Latest News in the pharma Industry

Policy & Regulation

FDA approves IND for Vectura's VR647

FDA approves IND for Vectura's VR647

24 Jan 2017

VR647 is a drug/device combination, using the AKITA JET smart nebuliser, for the delivery of nebulised budesonide.

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Endo agreement to resolve FTE investigation and litigation

Endo agreement to resolve FTE investigation and litigation

23 Jan 2017

No admission of wrongdoing, No monetary payment by Endo.

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Concert Pharmaceuticals receives FDA orphan drug designation for CTP-656 for the treatment of CF

Concert Pharmaceuticals receives FDA orphan drug designation for CTP-656 for the treatment of CF

22 Jan 2017

Topline results from the Phase II trial are expected by year-end 2017.

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EMA validates Gilead’s MAA for investigational chronic Hep C therapy

EMA validates Gilead’s MAA for investigational chronic Hep C therapy

22 Jan 2017

Sofosbuvir/Velpatasvir/Voxilaprevir cranted an accelerated assessment by the EMA.

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FDA approves Allergan's Rhofade cream, 1% for persistent facial erythema

FDA approves Allergan's Rhofade cream, 1% for persistent facial erythema

19 Jan 2017

Once-daily treatment reduces persistent facial erythema associated with rosacea through 12 hours.

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Suliqua approved in the EU for the treatment of adults with type 2 diabetes

Suliqua approved in the EU for the treatment of adults with type 2 diabetes

17 Jan 2017

Suliqua will be delivered in two pre-filled SoloSTAR pens, providing different dosing options that may help answer individual market and patient insulin needs.

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Tesaro receives CRL for rolapitant IV from FDA

Tesaro receives CRL for rolapitant IV from FDA

15 Jan 2017

No concerns raised by FDA related to the rolapitant IV efficacy or safety profile and additional clinical studies are not required.

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New-generation mealtime insulin approved in Europe

New-generation mealtime insulin approved in Europe

14 Jan 2017

Novo Nordisk to launch Fiasp in first half of 2017.

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VivaGel BV granted QIDP and Fast Track designation by FDA

VivaGel BV granted QIDP and Fast Track designation by FDA

14 Jan 2017

Product receives designations for both the BV treatment and prevention indications.

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FDA grants Fast-Track Designation to RHB-104 for nontuberculous mycobacteria infections

FDA grants Fast-Track Designation to RHB-104 for nontuberculous mycobacteria infections

12 Jan 2017

RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation.

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US Court of Appeals rules in Lilly's favour on Alimta vitamin regimen patent

US Court of Appeals rules in Lilly's favour on Alimta vitamin regimen patent

12 Jan 2017

If the patent is ultimately upheld through all remaining challenges, Alimta would maintain US exclusivity until May 2022.

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FDA accepts BLA for Mylan and Biocon's proposed biosimilar trastuzumab

FDA accepts BLA for Mylan and Biocon's proposed biosimilar trastuzumab

11 Jan 2017

If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the US.

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