Power Capital Consulting
Biotech News
May 19, 2012 06:18AM
May 18, 2012 08:34AM
Cancer Genetics' IPO delayed amid Facebook frenzy
Cancer Genetics has nixed plans to launch an initial public offering this week, having planned to raise $48 million to advance a pipeline of molecular diagnostics for cancer, Renaissance Capital reported Thursday. Last week Rib-X Pharmaceuticals delayed its own IPO, following a history of biotechs struggling to trade their shares on the public market. Seeking Alpha reasoned this week that Cancer Genetics' IPO might be small enough to slip through even though Wall Street has been bracing for the blockbuster maiden offering of Facebook. Guess not. Item
May 18, 2012 08:33AM
Over the last few years, the whole drug R&D ecosystem has been undergoing a sea change. Productivity in R&D on the Big Pharma side of the equation has been abysmal. And on the biotech side the emphasis has been on capital efficiency and cutting-edge innovation--which don't necessarily go hand in hand.
As a result of these forces, we're seeing pharma breaking down many of the old barriers that had been established to guard the research castle. Pharma scientists are being reorganized into smaller groups and redeployed to get closer to the top development hubs, while companies restructure internal research divisions from soup to nuts. And biotechs have been springing up in the richest fields aiming to advance disruptive ideas, increasingly looking to partner up with pharma at a very early stage of development.
Getting to mid-stage proof of concept data on a careful budget is now one of the most demanding mandates in the industry. And I'll be moderating a breakfast panel on June 19 with a group of experts who will explore just how this trend is reshaping the way drugs are discovered and developed.
Joining us at the Westin Waterfront in Boston will be Jason Gardner, head of the Center of Excellence in External Drug Discovery for GlaxoSmithKline; "Mene" Pangalos, executive vice president, innovative medicine, at AstraZeneca; Jim Burns, head of the Sanofi Boston R&D hub; biotech veteran Jill Milne, who helped found the virtual biotech company Catabasis Pharmaceuticals; and Bernard Munos, the founder of the InnoThink Center for Research in Biomedical Innovation, one of the most influential industry voices calling for change in R&D.
We're hosting this discussion as an affiliated event to the big BIO annual confab. So if you're already in Boston, or planning to attend BIO, I hope to see you there. It's one of the most important discussions now under way in biopharma. You won't want to miss it. And if there's something you'd like to tell me about, be sure to come by after the breakfast. I'm staying until the last guest leaves. Register for the breakfast here. -- John Carroll, Editor-in-Chief. Follow me on Twitter and LinkedIn.
May 18, 2012 08:24AM
Massachusetts plants seed for new biotech destination
With plans to kick-start a bumper crop of biotech activity in Fall River, MA, Massachusetts officials are touting plans for a $28 million biotech facility in the southeastern part of the Bay State. Plans call for the Massachusetts Accelerator for Biomanufacturing to attract a host of startups and companies that will hopefully put the small city on the biotech map.
Yet the site is far from even approaching the biotech largesse of Boston/Cambridge. This week Gov. Deval Patrick and officials from the University of Massachusetts, which will run the new facility, stood on the muddy construction site and talked up the future prospects of the project, The Herald News reported. With grand projections to employ 8,000 people at a life sciences park planned for the area, the biotech facility is expected to house a modest 10 UMass employees when it opens next year.
Patrick championed the growth of the life sciences industry in the Bay State with a $1 billion plan to stimulate biotech activity that was passed early in his first term, yet lawmakers from around the state demanded that the money flow to areas outside of the state's industry core in the Boston area. The state's Life Sciences Center, which administers the stimulus money, granted about half of the funding for the project with UMass and other sources cobbled together the rest, according to the Herald.
Fall River has a history as a hub of manufacturing in the Bay State, and officials hope that the production of life sciences products in the city will bring new jobs. The new facility will serve as a test site for producing biotech products and house startups involved in life sciences.
