.gif)
March 18, 2019
The FDA has issued several guidance documents in the past week that the agency hopes will help researchers get a handle on patient selection for increasingly complex trials.
March 18, 2019
Central laboratories need to be viewed as partners in clinical trials, not simply as vendors doing routine safety work, says a veteran laboratory auditor.
March 18, 2019
National Cancer Institute Director Norman “Ned” Sharpless will serve as acting commissioner of the FDA following Scott Gottlieb’s departure next month.
March 18, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Rocket Pharmaceuticals, Inc. | RP-L102 | Fanconi Anemia (FA) | Phase I trial initiated enrolling 2 FA pediatric subjects |
| Infinity Pharmaceuticals, Inc. | IPI-549 | triple negative breast cancer (TNBC) and renal cell cancer (RCC) | Phase II trial initiated |
| Theravance Biopharma, Inc. | TD-1473 | moderately to severely active ulcerative colitis | Phase IIb/III trial initiated |
| Biohaven Pharmaceutical Holding Company Ltd. | troriluzole | Spinocerebellar Ataxia (SCA) | Phase III trial initiated enrolling 230 subjects at approximately 22 sites in the U.S. |
| Alvotech | AVT02 | moderate to severe chronic plaque psoriasis | Phase III trial initiated enrolling 400 subjects at approximately 30 sites in Europe |
| Helsinn Group | anamorelin | advanced NSCLC with cachexia | Phase III trial initiated |
| Santhera Pharmaceuticals AG | Raxone | Leber’s hereditary optic neuropathy (LHON) | Phase IV trial initiated enrolling 197 subjects in 31 sites across nine European countries and the U.S. |
| Nvision Biomedical Technologies | Vector Hammertoe Correction System | foot and ankle procedures | 510(k) clearance granted by the FDA |
| Sonavex, Inc. | EchoSure | blood flow monitoring | 510(k) clearance granted by the FDA |
| Instrumentation Laboratory | GEM Premier ChemSTAT in vitro diagnostic (IVD) analyzer with Intelligent Quality Management (iQM) | rapid basic metabolic panel (BMP) testing at the point of care for diagnosing acute conditions, such as kidney failure, insulin shock, respiratory distress and arrhythmias | 510(k) clearance granted by the FDA |
| Purdue Pharma L.P. | nalmefene hydrochloride (HCl) injection | emergency treatment of known or suspected opioid overdose | Fast Track designation granted by the FDA |
| Alkem Laboratories Limited | Valsartan (generic Diovan) | high blood pressure and heart failure | Approval granted by the FDA |
| Aerie Pharmaceuticals, Inc. | Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% | open-angle glaucoma or ocular hypertension | Approval granted by the FDA |
| Genentech | Tecentriq (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albuminbound); nab-paclitaxel]) | unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-approved test | Approval granted by the FDA |
| Pfizer, Inc. | TRAZIMERA (trastuzumab-qyyp) | human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma | Approval granted by the FDA |
March 18, 2019
Twice monthly, CWWeekly provides featured listings of clinical research job openings, upcoming industry conferences and educational programs from JobWatch, CenterWatch’s online recruitment website for both clinical research employers and professionals.
March 11, 2019
An innovative social media company is developing a new model for matching trial sponsors with patients and caregivers who can offer ideas for making trials more patient-focused.
March 11, 2019
Contract research services are now the largest single cost category in pharma R&D spending, accounting for almost $90 billion last year, according to Tufts Center for the Study of Drug Development.
March 11, 2019
FDA Commissioner Scott Gottlieb will leave the agency within a month, the commissioner said in a surprise announcement last week.
March 11, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| AOBiome Therapeutics, Inc. | B244 | pediatric patients with atopic dermatitis (eczema) | Phase Ib trial initiated enrolling 36 subjects aged 2 to 17 years |
| Forbius | AVID200 | diffuse cutaneous systemic sclerosis (SSc) | Phase Ib trial initiated |
| I-Mab Biopharma | TJ107 (HyLeukin) | advanced solid tumors | Phase Ib/IIa trial initiated enrolling 58 subjects in China |
| Odonate Therapeutics, Inc. | tesetaxel | locally advanced or metastatic breast cancer (LA/MBC) | Phase II trial initiated enrolling 125 subjects with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive disease who have not previously received a taxane |
| Eidos Therapeutics, Inc. | AG10 | transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM) | Phase III trial initiated enrolling 510 subjects with symptomatic ATTR-CM, associated with either wild-type or mutant TTR, with New York Heart Association Class I-III symptoms |
| Inovio | VGX-3100 | cervical dysplasia caused by human papillomavirus (HPV) | Phase III trial initiated enrolling adult female subjects with HPV 16/18 positive biopsy-proven cervical HSIL, otherwise known as cervical intraepithelial neoplasia (CIN) 2 or 3 |
| Acceleron Pharma, Inc. | ACE-083 | Charcot-Marie-Tooth disease (CMT) | Orphan Drug designation granted by the FDA |
| Mitochon Pharmaceuticals | MP-101 | Huntington’s Disease | Orphan Drug designation granted by the FDA |
| Celgene Corporation | fedratinib | myelofibrosis | Priority Review granted by the FDA |
| NKMax America | SNK01 | refractory cancer | IND approval granted by the FDA |
| Breckenridge Pharmaceutical, Inc. | Imatinib Mesylate Tablets | cancer | ANDA approval granted by the FDA |
| Janssen | Spravato | major depressive disorder | Approval granted by the FDA |
| Baxter International, Inc. | eptifibatide | acute coronary syndrome (ACS) | Approval granted by the FDA |
| Adlon Therapeutics, L.P.m | Adhansia XR (methylpheni-date hydrochloride) extended-release capsules CII | Attention-Deficit/Hyperactivity Disorder (ADHD) | Approval granted by the FDA |
March 11, 2019
Research Center Spotlight is a monthly selection of clinical research centers who have Research Center Profile pages posted on CenterWatch.com. Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their expertise and services in conducting and managing clinical studies. To learn more about becoming a Research Center Profile page subscriber, contact Sales at (617) 948-5100.
Subscribe now to the industry's leading global news source providing hard-hitting, authoritative, data-rich coverage of the clinical research space.
.gif)
