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Managed Care April 2007 Martin Sipkof	Abbreviated Approval Process In the Works for 'Biosimilar' Drugs The Access to Life-Saving Medicine Act may be a first step to giving the FDA the legal authority to approve these drugs.
The Motley Fool May 31, 2006 Brian Gorman	Novartis Gets Its Way FDA approval for Omnitrope suggests Novartis has a bright future in biogenerics, and that's good news for the company's investors.
The Motley Fool September 23, 2008 Brian Lawler	Will Generic Biologics Get Special Treatment? While the rest of the market was lost in the financial meltdown, a little-noticed report discussing some of the biopharmaceutical bills going through Congress was released.
The Motley Fool March 23, 2010 Brian Orelli	No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.
Managed Care September 2003 Thomas Morrow	Managed Care Strategy: Create Competition In Expanding Biotech Field The biotech field is booming, and insurers are scrambling to find ways to deal with the high costs of new "biologic" treatments. One strategy is to try to create more competition among the producers of biotech drugs.
BusinessWeek November 3, 2003 Diane Brady	Biotech: Teva's Next Triumph? The Israeli maker of generics wants a piece of the fast-growing bio-drug market.
The Motley Fool April 17, 2006 Brian Gorman	Novartis Presses on Biogenerics The company wins a court case that could accelerate U.S. regulations for biogenerics. Recent developments suggest Novartis' strategy may be close to paying off. Investors, take note.
The Motley Fool September 20, 2005 Brian Gorman	Novartis Stays Focused New developments at the drug giant suggest the company is on track. Investors, take note.
Pharmaceutical Executive October 1, 2006 Joanna Breitstein	"I Pray for the Welfare of Your Company..." Big Pharma's drugs fill Teva Pharmaceutical's pipeline. CEO Israel Makov says he's not the enemy. To prove it, he offers lessons in survival.
The Motley Fool June 26, 2009 Brian Orelli	Novartis Leads the Pack Biosimilars come to Japan; will the U.S. be next? In the U.S., the main hang-up is how much guaranteed patent protection branded biologics will be given.
The Motley Fool March 3, 2009 Brian Orelli	Stop Worrying About Follow-On Biologics They're inevitable, but they won't hurt biotech as much as you might think.
Pharmaceutical Executive February 1, 2006 Sarah Houlton	Global Report: Moving Towards Generic Biologics The European Medicines Agency hopes to complete its guidelines for the approval of biosimilar drugs early this year, paving the way for the approval of biogenerics - and a potential goldmine for the generics companies.
Pharmaceutical Executive April 1, 2011	Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help.
Managed Care July 2002 Thomas Kaye	Managing the Drug Benefit: One Company's Experience The pharmacy director of Blue Cross of Oklahoma shares his company's success with using three tiers and coinsurance to promote member responsibility.
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.
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?
Pharmaceutical Executive September 1, 2011 Jill B. Conner	Complex Biologics: The View from Teva Industry and regulators alike must grapple with the sensitivities associated with developing bio-similar drugs.
The Motley Fool October 26, 2007 Brian Orelli	Investing in Follow-On Biologics Investors, while approvals of follow-on biologics in the U.S. are probably still years away, now is the time to do your research. Those that are leading the race overseas are likely to be first in line when the FDA opens its door to applications.
Pharmaceutical Executive May 1, 2007 Jill Wechsler	Washington Report: Pathways for Proteins The push is on to establish an approval pathway for generic versions of biotech therapies. Innovators want exclusivity and clinical studies for follow-on biologics, but visions of billion-dollar savings may short-circuit the scientific debate.
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.
Chemistry World March 25, 2010 Rebecca Trager	Big pharma scores in US healthcare reform President Obama has signed the biggest US healthcare reform since the 1960s, and although it is largely seen as a victory for the pharmaceutical industry, some analysts are characterising it as a 'double-edged sword'.
Pharmaceutical Executive July 1, 2011 Jill Wechsler	Battles over Biosimilars Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game.
