Latest News in the pharma Industry

Policy & Regulation

BMS and AbbVie receive positive CHMP opinion for investigational antibody, Empliciti, for the treatment of multiple myeloma

BMS and AbbVie receive positive CHMP opinion for investigational antibody, Empliciti, for the treatment of multiple myeloma

29 Jan 2016

Positive opinion based on reduction in the risk of disease progression or death with Empliciti in combination with standard of care regimen for multiple myeloma demonstrated in ELOQUENT-2 study.

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Merck announces FDA acceptance of BLA for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile infection recurrence

Merck announces FDA acceptance of BLA for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile infection recurrence

27 Jan 2016

FDA grants Priority Review with target action date of 23 July 23 2016.

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Shire resubmits NDA for lifitegrast to FDA

Shire resubmits NDA for lifitegrast to FDA

25 Jan 2016

Resubmission includes positive data from OPUS-3, a Phase III efficacy and safety trial.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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