New England’s life sciences companies headed into the holiday break with mostly good news.

—Syndax Pharmaceuticals reported results from a mid-stage clinical trial which suggest that its lead drug, entinostat, might help lung certain cancer patients with a particular molecular marker live longer. The Waltham, MA-based startup, co-founded by researchers from the Salk Institute for Biological Studies in 2005, will have to confirm the results in future studies. The company is also testing the drug’s effectiveness as a breast-cancer treatment.

—Semprus BioSciences, an MIT spinoff based in Cambridge, MA, raised $18 million in Series B equity financing. New investors SR One and Foundation Medical Partners led the deal and return backers 5AM Ventures and Pangaea Ventures joined in, bringing Semprus’ total equity financing to $28.5 million.

—The drawn-out saga of Sanofi-Aventis’ attempt to buy out Cambridge-based Genzyme (NASDAQ:GENZ) was drawn out a bit farther, when the French drug giant extended the deadline for its tender offer for Genzyme stock until January 21. Sanofi is offering $69 per share, or $18.5 billion total, for Genzyme, which thinks the price is too low. Shareholders are betting that the bids will continue to go higher, as Genzyme stock closed yesterday at $69.87.

—The Defense Advanced Research Projects Agency (DARPA) made a $5.7 million grant to Lexington, MA-based Pulmatrix to fund development of an inhaled therapy that could treat and prevent lung infections caused by naturally occurring microbes and bioweapons. Pulmatrix’s dry-powder technology, which originated at MIT and Harvard, is also under development to address respiratory ailments such as asthma and chronic obstructive pulmonary disease.

—Lebanon, NH-based Adimab announced that Genentech, Eli Lilly (NYSE:LLY), and Human Genome Sciences (NASDAQ:HGSI) have joined the roster of pharma companies using its technology for discovering antibody-based drugs. The new agreements bring Adimab’s number of antibody discovery partnerships to a whopping 15.

—Cardiac pump maker HeartWare International (NASDAQ:HTWR) of Framingham, MA, raised $143.8 million in a public offering of convertible notes.

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For those of you who, like me, wonder why the cost of getting a drug to market continues to grow each year, here’s what may be a piece of the puzzle: It’s getting harder to do clinical studies.

A report released this morning by the Tufts Center for the Study of Drug Development describes how clinical trials are getting more complex and harder to execute, and how it’s becoming more difficult to recruit and retain patients in these studies.

The report is a follow-up to a 2007 analysis performed by the center. The study looked at over 8,000 protocols from more than 75 pharmaceutical and biotechnology companies.

The report found, among other things, that the median number of procedures in a clinical trial increased by 49 percent, comparing the period of 2000-2003 with 2004-2007. Reflecting the rising complexity of trials, the number of eligibility criteria for entering patients into a study grew by 58 percent over that time, causing fewer patients to enroll in trials (enrollment rates fell 21 percent). Not only that, but it was harder to keep patients in studies because of the large number of procedures, the report said.

The Tufts researchers also found that between 2002 and 2007 trials in oncology, immunology, and central nervous systems indications saw the biggest rise in procedures per trial.

Kenneth Kaitin, director of the center, says the increasing complexity comes from a number of factors, chief among them that the types of products being developed today tend to be geared towards more chronic and challenging indications. “Therefore the trials tend to be more complex,” he says.

The report, however, did not correlate the rise in complexity with any cost figures. How much does an average phase II trial cost today compared to, say, five years ago? How have the costs of a phase III or phase IV study changed? Dr. Kaitin says that as far as he knows there are no studies out there with those kinds of figures. There is an explanation, though: Companies are not very eager to share these numbers. Still, he says he strongly believes the overall increase in complexity goes hand in hand with higher costs.

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Another week, another cadre of CEOs with big plans for growing their New England life sciences companies even bigger.

—Diagnostics For All CEO Una Ryan talked about her multi-pronged effort to raise money for testing and deployment of her Cambridge, MA-based firm’s affordable diagnostic technology. Developed in the legendary Harvard lab of chemist George Whitesides, the nonprofit’s paper-based, postage stamp-sized devices could begin helping patients in developing countries with HIV/AIDS and other ailments by year’s end, if Ryan has her way.

—Vertex Chief Medical Officer Bob Kauffman told Luke about the biotech’s to develop a drug cocktail to fight hepatitis C virus while avoiding the flu-like symptoms of standard treatments for the infection. Vertex (NASDAQ: VRTX) is poised to begin clinical testing of one such cocktail, which includes its experimental drug telaprevir, even as it pursues approval for telaprevir for use with standard hepatitis drugs—a milestone the company hopes to reach sometime in 2011.