- here's the Herald article
Related Articles:
Biotech building boom restricted to top 'micro' hot spots
Biotech clusters defend their turf as challenges mount
Boston biotech hub spawns more jobs, grabs big share of VC bucks
May 18, 2012 07:16AM
New cloud hovers over class of 'good cholesterol' drugs
Fresh doubts have cropped up for raising "good cholesterol" to combat heart attack risk, after a new study showed that patients genetically programmed to have higher levels of HDL cholesterol didn't appear to be more protected from heart disease than those with low levels. The news comes as Merck ($MRK) and Eli Lilly ($LLY) are spending millions of dollars to develop HDL-raising treatments, aiming to deliver on the blockbuster potential of the CETP drug class.
"I'd say the HDL hypothesis is on the ropes right now," said outside observer Dr. James A. de Lemos, a professor at the University of Texas Southwestern Medical Center, as quoted by The New York Times.
The HDL mechanism took a recent blow last week when Swiss drug giant Roche ($RHHBY) announced that it was nixing development of its contender designed to raise good cholesterol to thwart heart disease because of absent efficacy, following previous failures at Pfizer ($PFE) and Abbott ($ABT). Informed of the new genetic study revealed this week in The Lancet, Merck and Lilly representatives told the Times that the companies were both undeterred and continuing with their massive CETP programs. Yet the findings have dampened expectations for the drugs.
"This will have a sobering effect, it would have to," said John LaMattina, a senior partner at PureTech Ventures and former Pfizer R&D chief, as quoted by Bloomberg. "HDL has always been a controversial area. You have a question that you have to be willing to commit over a billion dollars in order to get the answer, and that is a very daunting commitment."
With billions of dollars in development costs and potential revenues on the line, expect scientists inside and outside of biopharma companies to take heed of the findings and dig deeper into the role of HDL in heart disease. As the Times notes, mouse studies showed that HDL carried cholesterol out of the arteries. But scientists will now look into whether HDL is an indicator or driver of reduced heart-attack risk.
- read the NYT's article
- and Bloomberg's report
Related Articles:
Roche abandons potential blockbuster cholesterol drug
Developers spotlight huge potential of new class of cholesterol drugs
Lilly heralds PhII success for mega-blockbuster cholesterol drug contender
May 18, 2012 07:09AM
Kleiner Perkins to back early-stage biotechs with $525M fund
![]() |
| Beth Seidenberg, Investment Partner--Source: KPCB |
Kleiner Perkins Caulfield & Byers has closed the books on a new $525 million fund. And a chunk of that treasure is earmarked for early-stage life science companies promising to satisfy Kleiner Perkins' trademark appetite for disruptive new technologies.
"Portfolio companies in KPCB 15 will benefit from the firm's holistic approach to company building that we pioneered more than a decade ago," said Ted Schlein, partner at KPCB, in a statement. "We will identify promising early-stage companies in our areas of focus and bring value-added resources in key areas to help early-stage companies grow and succeed. This includes applying our considerable industry, operational and financial expertise and network of relationships to help entrepreneurs build lasting enterprises."
Among the group of partners with a key to the cash box is Beth Seidenberg, the former chief medical officer at Amgen ($AMGN) who has been handling the fund's investments in Tesaro, Epizyme, iPierian and Auxogyn, among others. KPCB has also invested in Foundation Medicine and Celladon.
Seidenberg's interest in biotech goes well beyond the boardroom. She's been one of the leading forces at the Medical Innovation and Competitiveness Coalition, which joined up with the National Venture Capital Association to apply pressure on the FDA to change. The lobbying effort has helped inspire new legislation aimed at speeding drug approvals while putting the FDA on the defensive about its regulatory track record.
"The major problem is the lack of predictability, which leads to delayed timelines," Seidenberg told The Wall Street Journal last fall. "Entrepreneurs are smart people, and they want to get their products to patients. And because of the lack of transparency, and the lack of consistency (at FDA), they are moving to Europe, setting up their organizations and creating jobs overseas."
