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. |
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. |
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 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. |
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Ranbaxy sues over withdrawn US approvals Ranbaxy -- India's largest generics manufacturer -- has sued the US Food and Drug Administration after the agency withdrew tentative approval for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 |
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. |
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 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. |
Pharmaceutical Executive September 1, 2008 Jill Wechsler |
Foreign Affairs FDA missteps and global outsourcing are drawing Congressional scrutiny and prompting new oversight approaches. |
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 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 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 |
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 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. |
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. |
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 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. |
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. |
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. |
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. |
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? |
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. |
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. |
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? |
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. |
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. |
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. |
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. |
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 December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
The Motley Fool February 26, 2011 Brian Orelli |
FDA Applications and a Look Ahead It isn't pretty. |
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 |
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. |
The Motley Fool June 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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? |
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. |
The Motley Fool May 31, 2011 Brian Orelli |
Pay Attention, Biotech Investors Competitors and partners can't be ignored. |
Pharmaceutical Executive November 1, 2011 Jill Wechsler |
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices. |
The Motley Fool November 3, 2009 Brian Orelli |
A Little Distracted, Are You, Merck? The FDA rejects its latest application. |
IndustryWeek October 19, 2011 |
FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies? |
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. |