Dendreon Files Provenge Application to FDA Ahead of Schedule, Now It’s Time to Wait

Seattle-based Dendreon said today it has completed all the necessary paperwork for its lead drug candidate, and handed over the amended application for approval to the FDA. The company had told investors to expect this milestone by “mid-November,” so this application came in a few days or even a few weeks ahead of schedule. Investors … Continue reading “Dendreon Files Provenge Application to FDA Ahead of Schedule, Now It’s Time to Wait”

Pulmatrix Scores $30M To Block All Sorts of Bugs That Make People Sick in the Lungs

Pulmatrix, the Lexington, MA-based company working to stop infectious bugs from being absorbed into the lungs, has raised $30.2 million in a Series B venture round to advance its unorthodox method for treating and preventing respiratory diseases like flu, the company is announcing today. Arch Venture Partners and Novartis Bioventures Fund co-led the new financing, … Continue reading “Pulmatrix Scores $30M To Block All Sorts of Bugs That Make People Sick in the Lungs”

QuantumCor Sees Future of Heart Failure Treatment in No Device Left Behind

The leading edge of innovation in medical devices is often concentrated on nifty implantable tools that a doctor can insert without a scalpel, as a less-invasive alternative to surgery. But now we’re seeing more startups, like Bothell, WA-based QuantumCor, designing devices to fix what’s broken in the body without even leaving any sort of implant … Continue reading “QuantumCor Sees Future of Heart Failure Treatment in No Device Left Behind”

Amylin Strikes $1 Billion Deal with Takeda to Co-Develop Weight Loss Drugs

San Diego-based Amylin Pharmaceuticals, the dark horse in the race to develop a new breed of weight-loss drugs, has struck a partnership with Japan-based Takeda Pharmaceuticals that could be worth more than $1 billion over time if the drug reaches certain goals in development and in the marketplace. The agreement calls for Amylin (NASDAQ: [[ticker:AMLN]]) … Continue reading “Amylin Strikes $1 Billion Deal with Takeda to Co-Develop Weight Loss Drugs”

Vertex Hepatitis C Drug Passes Key Test With More Convenient, Twice-Daily Dose

Vertex Pharmaceuticals wants to make sure doctors walk away from this weekend’s big liver disease research meeting with two main ideas stuck in their heads. No. 1—The company’s experimental drug is showing that it can cure even the toughest-to-treat patients with hepatitis C. No. 2—it may work just as well in a twice-daily dose as … Continue reading “Vertex Hepatitis C Drug Passes Key Test With More Convenient, Twice-Daily Dose”

Amylin, Lilly’s Byetta Wins FDA Approval as Standalone Therapy, Without Combo Drugs

San Diego-based Amylin Pharmaceuticals (NASDAQ: [[ticker:AMLN]]) and its partner Eli Lilly got some positive news late Friday from the FDA. The agency now says the companies have clearance to market exenatide (Byetta) as a standalone therapy for diabetes, which means doctors won’t need to combine it  with other common drugs, or hold it in reserve … Continue reading “Amylin, Lilly’s Byetta Wins FDA Approval as Standalone Therapy, Without Combo Drugs”

Cequent Pharmaceuticals, With First Oral RNAi Drug Soon to Enter Humans, Raises $3.4M

[Update: 7:15 pm Eastern, 10/30/09] Cambridge, MA-based Cequent Pharmaceuticals, one of the many aspiring firms in the field of RNA interference drug technology, has raised $3.35 million in equity in the first tranche of a venture round that could be worth as much as $15 million, according to CEO Peter Parker. A regulatory filing released … Continue reading “Cequent Pharmaceuticals, With First Oral RNAi Drug Soon to Enter Humans, Raises $3.4M”

Idenix Shares Drop as Novartis Walks Away From Hepatitis C Drug

Shares of Cambridge, MA-based Idenix Pharmaceuticals plummeted in early trading this morning after Novartis declined an option to further develop an Idenix drug for the liver disease hepatitis C. Idenix (NASDAQ: [[ticker:IDIX]]) dropped 14 percent to $2.15 shortly after the opening bell this morning after the announcement, and the stock was downgraded by the investment … Continue reading “Idenix Shares Drop as Novartis Walks Away From Hepatitis C Drug”

Cleantechies Schmooze With the Gov, Compete for Cash as Three Regional Finalists Go National

