Latest News in the pharma Industry

Policy & Regulation

Novartis' Votubia receives EU approval to treat refractory partial-onset seizures in patients with TSC

Novartis' Votubia receives EU approval to treat refractory partial-onset seizures in patients with TSC

31 Jan 2017

Decision marks the third TSC-related indication for Votubia in the EU.

Read more 
Mylan wins US District Court ruling related to Copaxone 40 mg/mL patents

Mylan wins US District Court ruling related to Copaxone 40 mg/mL patents

31 Jan 2017

Patents in question invalidated based on obviousness.

Read more 
FDA approves Allergan's sNDA for Avycaz to include new Phase III data in patients with cUTI

FDA approves Allergan's sNDA for Avycaz to include new Phase III data in patients with cUTI

30 Jan 2017

New clinical data for Avycaz demonstrates efficacy in cUTI patients including those with infections due to resistant Gram-negative pathogens.

Read more 
Sunovion’s Latuda receives FDA approval to treat adolescents with schizophrenia

Sunovion’s Latuda receives FDA approval to treat adolescents with schizophrenia

30 Jan 2017

First treatment approved in 5 years for adolescents aged 13-17 years with schizophrenia.

Read more 
First adalimumab biosimilar candidate recommended for EMA approval

First adalimumab biosimilar candidate recommended for EMA approval

29 Jan 2017

Amgen receives positive CHMP opinion for biosimilar adalimumab.

Read more 
FDA approves 72 mcg dose of Linzess for adults with chronic idiopathic constipation

FDA approves 72 mcg dose of Linzess for adults with chronic idiopathic constipation

26 Jan 2017

New dosage strength expected to be available in first quarter of 2017.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more