—Cambridge-based Biogen Idec (NASDAQ: BIIB) and its Swiss partner Roche reportedly halted development of ocrelizumab, an experimental drug for rheumatoid arthritis, because of safety concerns. Bloomberg News reported that the drug is still being tested for multiple sclerosis.

—Bob Weiler, chairman and CEO of Waltham, MA-based health IT pioneer Phase Forward (NASDAQ:PFWD) told Ryan about his company’s strategy for maintaining its decade-long growth spurt. Having started out by convincing drug companies to switch from paper records to software for collecting and managing data in clinical trials, Phase Forward is making a series of acquisitions to build up a suite of software products that automate everything from the early clinical development to post-marketing safety studies.

—Swiss pharmaceutical behemoth Novartis signed up to back an online community for organ transplant recipients hosted by Cambridge-based social networking site PatientsLikeMe. Novartis, which has a large R&D organization in Cambridge, previously tapped PatientsLikeMe for information about patients with multiple sclerosis.

—The FDA said it intends to reveal today whether it has approved a once-a-week diabetes drug from Waltham, MA-based Alkermes (NASDAQ: AMLN) and San Diego-based Amylin Pharmaceuticals (NASDAQ: AMLN). Alkermes stands to collect a 7.5 percent royalty on worldwide sales of the drug, an version of exenatide (Byetta) that can be injected just once a week, instead of twice a day.

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I’ve got a couple weeks’ worth of New England life sciences news to catch you up on, so let’s dive in.

—Shares of Watertown, MA-based pSivida (NASDAQ: PSDV) jumped more than 50 percent after the company reported its treatment for diabetic macular edema, an eye disorder, did well in a clinical trial. The treatment employs an implant that is placed in the back of the eye and releases a steady dose of the corticosteroid drug fluocinolone acetonide.

—Ryan caught up with Bill Sims, the CEO of Cambridge, MA-based Joule Biotechnologies, which is out to produce fuels and chemicals with a process that mimics photosynthesis. Sims shared his firm’s plans to build a pilot ethanol production operation in the American southwest and to advance its process for making diesel without using food crops as feedstock or expensive refining techniques.

—Boston Scientific (NYSE:BSX), the Natick, MA-based medical device giant, agreed to pay $22 million in a civil settlement with the U.S. Department of Justice. The settlement ends the DOJ’s investigation of post-marketing surveys conducted by a Boston Scientific subsidiary, Guidant, before it was acquired by the Natick firm.

—Watertown, MA-based drug developer Dicerna Pharmaceuticals inked a potentially mammoth deal with Japan-based Kyowa Hakko Kirin. The agreement gives the Japanese firm access to use Dicerna’s RNA-interference-based drug technology against one undisclosed target on cancer cells, in return for $4 million upfront cash, $120 million in potential milestone payments, and royalties. Over time, the partnership could be expanded to cover as many as 10 more drug targets, each with the same financial terms.

—Cambridge-based Biogen Idec (NASDAQ: BIIB) announced that its CEO, James Mullen, will step down in June after more than 20 years at the company. Mullen and the rest of the Biogen leadership have been the subject of blistering criticism from billionaire investor Carl Icahn, who launched a proxy battle for control of the company’s board last May. A spokesman said that pressure from shareholders was not a factor in Mullen’s decision to step down.

—Ryan profiled the efforts of Newton, MA-based AesRx to bring its experimental treatment for sickle cell disease into clinical trials. The startup’s founder, Stephen Seiler—the former CEO of Cambridge -based Idera Pharmaceuticals (NASDAQ:IDRA) has used his own money to support the company so far, and is now looking to raise about $10 million in venture capital.

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A number of New England’s life sciences companies had good news to report this week.

—Cambridge, MA-based Vertex Pharmaceuticals (NASDAQ: VRTX) reported results from clinical trials that indicate its experimental hepatitis C drug, telaprevir, could work well for patients who haven’t responded fully to standard treatments, and could be as effective taken twice a day as it is taken three times a day. Luke explains what the news means for Vertex’s efforts to capture a share of the potentially huge market for hepatitis treatments.

—Medical device maker Interlace Medical of Framingham, MA, won FDA clearance to market its minimally invasive device for removing uterine fibroids and polyps.

—Burlington, MA-based CorNova raised $2.5 million of a proposed $6 million in equity financing, according to regulatory filings. CorNova is developing coronary stents with platinum surfaces.

—Anti-inflammatory drug developer Virdante Pharmaceuticals completed a second closing of its Series A financing round, bringing the total collected so far to $30 million. Thomas, McNerney & Partners led the deal, which was joined by Osage Partners, Biogen Idec New Ventures, Clarus Ventures, MedImmune Ventures, and Venrock Associates.