Money may be tight for aspiring cleantech entrepreneurs in a downturn, but they got a little cash and some precious attention for their ideas last night. Gov. Chris Gregoire showed up to mingle at the ACT Theatre in Seattle with about a dozen entrepreneurial semi-finalists who were gathered to compete at the first Clean Tech … Continue reading “Cleantechies Schmooze With the Gov, Compete for Cash as Three Regional Finalists Go National”

Excaliard, an Isis Spinoff With Anti-Scarring Drug, Marches Ahead in Clinical Trials

Isis Pharmaceuticals (NASDAQ: [[ticker:ISIS]]) likes to talk about how its gene-silencing technology known as antisense creates so many innovative ideas for new drugs that it can’t commercialize them all itself, so it spins a few off into what CEO Stanley Crooke calls “satellite companies.” One of the more interesting ideas orbiting around Isis in Carlsbad, … Continue reading “Excaliard, an Isis Spinoff With Anti-Scarring Drug, Marches Ahead in Clinical Trials”

ZymoGenetics Rival Emerges, Omeros IPO Casts Shadow, Microsoft’s HealthVault Seeks Users, & More Seattle Area Life Sciences News

We had a little something for everybody on the life sciences beat this week, with news on biopharmaceuticals, devices, and healthcare software. —Seattle-based Omeros (NASDAQ: [[ticker:OMER]]) had potential to be a bellwether for the U.S. biotech sector earlier this month, as the first true biopharmaceutical company to go public since February 2008. But its stock … Continue reading “ZymoGenetics Rival Emerges, Omeros IPO Casts Shadow, Microsoft’s HealthVault Seeks Users, & More Seattle Area Life Sciences News”

Stryker Biotech Division Indicted for FDA Fraud by Massachusetts Grand Jury

Stryker, the Kalamazoo, MI-based maker of orthopedic hip implants and other medical devices, said today that its biotech division in Hopkinton, MA, along with certain current and former employees, have been indicted by a federal grand jury for conspiracy to defraud the FDA. The company (NYSE: [[ticker:SYK]]) disclosed on March 10 that its Stryker Biotech … Continue reading “Stryker Biotech Division Indicted for FDA Fraud by Massachusetts Grand Jury”

Vertex Hepatitis C Drug Wipes Out Virus For Toughest-to-Treat Patients

Vertex Pharmaceuticals (NASDAQ: [[ticker:VRTX]]) is vying to set a new standard of care for hepatitis C in some of the toughest patients to treat, and today it is reporting some surprisingly strong evidence that suggests the drug is working like researchers hoped it would over the long haul. The Cambridge, MA-based biotech company offered an … Continue reading “Vertex Hepatitis C Drug Wipes Out Virus For Toughest-to-Treat Patients”

Sequel Pharmaceuticals’ CEO on How to Start a Biotech and Sell it For a Bundle, and Repeat

I’ve heard about serial entrepreneurs who start a company, build it up to a certain point, sell it to someone bigger, and then repeat the whole cycle again. But I had never heard of a true biotech sequel until I met Randall Woods a couple weeks ago. Woods is the CEO of San Diego-based Sequel … Continue reading “Sequel Pharmaceuticals’ CEO on How to Start a Biotech and Sell it For a Bundle, and Repeat”

Helixis, Caltech Spinoff With Desktop Genetic Analysis Tool, Nabs $7.3M Venture Financing

Carlsbad, CA-based Helixis, the startup maker of genetic analysis tools founded from the Caltech lab of Nobel Laureate David Baltimore, has raised $7.3 million out of a venture capital round potentially worth $10 million, according to a regulatory filing today. Helixis reported back in July that it had raised $5.5 million, so today’s filing is … Continue reading “Helixis, Caltech Spinoff With Desktop Genetic Analysis Tool, Nabs $7.3M Venture Financing”

Ligand Buys Metabasis For $3.2M

San Diego-based Ligand Pharmaceuticals (NASDAQ: [[ticker:LGND]]) said today it has agreed to pay $3.2 million to acquire Metabasis (NASDAQ: [[ticker:MBRX]]), the developer of treatments for diabetes and high cholesterol. Ligand has also committed $8 million to finance Metabasis’ drug development programs within the next 42 months. The sale comes after a rough year for Metabasis, … Continue reading “Ligand Buys Metabasis For $3.2M”

Zymo Gets $70M for Starting Trial

Seattle-based ZymoGenetics (NASDAQ: [[ticker:ZGEN]]) will receive a $70 million milestone payment from its partner, Bristol-Myers Squibb, for starting a mid-stage clinical trial of pegylated interferon lambda for hepatitis C, according to a statement. The trial, called Emerge, will initially enroll 50 patients on a variety of doses, then expand to 500 patients who are randomly … Continue reading “Zymo Gets $70M for Starting Trial”

Why is Pharma Betting So Big on Innovation in Boston?

