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August 2010 Issues

FDA Advisory Committee Recommends Either Serious Restrictions on Use of Withdrawal of GSK's Avandia -- Quick Pulse
Summary: After spending two days hearing from a long list of experts, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, meeting jointly, voted that concerns over the cardiovascular (CV) safety of GlaxoSmithKline’s diabetes drug Avandia (rosiglitazone), a thiazolidinedione (TZD), were serious enough that the drug either should have its use restricted or be withdrawn from the market.

FDA Proposes Changes to 510(k) Program for Medical Device Approvals -- Quick Pulse
Summary: Saying it wants to accomplish three goals − fostering device innovation, creating a more predictable regulatory environment, and enhancing device safety − the FDA on August 3, 2010, issued preliminary recommendations for changes relating to the 510(k) program under which many medical devices are approved. These proposed changes, which come after multiple public and internal meetings, will be open for public comment for 60 days. After reviewing the public comments, the FDA will announce which improvements it plans to implement and the timeline
for that implementation.

FDA Advisory Committee Recommends Approval of Glaukos' iStent -- Quick Pulse
Summary: Although panel members had mixed feelings about the data, the FDA's Ophthalmic Devices Advisory Committee voted overwhelmingly to recommend approval of Glaukos' iStent Trabecular Micro-Bypass Stent in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in patients with mild-to-moderate open-angle glaucoma. Panel members agreed that the FDA analyses showed that the iStent has limited efficacy, but they appeared to be swayed by the glaucoma specialists who wanted another tool for their toolbox.

European League Against Rheumatism
Summary: Osteoarthritis (OA). Pfizer's nerve growth factor tanezumab is on clinical hold due to osteonecrosis resulting in joint surgery, and the outlook for resumption doesn't look promising. The neuropathic side effects are also concerning. ♦ Rheumatoid arthritis (RA). The economy is starting to have a chilling effect on the use of approved biologics in RA. In this environment, the newer biologics are gaining market share very slowly, even with discount offers. The excitement in RA is over the new oral drugs in development − the JAK and Syk inhibitors − which doctors think will dramatically change the way patients are treated when they are available. While the oral agents are very exciting, there is a concern that there will be unwanted side effects, and there is still no radiographic data. ♦ Lupus. Rheumatologists are also very excited about Human Genome Sciences. Benlysta (belimumab) for lupus, and most believe the benefit, though small, is clinically meaningful. They predicted that 15%-43% of lupus patients will be eligible, with up to half of these taking the drug . at least for one year. Cost will be the big limiting factor. ♦ Gout. Ardea's RDEA-594 looks promising, either alone or in combination with allopurinol. Safety appears good, but doctors want to see Phase III safety data.

FDA Guidance for Industry on Self-Induced Liver Injury -- Quick Pulse
Summary: Three FDA officials, speaking on a recent Drug Information Agency webinar, discussed the FDA.s guidance on drug-induced liver injury (DILI). The guidance was published in July 2009, but the Agency saw a need to further explain the guidance to industry. The comments, which were intended to help industry in applying the guidelines, also may be useful in interpreting liver issues in clinical trials.

July 2010 Issues

FDA Advisory Panel Recommends the FDA Pull Avasitin's Metastatic Breast Cancer Indication -- Quick Pulse
Summary: The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted nearly unanimously that Roche/Genentech’s cancer drug Avastin (bevacizumab) should not keep its label for first-line metastatic breast cancer. The panel said the risk:benefit in two postmarketing trials were not favorable and did not confirm the original benefit seen in the E2100 trial, on which accelerated approval was granted, so regular approval should not be given.

FDA Advisory Panel to Review New Data on Roche/Genentech's Avastin in Breast Cancer -- Quick Pulse
Summary: On Tuesday, July 20, 2010, the FDA’s Oncology Drug Advisory Committee (ODAC) will meet to review whether Roche/Genentech’s cancer drug Avastin (bevacizumab) should keep its label for first-line metastatic breast cancer. The panel will consider whether Avastin met the requirements for accelerated approval for breast cancer, which was granted two years ago.

FDA's Council on Medical Device Innovation -- Quick Pulse
Summary: The FDA’s Center for Devices and Radiological Health (CDRH) established a Council on Medical Device Innovation, and the panel met recently to hear from industry and public witnesses about ways the agencies can help spur device innovation in areas of unmet public health need. They heard a lot of complaints about unpredictable regulatory requirements imposed by the FDA and a lengthy CMS reimbursement process. There were few concrete suggestions relating directly to unmet medical needs. The docket will remain open until July 24, 2010, for additional comments.