- here's the press release
Related Articles:
Google, Kleiner Perkins boost sequencing startup's A round to $33.5M
Foundation Medicine raises $33.5M in expanded Series A
May 18, 2012 06:03AM
Canada hands Osiris historic approval for stem-cell drug
Osiris Therapeutics ($OSIR) has made history. The Columbia, MD-based biotech has won the first approval of an off-the-shelf therapy made with stem cells, a major milestone for the field but one with unremarkable business implications for the developer.
Canadian authorities have stamped an approval on Osiris' Prochymal, a drug made with mesenchymal stem cells from adult donors, to treat certain children with potentially lethal graft versus host disease (GvHD), the company announced Thursday. The stem-cell drug has approval only for children whose disease can't be controlled with steroids, which doctors typically use to ward off the immune attacks from the ailment. Osiris will have to conduct post-approval clinical studies as a condition of the market nod for the treatment in Canada.
"This is the first regulatory approval of a stem-cell drug--where the active ingredient of the drug is a stem cell--in the world," Osiris CEO Randal Mills said, as quoted by Bloomberg. "It's a huge deal for us and a huge deal for the entire field of stem-cell therapy."
The approval provides a welcome turnaround for Osiris, which has been riddled by a string of recent setbacks. In February French drug giant Sanofi ($SNY) ditched work on Prochymal, for which the company had rights the sell outside of North America, The New York Times reported. The FDA last year rejected Osiris' bid for approval of the therapy as a treatment for GvHD, requesting more data from the developer. And the stem-cell field as a whole suffered a blow when Geron ($GERN) revealed last year that the biotech was shutting down its stem-cell programs.
Yet Osiris hasn't hit the jackpot. After spending years developing Prochymal, the company is expected to make only modest revenues from the drug for children in Canada with GvHD. Piper Jaffray analyst Edward Tenthoff projected sales of the drug to hit $16.7 million next year, Bloomberg reported. In the meantime, Osiris aims to build on this approval with another regulatory submission in the U.S. this year and has been developing the drug for other uses such as Type 1 diabetes, Crohn's disease and for patients who have suffered heart attacks.
- here's the release
- get more from the NYT article
- check out Bloomberg's report
Related Articles:
Osiris stem cell treatment can't beat placebo in diabetes study
Stem cell research progress proliferating in 2012
May 17, 2012 04:26PM
Allergan to enlist new hires in R&D expansion
After other pharma players have slashed thousands of jobs in New Jersey, Botox maker Allergan ($AGN) has ambitious plans to swell its ranks with the opening of a new R&D facility in the Garden State. The news comes amid a major push at Allergan to expand the use of Botox far beyond fixing facial wrinkles and to develop therapies for a variety of ailments.
Irvine, CA-based Allergan aims to build a 93,000-square-foot R&D expansion in Bridgewater, NJ, with the help of $14.9 million grant awarded last year from the state's economic-development authority, the New Jersey Star-Ledger reports. The timing and exact number of new jobs planned at the Allergan facility was unclear, though the newspaper wrote that the facility was expected to bring 400 jobs to the state.
FierceBiotech left a message for Allergan to seek clarification, as it wasn't clear how many of the 400 new jobs would be for R&D positions and other roles at the new facilities.
Allergan--which is known for Botox and products such as the Lap-Band obesity device--hit $1.6 billion in Botox sales last year and aims to expand use of the product in new indications such as a blockbuster use treating arthritis. The company, which about 10,000 employees in 100 countries, has many developmental projects in the pipeline in the fields of neurology, ophthalmology, dermatology, urology and devices.
"As a multispecialty health care company, a critical component to our business is the scientific innovation derived from the work of our R&D facilities throughout the United States," Allergan Spokeswoman Cathy Taylor said, as quoted by the Star-Ledger. "The expansion of our facility in New Jersey will enable us to further enhance our product pipeline and advance our pursuit of novel medical therapies for patients."
