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Scholar Rock announces $47 million Series C financing to advance innovative pipeline

Scholar Rock announces $47 million Series C financing to advance innovative pipeline

3 Jan 2018

SRK-015 to move into clinical development for Spinal Muscular Atrophy (SMA) in first half of 2018; development in additional neuromuscular disorders to follow.

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Recipharm acquires remaining shares in Nitin Lifesciences

Recipharm acquires remaining shares in Nitin Lifesciences

2 Jan 2018

The transaction will allow Recipharm to combine and better exploit operational synergies with the company's other Indian business.

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Juniper Pharma Services’ co-founder awarded CBE in the Queen’s New Year’s Honours List

Juniper Pharma Services’ co-founder awarded CBE in the Queen’s New Year’s Honours List

2 Jan 2018

Martyn Davies recognised for his contribution to UK science and his ground-breaking achievements in pharmaceutical research and drug development.

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Novel Sorrento CAR-T technology a potential “game-changer

Novel Sorrento CAR-T technology a potential “game-changer

2 Jan 2018

Company envisions the development and IND filings of multiple “next-frontier” CAR-T programs in 2018 and beyond, which will position the company as a potential major player in the fast-growing CAR-T space of immunotherapies against cancers.

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Novartis' combination therapy Tafinlar + Mekinist granted FDA Priority Review

Novartis' combination therapy Tafinlar + Mekinist granted FDA Priority Review

1 Jan 2018

If approved, Tafinlar + Mekinist expected to be the first adjuvant targeted therapy combination to demonstrate a significant clinical benefit in patients with a BRAF V600 mutation.

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ANVISA approves Biocon and Mylan's biosimilar Trastuzumab

ANVISA approves Biocon and Mylan's biosimilar Trastuzumab

29 Dec 2017

Libbs will commercialize the product in Brazil under the brand name Zedora.

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FDA approves first generic for Estrace Cream

FDA approves first generic for Estrace Cream

29 Dec 2017

Mylan now offers estradiol in four delivery methods.

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Shire files for FDA approval of a new plasma manufacturing facility

Shire files for FDA approval of a new plasma manufacturing facility

28 Dec 2017

The additional capacity from this site is a key element to support the growth in the company's Immunology franchise.

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FDA accepts NDA filing for Epidiolex in the treatment of Lennox-Gastaut syndrome and Dravet syndrome

FDA accepts NDA filing for Epidiolex in the treatment of Lennox-Gastaut syndrome and Dravet syndrome

28 Dec 2017

The PDUFA goal date for completion of the FDA review of the Epidiolex NDA is 27 June 2018.

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Teva launches generic version of Reyataz in the US

Teva launches generic version of Reyataz in the US

28 Dec 2017

The exclusive launch of Teva's generic version of Reyataz marks the company's fifth generic product offering for the treatment of HIV-1 infection.

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Novartis drug Tasigna approved by FDA

Novartis drug Tasigna approved by FDA

28 Dec 2017

First and only CML therapy with Treatment-free Remission data in its label.

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MAA submitted to EMA for patisiran for the treatment of hereditary ATTR amyloidosis

MAA submitted to EMA for patisiran for the treatment of hereditary ATTR amyloidosis

27 Dec 2017

Sanofi and Alnylam's patisiran MAA to be reviewed under accelerated assessment.

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