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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.
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.
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.
Managed Care July 2007 John Carroll	A Model Approach to Biologics Premera's method of analyzing the potential benefits of diabetes drug Byetta shows how third-party modeling can pinpoint which members can benefit from easier access -- and how insurance plans can determine authentic cost savings.
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.
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 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.
Pharmaceutical Executive October 1, 2011 Jill Wechsler	"Representing" Healthcare to the Fullest Since coming to Congress about 35 years ago, Henry Waxman, Congressional Representative from Los Angeles, California, has been pivotal in shaping legislation on health and drug regulatory issues.
Pharmaceutical Executive December 1, 2008 Jill Wechsler	Challenge and Challenges Expanded healthcare coverage also fits the goals of pharma manufacturers.
The Motley Fool March 23, 2010 Brian Orelli	No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.
Pharmaceutical Executive October 1, 2008 Jill Wechsler	Part D Under Attack Congressional leaders ready campaign to curb Medicare drug plans.
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 July 29, 2010 Brian Orelli	Buy, Sell, or Hold: Biotech Generics Generic biotech drugs are coming. Hop on.
Pharmaceutical Executive December 1, 2006 Jill Wechsler	Washington Report: The New Agenda Democrats are back on top in Congress after more than a decade as underdogs. The new leaders are mapping out a broad agenda with drug pricing and access high on the list.
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.
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.
BusinessWeek July 29, 2009 Arlene Weintraub	Teva Fights for Biotech Generics Teva's Debra Barrett is lobbying hard to shorten the protection period for biotech drugs and get generic versions to market more quickly
Pharmaceutical Executive October 1, 2010	Taking a Less-Generic Route to Generics A leading pharmaceutical industry player speaks out on what is fueling success in the sector.
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.
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 July 1, 2011 Jill Wechsler	Battles over Biosimilars Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game.
Pharmaceutical Executive October 1, 2012 J. Michael Nicholas	Complex Drugs and Biologics: Policy Considerations in Brazil The Brazilian government's policy on biologics doesn't adequately address non-biologic complex drugs. Additional guidance is needed to bring these important medicines to market.
The Motley Fool December 20, 2011 Brian Orelli	If You Can't Beat 'Em, Join 'Em: Amgen Goes Generic Biosimilars are coming -- might as well get a piece of the action.
The Motley Fool January 21, 2009 Brian Orelli	A Copycat on the Prowl Teva Pharmaceutical announces it is partnering with Lonza to develop generic versions of biologics, called biosimilars, or follow-on biologics.
Pharmaceutical Executive April 1, 2009 Jill Wechsler	Kickoff for Reform In addition to overhauling healthcare, Congress is weighing proposals for updating FDA policies and expanding access to drugs.
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.
Pharmaceutical Executive December 1, 2010 Jill Wechsler	New Ballgame in Washington Republican gains in Congress create uncertainty for health reform, drug regulation, and biomedical research
The Motley Fool March 22, 2010 Brian Orelli	Health-Care Reform Passes! Here's Where to Invest Now Some healthy suggestions for your portfolio.
Managed Care November 2005 Patrick Mullen	This Biologics Industry Spokesman Knows That Health Plans Can Only be Won Over by the Financial Argument. Biotech's focus is expanding from products that treat relatively rare diseases to treatments for conditions that affect much larger populations, including various cancers, diabetes, rheumatoid arthritis, and asthma because of health plan costs.
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 October 1, 2005 Glass & Worrell	Whose Afraid of Authorized Generics Losing a patent challenge lets a generic competitor grab market share and slash branded profits. Sound scary? Ignoring authorized generics is worse.
Pharmaceutical Executive January 1, 2014 Jill Wechsler	Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing
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.
The Motley Fool January 26, 2011 Brian Orelli	Health-Care Reform Lives: Here's Where to Invest State of the Union turned investment thesis regarding health insurance companies.
Pharmaceutical Executive October 1, 2011 Jill Wechsler	At the Helm of Industry As the lead FDA official overseeing the testing and approval of new drugs and biotech therapies for some 20 years, Dr. Janet Woodcock has built a robust and modern drug regulatory system.
Pharmaceutical Executive January 1, 2012 Jill Wechsler	New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation.
Pharmaceutical Executive April 1, 2011	Revisiting Reform Courts, Congress review policies and programs shaping drug costs and access.
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.
Managed Care February 2005 Thomas Morrow	Competition Heralds Beginning of Bio-Generics There is very little competition in the biopharmaceutical sector. With the introduction of generic forms of human growth hormone, can managed care get a lower price?
The Motley Fool September 20, 2007 Brian Orelli	Winners and Losers in Universal Health Care Here's a look at the companies that stand to win or lose if Hillary Rodham Clinton is elected -- and gets her three-pronged health-care reform plan through Congress.
The Motley Fool August 10, 2004 Brian Gorman	Biotech Cost Control Will the high cost of therapies slow sales in the sector? Investors can avoid problems by paying close attention to companies' pipelines and reimbursement trends.
Pharmaceutical Executive September 1, 2006 Reznick & Kobak	Legal: Authorized Generics: Still Legal--and Holding Despite the rattle and hum, courts continue to support the practice of authorized generics. The response? Generic manufacturers are changing the way they argue these cases.
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 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 25, 2008 Brian Orelli	Look Across the Pond for Biosimilars Teva, ratiopharm, and CT Arzneimittel all get positive recommendations for their new biosimilars, as approvals for generic equivalents to biotech drugs are heating up in Europe.
Managed Care December 2007	Insurers Lean Toward Generic Alternatives More insurers are focusing their attention on a second approach to generic drug management -- generic alternatives, which contain different active ingredients, but have comparable efficacy to brand-name drugs in the same class.
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 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.
The Motley Fool January 31, 2007 Brian Lawler	Mylan on the Generic Attack Two new drug approvals for the generic drugmaker come in the midst of a changing regulatory environment. 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.