The Motley Fool December 2, 2009 Brian Orelli	Tired of Waiting, Teva Advances Teva Pharmaceutical decides it's not worth waiting for the U.S. government to establish a pathway for approval of generic versions of biologic drugs. Instead, it's asking for approval for its copycat of Amgen's Neupogen under the normal branded-drug process.
Managed Care May 2006 John Carroll	Effective Ways To Increase Usage of Generics Generics is one of the few areas where insurance plans can economize effectively. BlueCross & BlueShield of North Carolina is one of many insurers that are changing members' and prescribers' behavior.
The Motley Fool September 9, 2010 Jim Mueller	Today's Buy Opportunity: Teva Pharmaceutical Take advantage of this growing generic-drug maker.
The Motley Fool July 29, 2010 Brian Orelli	Buy, Sell, or Hold: Biotech Generics Generic biotech drugs are coming. Hop on.
The Motley Fool June 30, 2009 Brian Orelli	Following the Pack to Future Returns Mylan's playing catch up, but there's room for more.
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.
Managed Care September 2002 John Carroll	When Success Sours: PBMs Under Scrutiny Pharmacy benefit managers are under fire from many corners. What will the push for transparency mean for the industry?
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.
The Motley Fool August 30, 2006 Brian Gorman	Mylan's Biogeneric Play The generic drugmaker buys an Indian firm to strengthen its long-term prospects. Investors, take note.
Pharmaceutical Executive June 1, 2009 John F. Kouten	On the Right Pathways With staggering year-over-year growth, biosimilars are "the future of medicine." Marketers must position their companies for the inevitable changes. President Barack Obama has pledged support for legislation governing biosimilars.
Pharmaceutical Executive July 30, 2007 Jill Wechsler	Washington Report: Exclusivity vs. Patents To encourage innovation while supporting access to less costly therapies, Congress proposes an extensive data-exclusivity period that would delay Food and Drug Administration approval of a follow-on biologic application for 12 years.
Managed Care January 2007 John Carroll	Debate Over Biologics Heats Up in Congress One of the possible issues is 'biosimilars,' agents that would fill the role that generics play in traditional pharmacy coverage.
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 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.
Pharmaceutical Executive September 1, 2011 Jill Wechsler	Rebates and Reform User-fee renewal legislation sets the stage for new policies affecting reimbursement, research, and regulatory oversight.
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 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.
Chemistry World January 9, 2015 Rebecca Trager	US poised to approve its first 'biosimilar' drug A key committee of the US Food and Drug Administration has voted in favor of licensing a copycat version of a biological drug. If approved, Sandoz's Zarxio (filgrastim) would be the first 'biosimilar' drug available in the US.
Chemistry World June 22, 2011 Sarah Houlton	US Approves Cancer Drugs Twice as Fast as Europe Cancer drugs are, on average, approved nearly twice as fast in the US than they are in Europe.
The Motley Fool December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
Pharmaceutical Executive May 1, 2011 Mason Tenaglia	Out of Control The pharmaceutical industry needs to use new and better data to accurately measure how much it is willing to invest in avoiding plan control.
The Motley Fool December 12, 2007 Brian Lawler	Patent Bill Is No Panacea A new bill that was meant to strengthen the patent and other intellectual-property rights of drugmakers doesn't do enough to encourage pharma innovation.
The Motley Fool November 8, 2006 Brian Lawler	Teva Is Rolling in Cash Again Investors, the bottom line is that with 13 proprietary drugs in phase 2 trials or later for some very large indications, plus 144 applications to sell generic versions of branded drugs waiting at the FDA, Teva's near-term future is strong.
Managed Care March 2008 Martin Sipkoff	The Epilepsy Battle in the War Between Brands and Generics Brand-name manufacturers and many neurologists see danger in generic substitution, but the FDA insists that the practice is safe
Pharmaceutical Executive January 1, 2014 Jill Wechsler	Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing
The Motley Fool June 11, 2009 Brian Orelli	The FTC Hates You, Too The agency weighs in (unhappily) on follow-on biologics.
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.
Pharmaceutical Executive November 1, 2012 Jill Wechsler	Budgets, Biosimilars, and Bad Ads While the nation was embroiled in the presidential elections, a number of important legal and regulatory issues absorbed pharmaceutical executives.