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Biotech News
Feb 07, 2012 08:00AM

http://www.fiercebiotech.com/news/frontpage

Feb 07, 2012 07:36AM

Merck tracks positive results, bleeding risk in second big vorapaxar study

Merck says that vorapaxar, its troubled blood thinner once considered the jewel in Schering-Plough's crown when the pharma giant bought it for $41 billion, hit its primary efficacy endpoint in a second major late-stage study. But Merck ($MRK) investigators also noted that while the drug--which proved too dangerous to continue the first study to its conclusion--looked positive on the top line, patients taking it also suffered from a significant increase in bleeding.

Vorapaxar has caused a lot of trouble for Merck, which once hoped that it had a blockbuster treatment on its hands when the deal for Schering-Plough went through. A year ago the company shut down the first big study after investigators tracked a dangerous increase in the risk of bleeding.

In this second study, TRA-2P, researchers were testing the treatment using a composite score for cardiovascular death, heart attack and stroke, paying particular attention to whether it would prevent clots. The data will be reviewed in March.

"In developing vorapaxar, Merck and our scientific collaborators set a very high bar--would the addition of vorapaxar to standard of care provide incremental benefit in preventing clots?" said Peter S. Kim, president, Merck Research Laboratories. "We are pleased that TRA-2P met its primary endpoint, and we look forward to discussing the results with the scientific community."

So where does it go from here? For Merck's part the pharma company says it will ponder all the data and then consider its options, including a potential regulatory filing. With one monumental pratfall and mixed results for the second study, plenty of questions beg to be answered first.

- here's the press release

Feb 07, 2012 06:45AM

GSK will cut 3 research units, add 4 as R&D productivity swells

Following a three-year review of its new approach to R&D, GlaxoSmithKline ($GSK) today revealed that it has decided to ax three of its 38 tightly-focused research units and add four more in a shakeup. The final tally, which doesn't specify exactly who wins or loses, also included plans to beef up the budgets for 6 of their Discovery Performance Units while slicing funding on 5 others. And CEO Andrew Witty (photo) pronounced himself quite satisfied with the DPUs' overall performance, with the new annual numbers reflecting a boost in productivity as GSK moves ahead with plans to file for approvals on four new drugs and vaccines--including an MEK inhibitor for melanoma, trametinib, which scored paydirt data in Phase III, according to today's release.

Alone among the Big Pharma companies, GlaxoSmithKline has been tracking the rate of return on the money it spends on its late-stage pipeline work. In 2010, the return rate was 11%. Last year, that figure swelled to 12% as Witty vows to make it to the 14% mark. GSK says it will keep its R&D budget, a bellwether in the industry, flat at 3.7 billion euros.

In one of the most closely watched R&D restructurings in the industry, GSK launched its DPU approach to drug development back in 2008, promising to cut groups that underperform and back those making headway after winning three-year budgets for their work. The idea, advanced by Witty and R&D chief Moncef Slaoui, was that scientists would stay more closely focused if they knew their teams' funding relied on tangible progress--a daily reality for most biotech companies.

"These units comprise 5-70 scientists, with each group focusing on one particular disease or pathway," noted Witty in GSK's annual report. "Over the last three years, I have visited many of the DPUs and am very pleased with the energy, approach and productivity we are seeing from our scientists in these units." There's no word of any layoffs or departures in R&D today. GSK has made it clear that even if some teams didn't make the cut, it would transfer employees to other DPUs.

Now that the three-year review is over, GSK says the next three years will see 30 programs move into late-stage development.

Those DPUs are now wrapping six late-stage programs, Witty says. The four slated to be filed for approval this year include Relovair, its COPD treatment partnered with Theravance ($THRX), Promacta for hepatitis C and the MEK inhibitor for melanoma. The melanoma drug is GSK'212, or trametinib, which went into Phase III about a year ago.

- here's the release from GSK (.pdf)

Feb 06, 2012 10:00AM

Amgen's Xgeva faces FDA skepticism

The FDA isn't convinced that Amgen ($AMGN) needs another bone-metastasis indication for its new drug Xgeva. The drug is already approved to treat skeletal side effects in cancer patients, but Amgen is asking to market it as a preventive tool for men with advanced prostate cancer. The idea is that earlier use of Xgeva might stave off--or at least delay--development of bone metastases in those men. The other idea, of course, is that marketing the drug for that use could increase sales. Story

Feb 06, 2012 09:57AM

GSK readies its much-anticipated 3-year review for DPUs

In one of the most anticipated R&D events of the year, GlaxoSmithKline ($GSK) execs are readying a summary judgment on the results of the first three-year round of results for their closely-watched Discovery Performance Units. But anyone looking for a dramatic corporate response at this stage of the game is likely to be disappointed.

