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Abigail Ruling Shows Feds More Concerned With Procedure Than Progress
BioWorld Perspectives Contributing Writer If the biotech industry had any doubt that the federal government is more concerned with following a complex array of rules and procedures than with actually advancing medical improvements – and really, did anyone in the industry think otherwise? – the recent ruling by the D.C. Court of Appeals proves that dying patients are only a minor concern when there is still a government form to be filled out. The D.C. Court of Appeals recently reversed anBy Greg Freeman | Bio Perspectives | Tuesday, October 21, 2008 -
Biotech Companies: New Dynamics of Profits vs. Scientific Progress
BioWorld Perspectives Contributing Writer There are about 1,300 biotech companies in the U.S., but few of them turn a profit.1 A few fledgling biotech companies have gone on to make a LOT of money, but most of them don't make any. 2 Curis: A Biotech Success or Failure? Cambridge, Mass.-based Curis Inc., for example, was founded in 1994 by four successful developmental biologists from Harvard University, Columbia University and the Hebrew Universities. Initially called Ontogeny Inc., theBy Sandy Becker | Bio Perspectives | Thursday, October 16, 2008 -
Finding Humor in a Dire Financial Market
BioWorld Perspectives Managing Editor Editor's note: This week's edition of BioWorld Perspectives introduces a new feature, "Short Takes." It's a new column of commentary about the best and most bizarre stories in BioWorld's newspapers, featuring snappy commentary on the industry by members of the BioWorld staff. Be sure to read future issues, where we'll continue the biotech soap opera "All My Clones" and have more cranky commentary in "BioWorld Bytes." If you'd also like to receive "ShortBy Amanda Lyle | Bio Perspectives | Tuesday, October 14, 2008 -
Keys to Success: Experts Offer Tips for All Stages of Partnering
BioWorld Managing Editor Ernst & Young said deal making between biotechnology and pharmaceutical firms reached "unprecedented levels" in 2007. The potential value of strategic alliances reached $27 billion, and values in Europe increased $6.5 billion to $13.5 billion. Regarding mergers and acquisitions, U.S. values increased to a total of more than $33 billion, an increase of 87 percent. In Europe, the total biotech M&A value increased from $2.5 billion in 2006 to $20.2 billion in 2007. M&AsBy Amanda Lyle | Bio Perspectives | Tuesday, October 14, 2008 -
Philanthropy and Nonprofit Dollars Drive up Discovery Value
BioWorld Executive Editor An unexpected source of alternative funding is manifesting itself in the form of increasing amounts of money contributed to biotechnology research by private benefactors and nonprofit organizations that most often expect only a non-monetary ROI: a cure. Those two sources have upped the biopartnering ante in contributing ever-increasing, even record amounts of, financial support aimed at pushing biotech R&D from discovery to late-stage and further, while perhapsBy Michael Harris | Bio Perspectives | Tuesday, October 14, 2008 -
Will Credit Crunch Rescuers Demand More Cost Cutting?
BioWorld Today Correspondent LONDON — With the credit crunch drying up access to capital for biotechs, partnering with cash-rich pharma looks like the only route to access money. So apart from landing the deal, the worry for biotech CEOs is that the pharmaceutical industry - while in a position of strength in relation to its highly leveraged counterparts in other sectors - is not immune to the pressures that are sweeping through the global economy. David Brennan, CEO of AstraZeneca plcBy Nuala Moran | Bio Perspectives | Tuesday, October 14, 2008 -
In Times of Financial Turmoil, Partnering Remains a Constant
BioWorld Today Correspondent LONDON — When the going gets tough, the tough get going. "That title was fixed some weeks ago, but it turns out to be more relevant than I ever imagined," said the keynote speaker David Brennan, CEO of AstraZeneca plc, addressing BioPartnering Europe delegates Monday. "But it could be worse," he added. "I could be CEO of a bank." As he stood up to give his address, the U.S. and UK governments and others around Europe were announcing yet more infusions of taxpayersBy Nuala Moran | Bio Perspectives | Tuesday, October 14, 2008 -
What's Next for Quality Risk Management Case Studies?
