Windhover's Commentary

Deals in Depth: September 2008 (IN VIVO)

IN VIVO

September 2008 dealmaking highlights: Medivation landed a potential $725mm through its deal with Pfizer for AD/Huntington's candidate Dimebon. In top M&As, Japanese firm Shionogi acquired US-based Sciele for $1.4bn and Getinge paid $841mm for fellow CV-focused Datascope. Compared with September, FOPO money into biopharma almost doubled thanks to Vertex's $218mm offering, while on the device side no follow-ons were completed and private financing decreased about $100mm.

Pharmaceutical/Biotechnology Deal Statistics Quarterly, Q3 2008 (IN VIVO)

IN VIVO

Highlights from the Q3 2008 review of pharmaceutical and biotechnology dealmaking: Financing dollar volume was more than twice that of Q2 with 105 deals bringing in over $4.4 billion, but not one IPO to be found. M&A dollars also nearly doubled to $23 billion in the third quarter--versus the previous three months--and of the 26 transactions with known values, more than half were over $100 million. Alliances saw activity focused primarily in two areas: drug delivery and large molecules, each category with 16 deals apiece. Total potential deal value (for the 43 alliances with known values) reached $4.5 billion, over one and a half times that of the previous quarter.

Economic Forecast for Pharma: Winter Weather Advisory Ahead (IN VIVO)

IN VIVO

Pharma has weathered its share of economic downturns, but the data shows that the industry could be in for a tough winter. Prolonged cutbacks by consumers failing to refill prescriptions in tough economic times could become yet another obstacle for drug manufacturers already facing plenty of challenges in the coming year in the form of patent expirations, lackluster pipelines and stricter regulatory oversight.

Northstar's Second Chance (IN VIVO)

IN VIVO

For Northstar Neuroscience, which is exploring new approaches for neurostimulation devices, the decision to take the money and run when the device IPO window was open in 2006 has meant the difference between survival or closing up shop. The FDA's recent approval of the company's second study of its Renova cortical stimulation device for the treatment of major depressive disorder is one sign that reports of Northstar's demise may, have been premature. The company's second chance can largely be attributed to the fact that it flew in the face of conventional wisdom that held that it was too early for the company to go public in 2006.

End of an Era for GSK and Exelixis (IN VIVO)

IN VIVO

GlaxoSmithKline in October decided to decline its option to license Exelixis's late-stage XL184 small molecule oncology candidate and four earlier-stage compounds, effectively ending the six-year R&D collaboration between the two firms. The decision ends an early foray into license-and-option agreements by GSK, a company that has been at the forefront of striking option deals over the past several years. Its latest such agreement was announced the same day the Exelixis deal wrapped, as part of an alliance with the Austrian vaccines play Affiris in the area of Alzheimer's disease.

Best of the IN VIVO Blog, October 2008 (IN VIVO)

IN VIVO

Best of the Blog is a monthly column highlighting the best of our free online content at www.windhover.com/blog. In October, Windhover's editorial staff posted 36 articles to the site, covering biopharma, device and diagnostics R&D, business development, regulatory and commercial news. A few of our favorite blog posts include: Lilly's Prasugrel Delay; Glaxo has Seen the Future and the Future is Mouthwash; and FDA Has a New Guard Dog and He's a Wolfe.

Can Big Pharma Save Biotech Investors? (IN VIVO)

IN VIVO

All the biotech stock indices are down; record numbers of companies are selling at lower-than-cash valuations. Investors want Pharma to step up and buy, removing inventory from the market, and spreading limited investment dollars over a smaller set of opportunities. While buyers say they aren't going to radically change their strategies simply to take advantage of cheap prices, it's clear that more deals will get signed - mostly because more sellers will accept terms they once would have rejected. . In short, a hotter dealmaking climate will keep biotech healthy enough to survive as an industry, albeit a smaller one, and, perhaps, with a slightly lower ceiling on returns.