Just about every major news outlet in the world that covers GSK has been trying to find out exactly how those DPUs performed. GSK garnered plenty of attention when it decided to regroup its R&D empire into smaller, more biotech-like organizations. Dogged by poor productivity, R&D chief Moncef Slaoui and CEO Andrew Witty determined this was their best shot at getting the investigators to understand they had some skin in the game, and get their best efforts.

Now that GSK is readying a review of its annual results tomorrow, though, it's becoming increasingly clear that while some of the DPUs may not fare as well as others, anyone looking at this as the opening of a new chapter on its restructuring is likely to be disappointed. As The Telegraph notes, some investigators may get reassigned in the new accounting, but no major upheavals are expected.

The Telegraph also notes that while some DPUs may not be funded going forward, GSK is likely to leave its multibillion-dollar budget flat for the year ahead.

- here's the story from The Telegraph

Feb 06, 2012 09:37AM

Merck steers top drug prospect to an NDA, analysts ponder R&D weakness

Merck today says it has the late-stage data it needs to gain an approval for a new insomnia drug, one of 5 treatments the pharma giant believes it can gain an official OK on before the end of 2013. But highlighting plans for a little-known insomnia treatment that would be entering a crowded market may be sending a different kind of message to industry analysts than the one Merck ($MRK) intends.

Merck wasn't talking data points today, but it says the treatment--an orexin receptor antagonist--hit endpoints on a change from baseline in subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep at one and three months.

"Suvorexant selectively targets an important pathway involved in helping to promote sleep and, if approved, will be a new, first-in-class treatment for patients with insomnia," said Peter Kim, president, Merck Research Laboratories. "We are enthusiastic about the potential of this investigational medicine, and look forward to sharing the results from these studies with the medical community."

Orexin receptor drugs have had their problems. Just a year ago Glaxo and Actelion shuttered a trial on almorexant, which has a similar mechanism.

Suvorexant, which gained little attention while in clinical development, joins osteoporosis drug odanacatib, the anesthesia-reversing Bridion, an anti-hardening of the arteries drug dubbed Tredaptive and a vaccine called V503 as among the pharma giant's brightest hopes, according to a recent AP story. But some analysts see the lineup as a thin front line for a company that needs substantial new revenue. As a result, there's been some buzz recently that Merck may be altering its deal-making game plan and focusing more on drugs in late-stage development to gain some respect.

- here's the press release

Feb 06, 2012 08:37AM

PhRMA's COPD pipeline report spotlights blockbuster hopefuls

Anyone looking for a basic primer on experimental COPD drugs should check out PhRMA's latest compilation of new drugs in the pipeline. The big trade group found 54 COPD studies underway, which include trials for some of the biggest potential blockbusters nearing an FDA decision. But be prepared to do some digging if you want to find out what's really happening here.

For PhRMA, which mistakenly categorized everything in clinical development as distinct, late-stage treatments, some of the highlights in the report include an adult stem cell therapy, an IL-1 receptor-targeted antibody and a therapy that zeroes in on inflammation related to COPD. Their success could help reduce the nearly $50 billion annual tab for treating the disease.

Dig down into the report and you'll find eight Phase III studies underway. That includes Relovair, a new drug from GlaxoSmithKline ($GSK) and Theravance ($THRX), which chilled analysts with mixed data recently, and Novartis' ($NVS) potential giant slayer QVA149, which has run into dosage issues in the U.S. Pearl Therapeutics, a 2011 Fierce 15 company, is in the race now that it is wrapping an ambitious mid-stage program.

Elevation and Osiris are also focused on Phase II. Osiris's Prochymal, the stem cell treatment noted by PhRMA, hasn't performed very well. In an update, Osiris recently noted that the treatment had failed to outperform a placebo after a year of treatment.

- here's the press release
- read the full report (.pdf)

Feb 06, 2012 07:40AM

Sanofi chief can't spark much enthusiasm for new MS drugs

Back when Sanofi's Chris Viehbacher was in the hunt for Genzyme, one of the big sticking points was assessing the value of the experimental MS drug Lemtrada. Genzyme's forecasts were starry eyed. Sanofi ($SNY), which had its own late-stage MS drug in the pipeline, issued bleak forecasts. Which is why they ultimately established a CVR on the program to separate it in their $20 billion buyout deal.

Now, though, Viehbacher says he's seen the results of the late-stage trial, and he's a believer.

