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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.
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 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 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.
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.
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 October 18, 2010 Brian Orelli	Pfizer Flexes Its Generic Muscles The pharma giant moves farther into generic 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 March 23, 2010 Brian Orelli	No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.
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.
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 July 29, 2010 Brian Orelli	Buy, Sell, or Hold: Biotech Generics Generic biotech drugs are coming. Hop on.
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.
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.
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.
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?
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.
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 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.
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.
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 October 5, 2011 Arlene Weintraub	Merck Fine-Tunes Biosimilars Strategy as FDA Guidelines Loom Merck readies itself to enter this potential new market.
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.
Pharmaceutical Executive January 21, 2014 Ben Comer	Biosimilars or Bust Will biosimimilars make much of an impact on drug cost?
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.
The Motley Fool December 20, 2007 Brian Orelli	2007: The Year Pharma Fell in Love With Biologics The reason for pharma's newfound infatuation for biotech is quite clear. Many pharmaceutical companies are facing a patent cliff in the coming years, and they need to replace their blockbusters with something.
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 October 9, 2006 Brian Lawler	The Commandments of Biotech Investing, Part 2 It's a complex field, but it's not impossible for investors to master. The more in-depth your research of a potential biotech investment, and the more you remember to follow these commandments, the better your potential for success will be when investing in this fascinating field.
The Motley Fool July 8, 2008 Brian Lawler	Blockbuster Drugs Bound for Extinction? One of the biggest classes of prescription drugs, those for diabetes treatments, faces tougher FDA standards.
Pharmaceutical Executive March 1, 2012 Ron Cohen	FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership.
Pharmaceutical Executive June 1, 2007 Clinton & Wechsler	The View From Inside Commissioner Andrew von Eschenbach on drug safety, DTC advertising, FDA's culture, and how the agency plans to bring itself into the age of molecular medicine.
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 April 1, 2004 Charly Travers	Atrix Batting 1.000 Atrix Laboratories' drugs have breezed past the Food and Drug Administration.
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 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'.
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.
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.
The Motley Fool July 17, 2007 Brian Orelli	An Investor's Guide to the New PDUFA It's important for investors in drug companies to keep up with the latest clinical trial news, but policy changes in Washington can affect companies' bottom lines just as much.
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.
The Motley Fool June 29, 2011 Brian Orelli	So Much Insulin, So Little Use for It MannKind settles its supply agreement with Merck.
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 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.
Chemistry World June 30, 2014 Phillip Broadwith	Inhaled insulin approved in US Mannkind's Affreza is aimed at reducing the need for patients to inject themselves with insulin so frequently.
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 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 June 1, 2012 Jill Wechsler	Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market.
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.
The Motley Fool December 4, 2007 Brian Orelli	An Early Gift to Drugmakers Drugmakers could be allowed to market for drugs' off-label indications.
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.
Chemistry World November 9, 2010 Andrew Turley	Company snapshot: Novo Nordisk As the results for the third quarter of this year roll in, one pharma major - Danish company Novo Nordisk - seems to have done better than most with its diabetes medicines.