hot issues on tap for 2007. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2006
Kenneth I. Kaitin
Opinion: Memo to von Eschenbach FDA's acting commissioner has an opportunity to clarify a lot of misconceptions about the agency's role in regulating drug safety. His first order of business should be to explain exactly what FDA doesn't do. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2005
Jill Wechsler
Washington Report: Crawford Steps Up As FDA's new commissioner takes the reins, his key challenge is restoring trust in the agency. mark for My Articles similar articles
The Motley Fool
August 23, 2010
Brian Orelli
No Way to Jazz Up This Result Jazz Pharmaceuticals investors went from ecstatic to devastated in less than a week. mark for My Articles similar articles
The Motley Fool
February 21, 2008
Brian Lawler
A Bit of Irony From the FDA The agency has a mixed message on drug importation, as evidenced in the recent possible contamination of China-produced Heparin. mark for My Articles similar articles
The Motley Fool
June 25, 2010
Brian Orelli
Mark Your Calendars: Obesity Drugs Take Center Stage Orexigen Therapeutics has been given an FDA advisory committee meeting date, completing the dates for the trio of obesity drugs up for review. mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2006
Jill Wechsler
Washington Report: A Warning Trend Washington's new answer to drug safety concerns is more warnings and more disclosure of undigested data. But warnings can go too far. Haven't FDA's critics ever heard the story of the boy who cried wolf? 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
The Motley Fool
May 31, 2011
Brian Orelli
Pay Attention, Biotech Investors Competitors and partners can't be ignored. mark for My Articles similar articles
Pharmaceutical Executive
November 1, 2011
Jill Wechsler
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices. mark for My Articles similar articles
The Motley Fool
November 3, 2009
Brian Orelli
A Little Distracted, Are You, Merck? The FDA rejects its latest application. mark for My Articles similar articles
IndustryWeek
October 19, 2011
FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies? 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