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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). |
Chemistry World August 2, 2007 Victoria Gill |
Europe Poised for a Surge in Generic Drugs The European Medicines Agency's Committee for Medicinal Products for Human use has recommended the approval of a schizophrenia treatment which is the first generic drug to be assessed under Europe's centralized procedure. |
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. |
The Motley Fool November 20, 2006 Brian Gorman |
Hospira's Bold Move The drug delivery outfit's stab at biosimilars is worth some attention, but investors shouldn't assume a major payoff. |
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 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. |
Chemistry World December 24, 2014 Phillip Broadwith |
EU recommends Parkinson's drug for approval The first new drug in 10 years for Parkinson's disease has been recommended for approval by the European Committee for Medicinal Products for Human Use. |
The Motley Fool February 11, 2009 Brian Orelli |
The FDA's Bipolar Decision Johnson & Johnson announces that the FDA has asked for more information before approving its application to market Risperdal Consta for frequently relapsing bipolar disorder. |
The Motley Fool August 29, 2008 Brian Orelli |
A Lawsuit Loss to Remember Barr Pharmaceuticals and Mylan get the patent overturned on Johnson & Johnson's Alzheimer's drug. |
Pharmaceutical Executive January 21, 2014 Ben Comer |
Biosimilars or Bust Will biosimimilars make much of an impact on drug cost? |
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 November 27, 2009 Brian Orelli |
A Mostly Meaningless FDA Approval After an accelerated approval, the positive effects of a full approval are minimal for Johnson & Johnson's drug, Intelence. |
The Motley Fool August 24, 2007 Brian Orelli |
Kids, Take Your Psychoactives J&J gains pediatric approval of its antipsychotic drug. Investors, take note. |
The Motley Fool April 21, 2010 Brian Orelli |
Yawn! Get Back to Me Next Quarter, J&J There's more stagnant growth from the health-care giant. |
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 April 14, 2008 Brian Orelli |
Teva Gets What It Wants Teva persuades a court to order the FDA to award it a marketing exclusivity for generic Risperdal. |
The Motley Fool October 3, 2008 Brian Orelli |
Amgen Draws Blood in Anemia-Drug War The pharmaceutical fights off rival Roche. |
The Motley Fool July 1, 2008 Brian Orelli |
As the FDA Generics Office Turns The FDA reluctantly gives Teva a 180-day exclusive period to sell generic Risperdal. |
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. |
The Motley Fool April 27, 2009 Brian Orelli |
Johnson & Johnson's Simponi Sticks to the Wall Johnson & Johnson gets its second-generation TNF-alpha inhibitor past the FDA. |
The Motley Fool September 12, 2005 M.D. Mitchell |
Big Problems for Big Pharma Creating new drugs is never easy, but the companies that excel in three key areas are the ones for investors to watch. |
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 July 14, 2009 Brian Orelli |
J&J Eats a Hard Quarter Tough year-over-year comparisons are no match for the health care giant. |
The Motley Fool May 2, 2011 Brian Orelli |
Prostate Cancer Drug Roars Ahead Johnson & Johnson's buy of Cougar paid off, but look in the rear view mirror. |
The Motley Fool May 19, 2009 Brian Orelli |
Flip-Flopping: Not Just for Politicians Anymore The FDA's change is good for companies. |
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 May 29, 2009 Brian Orelli |
Merck's Bad News Nothing to Sneeze At The U.S. Patent and Trademark Office reexamination of Merck's patent on allergy medication, Singulair, is nothing to sneeze at. The $2.8 billion worth of Singulair that Merck sold in the U.S. last year made up 12% of its total pharmaceutical sales. |
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 June 22, 2007 Brian Lawler |
Novartis' Good Week The pharma receives a pair of positive regulatory decisions. Investors, take note. |
The Motley Fool May 11, 2011 Brian Orelli |
Abbott's Lucky Number Seven might be Abbott Labs' Humira's lucky number. The anti-inflammatory is up for approval in its seventh indication and the data looks pretty good. |
Chemistry World August 9, 2012 |
Bapineuzunab dropped Pfizer and Johnson and Johnson have announced that they are ending development of the intravenous Alzheimer's drug bapineuzumab after it failed in two clinical trials. |
The Motley Fool January 5, 2011 Brian Orelli |
Spectrum Pharma Jumps in With the Big Dogs Spectrum is developing biosimilars. |
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. |
BusinessWeek October 25, 2004 Gene G. Marcial |
Par: Out Of The Rough? Since posting disappointing earnings in April, Par Pharmaceutical, No. 6 in U.S. generic drugs, has seen its shares plummet from 61 to 34. |
The Motley Fool May 12, 2004 Phil Wohl |
Mylan's Big Break? The maker of generic pimple cream wants to lead the pack. Can it? |
The Motley Fool July 31, 2007 Nathan Parmelee |
Break Out the Band-Aids at J&J Johnson & Johnson is making some deep cuts to change its cost structure. Shareholders haven't had much to cheer about lately here, but the potential benefits from this move could help cure some of the current softness in the business. |
The Motley Fool October 7, 2008 Brian Orelli |
Will a Better Drug Sell Better? Positive trial data isn't enough to significantly boost Johnson & Johnson's Remicade. |
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 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 November 26, 2010 Brian Orelli |
Get It Together, Johnson & Johnson Another day, another recall. |
The Motley Fool July 9, 2010 Brian Orelli |
Hey, Johnson & Johnson: Eight Is Enough If Johnson & Johnson can't overcome the negative image from recalls quickly, consumers will head to competing brand-name drugs or just grab generic versions of Johnson & Johnson's products. |
The Motley Fool June 30, 2009 Brian Orelli |
Johnson & Johnson Inflames Abbott $1.67 billion is one hefty reward. |
The Motley Fool October 13, 2009 Brian Orelli |
J&J Needs to Get Drugged Up Medical devices and diagnostics pass by drugs as the main revenue source. |
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 28, 2010 Brian Orelli |
How Much Is This Going to Cost J&J? Investors need an answer from Johnson & Johnson about low-quality drugs that were recalled. Is the problem systemic, and if so, how much will it cost the company to fix the problem? |
Chemistry World March 17, 2014 Phillip Broadwith |
UK to fast-track access to critical medicines Critically ill patients in the UK could receive new medicines before they are formally approved under a new scheme beginning in April. |
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 May 8, 2015 Matthew Gunther |
Court rejects Spain's challenge to EU patent reform The European Court of Justice has dismissed a legal challenge by Spain to block the introduction of a single patent system in Europe. |
The Motley Fool August 24, 2009 Brian Orelli |
J&J Would Rather Not Say Drug delayed, reason unknown. Should shareholders be worried? It's hard to tell. |
The Motley Fool July 30, 2007 Brian Orelli |
Is Par Pharmaceutical Settling for Less? The generic drugmaker avoids going to court in some recent cases. Patent lawyers are the lifeblood of a generic drugmaker, and investors should want them to act as aggressively as possible so that Par can expand its product line. |