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 if

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 in

Episode 17: Part Deux of 'Don't Be So Koi: The Thrill of Spending Shareholders' Capital' If you missed previous episodes of the biotech-themed soap opera "All My Clones," click here to read the beginning of the story. Odessa sighed as the Bombardier Global Express XRS ultra long-range business jet started its descent into EuroAirport Basel-Mulhouse-Freiburg. Her head still ached from the bombardment of BlackBerry buzzing from weeks of nauseating stock market gyrations right up to the point

PTC Therapeutics was ordered by a U.S. District judge to supply a drug still in Phase II trials to Jacob Gunvalson, who has muscular dystrophy. Despite alleged promises to do so, PTC declined to enroll him in a trial or obtain a treatment IND under 21 CFR 312.34. Should changes be made to compassionate use policies in light of this case? In a new BioWorld Today and Medical Device Daily audio briefing, clinical trial expert attorney Clint Hermes will examine the latest developments in

BioWorld Today Washington Editor WASHINGTON — Market competition is preferable for holding down costs of medications to that of opening up the U.S. borders to importation of drugs from Canada and other foreign nations or imposing price controls, like is done in Europe, said Rep. Henry Waxman (D-Calif.). Generic drugs, he argued, have played an essential role in promoting competition and stimulating innovation in the pharmaceutical industry, while at the same time lowering the nation's health

BioWorld Executive Editor Editor's Note: The following article is compiled from The BioWorld Genomics Technologies Report: Advances and Challenges in RNAi, Stem Cells and Synthetic Biology. This report provides a comprehensive analysis of the markets that are at the forefront of emerging R&D today and likely to be among society s most essential dynamics in the future. The Next-Big-Thing in biotechnology circles, more than a decade in the making, may be just about ready to make the transition

BioWorld Sourcebook Editor Editor's Note: The following article is compiled from The BioWorld Genomics Technologies Report: Advances and Challenges in RNAi, Stem Cells and Synthetic Biology. This report provides a comprehensive analysis of the markets that are at the forefront of emerging R&D today and likely to be among society s most essential dynamics in the future. Gene silencing with RNAi in humans is a relatively new science breakthrough, reaching back to 2001. It was originally a

BioWorld Today Staff Writer Less than three months after selling preclinical hemophilia drug MAXY-VII to Bayer HealthCare in a deal worth up to $120 million, Maxygen Inc. is at it again. This time, the Redwood City, Calif.-based biotech signed a potential $170 million partnership with Tokyo-based Astellas Pharma Inc. for preclinical autoimmune and transplant drug MAXY-4. All of Maxygen's drugs seek to improve existing biologics, and MAXY-4 is no exception. The CTLA4-Ig protein is similar to

BioWorld Executive Editor Editor's Note: The following is Part I of a two-part series. If you don't already receive it each week, opt-in for free to BioWorld Perspectives to receive Part II of this column, "The Impact of Big Pharma on the BioPartnering Industry," coming in a future edition. BioWorld's 2008 biopartnering report began with the statement that "The next-big thing ... is not a drug." In it, I suggested that it was the deal, not the drug, that was assisting the biotech industry in

BioWorld Perspectives Contributing Writer Editor's note: David Jensen is the publisher of the California Stem Cell Report and has written more than 1,700 items involving CIRM since 2005. California wants to help biotech enterprises navigate through the industry's famed financial "valley of death" with a $500 million loan program. It comes at a good time for the bio biz. Money is tight, but in the Golden State, one agency has $3 billion to spread around for research and clinical trials. The

A 510(k) submission is supposed to be a straightforward procedure. Increasingly, however, the FDA is asking for more evidence, and sometimes more than that to which it is entitled under the substantial equivalence standard. With the increase in agency requests, the process is becoming "PMA Lite." In this 90-minute audio conference, device submissions expert Mark DuVal will discuss what FDA is asking for in 510(k) submissions, and how you can effectively respond to FDA's ever increasing demands

BioWorld Today Assistant Managing Editor A day before the release of highly anticipated detailed risk-benefit data for osteoporosis drug denosumab, Amgen Inc. said it was divesting three marketed products to Swedish specialty pharma firm Biovitrum AB in exchange for $130 million up front, plus potential sales milestones and royalties down the road. Terms of the deal, set to close by the end of this year, call for Biovitrum to acquire marketed biologics Kepivance and Stemgen and pick up an

BioWorld Today Washington Editor Although Monday was a gloomy day for Wall Street, three drugmakers - ProStrakan Group plc, UCB SA and Merck & Co. - had reason to celebrate after gaining FDA approvals of their products. However, Frazer, Pa.-based Cephalon Inc. was not so fortunate, instead receiving a complete response from the agency stating it would not approve an expanded indication of Fentora (fentanyl buccal tablet) until the company implements and demonstrates effectiveness of its risk

BioWorld Today Staff Writer Editor's note: For more insight into the history, statistics and forecasts of the emerging biofuels market, check out The BioWorld Biofuels Report 2008: Economics of a Driven Market. Investment in biofuels declined last year, but the market is growing rapidly. In 2006, biofuels was the highest funded cleantech sector, receiving $462 million, according to the MoneyTree Report from PricewaterhouseCoopers and the National Venture Capital Association (NVCA). Last year

BioWorld Executive Editor Editor's note: For more insight into the history, statistics and forecasts of the emerging biofuels market, check out The BioWorld Biofuels Report 2008: Economics of a Driven Market. Every administration for a generation, beginning with President Richard Nixon during the 1973 oil embargo, has pushed through some gasoline-alternative initiatives, but all have generally fallen short on delivering on promises to free the nation from oil dependence. Beginning with the

Image Cranky commentary by Cynthia Robbins-Roth Hey, If They Don't Like Your Product, Play the 'Death' Card Reuters reports that the unfortunately named Thomas Lumpkin, head of the International Maize and Wheat Improvement Center, of Texcoco, Mxico, has decided to take a tough line with those slackers in Europe and Japan who are less than enthusiastic about embracing biotech wheat. "By denying them" — you know, those starving folks — "this technology, you are keeping them hungry, [and] they

BioWorld Perspectives Contributing Writer Editor's note: Rhona Allison is senior director of life sciences at Scottish Enterprise. For more information about relocation, you can download the BioWorld Expansion and Relocation Guide for free here. The guide covers booming biotech hubs in California, Maryland, Massachusetts, Georgia and other states, as well as Italy and France. As the demand for innovation in today's life sciences sector increases, many of the world's leading pharmaceutical and

BioWorld Today Staff Writer Biodel Inc. said that two Phase III trials of diabetes treatment VIAject met the studies' objective of noninferiority to Eli Lilly and Co.'s Humulin insulin injection, but Wall Street seemed leery of the results because data from India were excluded. Shares in the Danbury, Conn.-based company tumbled nearly 70 percent in light of the India data from a Type I diabetes trial, which differed from data at the other study sites in the U.S. and Germany. Gerard Michel

BioWorld Today Washington Editor WASHINGTON — While the National Institutes of Health (NIH) appears to be well on its way of fulfilling mandates imposed under reform legislation passed by Congress two years ago, the unpredictability of funding for the agency puts its reorganization plan and future in peril, NIH's director told lawmakers Tuesday. Congress passed legislation in 2006, enacted in January 2007, intended to reorganize and reauthorize funding for the NIH, an agency composed of 27