- see the Star-Ledger's article
Related Articles:
NJ wins heated competition for Allergan's new R&D facility
Allergan asks FDA for lucrative new Botox indication
Allergan to plow $350M into bigger Botox capacity
May 17, 2012 09:28AM
Pfizer's targeted drug knocks out child cancers in small study
Some of the biggest headlines coming out of the massive ASCO abstract release aren't focused on a promising experimental treatment. They're about Pfizer's ($PFE) recently approved treatment Xalkori. Now targeted at non-small-cell lung cancer tumors with ALK gene abnormalities, Xalkori was tested in children with rare cancers also linked to those defects. And its success in those kids illustrates how targeted drugs can progress beyond their initial uses to other cancers with similar genetic characteristics. FiercePharma's Tracy Staton reports on the ASCO news in our team coverage. Report
May 17, 2012 09:20AM
Study: FDA outpaces the EMA on drug reviews, new approvals
After cranking up as much pressure as the industry could muster over the last year, lawmakers have been queuing up new laws aimed at speeding the FDA's review of drugs while gaining fresh pledges from regulators on flexibility and swifter decision-making. But a new study published in The New England Journal of Medicine concludes that an objective look at the data scuttles the whole notion that regulators in the U.S. are too slow when it comes to saying yes to a new therapy.
Investigators looked at every approval handed out for a new chemical entity between 2001 and 2010. They found that FDA regulators were on average 15% faster than either the EMA or Health Canada. Of the 225 drug applications studied, the average review time hit 322 days at the FDA. And the U.S. agency was the first to approve two of every three new drugs filed with both the FDA and the EMA.
"This allows us to focus on the important question of whether there are real barriers to drug innovation in the U.S.," Kathleen Stratton of the Pew Charitable Trusts told the AP. "But it's clear from this study that the speed at which the FDA reviews drug applications is not one of them." Pew, a noted advocate for public safety, funded the study undertaken by investigators at Yale and the Mayo Clinic.
It's unlikely that many executives in the biopharma industry would agree with that remark. Negotiations over the new PDUFA law includes pledges of speedier reviews and more predictable responses. That came after a long and intense campaign in which industry leaders moaned about the risky and enormously expensive drug development process. And some might argue that just because U.S. regulators are faster than colleagues in Europe and Canada, that doesn't make them as fast as they should be.
One other point: The review was limited to approved drugs, excluding the time involved for drugs that were ultimately red-flagged by the agency.
- here's the AP report
Related Articles:
Regulators start thinking creatively about new approval pathway
Conflict threatens as FDA user-fee bills near a vote
Spike in approvals can't quell industry protests about the FDA
FDA combats criticisms over speed with ESRD pathway
May 17, 2012 08:25AM
HGS faces skeptics as it boasts of a crowded bargaining table
Human Genome Sciences has prescribed a poison pill for GlaxoSmithKline's hostile takeover bid. And after making a detailed case for a much better buyout deal, the biotech says it's already engaged in talks with other pharma and biotech companies interested in bidding on the company.
In a lengthy statement, HGS ($HGSI) asserts that it "has entered into confidentiality agreements with certain parties and is providing those parties an opportunity to engage in a due diligence review of confidential information." And the company goes on to complain that GSK ($GSK), its long-time development partner with an intimate understanding of the company's potential, simply waited until its share price hit a 52-week low before pouncing.
The biotech's remarks include a detailed case for its pipeline, which includes the potential blockbuster darapladib, a heart drug. Albiglutide, an experimental treatment for diabetes, is tied to $150 million in potential milestones alone. But the argument made little headway with at least one key analyst.
"This is all the usual and expected posturing," Cowen's Eric Schmidt noted to Bloomberg. "I believe GSK remains committed to buying HGSI and do not expect others to have much interest."
- here's the press release
- read the Bloomberg report
- get the story from The New York Times
Related Articles:
Glaxo goes hostile on HGS with $2.6B bid
GSK raises fists in $2.6B hostile bid for Human Genome Sciences
Pharma rides a wave of targeted M&A deals
Medical Device and Diagnostics News
May 19, 2012 06:02AM
May 18, 2012 02:00AM
Cheap New Paper-Based Diagnostic Test For Diabetes
With epidemics of Type 2 diabetes looming in rural India, China and other areas of the world where poverty limits the availability of health care, scientists are reporting development of an inexpensive and easy-to-use urine test ideally suited for such areas...