What type of drugs have the greatest potential to fill the void in Big Pharma company pipelines, as the industry barrels toward the well-documented patent expiration crisis of coming years? What are the best techniques pharma companies can use to stimulate innovation at smaller biotech companies? How can drugmakers raise the odds of success in … Continue reading “Why is Pharma Betting So Big on Innovation in Boston?”

Omeros, Worst Performing IPO of 2009, Casts Shadow Over Other Aspiring Biotechs

Seattle-based Omeros is the worst performing initial public offering so far in 2009, and its 36 percent decline in the first two weeks as a public company has cast a shadow over other life sciences companies that may be itching to take the leap. Omeros (NASDAQ: [[ticker:OMER]]) closed at $6.45 a share yesterday, a steep … Continue reading “Omeros, Worst Performing IPO of 2009, Casts Shadow Over Other Aspiring Biotechs”

Arena Positions Weight Loss Drug as the One That Won’t Raise Your Blood Pressure

Life would be wonderful at Arena Pharmaceuticals if it truly were the biggest loser, to borrow a phrase from the NBC reality TV show on people who are trying to lose weight. But no matter how hard you look at it, the clinical trial data just doesn’t say Arena’s weight loss pill that helps people … Continue reading “Arena Positions Weight Loss Drug as the One That Won’t Raise Your Blood Pressure”

Infinia, Backed by Paul Allen and Vinod Khosla, Raises $3M For Engines of the Sun

Infinia, the Kennewick, WA-based company developing solar-powered engines that generate electricity, has raised $3.25 million in new debt financing as it pushes through the final year before it starts selling its product on the market. The company raised $3.25 million in debt and options out of a total financing round worth as much as $10.5 … Continue reading “Infinia, Backed by Paul Allen and Vinod Khosla, Raises $3M For Engines of the Sun”

ZymoGenetics’ Former Medical Boss Leads Rival Startup, ProFibrix, With Drug For Bleeding

One of the key people who transformed ZymoGenetics from a basic research institute into a more balanced biotech company with both R and D, has set up shop in a rival startup just a few blocks away on Seattle’s Eastlake Avenue. If he plays his cards right, this little company will surpass his former employer, … Continue reading “ZymoGenetics’ Former Medical Boss Leads Rival Startup, ProFibrix, With Drug For Bleeding”

Burnham Recruits Michael Jackson (No Relation) To Create New Drugs

The Burnham Institute for Medical Research just recruited a big name guy from the pharmaceutical industry. His job is to move basic discoveries along the treacherous next few steps to make them into a pill in a bottle that helps patients. It’s important work, but if you don’t know him, don’t even bother trying to … Continue reading “Burnham Recruits Michael Jackson (No Relation) To Create New Drugs”

Biogen Shares Drop as Tysabri PML Cases Climb to 23, Europe May Seek Drug ‘Holiday’

[Update: 10/23/09, 1:10 pm Eastern] Shares of Biogen Idec and its Irish partner Elan dropped this morning after European regulators said they are taking a new look at the risk and benefit of natalizumab (Tysabri) for multiple sclerosis, now that 23 patients on the drug have been diagnosed with a rare, potentially fatal brain infection … Continue reading “Biogen Shares Drop as Tysabri PML Cases Climb to 23, Europe May Seek Drug ‘Holiday’”

Nuclea Nabs $3.4M Deal

Nuclea Biotechnologies, the Pittsfield, MA-based developer of genomic tests for cancer research, has raised $3.4 million in new equity financing, according to a regulatory filing. The company, which says on its website that it has collaborations with the Dana-Farber Cancer Institute in Boston and the Johns Hopkins School of Medicine in Baltimore, is seeking to … Continue reading “Nuclea Nabs $3.4M Deal”

Five Red Flags of a Biotech, Pathway Medical Learns Lessons, Amgen Faces FDA Delay, & More Seattle-Area Life Sciences News

This week we were jamming on our big event on the 20-year outlook for Seattle’s life sciences hub, but we still found a way to squeeze in a lot of news and features. —Biotech pioneer Chris Henney offered an insightful and entertaining talk about how to invest in biotech at a recent speech before the … Continue reading “Five Red Flags of a Biotech, Pathway Medical Learns Lessons, Amgen Faces FDA Delay, & More Seattle-Area Life Sciences News”