The FDA's Proposed Opioid Risk Evaluation and Management Strategy (REMS) -- Quick Pulse
Summary: On June 28, 2010, the FDA surprised just about everyone by issuing what appears to be a rather weak REMS for long-acting (LA) and extended-release (ER) opioids, including morphine ER, oxymorphone ER, oxycodone ER, hydromorphone ER, fentanyl transdermal patches, and methadone. The draft proposal will be discussed on July 22 and 23, 2010, by a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

A Preview of the FDA Advisory Committee on GSK's Avandia -- Quick Pulse
Summary: On July 13 and 14, 2010, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, meeting jointly, will consider the cardiovascular (CV) safety of GlaxoSmith- Kline’s diabetes drug Avandia (rosiglitazone), a thiazolidinedione (TZD). The briefing documents and the slides for the meeting were released in advance, and overall the FDA is making a fairly balanced presentation to the panel, offering both sides of the issue.

June 2010 Issues

FDA Advisory Panel Clears the Use of GSK's Rotarix and Merck's RotaTeq -- Quick Pulse

Summary: Both rotavirus vaccines -- GlaxoSmithKline’s (GSK’s) Rotarix and Merck’s RotaTeq -- are safe to use.  That is the FDA’s latest decision, and the Agency followed the advice of its Vaccines and Related Biological Products Advisory Committee.  However, the Centers for Disease Control and Prevention (CDC) recently warned that neither vaccine should be given to infants with severe combined immunodeficiency (SCID).

EuroPCR

Summary: Abbott’s BVS bioabsorbable stent was generating interest, but there are issues with it as well. ♦ Johnson & Johnson’s Nevo is looking very promising and could be the next big news in DES. ♦ Medtronic’s Resolute stent proved non-inferior to Abbott’s market leading Xience V, but doctors were not impressed because of the early stent thrombosis rate, so it may replace Endeavor without expanding Medtronic’s market share much. ♦ The economic climate is starting to put some pressure on percutaneous valve volume, and experts are concerned it will stifle innovation. ♦ New data on Abbott’s MitraClip for percutaneous mitral valve repair were good, but enthusiasm remains muted because of cost and the difficulty of the procedure. ♦ Doctors are not yet convinced of the usefulness of platelet aggregation measurement with Accumetrics’ VerifyNow to guide therapy.

May 2010 Issues

American Society of Cataract and Refractive Surgery (ASCRS)

Summary: Traffic on the exhibit floor was sparse -- even worse than in 2009. However, the mood of exhibitors wasn't quite the doom and gloom as in 2009. ♦ LASIK procedures have not picked up, and industry reps were worried. ♦ The biggest buzz was the new generation of femtosecond lasers for cataract procedures, and the companies receiving the most femto attention were LensAR, LenSx, and OptiMedica. ♦ LensAR had a small booth on the perimeter of the conference, as it did last year, but its series of featured speakers attracted some attention. ♦ LenSx's flashy, high profile booth and femtosecond laser -- the only one with FDA 510(k) clearance for cataracts -- attracted a lot of attention. ♦ OptiMedica's booth was filled with enthusiastic doctors. ♦ A Ziemer meeting on its femtosecond LDV laser attracted a standing room only crowd, and session speakers spoke highly about their clinical practice with the machine.

World Vaccine Congress

Summary: Vaccine growth in the U.S. is flattening, and industry is focusing on pediatric vaccines, parasitic disease, the elderly, immunecompromised patients, and hospitalized infections. Most vaccine growth is expected OUS and in parasitic disease, therapeutics, and vaccines for diseases such as cancer. ♦ The buzzword is globalization, and companies are collaborating more, especially in the growth areas . India, Southeast Asia, Latin America, and Africa. ♦ Companies were extremely disappointed that the CDC did not recommend ACWY vaccines for children up to age 11. ♦ The MenB vaccine is likely to do well in the U.S. but will not be a blockbuster. ♦ Intercell plans to target its encephalitis vaccine to Asia and is excited about its patch delivery system. ♦ The District of Columbia's mandate to vaccinate 6th grade girls against HPV is not working well and is unlikely to spur other states to follow suit. ♦ Industry's response to H1N1 was successful, but more public education about vaccine safety is needed. ♦ There are few small international vaccine companies left to be acquired.

FDA Public Hearing on Expanded Access to Hepatitis Drugs -- Quick Pulse

Summary: The FDA held a public hearing on expanded access to investigational drugs to treat the hepatitis C virus (HCV) and on new criteria for clinical trials of direct-acting antiviral agents (DAAs) in patients with an unmet medical need, including those with the greatest risk of progression of liver disease and/or the lowest predicted sustained virologic response (SVR) rates. This was not an advisory committee meeting. Rather, a panel of FDA officials listened to comments from 16 speakers, from patients to pharmaceutical companies, to gather input for new HCV drug development guidance the Agency plans to issue later this year. The public record will be kept open until June 25, 2010, for people who want to submit written comments.

