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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 August 31, 2007 Brian Lawler |
Novartis on the Biosimilar Attack Novartis received final marketing approval today for only the second biosimilar product ever to gain a regulatory OK in the European Union. The EU market welcomes the drugmaker's copy of a treatment for anemia. |
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 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. |
Pharmaceutical Executive January 21, 2014 Ben Comer |
Biosimilars or Bust Will biosimimilars make much of an impact on drug cost? |
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 22, 2007 Brian Lawler |
Novartis' Good Week The pharma receives a pair of positive regulatory decisions. Investors, take note. |
Chemistry World July 2, 2013 Phillip Broadwith |
Biosimilar drugs step up complexity The first ever generic monoclonal antibody therapies have been recommended for approval in Europe. |
Chemistry World September 11, 2013 Phillip Broadwith |
First biosimilar antibody drugs approved in Europe The European commission has given final marketing approval to the first generic versions of monoclonal antibody drug infliximab (Johnson & Johnson's Remicade). |
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. |
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 July 18, 2011 Brian Orelli |
A $3.6 Billion Franchise at Stake Amgen and Teva settle their patent dispute, and Amgen investors have a little better idea of when the company's $3.6 billion Neupogen and Neulasta franchise might come under attack in the United States. |
The Motley Fool July 29, 2010 Brian Orelli |
Buy, Sell, or Hold: Biotech Generics Generic biotech drugs are coming. Hop on. |
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 January 5, 2011 Brian Orelli |
Spectrum Pharma Jumps in With the Big Dogs Spectrum is developing biosimilars. |
The Motley Fool January 7, 2010 Brian Orelli |
Warning: Potential Anemic Growth Ahead Anemia-drug makers get more scrutiny from the FDA. |
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. |
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 December 9, 2009 Brian Orelli |
Welcome to Club Biogeneric, Pfizer! The megadrugmaker jumps on the biogeneric bandwagon. |
The Motley Fool November 11, 2004 Brian Gorman |
Hospira's Possibilities The medical products and services outfit is not flashy, but it may benefit from long-term trends. Their stock may be worth monitoring. |
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. |
The Motley Fool October 3, 2008 Brian Orelli |
Amgen Draws Blood in Anemia-Drug War The pharmaceutical fights off rival Roche. |
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 March 10, 2015 Rebecca Trager |
US approves biosimilar filgrastim Sandoz's Zarxio is a generic version of filgrastim, which Amgen markets as Neupogen. |
The Motley Fool May 13, 2005 Brian Gorman |
Hospira's Hopeful Signs The medical products company's strong quarter belies a less exciting future. Investors should probably take a wait-and-see attitude. |
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. |
Chemistry World January 27, 2014 Phillip Broadwith |
US blocks imports from fourth Ranbaxy plant The US Food and Drug Administration has banned Indian drugmaker Ranbaxy from importing active pharmaceutical ingredients produced at its plant at Toansa, India, into the US. |
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 July 1, 2011 Jill Wechsler |
Battles over Biosimilars Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game. |
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 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 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. |
The Motley Fool June 2, 2005 Brian Gorman |
Hospira's Little Purchase There may be more to Hospira's recent acquisition than meets the eye. |
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. |
Chemistry World May 14, 2015 Rebecca Trager |
Injunction blocks first US biosimilar A US federal circuit court has granted a request by Amgen to temporarily block sales of the first biosimilar product approved by the US Food and Drug Administration |
The Motley Fool January 5, 2010 Brian Orelli |
A Deal Manufactured by Necessity Genzyme gets some help from a new friend. |
The Motley Fool October 21, 2004 W.D. Crotty |
One Value-Priced Biotech Giant Amgen is a growing cash machine selling at the market's multiple to earnings. |
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 March 1, 2007 Brian Lawler |
Hospira's Boring Growth The medical products provider announces its fourth quarter financial results and gives guidance for 2007. Investors, take note. |
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 December 20, 2011 Luke Timmerman |
Amgen, Watson Strike $400M Deal for Biosimilar Cancer Drugs What does this important collaboration mean for biosimilars? |
The Motley Fool February 23, 2004 Brian Gorman |
Abbott Cleans Up Its Act Abbott closes the books on its problems with the FDA and clears the way to a spinoff. Abbott finally passed FDA muster with its Illinois diagnostics plant. Its multi-year problem highlights the importance of investors monitoring manufacturing while watching a pharmaceutical company's pipeline. And with its FDA compliance issues behind it, Abbott can look forward to spinning off its Hospital Products Division. |
The Motley Fool August 10, 2006 Stephen D. Simpson |
Volatility, Thy Name Is Hospira Margins continue to stand in the way of consistent performance at the health-care company. Investors, take note. |
Chemistry World September 1, 2015 Rebecca Trager |
FDA takes action to remove biosimilars roadblock In a move expected to facilitate the entry of biosimilar drugs into the US market, the US Food and Drug Administration has proposed a system for naming such copycat versions of biological drugs. |
Chemistry World February 12, 2015 Rebecca Trager |
Hospira buyout is a shot in the arm for Pfizer's biosimilars Pfizer said in a statement that its acquisition of Hospira will create 'a leading global sterile injectables business. |
The Motley Fool September 22, 2006 Brian Lawler |
Hospira's New Mate Down Under The specialty injectable pharmaceutical announces an acquisition, but the move means adding on a lot more debt. Investors, take note. |
BusinessWeek May 31, 2004 Robert Barker |
Hospira Just May Put You In The Pink If the Abbott Laboratories spin-off's first steps hardly seem promising, that's one reason why I see the company as worth much more of the intelligent investor's attention than the long calendar of pending tech and biotech IPOs. |
Chemistry World December 22, 2011 Sarah Houlton |
Pharma braces for patent cliff impact It remains to be seen quite how far Lipitor sales will fall. Ranbaxy has six months of exclusivity for generic competition. |
The Motley Fool August 8, 2007 Ryan Fuhrmann |
Hospira Looks to Deliver Will a recent acquisition boost drug delivery firm Hospira's growth prospects? The new Mayne Pharma Limited division played a primary role in delivering an impressive 30% reported sales growth. |