Latest News in the pharma Industry

Policy & Regulation

FDA grants Genentech’s Alecensa Priority Review

FDA grants Genentech’s Alecensa Priority Review

3 Aug 2017

Designation given for initial treatment of people with ALK-positive lung cancer.

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BMS receives FDA approval for Opdivo Injection for metastatic colorectal cancer

BMS receives FDA approval for Opdivo Injection for metastatic colorectal cancer

3 Aug 2017

Approval based on CheckMate -142, in which Opdivo demonstrated an objective response rate of 28% among patients who received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

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Amgen submits sBLA for Prolia in glucocorticoid-induced osteoporosis

Amgen submits sBLA for Prolia in glucocorticoid-induced osteoporosis

31 Jul 2017

Results from the Phase III study included in the sBLA submission showed that treatment with Prolia for 12 months led to statistically significant greater gains in BMD at the lumbar spine and total hip compared to risedronate.

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BMS's Orencia receives second EC approval in less than a year

BMS's Orencia receives second EC approval in less than a year

26 Jul 2017

New approval for treatment of active psoriatic arthritis (PsA).

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New research highlights lack of confidence in serialization preparations

New research highlights lack of confidence in serialization preparations

25 Jul 2017

40% of industry professionals admit they are not clear about the global requirements for serialization.

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Merck launches Remicade biosimilar for all eligible indications, in the US

Merck launches Remicade biosimilar for all eligible indications, in the US

24 Jul 2017

The biosimilar's list price will represent a 35% discount to the current list price of Remicade.

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Novartis receives positive CHMP opinion for Rydapt

Novartis receives positive CHMP opinion for Rydapt

23 Jul 2017

If approved, Rydapt would represent the first targeted treatment for newly diagnosed FLT3-mutated AML in the EU.

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GSK receives FDA approval for a new self-injectable formulation of Benlysta

GSK receives FDA approval for a new self-injectable formulation of Benlysta

23 Jul 2017

The approval marks the first subcutaneous self-injection treatment option for patients with systemic lupus erythematosus.

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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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