Public Device Companies Take a Hit, But Still Stand (IN VIVO)

IN VIVO

The health care sector has traditionally provided a haven for investors seeking the security of an industry blessed with a rock solid customer base. After all, consumer confidence plays a limited role in the bulk of health care decisions. But IN VIVO's survey of 62 publicly traded medical device companies shows the sector has taken a beating along with the rest of Wall Street. Surprisingly, potentially vulnerable sectors, like orthopedics and big ticket equipment, have shown a remarkable resiliency.

Pfizer's Increasingly Specialist Focus (IN VIVO)

IN VIVO

Pfizer's brand-new oncology business unit appears to be the linchpin in its transformation from primary care behemoth to specialty powerhouse. The Big Pharma also followed this up with the announcement that it was cutting early-stage R&D programs focused on obesity, bone health, and what has been its mainstay--cardiovascular disease. Together, these moves should be viewed as the most extreme example of the industry's flight from primary care medicine into the safer haven of specialty-focused pharmaceuticals,

Ablation Frontiers: Making AF Ablation Simple and Universal (IN VIVO)

IN VIVO

Despite widespread and increasing prevalence, atrial fibrillation has frustrated clinicians, device companies, and investors, resulting in only a small number of doctors treating a small number of patients. Ablation Frontiers believes its system will finally enable many more doctors to treat all types of AF patients because it is developing products and procedures that are simpler for doctors to use and perform, finally providing a broad-based solution to this rapidly growing market.

Regulatory Risk and Business Development: Type 2 Diabetes Falls Out of Favor (IN VIVO)

IN VIVO

If you think this is a bad time to try to get a loan, try selling a type 2 diabetes research project to a Big Pharma company. Diabetes, simultaneously one of the largest yet most under-treated prescription drug markets in the world, is suddenly out of favor with Big Pharma business development executives. And the reason isn't hard to spot: the belief that regulatory hurdles have fundamentally changed the business case for drug development in the category.

On the Frontiers of Surgery: An Interview with Fred Moll, MD (IN VIVO)

IN VIVO

Few people have been so integrally connected to surgery's various revolutions as Fred Moll, MD. Two decades ago Moll introduced one of the first enabling tools designed specifically for minimally invasive surgery, ushering in an age of surgery in closed spaces, before turning his attention in the 1990s to surgery's revolution-in-waiting, robotics, helping to launch the MIS revolution, In a recentinterview, Moll talks about those early days, what it was like for a young surgeon to build his first companies, and about the promise of robotics for the future of medicine.

Selected Start-Ups (11/2008) (IN VIVO)

IN VIVO

In Vivo briefly describes these recently founded companies: Archer Pharmaceuticals, Arginetix, Carmat, Catena Pharmaceuticals, EnzymeRX, and P&H Therapeutics.

Start-Up Previews (11/2008) (IN VIVO)

IN VIVO

A preview of the emerging health care companies profiled in the current issue of Start-Up. This month's profile group, "In Immunotherapy, Finally Time for T Cells?," features profiles of Adaptimmune, Altor BioScience, and Cell Medica. Plus these Start-Ups Across Health Care: Adnavance Technologies, Amplyx Pharmaceuticals, IlluminOss Medical, and KM Medical.

On the Move (Company Changes and Promotions (11/2008) (IN VIVO)

IN VIVO

Recent executive-level company changes and promotions in the biotech, pharmaceutical, and medical device industries.

Deals Shaping the Medical Industry (11/2008) (IN VIVO)

IN VIVO

The dealmaking column is a survey of recent transactions, including strategic alliances, mergers & acquisitions, and financings, in the life sciences industries. Deals are listed by the following industry sectors: in vitro diagnostics, pharmaceuticals, medical devices, and research/analytical instrumentation and reagents. All transactions are excerpted from Windhover's Strategic Transactions Database, providing comprehensive transaction coverage from 1991 to the present.