Burnham Hires Paul Laikind

The La Jolla, CA-based Burnham Institute for Medical Research said it has hired Paul Laikind, the co-founder of Gensia Pharmaceuticals, Viagene, and Metabasis, to be the institute’s senior vice president of business development and chief business officer. The hiring is a sign of the Burnham’s increasing emphasis on spinning out technologies, and forming deals with … Continue reading “Burnham Hires Paul Laikind”

Antigenics Shares Plummet as Cancer Vaccine Application Rejected in Europe

Antigenics, the Lexington, MA-based developer of a personalized treatment to stimulate the immune system to fight cancer, saw its shares plummet today after a European regulatory commission told the company that its lead drug candidate isn’t ready for the marketplace. Shares of Antigenics (NASDAQ: [[ticker:AGEN]]) dropped 40 percent to $1.25 at noon Eastern time after … Continue reading “Antigenics Shares Plummet as Cancer Vaccine Application Rejected in Europe”

Seattle Biotech Needs More Bars, Less University Red Tape, and the Same Daring Attitude, & Other Highlights from Seattle Life Sciences 2029

Seattle has more than its share of brilliant biologists for a medium-sized American city. But if people and ideas are going to properly mix to create a thriving local biotech industry over the next two decades, we could use a few more common places with intellectual sparks—like bars. At least according to one of the … Continue reading “Seattle Biotech Needs More Bars, Less University Red Tape, and the Same Daring Attitude, & Other Highlights from Seattle Life Sciences 2029”

Isis CEO Vows that Cholesterol Drug, Partnered With Genzyme, Will be “Remarkable” Advance

Isis Pharmaceuticals CEO Stanley Crooke is a man who knows how to make a grand gesture. The market may have been underwhelmed by what Isis and its partner, Genzyme, had to say about their first-of-a-kind cholesterol-lowering drug back in May, but to him that just means they’re missing the point. When I stopped by to … Continue reading “Isis CEO Vows that Cholesterol Drug, Partnered With Genzyme, Will be “Remarkable” Advance”

Seattle Life Sciences 2029 Photo Gallery

Thanks to everyone who made last night’s Xconomy event on Seattle’s 20-year outlook for life sciences such a big success. The house was packed at Seattle Biomedical Research Institute; we had a highly interactive conversation between the audience and a distinguished panel, and brief introductions to some of the most exciting life sciences startups in … Continue reading “Seattle Life Sciences 2029 Photo Gallery”

Pathway Medical Learns Lessons During Tougher Than Expected First Year on Market

Kirkland, WA-based Pathway Medical Technologies has to be considered one of the bright spots in the recent history of Seattle life sciences. The medical device maker won FDA approval for its first product about 15 months ago, raised $42 million in venture capital, and recruited a CEO with loads of experience in commercializing medical devices. … Continue reading “Pathway Medical Learns Lessons During Tougher Than Expected First Year on Market”

See You Tonight at Seattle Life Sciences 2029

I still have one more feature story I hope to bang out this afternoon, but the Xconomy team will soon be heading over to Seattle Biomedical Research Institute tonight for our big event on the 20-year outlook for the Northwest’s life sciences cluster. This sold-out event will bring together some of the world’s leading life … Continue reading “See You Tonight at Seattle Life Sciences 2029”

Augmenix Snags $6.1M

Waltham, MA-based Augmenix, the maker of implantable material to minimize the side effects of radiation therapy, said today it has closed a Series B round of financing worth $6.1 million. Ascension Health Ventures led the round, and was joined by Versant Ventures, Pinnacle Ventures, Catalyst Health Ventures, and several private investors, the company said. The … Continue reading “Augmenix Snags $6.1M”

Hydra, Cubist Seek New Pain Drugs

Cambridge, MA-based Hydra Biosciences said today it has formed a partnership with Lexington, MA-based Cubist Pharmaceuticals (NASDAQ: [[ticker:CBST]]) to develop new pain medications. Hydra will receive $5 million upfront, plus another $5 million annually for two years to support Hydra’s R&D, with an option to renew the partnership. The deal focuses on Hydra’s work on … Continue reading “Hydra, Cubist Seek New Pain Drugs”

Amgen’s Dmab Faces FDA Delay

Amgen, the world’s largest biotech company, said today that the FDA has delayed its application to market denosumab (Prolia) for treatment of osteoporosis. The FDA requested that Amgen (NASDAQ: [[ticker:AMGN]]) include a risk evaluation and mitigation strategy, and more information on the company’s safety surveillance plan for when the drug is on the market. The … Continue reading “Amgen’s Dmab Faces FDA Delay”

