Showing 1471-1480 of 1533 results for "".
- FDA Seeks More Information on Pliaglishttps://practicaldermatology.com/news/20120419-fda_seeks_more_information_on_pliaglis/2459818/FDA's Complete Response Letter to Galderma Laboratories LP outlines additional information the FDA requires before it will approve the sNDA for Pliaglis, developer Nuvo Research, Inc. reports. The response is to the supplemental New Drug App
- Kythera Initiates Phase 3 trials for Investigational Injectablehttps://practicaldermatology.com/news/20120320-kythera_initiates_phase_3_trials_for_investigational_injectable/2459841/Kythera Biopharmaceuticals has initiated two Phase 3 trials of ATX-101, a first-in-class injectable drug under clinical investigation for the reduction of submental fat. The Phase 3 trials, known as REFINE-1 and REFINE-2 (Randomized Doubl
- FDA's 45-day TV ad reviewhttps://practicaldermatology.com/news/20120313-fdas_45-day_tv_ad_review_shot_clock_in_guidance/2459846/TV ads for most prescription drugs must be submitted to FDA for pre-review 45 days before the manufacturer intends to air them, according to an FDA draft guidance in tomorrow's Federal Register. The guidance isn't a bolt from the blue but rather a case of the agency catching up on old business – i
- Syneron to Acquire TransPharma Medicalhttps://practicaldermatology.com/news/20120313-syneron_to_acquire_transpharma_medical/2459847/Syneron Medical Ltd. (NASDAQ: ELOS) has signed a definitive agreement to acquire substantially all the assets of TransPharma Medical Ltd. TransPharma Medical, a specialty pharmaceutical company focused on the development and commercialization of drug-
- Cellceutix Files pre-IND Submission for Prurisol for Psoriasishttps://practicaldermatology.com/news/20120312-cellceutix_files_pre-ind_submission_for_prurisol_for_psoriasis/2459849/Cellceutix Corporation (OTCBB: CTIX) filed a pre-IND submission with the FDA for Prurisol (also termed KM-133), a drug in development for treatment of psoriasis. The company is seeking guidance to attain approval for a section 505(b)(2) designa
- Health plans sue Big Pharma over co-pay couponshttps://practicaldermatology.com/news/20120308-health_plans_sue_big_pharma_over_co-pay_coupons__read_more_health_plans_sue_big_pharma_over_co-pay_coupons_-_fiercepharma_httpwwwfiercepharmacomstoryh/2459850/Pharma's co-pay discounts have their fans--patients, certainly, and companies that have been able to boost prescriptions for high-priced drugs or hang onto sales as brands go off patent. But co-pay coupons and discount cards also have their detractors--namely, insurers and other payers trying to ste
- Global Derm Market Reaches $11.6 Billionhttps://practicaldermatology.com/news/20120224-global_derm_market_reaches_116_billion/2459867/The global prescription dermatologic therapy market grew 6.2% from 2009 to 2001, to reach $11.6 billion. A new MarketWatch.com. report notes that the most dramatic gains were in the antiaging/photodamage, hair loss and hair removal, psoriasi
- Joel Schlessinger, MD, FAADhttps://practicaldermatology.com/profiles/joel-schlessinger-md-faad/jRx3wY/
- Joel M. Gelfand, MD, MSCEhttps://practicaldermatology.com/profiles/joel-m-gelfand-md-msce/L0vdl9/Joel M. Gelfand MD MSCE is Professor of Dermatology and Epidemiology (with tenure) at the University of Pennsylvania's Perelman School of Medicine. He is also Vice Chair of Clinical Research, Medical Director of the Dermatology Clinical Studies Unit, and Director of the Psoriasis and Phototherapy T…
- Daniel I. Schlessinger, MDhttps://practicaldermatology.com/profiles/daniel-i-schlessinger-md/7r0yz5/