"Now that we have seen the clinical trial results--I have seen them but I cannot say more because we are going to publish them in April--we are very excited about this multiple sclerosis franchise," Viehbacher tells Reuters' Ben Hirschler.

But now he's finding it harder to get analysts enthusiastic as well. The problem: Novartis ($NVS) has beaten the competition to the marketplace with Gilenya and Biogen Idec has wowed the industry with impressive data on BG-12, its big new MS drug that appears to be on track to a blockbuster approval.

Reuters notes that peak sales forecasts for Lemtrada range from a billion euros a year at Morgan Stanley to a mere 360 million at Nomura. And the fact that Sanofi has a shot of debuting a second MS treatment, Aubagio, has done nothing to whet the enthusiasm of the analysts.

"Sanofi will remain a small player compared with Biogen or Novartis, but it will still remain on the radar screen," Natixis analyst Beatrice Muzard tells the wire service. Maybe Viehbacher did too good a job at downplaying Lemtrada.

- here's the article from Reuters

Feb 06, 2012 06:40AM

Will $1B cancer IP theft suit trigger tighter vigilance on researchers' work?

The University of Pennsylvania's cancer research institute believes it's been ripped off to the tune of $1 billion. The center is pointing a finger at its former scientific director--a prestigious cancer researcher now CEO of Memorial Sloan-Kettering--as the inside man responsible for the heist. But an in-depth article on the high-profile confrontation by The New York Times is raising fresh questions about the allegations of stealth and subterfuge being made against the investigator.

The Abramson Family Cancer Research Institute filed suit against Craig Thompson back in mid-January, claiming that he used IP on cancer metabolism--a hot field in oncology research--to secretly launch Agios, a biotech company partnered with Celgene on new cancer remedies. And the university alleges that Thompson continued to conceal his role when asked about it.

"As a result of Dr. Thompson's concealment, the Institute did not learn of Thompson's involvement with Agios until late 2011," the suit claims, according to a report by the Philadelphia Inquirer. But The New York Times quotes several insiders saying that Thompson may not have been playing such a cloak-and-dagger role as the lawsuit makes out.

The Times piece, written by Andrew Pollack, includes a claim that Agios worked with Penn to get patents on work done there. And several sources involved in the discussion note that Agios may have been something less than a well-kept secret. "Yes, Penn knew about Agios," Michael J. Cleare, executive director of Penn's Center for Technology Transfer, tells the Times.

The suit, though, does amplify the heightened security that research institutions are applying to their intellectual property. Several biotechs owe their existence to groundbreaking investigative work done by academic researchers. With billions of dollars at stake for any successful new cancer drugs, the lawsuit indicates that institutes are more willing to play legal hardball to protect their share of the cash. And it's almost certain to make researchers and institutes far more vigilant about safeguarding their relative IP rights.

- here's the article from The New York Times

Feb 03, 2012 09:06AM

FDA commish counters industry critics on expert conflict rules

There's been an ongoing debate in biopharma circles over the impact a shortage of drug experts is having on the FDA's panel review process. But anyone looking for the agency to welcome changes in the rules governing conflicts of interest--which have been keeping some of the experts at bay--can rule out any support from FDA Commissioner Margaret Hamburg.

In testimony to Congress this week, Hamburg made it crystal clear that the agency isn't supporting any new legislative initiatives to ease the 4-year-old set of rules, despite calls from supporters who say the changes would significantly reduce approval times and enhance innovation in the industry. The FDA has more than enough waivers to use if the agency believes that it needs to get more panelists, says the commissioner.

"At the present time, we are not bumping up against our cap in terms of waivers," Hamburg told a House committee, according to a report in Reuters. "We don't at the moment see major areas where a legislative fix is required."

Patient advocacy groups are likely to cheer that position. But it won't sit well with many on the drug development side of the fence, especially as critics constantly roast the agency over what they see as an unresponsive bureaucracy that moves far too slowly.

"Our view is there is a need to improve the process of the advisory committees, particularly in areas where there is a paucity of experts," noted Geno Germano, president of Pfizer's ($PFE) specialty care and oncology unit, according to Reuters.

Given the difference of opinion, this is one issue not likely to go away anytime soon.