What's Next for Cardiovascular Systems? (Start-Up)

Start-Up

Cardiovascular Systems beat out 119 other suitors for the right to purchase publicly traded biopharma company, Replidyne, which had fallen on hard clinical times, or, more precisely, to acquire the company's place on the public markets. But now what? With CVS headed toward the public market, it will be interesting to see how the company is valued by public investors after its merger is complete. This month, we survey small cap medical device companies that are in similar situations to see how they're faring on the public markets.

Neuronetics' FDA Nod Opens Doors to New CNS Market (Start-Up)

Start-Up

The seeds planted in neurostimulation ventures over the past 10 years have produced more disappointments than results, but the fallow period is over. The Food & Drug Administration recently cleared Neuronetics to begin selling its NeuroStar TMS as a treatment for people who haven't responded to a drug regimen taken during their current episode of depression. This is good news for scores of venture-backed neurostimulation companies, although Neuronetics is somewhat unique. It is developing a non-invasive device that delivers magnetic, rather than electrical pulses.

Vitae's Debt Financing: Crucial Lifeline in a Tightening Financial Market (Start-Up)

Start-Up

Roughly one week after GlaxoSmithKline gave Vitae Pharmaceuticals back rights to its renin inhibitor, the biotech signed a $13 million loan deal with Silicon Valley Bank and Oxford Finance, providing a cash runway at least into 2010. The cash lifeline was relatively small in dollar value but significant for even happening in the first place. The hard economic times have all but shut down the venture capital supply, leaving serious questions about money strategies for other biotechs.

For GlobeImmune, Early HCV Vaccine Data May Spark Coveted Partnership (Start-Up)

Start-Up

The first big reveal has arrived for GlobeImmune. On November 1, the company presented positive interim Phase II clinical trials data at the 2008 American Association for the Study of Liver Diseases meeting showing that its GI-5005 hepatitis C vaccine doubled viral clearance in all major patient populations tested in its randomized, multi-center trial. These data represent early but important evidence that a patient's natural immune response can be harnessed to positively influence important virologic endpoints with the potential to impact the course of chronic HCV infection.

The Golden Age in Cancer Medtech Investing (Start-Up)

Start-Up

Short of investing in the kinds of products that must demonstrate five-year survival rates, the field of cancer offers many near term investment opportunities, and large markets to support them. As noted in US Disease Incidence and Prevalence, a report recently published by the Medtech Insight division of FDC-Windhover, like many diseases, the incidence of cancer increases with age. More than 10.8 million people in the US have a history of cancer; and in 2008, at least 1.4 million more people will be diagnosed. According to the Medtech Insight report, breast cancer has the highest prevalence rate, followed by prostate and colorectal cancers.

Start-Up Quarterly Statistics, Q3 2008 (Start-Up)

Start-Up

Start-Up analyzes fundraising and alliances among emerging companies in the biopharmaceutical, medical device and in vitro diagnostics segments from July through September 2008. Data comes from FDC-Windhover's Strategic Transactions Database.

Best of the IN VIVO Blog (11/2008) (Start-Up)

Start-Up

Best of the Blog is a monthly column highlighting the best of our free online content at www.windhover.com/blog. In November, Windhover's editorial staff posted 36 articles to the site, covering biopharma, device and diagnostics R&D, business development, regulatory and commercial news. Highlights include : Fundrasing...Forget about it. Exits: Drought is an understatement. But there's new hope for biotech: In starkest terms, the regulatory system, the single biggest stumbling block to pharmaceutical success, is tilting biotech-wards.

Can Nanotech Be a Game-Changer for In Vitro Diagnostics? (Start-Up)

Start-Up

People have awakened to the opportunities in diagnostics. Molecular information offers the potential for increased test sensitivity, and reduced upfront sample prep using nanotechnology could provide the means for many gene- and protein-based diagnostic tests to transition out of the central lab. Nanotech may also enable the use of newly discovered or newly usable biomarkers. Finally, unlike the traditional point-of-care model, a new wave of nanotech-based instruments could bring testing even closer to the patient.