—Bedford, MA-based iRobot (NASDAQ:IRBT) launched a new healthcare unit. Under the direction of technology veteran Tod Loofbourrow, the unit will focus on developing robots to help seniors live independently.

—Pharma giant Novartis declined an option to continue development of a hepatitis C drug from Cambridge-based Idenix Pharmaceuticals (NASDAQ: IDIX). Idenix, whose stock dropped on the news, will seek another partner to back development of the drug, IDX184.

—RNA-interference drug developer Cequent raised $3.35 million in the first tranche of a venture round that could be worth as much as $15 million. The Cambridge-based startup is engineering E. coli bacteria to deliver RNAi molecules designed to combat a certain type of polyp in the colon.

—Pulmatrix raised $30.2 million in a Series B venture round led by Arch Venture Partners and Novartis Bioventures Fund and joined by Polaris Venture Partners and 5AM Ventures. The Lexington, MA-based startup is using technology from MIT and Harvard to prevent flu viruses and other pathogens from invading lung tissue.

—Cancer diagnostics developer On-Q-ity of Waltham, MA, reportedly raised $21 million in a Series A round of venture capital from Mohr Davidow, Bessemer Venture Partners, Physic Ventures and Northgate Capital. The firm was formed through the merger of CELLective Diagnostics and The DNA Repair Company, both Mohr Davidow Ventures portfolio companies.

—Ironwood Pharmaceuticals of Cambridge and its partner, New York-based Forest Laboratories (NYSE: FRX), said that Ironwood’s lead drug candidate, linaclotide, fared well in two pivotal clinical trials. The drug is designed to relieve chronic constipation; Luke has all (and I mean all) the details.

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It’s been a short week and a long weekend since last I rounded up New England’s life sciences news, but there were still a few stories worth mentioning.

—Luke took an in-depth look at giant Amgen’s (NASDAQ: AMGN) efforts to boost its rate of success in getting new drugs to market. Though Amgen is based in Thousand Oaks, its 200-person-strong outpost in Cambridge, MA, plays an important role in its R&D operation.

—Ernst & Young released a sweeping analysis of the medical device industry that indicated that it’s a challenging time for device firms, particularly the smaller players that develop many of the new technologies the industry depends on for growth. Fundraising was down 53 percent among U.S. device companies, M&A activity was down by 41 percent, and the IPO market was flat-lining, according to the report.

—In contrast, our friends at ChubbyBrain sent us the data on September startup funding and the news for life sciences as a whole was fairly rosy. That sector accounted for $98.8 million of the $228 million total raised by Massachusetts companies that month.

—Cambridge-based Alkermes (NASDAQ: ALKS) reported that its anti-addiction drug, ALKS 33, was well-tolerated and able to block the effects of the powerful opioid painkiller remifentanil (Ultiva) long enough to enable once-daily dosing. Based on those results, from a pair of early-stage clinical trials, Alkermes is preparing for a mid-stage clinical trial of the drug, to start before the end of this year.

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New England’s life sciences companies gave us a number of cool new technologies and interesting deals to talk about this week.

—Cambridge, MA-based Genzyme (NASDAQ: GENZ) finished cleaning up its Allston, MA-based plant after a viral contamination which caused 6-to-8 week supply shortages of two of its best-selling drugs.

–-Archemix, also of Cambridge, forged an alliance with Boulder, CO-based miRagen Therapeutics to develop drugs that combine the Massachusetts firm’s “aptamer” technology with the Colorado company’s microRNA technology. Specific financial terms of the arrangement weren’t disclosed.

—Waltham, MA-based medical device company Augmenix revealed in an SEC filing that it had collected $4.7 million out of an equity round potentially worth $7.5 million. Augmenix is developing a synthetic material to protect healthy tissue during radiation treatments for prostate cancer.

—Joule Biotechnologies, a heretofore stealthy startup in Cambridge stepped into the sunlight to show off its technology, which aims to produce fuels and chemicals using engineered microbes capable of photosynthesis—no plant material or algae required. Founded in 2007 by partners at Flagship Ventures, Joule believes its technology is capable of producing more than 20,000 gallons of ethanol or hydrocarbons per acre on an annual basis, and yielding transportation fuels at prices that rival those of petroleum-based fuels.

—Waltham-based Avila Therapeutics raised $30 million in a Series B financing round led by the Novartis Option Fund and joined by return investors Abingworth, Advent Venture Partners, Atlas Venture, and Polaris Venture Partners. Avila and Novartis Option Fund also reached an agreement worth as much as $200 million in upfront and future milestone payments to co-develop Avila’s drugs, which are designed to bind more tightly to their targets that traditional drugs.

—Clinical trials management software maker Phase Forward (NASDAQ: PFWD), also of Waltham, shelled out $11 million to acquire Indianapolis, IN-based Maaguzi. The Indiana firm runs an online service for collecting data from patients.