May 17, 2012 02:00AM
Groundbreaking Advance In Medical Diagnostics
Researchers have created an ultrasensitive biosensor that could open up new opportunities for early detection of cancer and "personalized medicine" tailored to the specific biochemistry of individual patients. The device, which could be several hundred times more sensitive than other biosensors, combines the attributes of two distinctly different types of sensors, said Muhammad A...
May 16, 2012 09:00AM
Keeping Ahead In The Medical Device Sector
"Medical device industry executives often develop products that are deemed safe and effective by the FDA, but that do not sell as they are not reimbursable," says Donald DeLauder, Executive Director - Corporate Innovation, Bayer Radiology and Interventional. They must spend more time on developing their products, he adds...
May 16, 2012 09:00AM
Optimizing Process Management In Medical Device Manufacturing
Medical device manufacturing executives are currently challenged with getting products to market faster; however with increased FDA regulatory requirements and validations, they must ensure that the manufacturing processes are robust, says William J. Bergen, President & Chief Executive Officer, MicroGroup. Effective and timely communication at each stage of production is crucial, he adds...
May 16, 2012 02:00AM
Key Genes And Prototype Predictive Test Identified For Schizophrenia
An Indiana University-led research team, along with a group of national and international collaborators, has identified and prioritized a comprehensive group of genes most associated with schizophrenia that together can generate a score indicating whether an individual is at higher or lower risk of developing the disease...
May 16, 2012 01:00AM
An ultrasound scan, also referred to as a sonogram, diagnostic sonography, and ultrasonography, is a device that uses high frequency sound waves to create an image of some part of the inside of the body, such as the stomach, liver, heart, tendons, muscles, joints and blood vessels. Experts say that as sound waves, rather than radiation are used, ultrasound scans are safe...
May 15, 2012 05:00AM
Any And All Toxic Materials Identified By "Dip Chip" Technology On-The-Go
From man-made toxic chemicals such as industrial by-products to poisons that occur naturally, a water or food supply can be easily contaminated. And for every level of toxic material ingested, there is some level of bodily response, ranging from minor illness to painful certain death. Biosensors have long been used to safeguard against exposure to toxic chemicals...
May 15, 2012 03:00AM
Medical Device Controls Acute Inflammation, May Prevent Sepsis
The body's natural inflammatory response is an essential reaction to injury and infection. When acute inflammation escalates out of control, such as in sepsis, it causes nearly 10% of deaths in the U.S. and more than $17 billion in healthcare costs each year...
May 15, 2012 03:00AM
Immune System Model Created To Predict Vaccine Efficacy And Safety
Vaccine testing and development is an extremely lengthy and complex process that costs billions of dollars every year. In an effort to dramatically improve the speed and success of vaccine research and development, researchers have created an innovative biomimetic model of the human immune system known as the MIMIC system...
May 15, 2012 03:00AM
Research from North Carolina State University will allow the development of energy-efficient LED devices that use ultraviolet (UV) light to kill pathogens such as bacteria and viruses. The technology has a wide array of applications ranging from drinking-water treatment to sterilizing surgical tools...
May 15, 2012 01:00AM
Automated External Defibrillators Rarely Close To Locations Of Public Cardiac Arrests
More than 75 percent of cardiac arrest victims are stricken too far away from an automated external defibrillator for the lifesaving device to be obtained quickly enough to offer the best chance at saving their lives, according to new research from the Perelman School of Medicine at the University of Pennsylvania that was presented at the annual meeting of Society for Academic Emergency Medicine...
May 15, 2012 01:00AM
Novel Self-Adhesive Device To Diagnose Irregular Heartbeat
A study conducted at Scripps Health has found that a novel new heart monitoring device helped emergency room patients avoid unnecessary follow-up care...
May 14, 2012 02:00AM
Vision Loss Due To Degenerative Eye Diseases May Be Restored By New Type Of Retinal Prosthesis
Using tiny solar-panel-like cells surgically placed underneath the retina, scientists at the Stanford University School of Medicine have devised a system that may someday restore sight to people who have lost vision because of certain types of degenerative eye diseases...