Will Simpler Devices Tap the Largest Diabetes Market? (Start-Up)

Start-Up

The clinical community and the medical device industry are finally turning their attention to the majority of patients with diabetes: the type 2s. They're an underserved group in a potential market that dwarfs that of type 1 diabetes. Health Advances LLC believes that the next disruptive technology in diabetes management will come in the form of lower-cost, easy-to-use insulin pumps for the masses. And there are at least 16 such pumps in development. (See also the sidebar, CeQur: Conforming to the Lifesyle of the Type 2).

CeQur: Conforming to the Lifestyle of the Type 2 (Start-Up)

Start-Up

Insulin delivery devices don't fit into the lifestyles of patients with type 2 diabetes so they don't comply with their prescriptions. As a result, patients don't feel as well as they could today and down the road face the complications of poorly controlled diabetes. CeQur hopes to offer patients with diabetes a simple, inconspicuous and disposable patch pump that they can stick on the body. There will be no complicated programming or instructions--they'll simply dispense insulin at the touch of a button. (This article is a side bar to "Will Simpler Devices Tap the Largest Diabetes Market?" Start-Up, November 2008. )

Medtech Venture Capital Heads into Unfamiliar Terrain (Start-Up)

Start-Up

The landscape in medtech investing is changing, and one need only look at two signposts to see that this is so: the exit values of VC-backed companies over the past eight years (lower than anticipated), and the amount of time required to achieve those exits (longer than ever before). De Novo Ventures' Richard Ferrari presents the trends that emerge from eight years of venture investing in medical technology companies.

In Immunotherapy, Finally time for T Cells? (Start-Up)

Start-Up

Immunotherapy has seen its share of failures in recent months, but T-cell oriented therapies are by no means dead in the water and therapeutic cancer vaccines continue to attract funding. This month START-UP profiles three companies that nevertheless have been able to attract funding . They aim to avoid the difficulties that have sunk other efforts to commercialize immunotherapies. The firms are transplanting T cells along with same-donor bone marrow to fight infection, delivering powerful cytokines and other therapeutic payloads via T-cell receptor targeting, and genetically enhancing the ability of T-cell receptors to recognize antigens before growing those T cells in culture and re-infusing them into a patient's body.

Adaptimmune Ltd. (Start-Up)

Start-Up

Adaptimmune has recently spun out of MediGene AG to carry forward T cell receptor engineering with HIV as its initial target. The company's ex vivo approach sees a patients' own T cells harvested, those cells' receptors genetically enhanced for increased potency against certain infections or tumors in the manner of monoclonal antibody selection, and re-infused into the patient.

Altor BioScience Corp. (Start-Up)

Start-Up

Altor BioSciences aims to exploit the intrinsic selectivity of T-cell receptors (TCRs) by pairing soluble receptors with therapeutic payloads. These TCR/drug combos are smaller than antibodies and could theoretically bind to targets within cells, not just on the cell surface, a main selling point of the firm's so-called STAR technology. At first Altor plans to enhance the safety and efficacy of existing marketed drugs by pairing them with monoclonal antibody-like TCRs for improved targeting.

Cell Medica Ltd. (Start-Up)

Start-Up

Cell Medica is pursuing what could be considered a relatively low-tech, low-risk approach to T-cell immunotherapy. The two-year-old spin-out of Imperial Innovations Group will treat immunosuppressed bone marrow donation recipients with T cells isolated from their bone marrow donors. The company's first project is in isolating cytomegalovirus-specific T cells from donors for infusion into patients who are at particular risk of CMV infection following bone marrow transplant.

Adnavance Technologies Inc. (Start-Up)

Start-Up

Even though mortality rates double each day an MRSA infection remains untreated, most hospitals have to outsource diagnostics test to off-site labs, losing precious treatment time. Adnavance Technologies hopes to change this. The company's ADNAstat amplification-free technology enalbes rapid detection of MRSA DNA on-site at any hospital.

