As BioWorld Insight readers know, our “Word on the Street” column provides a sample of the most entertaining and thought-provoking quotes our staff stumbles upon each week. Some are gathered during interviews, some gleaned from analyst reports, and some overheard at conferences. As we kick off 2012, here’s a look back at some of the quotes that defined 2011:   On Business “Biotech is all about picking the exception. Granting access to capital to everyone doesn’t strike me as the right idea.” ? Bob More, general partner with Frazier Healthcare Ventures, taking an optimistic view on capital constraints. Private biotechs...

The past year brought the biotech sector a mixed bag of news. Some of it was positive – for instance, the FDA picked up its drug approval pace in 2011 and, in some cases, even surprised the most hardened biotech investors by granting approval of some drugs a month or two before their PDUFA dates – while other headlines hailed discouraging trends such as the failure of Prospect Ventures to close its latest round, confirming predictions of a venture capital contraction. As we get ready to head into 2012 (and possibly an apocalyptic count-down, if those Mayans are to...

The evidence on evidence-based medicine speaks for itself. The approach is a vast improvement over everything that came before, and over current rival approaches. It’s often enough to give its practitioners a bit of hubris –which is why it’s so important to remember that evidence-based medicine can’t tell us everything we want to know, either. Possible pitfalls and limitations of evidence-based medicine were on stark display at a press conference of the American Society of Hematology last week, where not one, but two studies reported results that were the opposite of what one might suspect from looking at one part...

An FDA advisory committee this week gave a half-hearted vote of approval – 9-8, with two abstentions – for Alexza Pharmaceuticals Inc.’s Adasuve (Staccato loxapine). But the vote was conditioned on limiting the inhaled antipsychotic to one dose per day and imposing a much stiffer REMS than what the company had proposed. While Alexza didn’t feel that much love from the Psychopharmacologic Drugs Advisory Committee (PDAC), it did get enough to bolster its flailing shares and keep hope alive for FDA approval come the Feb. 4 PDUFA date. A day after the lackluster committee performance, Alexza (NASDAQ:ALXA) hit $1, a...

While all you biotechs out there scramble to meet your end-of-year milestones, BioWorld would like to announce a little milestone of our own. That’s right, this is our fifth annual biotech holiday gift guide. To celebrate five years of excellent gift recommendations for every biotechie on your list – be they scientist, fashionista, bibliophile, new parent, Wall Street exec, traveler, or anyone else – we’re bringing you a Top 10 list of our staff’s all-time favorites. So without further ado: 10. Ever wanted to wash yourself with E. Coli or S. Enteritidis? Now you can, with Petri Dish Soaps, a...

Stem cell therapies may be relatively early stage, but that hasn’t stopped their developers from giving some serious thought to late stage issues like reimbursement and health economics. At the recent 2011 Stem Cell Meeting on the Mesa, panelists debated how careful consideration of such issues might help them avoid following in the footsteps of Dendreon Corp. First hailed as a front-runner of the cell therapy field for getting FDA approval of prostate cancer vaccine Provenge (sipuleucel-T), Dendreon has since become the red-headed stepchild of many analysts and investors due to its failure to gain commercial traction for the product....

It seems to me that an increasing number of start-ups have been boot-strapping their way through preclinical without venture capital lately. I have no quantitative data to back this up. But it’s a feeling I had earlier this year, too, as we reported on some big non-VC start-up rounds, like Ascletis Inc.’s $100 million raised largely from high net worth investors in China, and Acetylon Pharmaceuticals Inc.’s $27 million Series B round raised in $1 million chunks from private individuals. We even made this subject the topic of BioWorld’s BIO 2011 panel. The trend appears to be continuing. Avaxia Biologics...

The biotech industry has long known it’s getting harder and harder for a small company to go public. As John Craighead, managing director of investor relations and business development for the Biotechnology Industry Organization, said during a recent conference, about two-thirds of the biotech initial public offerings (IPO) in 2000 were preclinical. Today however, even clinical-stage firms struggle to get public. With the exception of last week’s pricing by Clovis Oncology Inc., every biotech IPO this year has taken a haircut on price. Small biotechs are not the only ones suffering. At an SEC forum on small company capital formation...

In last week’s issue of BioWorld Insight, our esteemed Washington editor Mari Serebrov wrote an article titled, “Shorter Exclusivity Could Carry a Hefty Price Tag.” In it, she quoted sources who are very concerned that reducing the current 12-year exclusivity for innovator biologics to seven years, as the president and a number of lawmakers have proposed, would be bad news for patients, payers and drug makers. In the article, Mary Webster, a patent attorney with Nixon Peabody, said: "If you can't corner your market and recoup your costs, are you going to do it?" And suddenly I had a flashback...

No, that’s not a typo. I’m feeling optimistic about fundraising opportunities for small biotechs. Yes, I know we’re seeing venture firms pull back on an almost weekly basis (Prospect Ventures, Scale Venture Partners, etc.). And yes, I know the NVCA said VCs are fleeing life sciences. And yes, I know the initial public offering (IPO) window remains dubious at best. BUT . . . there are some really interesting new options making their way through Congress, as anyone who read either BioWorld Insight or BioWorld Today on Monday already knows. For everyone else, here’s the low-down: H.R. 1070 ? would...