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BGNE On Watch, AMRN Gears Up For Big Event, ZLAB Discontinues ZL-3101

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Today's Daily Dose brings you news about progress on BeiGene's investigational Bruton's tyrosine kinase inhibitor Zanubrutinib; FDA approval of Bausch Health's topical treatment of acne vulgaris and Zai Lab's discontinuation of its atopic dermatitis therapy.

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BeiGene Ltd.'s (BGNE) New Drug Application for Zanubrutinib, an investigational Bruton's tyrosine kinase inhibitor, for the treatment of patients with relapsed/refractory mantle cell lymphoma has been accepted for review by the China Drug Administration. This is BeiGene's first NDA.

The potential of Zanubrutinib is also being explored in Waldenstrom macroglobulinemia, a type of non-Hodgkin lymphoma.

BeiGene plans to submit an NDA to the FDA for Zanubrutinib as a potential treatment for patients with Waldenstrom macroglobulinemia in the first half of 2019 based on results from a global Phase 1 study.

BGNE closed Friday's trading at $171.63, up 2.65%.

Amarin Corp. plc's (AMRN) landmark cardiovascular outcomes study, REDUCE-IT, is now likely to be the next large cardiovascular outcomes study to report results.

REDUCE-IT is evaluating the effect of Vascepa, administered at 4 grams per day, as an add-on to statin therapy, on major adverse cardiovascular events as compared to statin treated patients plus placebo. REDUCE-IT is the first cardiovascular outcomes study to be conducted in patients who despite low density lipoprotein cholesterol (LDL-C) control have risk factors for cardiovascular disease, including elevated triglyceride levels.

As previously guided, top-line results from the REDUCE-IT study are expected to be reported before the end of September 2018.

FDA-approved Vascepa is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia.

AMRN closed Friday's trading at $2.77, up 0.73%.

The FDA has approved Bausch Health Companies Inc.'s (BHC)(BHC.TO) ALTRENO (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

ALTRENO, which is the first formulation of tretinoin in a lotion, is expected to be available during the fourth quarter of 2018.

Commenting on the approval, Joshua Zeichner, M.D., director, Cosmetic and Clinical Research in Dermatology, The Mount Sinai Hospital, New York City, said, "Topical retinoids are a foundational treatment for all patients with acne, but they often cause skin irritation. With the efficacy expected from a retinoid, plus a proven tolerability profile, ALTRENO will be an ideal choice for many of my patients."

BHC closed Friday's trading at $22.93, down 1.33%.

Zai Lab Limited (ZLAB) has pulled the plug on its investigational atopic dermatitis therapy ZL-3101, following disappointing top-line results from a phase IIa trial in patients with mild to moderate subacute eczema.

In the trial that enrolled 295 Chinese patients with atopic dermatitis, although topical ZL-3101 was found to be safe and well-tolerated, the treatment showed no difference compared to placebo in the primary efficacy endpoint, a change in the Eczema Area and Severity Index (EASI) score at day 21.

ZLAB closed Friday's trading at $22.99, down 1.08%.

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