Amplyx Pharmaceuticals Inc. (Start-Up)

Start-Up

Other companies' disappointments could turn out to be blessings for Amplyx Pharmaceuticals. The start-up thinks it has a solution for ADME problems that derail candidates in clinical trials or that lead to side effects and reduced efficacy in marketed drugs. Amplyx believes it can improve problematic small-molecule drugs by extending their half-life without making the compounds too big to be delivered orally.

IluminOss Medical Inc. (Start-Up)

Start-Up

IlluminOss Medical is pioneering a percutaneous approach for repairing broken bones. There is very little disruption to the soft tissue surrounding the affected bone, which should lead to rapid patient recoveries.

KM Medical Ltd. (Start-Up)

Start-Up

KM Medical was formed to develop a revolutionary neonatal resuscitator to meet the needs of an underserved market. KM Medical's offering is an automatic, hand-held resuscitator with transport ventilator capability designed for controlled delivery of the small volumes of air that neonates require and a display technology that verifies that delivery.

Structure Work Unveils a New Apoptosis Drug Target (Start-Up)

Start-Up

In 1997, Abbott Lab's Steve Fesik showed how a complex between a survival protein and a cell death-inducing helix interacted, triggering a spate of apoptosis-oriented (programmed cell death) cancer research. Now a research team has identified a distinct and completely unforeseen site on a death protein that activates its cell-killing function, potentially kicking off a renaissance in this still challenging field.

On The Move: Who's Going Where in Biopharma and Medtech Start-Ups (11/2008) (Start-Up)

Start-Up

Recent executive-level hires and director appointments at venture capital firms and biopharma and medtech start-ups.

Recent Financings of Private Companies (11/08) (Start-Up)

Start-Up

Emergings in Brief (11/2008) (Start-Up)

Start-Up

Brief profiles of these recently formed companies: Archer Pharmaceuticals, Arginetix, Carmat, and Catena Pharmaceuticals.

Recent Tech Transfer Deals (11/08) (Start-Up)

Start-Up

Cardiac Assist: Pumping up the Heart Failure Market (Medtech Insight)

Medtech Insight

After struggling for years to gain momentum, the ventricular assist device market appears finally to be coming of age. Second-generation VAD designs are performing well and seem to have largely addressed the pump durability and safety issues of the past that stymied growth and prevented this market from reaching its full potential. In the process, these new pumps, and their third-generation counterparts now waiting in the wings, are revitalizing interest in VADs among both physicians and patients, and propelling this potential multibillion dollar market to the forefront once again.

Spine Market: A Perfect Storm (Medtech Insight)

Medtech Insight

While most Wall Street analysts predict that the current economic crisis will have little effect on the spine industry over the long haul, there are storm clouds on the horizon that should put spine product manufacturers on guard. With crackdowns by the Department of Justice tipping over into the spine arena and whistleblower lawsuits regarding surgeon/industry relationships in the news, along with several important bills before Congress designed to change how the business of spine surgery is done, current financial constraints may be only the tip of the iceberg in terms of things to come.

Industry Outlook: Is Health Care Recession-Proof? (Medtech Insight)

Medtech Insight

In the current credit crisis, the widely held notion that health care is a recession-proof industry is being put to the test. The pretext has been that no matter how poor the economy becomes, people will still need medical treatment, and private and public insurers will still have money set aside to pay for those treatments. Although there's some validity to that oversimplification of health care as a business, it doesn't take into account the real fuel that keeps any business running--the availability of credit. While medical supply manufacturers may be in a better position than many companies in other industries, hospitals, which purchase those medical supplies, are not faring as well. That should be a concern to all.

Depression Bolsters the Neuromodulation Market (Medtech Insight)

Medtech Insight

More than a decade ago, venture capitalists identified neurostimulation as a fertile new field for investment, but efforts to date have produced more disappointments than results. The losing streak appears to be over: the FDA recently cleared Neuronetics to begin selling its NeuroStar TMS system for treatment-resistant depression. Meanwhile, Northstar Neuroscience has received FDA approval for the second study of its Renova cortical stimulation device for treating major depressive disorder.