- here's the story from Reuters

Feb 03, 2012 08:13AM

Scoring winners and losers in Japan pharma M&A bout

Japan's biggest pharma players have been roaming the world in recent years in a restless search for new acquisitions. They've been looking for deals to put an extra oomph into their earnings. Now The Wall Street Journal is reviewing the biggest buyers and seeing who scored the juiciest gains, and who harvested bitter losses. Astellas Pharma, which acquired OSI Pharmaceuticals in 2010, comes out on top. Story

Medical Device and Diagnostics News
Feb 07, 2012 08:03AM

http://www.medicalnewstoday.com/sections/medical_devices/

Feb 06, 2012 02:00AM

New Device Removes Stroke-Causing Blood Clots Better Than Standard Treatment

An experimental device for removing blood clots in stroke patients dramatically outperformed the standard mechanical treatment, according to research presented by UCLA Stroke Center director Dr. Jeffrey L. Saver at the American Stroke Association's 2012 international conference in New Orleans...

Feb 06, 2012 01:00AM

New Hope For Patients With Deadly Brain Tumor

Jim Black is fighting the meanest, most aggressive, most common kind of brain tumor in the United States: recurrent glioblastoma multiforme (GBM). In the United States, each year, approximately 10,000 patients are affected by GBM. Now, a novel investigational device - available only at clinical trial sites - is offering new hope to these patients...

Feb 04, 2012 01:00AM

Heartbeat Vibrations Power Pacemakers

Though pacemakers require only small amounts of energy (about 1 millionth of a Watt), their batteries have to be replaced periodically, which means multiple surgeries for patients...

Feb 04, 2012 01:00AM

Brain Blood Flow And Oxygen Monitored By First-Of-Its-Kind Head Patch

A research team led by investigators at Mayo Clinic in Florida has found that a small device worn on a patient's brow can be useful in monitoring stroke patients in the hospital. The device measures blood oxygen, similar to a pulse oximeter, which is clipped onto a finger...

Feb 03, 2012 02:00AM

Device Provides A Platform For Viewing Cancer Cells And Other Macromolecules In Dynamic, Life-Sustaining Liquid Environments

A photograph of a polar bear in captivity, no matter how sharp the resolution, can never reveal as much about behavior as footage of that polar bear in its natural habitat. The behavior of cells and molecules can prove even more elusive...

Feb 03, 2012 02:00AM

Protein Structures Offer Clues To Breast Cancer, Alzheimer's Treatment, Prevention

Using some of the most powerful nuclear magnetic resonance equipment available, researchers at the University of California, Davis, are making discoveries about the shape and structure of biological molecules - potentially leading to new ways to treat or prevent diseases such as breast cancer and Alzheimer's disease...

Feb 03, 2012 02:00AM

Portable Recording Of Vital Signs Via "Life And Activity Monitor"

Researchers have developed a type of wearable, non-invasive electronic device that can monitor vital signs such as heart rate and respiration at the same time it records a person's activity level, opening new opportunities for biomedical research, diagnostics and patient care...

Feb 03, 2012 01:00AM

Researchers from the Center for Vital Longevity at the University of Texas at Dallas and UT Southwestern Medical Center have completed a large-scale neuroimaging study of healthy adults from age 30 to 90 that measured beta-amyloid protein - a substance whose toxic buildup in the brain is a diagnostic marker for Alzheimer's disease...

Feb 02, 2012 11:00AM

Are CT Scans For Dizziness In ER Cost-Effective?

Henry Ford Hospital researchers have found that conducting CT scans in the emergency department (ED) for individuals experiencing dizziness may not be cost effective. The researchers discovered that less than 1% of CT scans carried out in the ED showed a more serious underlying cause for dizziness (stroke or intracranial bleeding), which required intervention...

Feb 02, 2012 09:00AM

Medical Device Industry And FDA Reach Provisional Fees Agreement

An agreement, in principle, regarding proposed recommendations for the new reauthorization of a medical device user fee program, has been agreed by the FDA and the Medical Device Industry. If the recommendations go through, the FDA would be authorized to collect $595 million from the medical device industry in user fees for a five-year period, with adjustments according to annual inflation rates...

Feb 02, 2012 01:00AM

Researchers Develop Novel Drug Delivery System

Long duration, controllable drug delivery is of wide interest to medical researchers and clinicians, particularly those seeking to improve treatment for patients with chronic pain or to prevent cancer recurrence after surgery...

Feb 02, 2012 01:00AM

Liquid Lasers May Better Detect Genes Linked To Cancer

Using a liquid laser, University of Michigan researchers have developed a better way to detect the slight genetic mutations that might predispose a person to a particular type of cancer or other diseases. Their results are published in the current edition of the German journal Angewandte Chemie. This work could advance understanding of the genetic basis of diseases...

