Showing 4831-4840 of 7669 results for "".
- Galderma Completes Phase 3 Rosacea Erythema Studyhttps://practicaldermatology.com/news/20120320-galderma_completes_of_phase_3_rosacea_erythema_study/2459839/Galderma Laboratories announced the completion of two independent Phase 3 clinical trials that evaluated the safety and efficacy of CD07805/47, a proprietary topical gel under investigation in patients with moderate to severe facial erythema of rosacea. The trials examined the safety and efficacy o…
- 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 Double-blind Evaluation of Submental Fat Reduction IN ATX-101 TrEa…
- Phase 3 Trials launching for adalimumab for hidradenitis suppurativahttps://practicaldermatology.com/news/20120315-phase_3_trials_launching_for_adalimumab_for_hidradenitis_suppurativa/2459842/Two Phase 3 clinical trials are underway to evaluate the safety and efficacy of Abbott's Humira (adalimumab) in adult patients with moderate to severe hidradenitis suppurativa (HS). The trials (M11-313 and M11-810) are 36-week, multinational, randomized, double-blind, placebo-controlled studies des…
- ASLMS to Honor David J. Cuccia, PhDhttps://practicaldermatology.com/news/20120314-aslms_to_honor_david_j_cuccia_phd/2459844/David J. Cuccia, Ph.D, Chief Technology Officer and CEO at Modulated Imaging, Inc. Irvine, California, will receive the 2012 Dr. Horace Furumoto Innovations Professional Development Grant at the Annual Conference of the American Society for Laser Medicine and Surgery (ASLMS) April 20-22 in Kissimme…
- 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drugs must be submitted to FDA for pre-review 45 days before the manufacturer intends to air them, according to an FDA draft guidance in tomorrow's Federal Register.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 – …
- Xeomin Injunction Stands; Another Hearing Scheduled for Tomorrowhttps://practicaldermatology.com/news/20120312-xeomin_injunction_stands_another_hearing_scheduled_for_tomorrow/2459848/Handing down his order as promised on Friday, US District Court Judge Andrew J. Guilford imposed a 10-month injunction barring Merz from selling or soliciting purchases of Xeomin®, in the US facial aesthetics market for 10 months. However, Judge Guilford called for another hearing on the case, orig…
- 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) designation for Prurisol, allowing clinical trials to begin in…
- 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 st…
- FDA Approves Differin Pumphttps://practicaldermatology.com/news/20120308-fda_approves_differin_pump/2459851/FDA approved a new pump dispenser for Galderma's Differin Gel 0.3% (adapalene). The new pump dispenser will be available in pharmacies by prescription in the second quarter. According to results of a recent preference survey, involving 291 physician-diagnosed acne patients ages, 12-35, 79% of acne…
- Judge Blocks Launch of Xeomin for Aesthetic Indicationshttps://practicaldermatology.com/news/20120307-judge_blocks_launch_of_xeomin_for_aesthetic_indications/2459852/The planned March 12 launch of Merz's Xeomin (incobotulinumtoxinA) for aesthetic indications will almost certainly be delayed due to a court order blocking marketing of incobotulinumtoxinA. The order comes in response to a suit by Allergan , alleging that its trade secrets related to Botox (onabot…