Vertebral Compression Fracture Market Update: New Products Gain Traction (Medtech Insight)

Medtech Insight

Vertebral compression fracture repair remains one of the fastest growing segments of the spinal market. Although the VCF industry as a whole remains strong, competitive dynamics in this industry are beginning to shift, with a growing number of new products now available to address this expanding market.

Health Care Trends: The Future of Remote Monitoring (Medtech Insight)

Medtech Insight

A new report finds the US health care system could reduce costs by nearly $200 billion during the next 25 years if remote monitoring tools were utilized much more widely. These conclusions come from Robert Litan, PhD, an economist who analyzed data from a remote monitoring program at the Veterans Administration, as well as other smaller programs, and extrapolated the findings to show how much money health care could save annually if the proper remote monitoring tools were used. We interview Litan in this issue.

Market & Industry Briefs (Medtech Insight)

Medtech Insight

Brief summaries of recent medtech market and industry developments. This month we cover highlights from the Heart Failure Society of America meeting, China's streamlined regulatory requirements for imported medical devices, and the FDA's positive panel recommendation for J&J's AF ablation catheter.

Deals Update (Medtech Insight)

Medtech Insight

A roundup of recent medtech strategic alliances, mergers & acquisitions and financings.

Clinical Edge (Medtech Insight)

Medtech Insight

Brief summaries of recent advances in device research and clinical trials, including a new nanofiber to reduce scarring, a credit-card sized scanning health scanning device, a therapeutic nanobot and a program to reduce ICU-related infections.

Start-Up News (Medtech Insight)

Medtech Insight

Noteworthy news from medtech start-ups, including InspireMD's protected coronary stents and MicroTransponder's injectable neurostimulation device for pain.

Free Speech -- October 2008 (The RPM Report)

The RPM Report

FDA Advisory Committees on the Brink: More Meetings, Fewer Members (The RPM Report)

The RPM Report

A year ago, Congress sent FDA two very clear, somewhat contradictory messages: Hold more advisory committee meetings, but without the use of many expert panelists used in the past. The result is a system that is stretched to the limits.

FDA Hits the Road: Promacta's ASCO Review (The RPM Report)

The RPM Report

Biotech companies use road shows to attract investors. FDA is trying a similar approach to try to recruit advisory committee members.

Stand Up and Be Counted-Or Raise Your Hand, or Hit Your Button (The RPM Report)

The RPM Report

FDA is implementing simultaneous voting procedures for its advisory committees to help eliminate the potential for bias during deliberations. It doesn't look like everyone got the memo.

Regulatory Risk and Business Development: Type 2 Diabetes Falls Out of Favor (The RPM Report)

The RPM Report

It's a buyer's market for type 2 diabetes drugs, and you can thank FDA for that. At least, that is the sentiment of business development executives from Big Pharma. Transaction data in 2008 back up that view.

Wyeth Wary of Antipsychotics (The RPM Report)

The RPM Report

If you are looking for another category that may fall out of favor with dealmakers, consider antipsychotics. Vanda's recent setback is getting a lot of attention.

How Risky Is Too Risky? (The RPM Report)

The RPM Report

Would a Big Pharma company ever sell a product like Tysabri?

Don't Cry Too Hard for Avandia (The RPM Report)

The RPM Report

GSK suffered a major commercial loss after news of Avandia's cardiovascular safety exploded onto the market in 2007. But there is a sliver of a silver lining for GSK: FDA's post-Avandia safety rules may make it tougher for new competing products to reach the market.

Watch What You Eat: A PhRMA Marketing Code Q&A (The RPM Report)

The RPM Report

Revisions to PhRMAs 2002 voluntary marketing code that go into effect in January delve into the specifi cs of what pharma sales reps are allowed to do and what they should avoid when interacting with health professionals.

"Priority" Review Slow Down: The Prasugrel Delay (The RPM Report)

The RPM Report

FDA is looking at a February advisory committee for the Lilly/Daiichi anti-clotting drug. That would put the review of the "priority" application at 14 months and counting. What does prasugrel mean for the priority review process?