Calistoga Cancer Drug Shows “Encouraging” Preliminary Results in Small Study

Seattle-based Calistoga Pharmaceuticals has taken another peek at preliminary results from an ongoing clinical trial of its drug that’s made to block one of the hottest targets in cancer biology, and it continues to like what it’s seeing. Researchers saw that five of 17 evaluable patients (29 percent) with chronic lymphocytic leukemia had at least … Continue reading “Calistoga Cancer Drug Shows “Encouraging” Preliminary Results in Small Study”

Faster, Cheaper Stem Cells: Fate Therapeutics Co-Founder, With Scripps Team, Finds Key

One of the scientific co-founders of San Diego-based Fate Therapeutics, along with his team at The Scripps Research Institute, is reporting a major advance that will make it faster, cheaper, and potentially practical on an industrial scale to turn adult cells into stem cells that can morph into any type of cell in the human … Continue reading “Faster, Cheaper Stem Cells: Fate Therapeutics Co-Founder, With Scripps Team, Finds Key”

Flexion Therapeutics Gets $33M For Faster, Cheaper Drug Development

[Update: 10/16/09, 3:18 pm Eastern] Flexion Therapeutics, the Woburn, MA-based company that seeks to reduce the time and expense of drug development’s risky early steps, has raised $33 million in a Series A venture round, according to a statement. Earlier in the day, we reported the deal was for $20 million, out of a potential … Continue reading “Flexion Therapeutics Gets $33M For Faster, Cheaper Drug Development”

Bellevue-based AudienceScience Gets $15M Financing Deal For Targeted Digital Advertising

AudienceScience, the Bellevue, WA-based company that helps advertisers connect with targeted audiences online, has pulled in about $4 million in new equity financing as part of a total deal worth $15.1 million, according to a regulatory filing. The new cash infusion is actually only one component of the transaction, which includes $10.8 million worth of … Continue reading “Bellevue-based AudienceScience Gets $15M Financing Deal For Targeted Digital Advertising”

Dendreon Recruits Aces to Board, Amgen Seeks to Raise Hit Rate, Lee Hood Startup Gets $30M, & More Seattle-Area Life Sciences News

The news has been breaking fast and furious here at Xconomy, just as we are putting the finishing touches on a terrific event on Monday that will explore the 20-year outlook for the Seattle region as a life sciences hub. —Xconomy dug up an exclusive late Friday afternoon from a couple SEC filings that showed … Continue reading “Dendreon Recruits Aces to Board, Amgen Seeks to Raise Hit Rate, Lee Hood Startup Gets $30M, & More Seattle-Area Life Sciences News”

Six Red Flags to Watch Out For in a Biotech, From Dendreon Co-Founder Chris Henney

Yesterday, we provided a rundown of the six hallmarks of a successful biotech company, according to Christopher Henney, the biotech pioneer who co-founded three of Seattle’s top biotechs—Immunex, Icos, and Dendreon. He made his remarks to an audience of about 100 investing professionals at the CFA Society meeting on Oct. 8 in Seattle. Today, we … Continue reading “Six Red Flags to Watch Out For in a Biotech, From Dendreon Co-Founder Chris Henney”

The 20-Year Future for Seattle Biotech, As Told By Industry Visionaries, Coming Monday

What is the single best thing that has happened in Seattle life sciences in the past five years? How might that make a difference over the next two decades as this region strives to become a more vibrant cluster for life sciences innovation? These are the kinds of questions you don’t see explored much in … Continue reading “The 20-Year Future for Seattle Biotech, As Told By Industry Visionaries, Coming Monday”

Lee Hood’s New Company Snags $30M to Spot Cancer and Alzheimer’s in Early Days

Lee Hood, the legendary researcher and entrepreneur who invented machines that made the Human Genome Project possible, has secured $30 million in venture capital for a startup that aims to detect cancer and neurodegenerative diseases like Alzheimer’s in their earliest and most treatable stages. The new company is called Integrated Diagnostics, or InDi for short … Continue reading “Lee Hood’s New Company Snags $30M to Spot Cancer and Alzheimer’s in Early Days”

Six Tips on How to Spot a Winning Biotech, From Dendreon Co-Founder Chris Henney

Investing in biotech can be scary. Only one out of 10 new drug candidates ever makes it through the gauntlet of clinical trials to become an FDA approved product, and it usually takes hundreds of millions of dollars and a decade or more of research to separate the winners from the losers. Investors usually can’t … Continue reading “Six Tips on How to Spot a Winning Biotech, From Dendreon Co-Founder Chris Henney”