April 2010 Issues

FDA Advisory Committee Rejects Opioid, Saying Niacin not an Abuse Deterrent -- Quick Pulse

Summary: Acura Pharmaceuticals’ and King Pharmaceuticals’ hopes for Acurox, an oral combination of immediate-release (IR) oxycodone and niacin, got flushed away at a joint meeting of the FDA’s Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The panel voted overwhelmingly (19 to 1) against approval of Acurox. Panel members agreed that Acurox may be effective in preventing abuse by snorting and injection but was not convinced that the flushing side effect caused by the niacin is an effective deterrent to abuse. In fact, many panel members questioned whether the niacin component was appropriate at all since there was no clear advantage to it, and it added side effects.

Cardiovascular Research Technologies (CRT)

Summary: DES are a steady ~two-thirds of stents used, with Abbott's Xience keeping about half the market. PCI volume is increasing somewhat. ♦ U.S. interventional cardiologists anxiously await the first percutaneous aortic valves to be approved, and European use continues to increase. Phase III U.S. data on Edwards Lifesciences' Sapien is expected in September 2010, and Medtronic is preparing to begin its pivotal U.S. trial. The big questions now are:
•     Can they be used in younger, healthier patients? Probably, but the FDA will require hard safety and efficacy data.
•     Will U.S. regulators limit the roll-out? Most likely both FDA and CMS will ensure this.
♦ Abbott/Evalve's MitraClip is already approved in the U.S. and Europe for percutaneous mitral valve repair, but it remains a niche procedure/ product due to time, cost, and expertise required. ♦ IABP shows no mortality benefit but remains the most common hemodynamic support in the cardiac cath lab, with CardiacAssist's Tandem-Heart and Abiomed's Impella remaining important but very niche products. ♦ Lilly's Effient (prasugrel) appears to have found a place in cath labs, but use is not growing much as cardiologists look to newer antiplatelet agents they hope to have soon, such as AstraZeneca's Brilinta. ♦ Use of platelet function testing, particularly Accumetrics' VerifyNow, requires outcomes studies, so doctors will be watching the GRAVITAS trial results this fall.

Pittsburgh Conference (PITTCON)

Summary: Lab budgets are still fairly flat, but the mood at Pittcon was somewhat optimistic. Managers were looking, if not buying. Many labs plan to buy new equipment in 2010 or 2011, even if it’s small items; only a few plan to buy big instruments, including HPLCs and UHPLCs, this year. ♦ Stimulus money does not appear to be turning into many sales yet for tools companies. ♦ Companies generally do not believe that the economic downturn has bottomed out. Although most were upbeat, only Waters claimed to be doing well with sales. Market share did not appear to be shifting. ♦ Attention was focused on UHPLC instruments, which companies were marketing heavily as the next must-have big ticket item. Peripheral vendors were focusing on add-ons for UHPLC, such as filters and valves. ♦ Mass spectrometry has been in a slump, but tools companies hope that will end when labs get stimulus funds. ♦ Company officials insisted that R&D spending is holding steady or even increased. Growth areas include China and food testing. ♦ A positive sign: The Export-Import Bank generated 40%-50% more loan guarantees and loans at Pittcon than last year.

American Academy of Cosmetic Surgery (AACS)
Summary: Volume: Cosmetic procedure volume appeared to have bottomed out and is likely to be relatively flat in 2010 vs. 2009. ♦ Pricing: Price is a big issue with patients, and many cosmetic surgeons are having to lower their prices, but patients are still getting turned down for financing. ♦ Purchasing: Big ticket purchases are being delayed, and financing has gotten much tougher for doctors and takes longer. ♦ Vendors: There has been a lot of merger/ acquisition activity, and that is expected to continue as the industry further consolidates. ♦ Aesthetic lasers: Cosmetic surgeons are unhappy with industry hype about these devices, though they agree they have a place, differ little from each other, and produce only limited results. ♦ Liposuction: The hot new products were Erchonia’s Zerona, a lower power, external laser for body contouring, and Eclipse Medical’s Body-Jet, a water-assisted device. ♦ Fat transfer: Interest and use is growing for breasts, face, and other areas -- at the expense of commercial fillers. Stem cells are an appealing concept, and doctors are looking for ways to improve the amount and quality of stem cells in their fat implants. ♦ Toxins: Medicis’s Dysport, which is priced ~20% less than Allergan’s Botox, has ~16% market share, and that is expected to increase to 22% by next year. ♦ Fillers: Market share appeared fairly steady.