Tougher FDA Safety Tollgate: Public Citizen's Wolfe Joins Key FDA Advisory Committee (The RPM Report)

The RPM Report

Long-time industry critic Sidney Wolfe will serve as permanent member of the Drug Safety & Risk Management Advisory Committee for the next four years. The committee is poised to grow in importance as FDA focuses more attention on post-market control (risk management) programs.

Exubera Gone, But Not Forgotten: FDA Imposes REMS, Mandates Trials (The RPM Report)

The RPM Report

Pfizer is no longer marketing inhaled insulin, but the regulatory work continues. FDA makes clear that any future inhaled insulin products will need a risk management plan and mandatory post-marketing studies.

Inhaled Insulin's Last True Believer: An Interview with Alfred Mann (The RPM Report)

The RPM Report

The following is an excerpt from an interview with Mannkind founder Alfred Mann, published in the September issue of FDC-Windhover's IN VIVO. Mann explains his conviction that inhaled insulin will be a blockbuster product-despite the commercial failure of Exubera and the decision of other sponsors to drop development of other versions.

Novartis Coartem NDA May Lead to First Priority Review Voucher (The RPM Report)

The RPM Report

Malaria drug receives "priority" status from FDA, which should mean Novartis receives a voucher for priority designation on another product under new incentive program for tropical disease research. December application deadline also sets a deadline for FDA to defi ne key elements of how PRVs will work.

Avoiding Another EPO: Amgens Nplate Has FDA Restrictions, But May Escape Medicare Controls (The RPM Report)

The RPM Report

The Centers for Medicare & Medicaid Services is considering national coverage restrictions for Amgen's newly approved Nplate (romiplostim). CMS is ostensibly concerned about a lack of long-term data. Based on Medicare's experience with previous Amgen products, CMS may also be worried about long-term costs. But Amgen says CMS there is no need for Amgen to get involved: FDA has the situation well in-hand with a REMS risk management program.

Communication Conundrum: Is Early Drug Safety Disclosure Better? (The RPM Report)

The RPM Report

FDA's inaugural quarterly web posting of early safety signals with marketed drugs and biologics has left investors bewildered over how to interpret the listings. But the presence of rigorous risk management programs may be a comforting factor for Wall Street and Big Pharma.

Reinventing Clinical Trials (The RPM Report)

The RPM Report

The clincal trial process needs to be modernized for the good of drug development.

Advisory Committee Reformers (The RPM Report)

The RPM Report

FDA's Advisory Committee Oversight & Management Staff is charged with developing policies and guidelines for the 30 expert panels across the agency. The staff has been busy developing four separate guidance documents that revamp the advisory committee system. Here are the principle players in that effort.

Windhover's Commentary

Deals in Depth: September 2008 (IN VIVO)

Pharmaceutical/Biotechnology Deal Statistics Quarterly, Q3 2008 (IN VIVO)

Economic Forecast for Pharma: Winter Weather Advisory Ahead (IN VIVO)

Northstar's Second Chance (IN VIVO)

End of an Era for GSK and Exelixis (IN VIVO)

Best of the IN VIVO Blog, October 2008 (IN VIVO)

Can Big Pharma Save Biotech Investors? (IN VIVO)

Public Device Companies Take a Hit, But Still Stand (IN VIVO)

Pfizer's Increasingly Specialist Focus (IN VIVO)

Ablation Frontiers: Making AF Ablation Simple and Universal (IN VIVO)

Regulatory Risk and Business Development: Type 2 Diabetes Falls Out of Favor (IN VIVO)

On the Frontiers of Surgery: An Interview with Fred Moll, MD (IN VIVO)

Selected Start-Ups (11/2008) (IN VIVO)

Start-Up Previews (11/2008) (IN VIVO)

On the Move (Company Changes and Promotions (11/2008) (IN VIVO)

Deals Shaping the Medical Industry (11/2008) (IN VIVO)