May 14, 2012 01:00AM
Unsedated Transnasal Endoscopy To Screen For Esophageal Disease Is Safe And Feasible
Researchers report that unsedated transnasal endoscopy is a feasible, safe, and well-tolerated method to screen for esophageal disease in a primary care population. This study is the largest reported experience with transnasal endoscopy in the United States...
May 13, 2012 01:00AM
Gene Expression By Ultraviolet
Imagine being able to control genetic expression by flipping a light switch. Researchers at North Carolina State University are using light-activated molecules to turn gene expression on and off. Their method enables greater precision when studying gene function, and could lead to targeted therapies for diseases like cancer...
May 12, 2012 01:00AM
New research from the University at Buffalo suggests that cardiologists may have a new way to identify patients who are at the highest risk of sudden cardiac arrest, and the most likely to benefit from receiving an implantable cardiac defibrillator (ICD). ICDs are used to prevent sudden cardiac arrest in patients with advanced heart disease, but many patients' devices are never triggered...
May 11, 2012 02:00AM
Better than antibiotics, it is being used in contact lenses to prevent infections and biomedical products are the next stage The superbugs have met their match. Conceived at Nanyang Technological University (NTU), it comes in the form of a coating which has a magnetic-like feature that attracts bacteria and kills them without the need for antibiotics...
May 11, 2012 01:00AM
New Diagnostic Approaches May Help Assess Brain Function In Unconscious, Brain-Injured Patients
Disorders of consciousness such as coma or a vegetative state caused by severe brain injury are poorly understood and their diagnosis has relied mainly on patient responses and measures of brain activity...
May 11, 2012 01:00AM
Cardiac catheterization - an invasive diagnostic procedure that allows doctors to see the vessels and arteries leading to the heart and its chambers - is performed thousands of times in the United States each year and, in some cases, can be the best method to diagnose heart problems...
May 10, 2012 02:00AM
Designing Better Prosthetic Limbs
People walking normally, women tottering in high heels and ostriches strutting all exert the same forces on the ground despite very differently-shaped feet, according to research funded by the Wellcome Trust and the Biotechnology and Biological Sciences Research Council...
May 10, 2012 02:00AM
Vibration Powers Portable Diagnostics
As medical researchers and engineers try to shrink diagnostics to fit in a person's pocket, one question is how to easily move and mix small samples of liquid. University of Washington researchers have built and patented a surface that, when shaken, moves drops along certain paths to conduct medical or environmental tests...
May 10, 2012 02:00AM
Newly published results from a clinical study of the Diabetes Insulin Guidance System (DIGS?), under development by Hygieia, Inc., demonstrate DIGS' potential to improve blood glucose control for insulin-using patients with type 2 or type 1 diabetes. DIGS automatically adjusted insulin dosage based on each individual's reported blood glucose results...
May 10, 2012 02:00AM
Droplet Array Sheds Light On Drug-Resistant Cancer Stem Cells
Researchers at the Institute of Bioengineering and Nanotechnology (IBN), the world's first bioengineering and nanotechnology research institute, have developed a miniaturized biochip for investigating the effect of drugs on cancer stem cells (CSCs). Published recently in Nano Today, this new technology could boost the development of more effective cancer drugs...
May 10, 2012 01:00AM
Quality Of Life And Symptoms Rapidly And Significantly Improved By Non-Drug Depression Treatment
New data released at the annual meeting of the American Psychiatric Association show that patients with unipolar, non-psychotic Major Depressive Disorder (MDD) receiving transcranial magnetic stimulation (TMS) with NeuroStar TMS Therapy achieved significant improvements in both depression symptoms and in quality of life measurements...
May 09, 2012 03:00AM
After ICD implants, Heart Patients With A Distressed Personality Reported Worse Health
People with a distressed (Type D) personality reported worse health than other patients after having devices implanted to ensure proper heart rhythm, according to new research in Circulation: Cardiovascular Quality and Outcomes, an American Heart Association journal...
Copyright 2012 Medical News Today