—Cerulean Pharma of Cambridge raised $10 million in a Series B financing round from return investors Polaris Venture Partners, Venrock Associates, Lux Capital, and Bessemer Venture Partners. The startup is developing nanoparticle-based treatments and plants to use some of the new funding to push it’s lead drug candidate, a cancer drug, through clinical trials.

—Shares of Cambridge-based Ariad Pharmaceuticals (NASDAQ: ARIA) surged after the company released promising preliminary data from a mid-stage trial of its lead drug candidate, ridaforolimus, as a treatment for breast cancer. More complete data on the drug should be available later this year.

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San Diego’s Histogen announced final results from a clinical trial of its baldness treatment over the weekend. Nearly 85 percent of 24 men with male pattern baldness had more hair at the end of three months, and experienced an increase in hair thickness and density, according to a press release. Results came after a single injection of the company’s hair regrowth product (formerly known as ReGenica, now called Hair Stimulating Complex). Histogen announced top line results of the trial in February; it presented the final results Saturday at the annual meeting of the International Society of Hair Restoration Surgeons in Amsterdam. Histogen spokeswoman Eileen Naughton Brand said some subjects continued to experience hair regrowth five months post-injection, and no serious adverse reactions to the experimental treatment were seen. A mid-stage study is planned, Brand said.

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Perhaps New England’s life sciences companies were busy building arks this past week, because the news flow was a heck of a lot lighter than the rainfall. There are still a few interesting developments to report, though.

—Cambridge, MA-based Biogen Idec (NASDAQ:BIIB) agreed to pay $110 million up front, plus up to $400 million in additional fees, for the rights to develop and commercialize the multiple sclerosis drug Fampridine-SR overseas. The drug’s developer, Hawthorne, NY-based Acorda Therapeutics (NASDAQ:ACOR), will retain U.S. marketing rights.

—Ryan caught up with Xconomist Alexis Borisy, who last week left his post as the CEO of CombinatoRx (NASDAQ:CRXX), the Cambridge, MA-based firm he launched in 2000 to develop novel treatments based on combinations of existing drugs. Borisy spoke candidly about the “miserable” experience of having to lay off about 100 workers after his company’s lead drug failed in a mid-stage clinical trial last October, and about his hopes for the firm’s future, which includes a planned merger with Vancouver’s Neuromed Pharmaceuticals.

—Luke profiled Boston-based Immuneering, the brainchild of 27-year-old CEO Ben Zeskind and 30-year biotech veteran Bob Carpenter who, among other accomplishments, sold one of his companies to Genzyme (NASDAQ: GENZ) for $1 billion. The startup wants to use its proprietary mathematical modeling tools, based on research from the MIT lab of Doug Lauffenburger, to help figure out from blood and biopsy samples which cancer patients will respond to which drugs. This could spare patients the side effects of drugs that won’t work for them and could spare insurance companies the expense of those drugs.

—Hologic (NASDAQ: HOLX), a women’s health-focused firm in Bedford, MA, won FDA approval for a device called Adiana designed to provide a less-invasive alternative to tubal ligation. The permanent contraceptive device was approved for the European market in January.

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Ryan and Luke profiled some extremely interesting companies this week. More on those, and the rest of the week’s New England life sciences news, below.

—Billionaire investor Carl Icahn succeeded—at least partially—in his attempt to gain representation on the board of Cambridge, MA-based Biogen Idec (NASDAQ: BIIB). Roxanne reported live from the highly contentious annual meeting at which four board seats were up for grabs. The voting was so close, however, that only three winners were initially named–among them, Icahn portfolio manager Alex Denner. After the meeting, Bob got an exclusive interview with Denner and Harvard Medical School’s Richard Mulligan, who talked about why they thought Icahn’s attempt this year attempt to get his people on the Biogen board was more successful than a similar attempt last year. And late yesterday Biogen announced that Mulligan has won a seat on the board as well.

—Life Image CEO Hamid Tabatabaie told Ryan about his year-and-a-half-old startup’s efforts to address the problem of over-utilization of medical imaging with a system that would allow healthcare providers to better store, search, and share X-rays, MRIs, CT scans, and other digital medical images. Life Image, whose core software was developed at Boston’s Massachusetts General Hospital, raised $2.5 million in April in a Series A round of equity financing from Partners Innovation Fund and Massachusetts Technology Development Corporation.

