New Drugs

  • IL-6 nanobody vobarilizumab advances despite equivocal phase II data

    on June 25th, 2017
    AT EULAR 2017 MADRID (FRONTLINE MEDICAL NEWS) – Despite failing its phase II primary endpoint, the single-domain antibody vobarilizumab, being developed for rheumatoid arthritis, will advance to phase III studies. A robust placebo response obscured the strength of clinical response to vobarilizuma[...]
  • CARs race for supremacy against aggressive non-Hodgkin lymphoma

    on June 25th, 2017
    AT EHA 2017 MADRID – Two chimeric antigen receptor T cell (CAR-T) constructs are showing promising activity against treatment-refractory, aggressive forms of non-Hodgkin lymphoma in multicenter clinical trials. In the ZUMA-1 trial, axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 CAR-T p[...]
  • Twofer drug blocks SYK/JAK pathways in advanced NHL

    on June 23rd, 2017
    AT EHA 2017 MADRID (FRONTLINE MEDICAL NEWS) – Cerdulatinib, a single oral agent targeting two different pathways that lymphomas rely on for survival, produced rapid tumor responses in patients with relapsed or refractory non-Hodgkin lymphomas (NHL) in a phase II study. The overall response rate am[...]
  • Weekly buprenorphine depot effective for opioid use disorder

    on June 22nd, 2017
    FROM JAMA Psychiatry A weekly subcutaneous buprenorphine depot could improve adherence and reduce the potential for misuse, according to a study presented at the annual meeting of the College on Problems of Drug Dependence and published simultaneously June 22 in JAMA Psychiatry. In a phase II, doubl[...]
  • FDA advisory committee supports new CV liraglutide indication

    on June 22nd, 2017
    A Food and Drug Administration advisory committee voted 17-2 in support of a supplemental new drug application for liraglutide (Victoza) injections to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease. Novo Nordisk, the maker[...]
  • Mydayis approved for teens, adults with ADHD

    on June 22nd, 2017
    The Food and Drug Administration has approved a once-a-day treatment for patients aged 13 years and older with ADHD, Shire announced June 20 in a press release. The approval of Mydayis was based on results from 16 clinical studies evaluating the medication in more than 1,600 adolescents (aged 13-17 [...]
  • Cotempla XR-ODT approved for children, adolescents with ADHD

    on June 21st, 2017
    The Food and Drug Administration has approved the first methylphenidate extended-release orally disintegrating tablet for treating ADHD in patients aged 6-17 years old, Neos Therapeutics announced June 19. The company said the approval came after a phase III trial showed that treatment in a laborato[...]
  • CLARIFICATION: Novel female sexual dysfunction drug effective, phase III studies show

    on June 21st, 2017
    In an article titled “Novel female sexual dysfunction drug effective, phase III studies show”, published June 19, 2017, the name of the company marketing Addyi and one of Dr. Clayton’s disclosures was misstated. The name of the company is Valeant.[...]
  • Len plus anti-CD19 Mab MOR208 active against advanced DLBCL

    on June 20th, 2017
    AT 14-ICML LUGANO, SWITZERLAND (FRONTLINE MEDICAL NEWS) – Combining lenalidomide (Revlimid) with an anti-CD19 monoclonal antibody labeled MOR208 showed promising activity in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who were ineligible for stem cell transplant and [...]
  • Hitting BTK, PI3K pays off in B-cell malignancies

    on June 20th, 2017
    AT 14-ICML LUGANO, SWITZERLAND (FRONTLINE MEDICAL NEWS) – A combination of ibrutinib and umbralisib, an investigational inhibitor of phosphatidylinostiol 3-kinase (PI3K), induced high response rates in patients with relapsed/refractory B-cell malignancies, with no dose-limiting toxicities, based o[...]
  • Brexanolone appears effective for severe postpartum depression

    on June 19th, 2017
    FROM THE LANCET A single 60-hour infusion of brexanolone dramatically and rapidly improves severe postpartum depression with minimal adverse effects, a small manufacturer-conducted phase II trial suggests. Brexanolone is a proprietary formulation of allopregnanolone, the major metabolite of progeste[...]
  • Novel female sexual dysfunction drug effective, phase III studies show

    on June 19th, 2017
    AT THE ASCP ANNUAL MEETING MIAMI (FRONTLINE MEDICAL NEWS) – Women distressed by a low desire for sex could have a novel pharmaceutical intervention soon. Phase III results from the two Reconnect studies of 1,247 premenopausal women with hypoactive sexual desire disorder in stable relationships sho[...]
  • Steatosis linked to persistent ALT increase in hepatitis B

    on June 12th, 2017
    FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY About one in five patients with chronic hepatitis B virus (HBV) infection had persistently elevated alanine aminotransferase (ALT) levels despite long-term treatment with tenofovir disoproxil fumarate, according to data from two phase III trials reported[...]
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