Latest News in the pharma Industry

Policy & Regulation

FDA approves new treatment to reduce the risk of breast cancer returning

FDA approves new treatment to reduce the risk of breast cancer returning

18 Jul 2017

Nerlynx is the first extended adjuvant therapy for patients with HER2-positive breast cancer.

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FDA approves Impax's AB rated generic Concerta Extended-Release Tablets CII

FDA approves Impax's AB rated generic Concerta Extended-Release Tablets CII

17 Jul 2017

Company expects to launch by the end of the year.

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FDA committee recommends approval of Mylan and Biocon's proposed biosimilar trastuzumab

FDA committee recommends approval of Mylan and Biocon's proposed biosimilar trastuzumab

16 Jul 2017

Vote marks first proposed biosimilar trastuzumab to be recommended by the committee.

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Novartis CAR-T cell therapy CTL019 recommended for FDA approval

Novartis CAR-T cell therapy CTL019 recommended for FDA approval

13 Jul 2017

A BLA for this indication is under FDA priority review; if approved, CTL019 could become first CAR-T cell therapy available.

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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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