—Ryan got the scoop on the technology being developed by Cambridge, MA-based Seventh Sense Biosystems, which closed its $4.75 million first round of financing from Flagship Ventures, Third Rock Ventures, and Polaris Venture Partners in December. CEO Doug Levinson (a Flagship partner) explained that the hitherto secretive startup wants to develop simple-to-use, unobtrusive health-monitoring tools. They would take the form of tattoo-like marks … Next Page »

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Newton, MA-based Clinical Data (NASDAQ:CLDA), announced positive results from the second Phase III trial of its antidepressant, vilazodone. In a study of 481 patients, the drug reduced depression symptoms, was well tolerated, and did not seem to result in sexual side effects; the results were similar to those from the first Phase III trial, which were announced in March. Clinical Data says it intends to file for FDA approval of vilazodone by the end of 2009. Development of the drug has been supported in part through the $17 million sale of Clinical Data’s genomics division, Cogenics, to Beckman Coulter (NYSE:BEC), an Orange County, CA life sciences company.

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New England’s life sciences firms reported a lot of encouraging clinical-trials news this week.

—A cholesterol-lowering drug developed by Cambridge, MA-based Genzyme (NASDAQ: GENZ) and Carlsbad, CA-based Isis Pharmaceuticals (NASDAQ: ISIS) reached its goals in a pivotal clinical trial. Genzyme intends to apply for approval of the drug, called mipomersen, first in a small population of patients with a rare genetic anomaly that causes high cholesterol, and later in much larger groups of patients that might turn the product into a blockbuster.

—Cambridge, MA-based startup E8 Pharmaceuticals, along with MIT, filed a lawsuit against Navigenics, a Foster City, CA-based genetic testing company. The suit alleges that Navigenics is infringing on a patent on genotyping technology developed by MIT’s David Housman, one of the founders of E8, by using microarrays manufactured by Santa Clara, CA-based Affymetrix; E8 and MIT filed suit against Affymetrix itself last year.

—Ryan caught up with one of the organizers of Dartmouth College’s first-ever Dartmouth Entrepreneurial Network (DEN) Business Plan Competition. Taking the $50,000 first prize was Hanover, NH-based Novoculi, which is out to develop a non-invasive device for blood-glucose testing that works by projecting light into a diabetic patient’s eye and measuring the rate at which pigments in the retina are regenerated after the retina is “bleached” by the light.

—Luke profiled Vancouver, BC-based Tekmira (TSX: TKM), whose drug-delivery technology is incorporated in Cambridge, MA-based Alnylam’s RNAi-based treatment for liver cancer. Alnylam (NASDAQ: ALNY) launched a trial of the treatment last month in 55 patients, the first significant clinical trial of an RNAi drug designed to circulate throughout the body, rather than being injected locally.

—RiskMetrics Group, an influential proxy advisor, endorsed two of the four people nominated by billionaire investor Carl Icahn to the board of Cambridge, MA-based Biogen Idec (NASDAQ: BIIB). Votes will be tallied on June 3 at Biogen’s annual shareholders meeting.

—Cambridge, MA-based Vertex Pharmaceuticals (NASDAQ: VRTX) launched a pivotal clinical trial program for VX-770, its drug candidate for cystic fibrosis. The three planned trials will include 240 patients at 110 clinical trial sites in North America, Europe, and Australia.

—Cancer drug developer Agios Pharmaceuticals of Cambridge, MA, named Genentech veteran David Schenkein as its first permanent CEO. Schenkein, who was the senior vice president in charge of cancer drug development at Genentech, will replace Third Rock Ventures partner Kevin Starr, who has been serving as Agios’ interim CEO.

—A diabetes treatment under development by CombinatoRx (NASDAQ:CRXX), also of Cambridge, MA, helped reduce blood sugar levels and provided other benefits in a mid-stage clinical trial. The treatment is a combination of bezafibrate and diflunisal.

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It’s not all bad news this week for New England’s life sciences firms (my headline notwithstanding), but there certainly were a few somber notes.

—Infinity Pharmaceuticals (NASDAQ:INFI) of Cambridge, MA, halted a late-stage trial of its lead cancer drug among patients with relapsed forms of malignant stomach tumors after interim results showed that more patients taking the drug were dying, compared to those who were not taking the drug. Infinity is still testing the drug, retaspimycin (or IPI-504), in separate trials among patients with non-small cell lung cancer, metastatic breast cancer, and advanced solid tumors, and will decide if any changes are needed in those studies.

—Waltham, MA-based Synageva BioPharma raised $30 million in a private equity financing led by Baker Brothers Investments and joined by Tullis Dickerson and Four Partners. Synageva plans to raise still more money in the weeks to come to support development of both novel and generic protein drugs.

—The FDA granted Cambridge, MA-based Biogen Idec (NASDAQ:BIIB) approval for a high-yield process for making the drug natalizumab (Tysabri), which is approved for multiple sclerosis and Crohn’s disease. But sales of the drug in the first quarter fell short of analyst’s predictions, generating $227 million worldwide rather than the predicted $246 million. The drug is now being taken by about 40,000 patients, an increase of about 3,000 over the previous quarter.

