News

New Pipeline Updates from Genentech, Alvotech and Sonavex

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

 

Gottlieb Calls it Quits

March 11, 2019

FDA Commissioner Scott Gottlieb will leave the agency within a month, the commissioner said in a surprise announcement last week.

New Pipeline Updates from Forbius, Inovio and Janssen

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 2019: Research Center Profiles

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.