Gilead Submits NDA for HIV Combo Therapy & More New Antibiotics Show Positive Results in Trials: Business Watch Report


This week’s report includes the latest from Gilead, Janssen, Spero Therapeutics, Clorox, and TECHLAB.

This week’s report includes the latest on Gilead’s new drug application (NDA) for their fixed-dose combination treatment, results of Janssen’s Phase 2b Trial for pimodivir, access to data presented at ASM Microbe 2017 from Spero Therapeutics on their new antibiotics, new product enhancements released by Clorox, and news that TECHLAB has received FDA 510(K) clearance to market their E. HISTOLYTICA QUIK CHEK™ Test.

Gilead Submits New Drug Application Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment

Gilead Sciences, Inc. (NASDAQ: GILD) announced this week that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults. BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase 3 clinical trials among treatment-naïve adult patients and among virologically suppressed adult patients who switched regimens.

Pimodivir Shown to Decrease Viral Load in Adult Patients with Seasonal Influenza A in Phase 2b Trial

Janssen Pharmaceuticals, Inc. (Janssen) announced results from the Phase 2b Topaz Trial which demonstrated that treatment with pimodivir (JNJ-63623872) significantly decreased viral load over seven days versus placebo, in adult patients with acute, uncomplicated seasonal influenza A. Patients treated with pimodivir and oseltamivir (OST) also demonstrated a significantly lower viral load compared with those who received pimodivir alone at the same dose. The primary endpoint data for the trial, presented in an oral presentation at the 5th International Society for Influenza and Respiratory Diseases Antiviral Group (ISIRV-AVG) Conference in Shanghai, China, showed treatment with pimodivir resulted in a statistically significant decrease in area under the curve (AUC) of viral load (by quantitative real-time-polymerase chain reaction [qRT-PCR]) over seven days from start of dosing, compared with placebo. Pimodivir received U.S. FDA Fast Track designation in March 2017 due to its potential to address an unmet medical need in those who develop influenza A infection and who are hospitalized or at high risk of related complications. Phase 3 studies are anticipated to start in the second half of 2017.

Spero Therapeutics Shows Scientific Momentum at ASM Microbe Annual Meeting

Spero Therapeutics recently presented 21 posters at ASM Microbe 2017 on new data supporting the ongoing clinical development program of the Company’s lead Potentiator candidate, SPR741, and the Company’s third drug candidate, SPR720. Research presented showed that SPR741, which is being studied in Gram-negative bacteria, significantly lowers the doses of co-administered antibiotics needed to stop bacterial growth. Posters focusing on SPR720 showed that the drug candidate was effective at reducing the level of bacteria present in both the tuberculosis (TB) and the non-tuberculous mycobacteria (NTM) lung disease models. To view the posters, please visit the Spero website here.

Clorox Healthcare Announces New Product Enhancements and Compatibility Resources

Clorox Healthcare announced important enhancements to two leading healthcare disinfectants at the APIC 2017 annual conference. Reformulated Clorox Healthcare® Hydrogen Peroxide Cleaner Disinfectants and Clorox Healthcare® Bleach Germicidal Wipes continue to offer the same powerful disinfection efficacy that hospitals trust, now with improved surface compatibility and visibly less residue. Also introduced was Clorox Healthcare Compatible, a new resource to help facilities identify disinfecting solutions compatible with the surfaces commonly found in healthcare settings and help manufacturers ensure their products align with essential infection prevention protocols. Through the program, Clorox Healthcare works with manufacturers to provide complementary screening of a broad platform of chemistries, compatibility expertise and access to a third-party lab for testing to help ensure the disinfecting products used to reduce the risk of HAIs won’t damage surfaces and equipment.

TECHLAB Receives FDA 510(K) Clearance to Market E. HISTOLYTICA QUIK CHEKTest

TECHLAB, Inc. announced that it received FDA clearance for E. HISTOLYTICA QUIK CHEK™ test. E. HISTOLYTICA QUIK CHEK ™ test is the only rapid diagnostic test that specifically detects pathogenic E. histolytica and does not cross react with non-pathogenic Entamoeba dispar. E. HISTOLYTICA QUIK CHEK™ test can be paired with the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test to provide a complete triple parasite screen. E. histolytica is morphologically identical to a non-pathogenic species, E. dispar, making accurate diagnosis very difficult. Other currently available tests and microscopy cannot differentiate between the two species, frequently resulting in an inaccurate diagnosis.

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