Latest News in the pharma Industry

Policy & Regulation

FDA accepts filing of cardiovascular outcomes data for Jardiance

FDA accepts filing of cardiovascular outcomes data for Jardiance

25 Jan 2016

Boehringer Ingelheim and Eli Lilly and Company expect to receive a decision from the FDA within the standard review time frame.

Read more 
Valeant announces FDA acceptance of BLA submission for brodalumab in moderate-to-severe plaque psoriasis

Valeant announces FDA acceptance of BLA submission for brodalumab in moderate-to-severe plaque psoriasis

25 Jan 2016

The brodalumab BLA is supported by data from the three AMAGINE Phase III pivotal studies.

Read more 
BMS's Opdivo + Yervoy regimen receives expanded FDA approval

BMS's Opdivo + Yervoy regimen receives expanded FDA approval

24 Jan 2016

Opdivo + Yervoy Regimen now indicated for unresectable or metastatic melanoma patients, regardless of BRAF mutational status, based on accelerated approval.

Read more 
FDA approves Botox for the treatment of lower limb spasticity in adults

FDA approves Botox for the treatment of lower limb spasticity in adults

23 Jan 2016

Botox is the first and only FDA-approved neurotoxin treatment for both upper and lower limb spasticity.

Read more 
NICE ‘yes’ for Opdivo offers patients with advanced skin cancer new treatment option

NICE ‘yes’ for Opdivo offers patients with advanced skin cancer new treatment option

21 Jan 2016

NHS patients in England and Wales will be able to access an innovative treatment option that offers a potentially rapid and durable response in patients with previously untreated advanced melanoma, compared with chemotherapy.

Read more 
Lilly and Incyte submit NDA to FDA for oral once-daily baricitinib

Lilly and Incyte submit NDA to FDA for oral once-daily baricitinib

20 Jan 2016

Baricitinib is for the treatment of moderate-to-severe rheumatoid arthritis.

Read more 
Mylan launches generic Felbatol tablets

Mylan launches generic Felbatol tablets

19 Jan 2016

Recommended for monotherapy or adjunctive therapy in the treatment of partial seizures.

Read more 
Benepali, the first etanercept biosimilar referencing Enbrel, approved in the EU

Benepali, the first etanercept biosimilar referencing Enbrel, approved in the EU

17 Jan 2016

Biogen will manufacture and commercialize Benepali in the EU.

Read more 
FDA grants Priority Review for venetoclax NDA

FDA grants Priority Review for venetoclax NDA

12 Jan 2016

Venetoclax, an investigational medicine, is a potential new way of treating the most common adult leukemia.

Read more 
Epigenomics receives FDA notification about status of pending approval decision for Epi proColon

Epigenomics receives FDA notification about status of pending approval decision for Epi proColon

8 Jan 2016

Final approval of the company's application is subject to the resolution of minor outstanding topics, such as the use of appropriate language in the product labeling.

Read more 
Regeneron and Sanofi announce sarilumab BLA Accepted for review by FDA

Regeneron and Sanofi announce sarilumab BLA Accepted for review by FDA

8 Jan 2016

Sarilumab is an investigational, human monoclonal antibody intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis

Read more 
Teikoku Pharma USA, Inc. announces FDA approval of docetaxel injection

Teikoku Pharma USA, Inc. announces FDA approval of docetaxel injection

30 Dec 2015

First non-alcohol formulation approved in the US.

Read more