What's Next for Cardiovascular Systems? (Start-Up)

Neuronetics' FDA Nod Opens Doors to New CNS Market (Start-Up)

Vitae's Debt Financing: Crucial Lifeline in a Tightening Financial Market (Start-Up)

For GlobeImmune, Early HCV Vaccine Data May Spark Coveted Partnership (Start-Up)

The Golden Age in Cancer Medtech Investing (Start-Up)

Start-Up Quarterly Statistics, Q3 2008 (Start-Up)

Best of the IN VIVO Blog (11/2008) (Start-Up)

Can Nanotech Be a Game-Changer for In Vitro Diagnostics? (Start-Up)

Will Simpler Devices Tap the Largest Diabetes Market? (Start-Up)

CeQur: Conforming to the Lifestyle of the Type 2 (Start-Up)

Medtech Venture Capital Heads into Unfamiliar Terrain (Start-Up)

In Immunotherapy, Finally time for T Cells? (Start-Up)

Adaptimmune Ltd. (Start-Up)

Altor BioScience Corp. (Start-Up)

Cell Medica Ltd. (Start-Up)

Adnavance Technologies Inc. (Start-Up)

Amplyx Pharmaceuticals Inc. (Start-Up)

IluminOss Medical Inc. (Start-Up)

KM Medical Ltd. (Start-Up)

Structure Work Unveils a New Apoptosis Drug Target (Start-Up)

On The Move: Who's Going Where in Biopharma and Medtech Start-Ups (11/2008) (Start-Up)

Recent Financings of Private Companies (11/08) (Start-Up)

Emergings in Brief (11/2008) (Start-Up)

Recent Tech Transfer Deals (11/08) (Start-Up)

Cardiac Assist: Pumping up the Heart Failure Market (Medtech Insight)

Spine Market: A Perfect Storm (Medtech Insight)

Industry Outlook: Is Health Care Recession-Proof? (Medtech Insight)

Depression Bolsters the Neuromodulation Market (Medtech Insight)

Vertebral Compression Fracture Market Update: New Products Gain Traction (Medtech Insight)

Health Care Trends: The Future of Remote Monitoring (Medtech Insight)

Market & Industry Briefs (Medtech Insight)

Deals Update (Medtech Insight)

Clinical Edge (Medtech Insight)

Start-Up News (Medtech Insight)

Free Speech -- October 2008 (The RPM Report)

FDA Advisory Committees on the Brink: More Meetings, Fewer Members (The RPM Report)

FDA Hits the Road: Promacta's ASCO Review (The RPM Report)

Stand Up and Be Counted-Or Raise Your Hand, or Hit Your Button (The RPM Report)

Regulatory Risk and Business Development: Type 2 Diabetes Falls Out of Favor (The RPM Report)

Wyeth Wary of Antipsychotics (The RPM Report)

How Risky Is Too Risky? (The RPM Report)

Don't Cry Too Hard for Avandia (The RPM Report)

Watch What You Eat: A PhRMA Marketing Code Q&A (The RPM Report)

"Priority" Review Slow Down: The Prasugrel Delay (The RPM Report)

Tougher FDA Safety Tollgate: Public Citizen's Wolfe Joins Key FDA Advisory Committee (The RPM Report)

Exubera Gone, But Not Forgotten: FDA Imposes REMS, Mandates Trials (The RPM Report)

Inhaled Insulin's Last True Believer: An Interview with Alfred Mann (The RPM Report)

Novartis Coartem NDA May Lead to First Priority Review Voucher (The RPM Report)

Avoiding Another EPO: Amgens Nplate Has FDA Restrictions, But May Escape Medicare Controls (The RPM Report)

Communication Conundrum: Is Early Drug Safety Disclosure Better? (The RPM Report)

Reinventing Clinical Trials (The RPM Report)

Advisory Committee Reformers (The RPM Report)

Avoiding Another EPO: Amgens Nplate Has FDA Restrictions, But May Escape Medicare Controls (The RPM Report)