Showing 101-110 of 308 results for "".
- Positive Phase 3 Results Reported for Medimetriks and Otsuka's AD Drughttps://practicaldermatology.com/news/positive-phase-3-results-reported-for-medimetriks-and-otsukas-ad-drug-1/2460322/Medimetriks Pharmaceuticals, Inc. and Otsuka Pharmaceuticals Co. Ltd.’s MM36 (difamilast) performed well in two Phase 3 Japanese clinical trials in adult and pediatric atopic dermatitis (AD) patients. Difamilast is a novel topical, non-steroidal phosphodiesterase IV (PDE4) inhibit
- Novartis Offers Free Genetic Testing for Advanced Melanomahttps://practicaldermatology.com/news/novartis-offers-free-genetic-testing-for-advanced-melanoma/2460095/The Know Now Testing Program is an initiative from Novartis in collaboration with Quest Diagnostics that offers genetic mutation testing at no cost for all patients with stage III or stage IV melanoma. Nearly half of all advanced melanoma patients carry a specific mutation, called BRAF.
- Galderma Ups Its Aesthetic R&D Gamehttps://practicaldermatology.com/news/galderma-ups-their-aesthetic-r-d-game/2457570/Galderma Laboratories, L.P. is initiating six new Phase III and IV U.S. aesthetic clinical trials. The six newly initiated studies include three pivotal trials evaluating XpresHAn Technology products; two studies for Dysport evaluating patient satisfaction and
- FDA Approves Paratek's Nuzyrahttps://practicaldermatology.com/news/fda-approves-parateks-nuzyra/2457579/The FDA has approved Paratek Pharmaceuticals, Inc's Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). Nuzyra, a modernized tetracycline, is a once-daily IV and or
- FDA Committee Recommends Approval of Paratek's Omadacyclinehttps://practicaldermatology.com/news/fda-committee-recommends-approval-of-parateks-omadacycline/2457656/The Antimicrobials Drug Advisory Committee of the FDA voted in favor of the approval of intravenous (IV) and oral omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) (17-1) and community-acquired bacterial pneumonia (CABP) (14-4). Paratek Pharmaceuticals,
- Opdivo Data: Superior Recurrence-Free Survival Versus Ipilimumabhttps://practicaldermatology.com/news/opdivo-data-superior-recurrence-free-survival-versus-ipilimumab/2457734/Updated results from the Phase 3 CheckMate -238 trial evaluating Opdivo (nivolumab, Bristol-Myers Squibb Company) versus Yervoy (ipilimumab, Bristol-Myers Squibb Company) in patients with stage IIIB/C or stage IV melanoma who are at high ri
- Patent Challenge Filed for Generic Version Of Soolantra Creamhttps://practicaldermatology.com/news/patent-challenge-filed-for-generic-version-of-soolantra-cream/2458120/Perrigo Company plc's subsidiary has filed a Paragraph IV Abbreviated New Drug Application with the FDA for a generic version of Soolantra® (ivermectin) cream, 1%. Following notification from Perrigo, Galderma Laboratories, L.P., Galderma S.A., and Nestle Skin Health S.A., filed a
- Paratek: Phase 3 Data Show Omadacycline Effective Against Common Skin Pathogens, Including MRSAhttps://practicaldermatology.com/news/paratek-phase-3-data-show-omadacycline-effective-against-common-skin-pathogens-including-mrsa/2458211/Analysis of microbiology data from a Phase 3 study of omadacycline in acute skin infections shows that once-daily treatment with IV-to-oral omadacycline is effective in treating the most frequently isolated bacterial pathogens associated with skin infections, including methicillin-resistant S
- Paratek Initiates Phase 3 Study of Oral Omadacycline for MRSA, Acute Skin Infectionshttps://practicaldermatology.com/news/paratek-initiates-phase-3-study-of-oral-omadacycline-for-mrsa-acute-skin-infections/2458465/The first patient has been dosed in Paratek Pharmaceuticals, Inc.’s second pivotal Phase 3 study of omadacycline for acute bacterial skin and skin structure infections (ABSSSI). Omadacycline is a new once-daily oral and IV, well-tolerated
- FDA Accepts Allergan's sNDA for TEFLARO Use in Childrenhttps://practicaldermatology.com/news/fda-accepts-allergans-snda-for-teflaro-use-in-children/2458700/The U.S. Food and Drug Administration (FDA) has accepted Allergan’s supplemental New Drug Application (sNDA) for IV antibacterial TEFLARO® (ceftaroline fosamil). If approved, this filing will expand the label of TEFLARO beyond adults to include children two months of age a