Clinical Intelligence

Lilly’s Taltz (ixekizumab) receives FDA approval for plaque psoriasis

Friday, March 25, 2016

The FDA has approved Eli Lilly’s Taltz (ixekizumab) injection 80mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Taltz should not be used in patients with a previous hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz is designed to specifically target IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.

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Experimental dengue vaccine protects all recipients in virus challenge study

Friday, March 25, 2016

A clinical trial in which volunteers were infected with dengue virus six months after receiving either an experimental dengue vaccine developed by scientists from the National Institutes of Health (NIH) or a placebo injection yielded starkly contrasting results. All 21 volunteers who received the vaccine, TV003, were protected from infection, while all 20 placebo recipients developed infection. The study, published in Science Translational Medicine, underscores the importance of human challenge studies, in which volunteers are exposed to disease-causing pathogens under carefully controlled conditions.

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FDA approves new treatment for inhalation anthrax

Wednesday, March 23, 2016

The FDA has approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

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FDA Alert on Gilead Sciences’ Zydelig

Friday, March 18, 2016

The FDA has issued an alert for healthcare professionals about reports of an increased rate of adverse events, including deaths, in clinical trials with the cancer medicine Zydelig (idelalisib) in combination with other cancer medicines.

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FDA grants Roche’s cancer immunotherapy Atezolizumab Priority Review

Friday, March 18, 2016

The FDA has accepted Roche’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

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MedImmune receives FDA Fast Track for influenza treatment

Thursday, March 10, 2016

AstraZeneca’s global biologics R&D arm, MedImmune, has received Fast Track designation from the FDA for its investigational human monoclonal antibody (mAb), MEDI8852, for the treatment of patients hospitalized with type A strain influenza. The FDA’s Fast Track program is designed to expedite the development and review of drugs to treat serious conditions and fill an unmet medical need.

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Vaxart begins oral Zika virus vaccine testing

Tuesday, March 8, 2016

Vaxart, a clinical stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, has initiated preclinical testing of an oral vaccine for Zika virus. With no available vaccine or treatment modalities, the World Health Organization (WHO) recently declared Zika virus an international public health emergency.

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Sanofi releases phase I/II Pompe disease study results

Friday, March 4, 2016

Sanofi and its specialty care global business unit Sanofi Genzyme have presented data from NEO1, its phase I/II clinical study evaluating the investigational novel enzyme replacement therapy neoGAA in 24 patients with late-onset Pompe disease. The safety and efficacy data from this study support further development of the therapy. Sanofi Genzyme plans to begin enrolling patients in a pivotal phase III trial for neoGAA in Q2 2016.

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