—Clarus Ventures of Cambridge, MA, helped lead a $10 million Series A round of financing for Ann Arbor, MI-based Lycera, a developer of … Next Page »

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[[Updated]] Dendreon has been vindicated. The Seattle biotech company, after living through years of controversy about whether its experimental drug helps prostate cancer patients live longer, said today that a clinical trial of 512 men now shows that the treatment can help prolong life with minimal side effects. Shares skyrocketed by more than $12, rising above $20 a share after the opening bell.

The trial, called Impact, randomly assigned men to get either the company’s experimental immune-boosting therapy, Provenge, or a placebo. The study found that men who took Provenge had a lower risk of death than those in the control group—the company needed to show at least a 22 percent improvement on that measure. Side effects were consistent with what was seen in previous trials—fever and chills that lasted a couple days. Dendreon (NASDAQ: DNDN) will now pull together this new information to update its application with the FDA in the fourth quarter, in the hopes of bringing this new drug to the U.S. market. Full data are expected to be announced at 2:20 pm Central time on April 28 at the American Urological Association meeting in Chicago.

The finding is a watershed moment for the field of cancer immunotherapy, sometimes called cancer vaccines, in which researchers try to stimulate the immune system to fight cancer cells like a virus. If Dendreon can win FDA approval, it will be the first company in this field to do so, after a long list of failures from the past couple of years, at companies like Cell Genesys, Favrille, and Genitope. Dendreon’s new drug will offer a new treatment option for about 30,000 men who die in the U.S. each year from prostate cancer, beyond the standard hormone deprivation and chemotherapy, which have side effects many men want to avoid. It is also a breakthrough moment for the Seattle biotech cluster and for Dendreon. The company was founded in 1992, has spent more than $560 million of investors’ money on R&D, and hopes to make Provenge its first marketed product in the U.S.

“Today is a historic day for patients, our industry, the scientific community, and certainly for Dendreon,” said CEO Mitchell Gold, on a conference call this morning with analysts. In a statement, he added, “The successful outcome from the Phase 3 Impact study provides validation of the long-pursued goal of harnessing the human immune system against a patient’s own cancer.”

Dendreon didn’t provide specifics about the trial outcome in today’s release, such as the magnitude of the survival benefit, or the degree of statistical significance of the finding, which measures how confident statisticians are that the finding isn’t a fluke.

Dendreon offered a few hints about how strong the result was on the conference call this morning. Provenge’s ability to prolong lives … Next Page »

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The past week saw substantial cuts at two of New England’s biotech firms, but a thorough analysis of the financial reporting for most companies in the sector shows the news isn’t all bad. That and more below.

—Luke delivered the second installment of his Biotech Survival Index, which assesses the financial health of more than 40 of Boston’s public life sciences companies. Things were predictably dire for many of them, but compared to the previous quarter more companies were in the enviable position of having over $100 million squirreled away.

—Cambridge, MA-based Biogen Idec (NASDAQ: BIIB) and partner Genentech were unable to show in a clinical trial that their drug rituximab (Rituxan) is effective as a treatment for lupus nephritis, an inflammatory disease of the kidneys. Rituximab is already approved as a treatment for non-Hodgkin’s lymphoma and rheumatoid arthritis.

—Ryan profiled Aura Biosciences, a startup in Cambridge, MA, that’s out to commercialize drug-delivery technology licensed from European research institutions. Having recently raised over $3 million to fund its efforts, Aura hopes to develop nano-sized particles to ferry cancer drugs directly to tumor cells, say, or to carry RNA-interference-based treatments into the body.

—Epix Pharmaceuticals (NASDAQ:EPIX) of Lexington, MA, announced plans to reduce its staff by half to cut costs. The layoffs, which will affect 44 workers, combined with a reduction in CEO Elkan Gamzu’s base salary, should save Epix $4.4 million a year.

—Epix’s Lexington neighbor, Synta Pharmaceuticals (NASDAQ:SNTA), also announced a planned staff reduction. Cutting 90 workers, or about 41 percent of its staff, should allow the firm to operate for two more years without new funding.

—Wade took a look at a collaboration between IBM and Boston’s Brigham and Women’s Hospital that could give geographically dispersed teams of doctors … Next Page »

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This week saw news of two interesting acquisitions and a couple of huge venture financings, among other deals cut by New England tech and life sciences firms.

