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Coherus' Neulasta Biosimilar At FDA Altar, CytoDyn On Fast Track, VIVE Abuzz

Pharma 100716

Coherus BioSciences Inc.'s (CHRS) 351(k) Biologics License Application for CHS-1701, a proposed biosimilar to Amgen's (AMGN) blockbuster Neulasta, has been accepted for review by the FDA.

Amgen's Neulasta boosts white blood cell count which strengthens the immune system and helps protect against risk for infection. The drug registered sales of $4.72 billion in 2015, up 3% over the prior year.

In July of this year, Novartis' (NVS) Sandoz unit failed to win FDA approval for its biosimilar version of Neulasta.

Will Coherus be lucky enough to pass the FDA muster? One will have to wait a few more months as the regulatory agency's decision on CHS-1701 is set for June 9, 2017.

In other news, the company announced that it has successfully completed two pharmacokinetic studies involving CHS-0214, a biosimilar candidate to Amgen's blockbuster anti-inflammatory Enbrel.

Erelzi, a biosimilar to Enbrel from Sandoz's stable, was approved by the FDA in August of this year.

CHRS closed Thursday's trading at $25.25, down 2.06%.

Cellectar Biosciences Inc. (CLRB) has enrolled the first patient into Cohort 3 of its phase I clinical study of CLR 131 in patients with relapsed or refractory multiple myeloma.

The phase I study is designed to study the safety and tolerability of CLR 131, establish a recommended phase II dose and assess the therapeutic activity, including progression-free survival (PFS) and efficacy endpoints.

The company plans to accelerate Cohort 3 enrollment and initiate a phase II study in the first half of 2017.

CLRB closed Thursday's trading at $2.61, down 0.38%.

As per the modified protocol, CytoDyn Inc.'s (CYDY.OB) phase III pivotal trial of PRO 140 in combination with current standard-of-care antiretroviral therapy for highly treatment-experienced patients with HIV will now enroll 30 patients compared to earlier requirement of 150.

The primary endpoint for viral load reduction has now been lowered to viral load of 0.5log from viral load of 0.7log.

In light of the favorable modifications, the company now expects to report the primary endpoint results from the phase III trial of PRO 140 as early as the first quarter of 2017.

CYDY.OB closed Thursday's trading at $0.68, up 1.49%.

Viveve Medical Inc.'s (VIVE) Viveve System has received FDA clearance for use in general surgical procedures for electrocoagulation and hemostasis.

Commenting on the approval, CEO of the company Patricia Scheller said, "This clearance represents the first step in our U.S. regulatory strategy. In September 2016, we announced that the company filed an Investigational Device Exemption to the FDA, for authorization to begin the VIveve Treatment of the Vaginal Introitus to EValuate Efficacy (VIVEVE II) study."

VIVE closed Thursday's trading at $6.70, down 4.35%.

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