Latest News in the pharma Industry

Research & Development

2017: A year of innovation and advances

2017: A year of innovation and advances

14 Jan 2018

A summary and highlights of new drug therapy approvals and other drug therapy advances in 2017 by FDA's CDER.

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New automated VPT systems for topical drug performance testing

New automated VPT systems for topical drug performance testing

11 Jan 2018

The MedStat-HT and MedFlux-HT help to de-risk development programs and shorten development timelines.

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3D human sebaceous glands technology for skin care applications

3D human sebaceous glands technology for skin care applications

9 Jan 2018

New 3D technology provides a powerful platform for skin care researchers wishing to study the function of sebaceous glands, in relation to a range of age-related, microbial and inflammatory skin disorders.

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Sangamo and Pfizer collaborate to develop zinc finger protein gene therapy for ALS

Sangamo and Pfizer collaborate to develop zinc finger protein gene therapy for ALS

7 Jan 2018

"The precision and flexibility of zinc finger proteins enables targeting of virtually any genetic mutation."

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Promacta receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia

Promacta receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia

4 Jan 2018

Data supporting designation showed over half of treatment-naïve SAA patients achieved complete response with Promacta when given with standard immunosuppressive therapy, with overall response rate of 85%.

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Momenta and Mylan to development proposed biosimilar to Eylea

Momenta and Mylan to development proposed biosimilar to Eylea

4 Jan 2018

Targeting the initiation of a pivotal patient clinical trial in the first half of 2018.

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Novartis Kisqali receives FDA Breakthrough Therapy designation

Novartis Kisqali receives FDA Breakthrough Therapy designation

3 Jan 2018

Designation based on Phase III MONALEESA-7 results demonstrating superior efficacy of Kisqali in combination with oral endocrine therapy compared to oral endocrine therapy in pre- or perimenopausal women who received no prior endocrine therapy for adva...

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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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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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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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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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