In order to ensure compliance and improve processing, how are your pharmaceutical industry colleagues using Quality Risk Management (QRM)? In a new BioWorld Today audio conference, insiders Kristin Murray and Stephen Reich will demonstrate what's been done to move beyond simple QRM applications and into more progressive areas. Through real-world case studies, they will show how to implement ICH Q9, and how to use QRM, to conquer complex quality issues and challenge long-standing industryBio Perspectives | Tuesday, October 14, 2008 -
Untitled
Image Cranky commentary by Cynthia Robbins-Roth And now for this month's assortment of entertaining news items! Timing Is Everything Just before the financial markets underwent a major implosion, Gaithersburg, Md.-based MedImmune Inc.'s ex-CEO David Mott decided to start a new career as a venture capitalist. Now a general partner at New Enterprise Associates, which has an office in Baltimore, Mott plans to focus on biotech and the ever-popular specialty pharma. Just last year, whenBio Perspectives | Tuesday, October 7, 2008 -
Raising Money in a Tough Environment: The 'You Ain't Seen Nothing Yet' Edition
BioWorld Today Science Editor Biotech has, of course, always been a financial universe unto its own to some degree. On the one hand, the willingness of investors to back companies whose products are simultaneously a long way off and a long shot can bear resemblance to faith healing: The decision to invest is based on a belief that, as often as not, defies rational evidence. Partly for this reason, creative financing strategies have long been the bread and butter of the industry. (See BioWorldBy Anette Breindl | Bio Perspectives | Tuesday, October 7, 2008 -
Getting Your EU Clinical Trials Ready for Approval
Although there are benefits to conducting a trial in the European Union, companies that don't understand the complicated process and the many ramifications of the Clinical Trials Directive, risk wasting significant time and money, and still may not get their drug approved. In a new BioWorld Today audio conference, Francis P. Crawley, Executive Director of the Good Clinical Practice Alliance, Europe, reviews what you need to know about the directive to effectively navigate the European clinicalBio Perspectives | Tuesday, October 7, 2008 -
It's Official: Lilly Offers $70 per Share for ImClone in $6.5B Deal
BioWorld Today Assistant Managing Editor Indianapolis-based Eli Lilly and Co. officially emerged Monday as the $70-per-share bidder for ImClone Systems Inc., affirming last week's speculation on the Street, as it aims to pick up a pipeline that includes marketed EGFR inhibitor Erbitux and three late-stage oncology programs. The companies signed a merger agreement, calling for Lilly to commence an all-cash tender offer for a majority of outstanding ImClone shares. The deal, estimated to beBy Jennifer Boggs | Bio Perspectives | Tuesday, October 7, 2008 -
France Missing the Boat as Biotech Moves Downstream
BioWorld Today Correspondent PARIS — The action is moving downstream in biotechnology with an estimated €10 billion (US$13.5 billion) being spent worldwide over the next few years for facilities to mass-produce a wave of bio-based medications expected to be approved for release by 2012. The spending is nearly evenly split among North America, Europe and Asia-Pacific, according to a French industry report presented ahead of the annual congress EuroBio that opens here today. Seven projects areBy John Brosky | Bio Perspectives | Tuesday, October 7, 2008 -
Another Case of PML: This Time Raptiva is Implicated
BioWorld Today Staff Writer Genentech Inc. has issued an alert to the health care community about a case of a rare life-threatening brain infection in an elderly patient treated with Raptiva, making it the third therapy to be linked to the disease. The viral infection known as progressive multifocal leukoencephalopathy (PML) was seen in a 70-year-old U.S. male patient who had received Raptiva (efalizumab) for more than four years to treat chronic plaque psoriasis. That patient was hospitalizedBy Catherine Hollingsworth | Bio Perspectives | Tuesday, October 7, 2008 -
The Candidates' Health Plans: A Matter of Cost, Effectiveness
BioWorld Today Washington Editor While Sens. John McCain (R-Ariz.) and Barack Obama (D-Ill.) are both proposing health plans intended to improve the quality and efficiency of care and reduce the growing number of the uninsured in the U.S., which now stands at more than 46 million, the two presidential candidates' proposals would put the nation's health system on very different paths, the nonprofit, bipartisan Commonwealth Fund said in a new analysis. The analysis, which examined keyBy Donna Young | Bio Perspectives | Tuesday, October 7, 2008 -
This Century's First Civil Rights Bill: The Privatization of Personalized Medicine
BioWorld Perspectives Contributing Writer Editor's note: Ilene Schneider, a writer and public relations consultant specializing in biotechnology and health care, is based in Irvine, Calif. Thanks to a new law, no American will have to fear the insurance and employment consequences of undergoing genetic tests. Specifically, no one will have to choose between obtaining health information and being employed or insured. After 13 years of debate, the Genetic Information Nondiscrimination Act (GINABy Ilene Schneider | Bio Perspectives | Tuesday, September 30, 2008 -
Drug Regulators Mark First Anniversary of FDAAA
BioWorld Today Washington Editor WASHINGTON — The new authorities granted by Congress last year under the FDA Amendments Act (FDAAA) has allowed the FDA to avoid the often drawn out bargaining process, which sometimes took some "arm-twisting," involved in seeking new safety warnings on drug labeling, regulators said Friday. FDAAA, which marked its first anniversary this past Saturday, gave regulators the ability to require, rather than negotiate, safety labeling changes. The agency four timesBy Donna Young | Bio Perspectives | Tuesday, September 30, 2008 -
GSK Stops Phase II Study of NPS Osteoporosis Drug
BioWorld Today Staff Writer NPS Pharmaceuticals Inc. said partner GlaxoSmithKline plc prematurely halted a Phase II trial of osteoporosis drug Ronacaleret (SB-751689) after a planned interim analysis showed a lack of efficacy. NPS executives could not be reached for comment, but the Bedminster, N.J.-based company said in a regulatory filing that the decision is not the result of any unexpected safety signals or concerns. The Phase II trial was a randomized, double-blind, placebo and activeBy Trista Morrison | Bio Perspectives | Tuesday, September 30, 2008 -
Reverse Mergers an Option for Firms Deemed Acquisition Risks
BioWorld Today Assistant Managing Editor (Editor's note: This is the second of two articles on one of the tactics biotech companies are employing to access capital and the public markets - reverse mergers. The first article appeared in Friday's issue.) Reverse mergers, like the one proposed by privately held ARCA Biopharma Inc. and publicly traded Nuvelo Inc. last week, are becoming a more popular route to the capital markets, especially in the stalled initial public offering market, even ifBy Jennifer Boggs | Bio Perspectives | Tuesday, September 30, 2008 -
Latest Reverse Merger Unites ARCA with Struggling Nuvelo
BioWorld Today Assistant Managing Editor (Editor's Note: This is the first of two articles on one of the tactics biotech companies are employing to access capital and the public markets - reverse mergers. The second article will appear in Monday's issue.) With the initial public offering window effectively closed to biotechs – and the tightening of purse strings among wary venture investors – private companies with late-stage products continue to be forced into seeking exit alternatives inBy Jennifer Boggs | Bio Perspectives | Tuesday, September 30, 2008
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