— Burlington, MA-based Nuance Communications (NASDAQ:NUAN), after a series of unsuccessful offers begun last summer, has finally convinced the board of the Canadian firm Zi (NASDAQ:ZICA) to accept Nuance’s $35 million buyout offer. Under the terms of the deal, shareholders of Zi, which competes with Nuance in the market for text messaging software, will get 34 cents in cash and 0.4 shares of Nuance stock for every share of Zi stock. Zi shareholders must still approve the deal, which is actually worth less than one Zi’s board rejected in August.

—Ariad Pharmaceuticals (NASDAQ: ARIA) of Cambridge, MA, earned a $10 million milestone payment from its partner, Merck, as part of an existing deal between the firms focused on Ariad’s experimental drug for lung cancer.

—Cambridge, MA-based Vertex Pharmaceuticals (NASDAQ:VRTX) inked a deal to acquire privately held ViroChem Pharma of Laval, Quebec, for some $375 million in cash and stock. The deal gives Vertex the rights to two promising drugs for hepatitis C that ViroChem is developing; Vertex hope the drugs will eventually work in combination with its own hep C drug, telaprevir, which if approved would be a first-in-class protease inhibitor drug for the liver disease.

—Waltham, MA-based ImmunoGen said it earned a $6.5 million milestone from Genentech for starting a late-stage clinical trial for breast cancer drug T-DM1, which incorporates ImmunoGen’s cancer cell-killing agent and a Genentech antibody, trastuzumab. Luke wrote a nice history of the project, ImmunoGen, and the field of “smart bomb” cancer drugs.

—Cambridge, MA-based Alnylam Pharmaceuticals (NASDAQ:ALNY) contributed $10 million to a Series A financing round for Carlsbad, CA-based Regulus Therapeutics. An additional $10 million came from Carlsbad’s Isis Pharmaceuticals (NASDAQ:ISIS), which launched Regulus jointly with Alnylam in September 2007 to develop drugs based on the nascent science of microRNA.

—Westford, MA-based Verivue, a maker of cross-platform video streaming technology, revealed it had raised $40 million in a Series B financing round closed last July. Comcast Interactive Capital led the round, and Matrix Partners, North Bridge Venture Partners, Accel Partners, and Arris participated as well.

—Waltham, MA-based Onset Technology, a provider of compliance software for smartphones, raised $3 million in a financing led by the Cedar Fund of Waltham, Israel, and Grand Cayman.

—Boston-area investors Spark Capital and Grandbanks Capital participated in a $12 million Series D funding of San Francisco’s SendMe Mobile, a provider of ringtones, games, wallpaper, and other content for mobile phones. Carmel, CA-based Triangle Peak Partners led the round.

—Waltham, MA-based Proteon Therapeutics raised $38 million in a Series B round of financing led by MPM Capital and joined by Vectis Healthcare & Life Sciences Fund, TVM Capital, Skyline Ventures, Prism VentureWorks, Intersouth Partners, and earlier angel investors. Proteon’s lead product candidate is a protein drug designed to improve the outcome of a surgery that prepares kidney disease patients’ blood vessels to be frequently hooked up to dialysis machines.

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It was a bit of a rollercoaster for New England’s biotech firms this last week, with Synta Pharmaceuticals taking the worst dip.

—Clinical Data (NASDAQ:CLDA) of Newton, MA, has raised $50 million in a convertible debt financing aimed at supporting late-stage development of its depression drug, vilazodone, and its cardiac imaging agent apadenoson (Stedivaze).

—There was a flurry of regulatory news for Genzyme (NASDAQ: GENZ). The Cambridge, MA-based biotech giant won two long-awaited approvals, one from the FDA for its long-lasting injection hylan G-F 20 (Synvisc-One) for treating pain from osteoarthritis of the knee, and the other from the European Commission for batches of its Pompe disease drug, alglucosidase alfa (Myozyme), produced at its Belgium plant in 4,000-liter bioreactors. But the FDA said it would not yet approve batches of the drug made in 2,000-liter bioreactors for sale in the U.S. market. (Batches of the drug made in 160-liter vats have been approved in the U.S. since 2006, and those made at the 2,000-liter scale are currently approved in more than 40 countries.) In response to the unexpected setback, Genzyme took 12 cents a share off its annual earnings forecast; the firm said it hopes to address the agency’s questions within three to six months.

—Luke got a briefing from Biotechnology Industry Organization president Jim Greenwood on how the group believes the economy and changing political environment will affect its more than 900 member companies and how it would like the government to support those companies’ efforts. The current numbers from BIO are grim, with about one-third of all publicly traded biotech companies having less than six months of cash on hand and only about one in 10 public biotechs in the black.

—Also grim was the news from Lexington, MA-based Synta Pharmaceuticals (NASDAQ: SNTA), which said it had halted a clinical trial involving more than 630 melanoma patients because more patients receiving the company’s experimental drug elesclomol in addition to traditional chemotherapy were dying compared with those who got the chemo alone. The failure of the trial was a huge blow for Synta, which has no products on the market.

