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What's Making News In These Pharma And Cannabis Stocks Today?

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AbbVie (ABBV) announced that the FDA has approved the use of IMBRUVICA in combination with Roche's Gazyva for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma.

Today's approval marks the 10th FDA approval for IMBRUVICA in six different disease areas since 2013.

The drug is approved for the treatment of mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström's macroglobulinemia, small lymphocytic lymphoma, marginal zone lymphoma, and chronic graft versus host disease.

Imbruvica generated sales of $2.58 billion in the first nine months of 2018, up 38.5% over the comparable year-ago period.

ABBV closed Friday's trading at $80.54, down 6.22%. In pre-market trading on Monday, the stock is up 0.96% to $81.31.

Cellect Biotechnology Ltd. (APOP), a regenerative and cell therapy company, has concluded the scale-up development and manufacturing of clinical grade FasL in collaboration with its outsourced supplier.

The FasL protein is central to Cellect's technology of cell separation and functional selection of stem cells and is the key active ingredient in Cellect's ApoGraft and Apotainer product lines.

APOP closed Friday's trading at $2.70, down 6.74%.

OrganiGram Holdings Inc. (OGI.V), a licensed producer of cannabis, has reported encouraging results for the first quarter of fiscal 2019.

The net sales from continuing operations for the three months ended November 30, 2018 (Q1'2019) is $12.4 million, up 419% from $2.4 million in Q1'2018, and up 287% from $3.2 million in Q4'2018.

The net income from continuing operations is $29.5 million or $0.195 per share on a diluted basis, for Q1'2019, up from a net loss of $1.2 million, or $0.012 per share in Q1'2018, and net income of $18.0 million or $0.152 per share in Q4'2018.

OGI.V closed Friday's trading at C$5.95, down 2.94%.

Pivot Pharmaceuticals Inc. (PVOT.CN) (PVOTF.OB) has entered into a strategic Contract Manufacturing Agreement with Growpacker Inc., a fully-licensed cannabis co-packing and bottling company, to produce Pivot's differentiated and patented topical gels, creams, and beverages for the California cannabis market.

According to Pivot, the agreement will enable it to launch its patented line of bio-cannabis products immediately and cost-effectively while complementing its existing production capacity at its licensed facility in Costa Mesa, California.

PVOT.CN closed Friday's trading at $0.23, down 4.17%.

Protalix BioTherapeutics Inc. (PLX) announced that it will be presenting preliminary pharmacokinetic data from its phase III study of Pegunigalsidase alfa for the treatment of Fabry disease, dubbed BRIGHT, at the 15th Annual WORLDSymposium 2019 on February 7.

Fabry disease is an inherited disorder that results from the buildup of a particular type of fat, called globotriaosylceramide, in the body's cells due to deficiency of the enzyme, alpha-galactosidase A (AGA).

PLX closed Friday's trading at $0.43, up 0.96%.

Trevena Inc. (TRVN), whose pain drug candidate Oliceridine, was turned down by the FDA last November on the grounds of inadequate size of safety database for the proposed dosing and inadequate clinical data on QT prolongation has good news for investors.

Now, the FDA has agreed that the current safety database will support labeling at a maximum daily dose of 27 mg. The regulatory agency also has agreed that the Company can conduct a study in healthy volunteers to collect the requested QT interval data and that the study should include placebo- and positive-control arms.

The Company is not required to provide any additional efficacy data to resubmit the Oliceridine NDA.

TRVN closed Friday's trading at $0.54, up 1.56%. In pre-market trading on Monday, the stock is up 27.54% to $0.69.

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