Trends-in-Medicine| Publisher: | Stephen Snyder |
| Writers: | Lynne Peterson |
| Marta Weber | |
| Diana Woods | |
| Editors: | Susie Bellitta |
| Kathleen Snyder | |
| Betty Teel | |
Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter.
Copyright© 2004
No articles may be reproduced without written permission of the publisher.
Return Home
Left Ventricular Assist Systems
Summary: Pulsatile and continuous flow devices are both expected to have a role, but the biggest market will go to continuous/ axial flow devices. However, sales of these devices is unlikely to take off until there is an approved continuous flow device for destination therapy, and sources do not believe anything currently in trials is likely to be the winner. Continuous flow devices have design issues, but they are generally considered safe. The major cardiac device companies are interested in LVAS, and they are likely to buy smaller companies to get into the market – but not until the products are developed further. The major companies just do not view current devices as ready for prime time, but they are watching the space.
American Society of Clinical Oncology
Summary: The hot news was that genetic mutations correlate with response to EGFR inhibitors and may be predictive of which NSCLC patients respond, with never smoking the strongest correlate. A commercial mutation test is expected within a year. However, some mutation negative patients respond or have stable disease, so it is unclear whether use of AstraZeneca’s Iressa and Genentech/ OSI’s Tarceva will be determined by mutation positivity. Tarceva showed a survival benefit in NSCLC, which may give it a marketing advantage over Iressa unless and until the Iressa survival trial is completed in 2005, and it showed benefit in combination with Avastin in renal cell cancer. Bayer/Onyx’s sorafenib and Pfizer’s SU-11248 both appear to work in renal cell cancer, but it appears that sorafenib could reach market first. ImClone/Bristol-Myers Squibb’s Erbitux showed outstanding results for head & neck cancer, and efficacy was speculated in lung cancer patients without mutations.
FDA’S Dermatologic and Ophthalmlic Drugs Advisory Committee Meeting on Allergan’a Tazoral for Moderate-to-Severe Psoriasis
Summary:Allergan is seeking FDA approval of Tazoral (oral tazarotene 4.5 mg) for the treatment of moderate-to-very severe psoriasis, and the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee agreed the drug is effective, but only in moderate-to-severe, not very severe, psoriasis. However, the panel did not believe the benefits of Tazoral outweigh the risks, particularly teratogenicity and bone loss.
7TH Annual Conference on Vaccine Research National Foundation for Infectious Diseases (NFID)
Summary:Participants appeared most interested in: Genomic research, including reverse vaccinology. Advances in vaccines for Ebola, menococcal and rotaviruses, SARS, and tuberculosis. New methods of delivery, including needle-free vaccines and mucosal immunization. Fast-track vaccine licensing.
Refractive Surgery Update - Quick Pulse
Summary: Refractive surgeons, representing a range of practices – from large to small and from academic to commercial chains – as well as industry experts were interviewed to check on trends in the industry. They were definitely upbeat and positive.
AMD Drugs: The Regulatory Path - Quick Pulse
Summary: Numerous new treatments to treat the wet form of age related macular degeneration (ARMD or AMD) are on the horizon. To better understand the regulatory issues and path that all these agents face, Dr. Wiley Chambers, Deputy Director of Ophthalmics in the FDA’s Division of Anti-inflammatory, Analgesic, and Ophthalmologic Drug Products, Office of Drug Evaluation V, Center for Drug Evaluation and Research (CDER), was interviewed. Other FDA officials also offered their expertise.
1879 Avenida Dracaena, Jensen Beach, FL, 34957, 772-334-7409, Fax 772-334-0856
Email webmaster about site: snyderk577@aol.com