—Ariad Pharmaceuticals (NASDAQ: ARIA) of Cambridge, MA, earned a $10 million milestone payment from its partner, Merck, in connection with the start of a mid-stage clinical trial of Ariad’s experimental drug for lung cancer.

—Waltham, MA-based ImmunoGen earned a similar milestone payment, worth $6.5 million, from partner Genentech when dosing of patients began in a late-stage clinical trial of T-DM1, a breast cancer drug comprised of ImmunoGen’s cancer cell-killing agent linked to Genentech’s antibody trastuzumab.

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New England’s life sciences firms got a lot of news from the FDA this past week—not all of it good. Here’s more on that, and the rest of the week’s news from the sector.

—Ryan caught up with the CEO of Targanta Therapeutics (NASDAQ:TARG) the day after the FDA has decided to not to approve the Cambridge, MA-based biotech firm’s antibiotic oritavancin. Mark Leuchtenberger says Targanta will need to raise money to fund the clinical trial that the FDA will require the company to conduct before once again considering oritavancin, which would be the firm’s first marketed product, and that Targanta will “take the appropriate steps” to use its existing funds appropriately.

—Another local life sciences firm, Watertown, MA-based Acusphere (NASDAQ:ACUS), also got bad news about its lead product candidate when an FDA advisory panel voted 16-1 against recommending approval of the heart imaging agent known as perflubutane polymer microspheres (Imagify). The FDA is not obligated to follow such advice, but it usually does.

—Cambridge, MA-based Semprus BioSciences reportedly raised $8 million in a Series A financing round led by 5AM Ventures and Pangaea Ventures. Semprus is developing antimicrobial coatings for medical devices.

—Infinity Pharmaceuticals (NASDAQ: INFI) of Cambridge, MA, announced that its partner, AstraZeneca, has decided to give back its share of a program focused on developing cancer drugs that block a target called heat shock protein 90. Luke offered a couple of points of view on what AstraZeneca’s decision means, and how it might affect Infinity.

—Ryan spoke with officials from several of the disease foundations that are an increasingly important source of funding for biotechs such as Cambridge, MA-based Vertex Pharmaceuticals (NASDAQ:VRTX). But with their own budgets being squeezed by the economic downturn, foundations are … Next Page »

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Lexington, MA-based cancer drug developer Synta Pharmaceuticals (NASDAQ: SNTA) announced it has earned a $15 million milestone payment from GlaxoSmithKline. The pyament is part of a deal inked last October and worth up to $1.1 billion that focuses on Synta’s elesclomol, which is currently in Phase 3 testing as a treatment for metastatic melanoma.

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All was far from quiet on the Boston-area life sciences front this past week. Behold…

—Luke did a massive analysis of the finances of public Boston-area life sciences firms, looking at how much money each one has in the bank—and how fast that cash is going up the chimney. Bottom line: Boston companies are overall better positioned than their San Diego and Seattle counterparts to weather the current economic storm, but many of them are hurting nonetheless.

—Sylvie Gregoire, the president of Shire Human Genetic Therapies (HGT), filled Ryan in on the rapid expansion of the Lexington, MA-based division of Irish specialty drug company Shire. Formed through Shire’s $1.6 billion acquisition of Cambridge, MA-based biotech firm Transkaryotic Therapies in 2005, the division is in the midst of adding 680 workers and has become one of Shire’s fastest-growing businesses.

—Resolvyx Pharmaceuticals unveiled plans for the first human clinical tests of its “resolvins.” The Bedford, MA-based startup will test one of the compounds, which are designed to mimic fish oil’s anti-inflammatory effects, as a treatment for dry eye.

—Cambridge, MA-based Idera Pharmaceuticals (NASDAQ:IDRA) extended its research collaboration with pharmaceutical behemoth Merck for another year. The collaboration is aimed at developing Idera’s drugs as treatments for cancer, infectious diseases, and Alzheimer’s.

—Radius Health, also of Cambridge, tacked another $15 million onto its Series C round of venture capital, bringing the total for the round—in which MPM Capital, the Wellcome Trust, HealthCare Ventures, Oxford Bioscience Partners, BB Biotech Ventures, and Scottish Widows Investment Partnership participated—to $82.5 million.

—Lebanon, NH-based antibody-based-drug developer Adimab completed a Series C round of financing from OrbiMed Advisors, Borealis Ventures, Polaris Venture Partners, and SV Live Sciences. No dollar figure for the deal was revealed.

—CombinatoRx (NASDAQ: CRXX) of Cambridge, MA, and the Andover, MA-based healthcare unit of Royal Philips NV both … Next Page »

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