Latest News in the pharma Industry

Policy & Regulation

FDA accepts sNDA for Xeljanz for the treatment of adult patients with active ulcerative colitis

FDA accepts sNDA for Xeljanz for the treatment of adult patients with active ulcerative colitis

13 Jul 2017

Anticipated Prescription Drug User Fee Act (PDUFA) action date for the sNDA is March 2018 .

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Lilly reaches settlement agreement in US Cialis patent litigation

Lilly reaches settlement agreement in US Cialis patent litigation

12 Jul 2017

Cialis exclusivity is now expected to end at the earliest on 27 September 2018.

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FDA approves Blincyto to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia

FDA approves Blincyto to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia

12 Jul 2017

Blincyto is the first and only Bispecific T cell Engager (BiTE) immunotherapy to demonstrate superior overall survival versus standard of care chemotherapy.

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SMC says ‘yes’ to Opdivo for blood cancer patients

SMC says ‘yes’ to Opdivo for blood cancer patients

12 Jul 2017

Patients in Scotland will now join those in England and Wales and be able to benefit from this potentially life-extending immunotherapy on the NHS.

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BMS's Orencia receives FDA approval for treatment of active psoriatic arthritis in adults

BMS's Orencia receives FDA approval for treatment of active psoriatic arthritis in adults

10 Jul 2017

Orencia now approved in three autoimmune diseases.

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UK Supreme Court rules in Lilly's favour on Alimta vitamin regimen patents

UK Supreme Court rules in Lilly's favour on Alimta vitamin regimen patents

9 Jul 2017

Actavis's products directly infringe Lilly's vitamin regimen patents in the UK, France, Italy and Spain.

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Almac Discovery granted Orphan Drug Designation for ALM201 programme in ovarian cancer

Almac Discovery granted Orphan Drug Designation for ALM201 programme in ovarian cancer

7 Jul 2017

ALM201 is a therapeutic peptide developed to mimic some of the properties of the naturally occurring protein FKBPL.

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Impax launches additional strengths of generic Focalin XR extended-release capsules CII

Impax launches additional strengths of generic Focalin XR extended-release capsules CII

6 Jul 2017

Company has immediately initiated commercialization activities.

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Novartis receives EU approval for Cosentyx label update

Novartis receives EU approval for Cosentyx label update

6 Jul 2017

Label update includes 52 week data from CLEAR study demonstrating long-term superiority of Cosentyx versus Stelara in psoriasis.

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Specialist CRO expands pharmacovigilance capabilities

Specialist CRO expands pharmacovigilance capabilities

6 Jul 2017

Pharma clients now have direct and immediate access to a fully compliant safety database without needing to invest in their own system or use an interim solution to ensure compliance.

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BIOCAD’s rituximab biosimilar to receive MA in India

BIOCAD’s rituximab biosimilar to receive MA in India

4 Jul 2017

First shipment of BIOCAD’s Acellbia to India is scheduled for September 2017.

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Lilly's Olumiant gets the thumbs up in Japan for the treatment of rheumatoid arthritis

Lilly's Olumiant gets the thumbs up in Japan for the treatment of rheumatoid arthritis

3 Jul 2017

In clinical studies, baricitinib has demonstrated significant improvement in the signs and symptoms of RA compared to standard-of-care therapies.

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