Feb 02, 2012 01:00AM

Brain Activity Can Show Scientists Words We Are "Thinking"

A study conducted by researchers at the University of California, Berkley, and published in PLoS Biology reveals neuroscientists' new breakthrough research on how they will be able to understand the thoughts of patients without actually hearing them speak. This will be incredibly helpful when treating patients who are unable to speak after strokes, paralysis, or even possibly during comas...

Feb 01, 2012 02:00AM

Decoding Brain Waves Could Lead To Communication With Patients Unable To Speak

Neuroscientists may one day be able to eavesdrop on the constant, internal monologs that run through our minds, or hear the imagined speech of a stroke or a locked-in patient with inability to speak, according to researchers at the University of California, Berkeley...

Feb 01, 2012 02:00AM

Improved Detection Of Colorectal Cancer By Flexible Sigmoidoscopy

Repeated screening by flexible sigmoidoscopy (FSG) increased the detection of colorectal cancer or advanced adenoma in women by one-fourth and in men by one-third, according to a study published Jan. 31 in the Journal of the National Cancer Institute...

Jan 31, 2012 03:00AM

Research At Rice University Leads To Nanotube-Based Device For Communication, Security, Sensing

Researchers at Rice University are using carbon nanotubes as the critical component of a robust terahertz polarizer that could accelerate the development of new security and communication devices, sensors and non-invasive medical imaging systems as well as fundamental studies of low-dimensional condensed matter systems...

Jan 30, 2012 10:00AM

Cyberknife Radiation Successful For Treating Tigeminal Neuralgia

A small study published online in the Journal of NeuroInterventional Surgery shows that a technique in which highly concentrated beams of radiation are used, known as Cyberknife, can relieve the stabbing pain of the facial nerve condition trigeminal neuralgia...

Jan 30, 2012 01:00AM

Medical Sensor Powered By The Rhythmic Action Of Rap Music

The driving bass rhythm of rap music can be harnessed to power a new type of miniature medical sensor designed to be implanted in the body. Acoustic waves from music, particularly rap, were found to effectively recharge the pressure sensor. Such a device might ultimately help to treat people stricken with aneurisms or incontinence due to paralysis...

Jan 30, 2012 01:00AM

Patient Care Could Be Revolutionized By Diagnostic Brain Tumor Test

Researchers at UT Southwestern Medical Center have developed what they believe to be the first clinical application of a new imaging technique to diagnose brain tumors. The unique test could preclude the need for surgery in patients whose tumors are located in areas of the brain too dangerous to biopsy...

Jan 29, 2012 01:00AM

Creation Of New Atomic X-Ray Laser Offers Potential For New Medicines, Devices And Materials

Lab scientists and international collaborators have created the shortest, purest X-ray laser pulses ever achieved, fulfilling a 45-year-old prediction and ultimately opening the door to new medicines, devices and materials...

Jan 27, 2012 05:00AM

Side Effect Severity Predicted In Head And Neck Cancer Patients By Thermal Imaging To Detect Oral Temperature Changes

Slight temperature increases of the oral mucus membranes early in a head and neck cancer patient's chemotherapy and radiation therapy (chemoradiotherapy) treatment is a predictor of severe mucositis later in treatment, according to a study presented at the Multidisciplinary Head and Neck Cancer Symposium, sponsored by AHNS, ASCO, ASTRO and SNM...

Jan 27, 2012 02:00AM

An Earlier Sign Of Autism In The Brain

In their first year of life, babies who will go on to develop autism already show different brain responses when someone looks at or away from them...

Jan 27, 2012 01:00AM

Patient-Centered Approach To Replacing Implantable Cardioverter-Defibrillators Suggested By Cardiologists

More than 100,000 implantable cardioverter-defibrillators (ICDs) are implanted in the United States annually, fully a quarter of those are generator replacements simply because the battery is depleted. But are all those replacements necessary and should they actually be performed? Writing in the Jan...

Jan 27, 2012 01:00AM

In Battle To Prevent Pandemic Infection, Clinical Technique Sets New Standard For Speed

A new diagnosis technique developed by researchers at the RIKEN Omics Science Center (OSC) has succeeded in detecting influenza virus infection in only 40 minutes and with one hundred times the sensitivity of conventional methods...

Jan 26, 2012 03:00AM

Engineered Bacteria Effectively Target Tumors, Enabling Tumor Imaging Potential In Mice

Tumor-targeted bioluminescent bacteria have been shown for the first time to provide accurate 3D images of tumors in mice, further advancing the potential for targeted cancer drug delivery, according to a study published in the Jan. 25 issue of the online journal PLoS ONE...