Latest News in the pharma Industry

Policy & Regulation

FDA accepts sNDA for Vraylar

FDA accepts sNDA for Vraylar

8 Mar 2017

Application seeks to expand Vraylar label to include Phase III clinical data for the maintenance treatment of schizophrenia.

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First ever biosimilar of interferon beta-1a approved in Russia

First ever biosimilar of interferon beta-1a approved in Russia

5 Mar 2017

Represents Biocad's third authorized medicine for the treatment of relapsing-remitting multiple sclerosis.

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NICE expands positive recommendation for Erbitux as first-line treatment for RAS wild-type mCRC

NICE expands positive recommendation for Erbitux as first-line treatment for RAS wild-type mCRC

2 Mar 2017

More patients now able to receive a standard-of-care treatment with Erbitux plus Folfiri or Folfox.

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FDA accepts BLA for avelumab for the treatment of metastatic urothelial carcinoma for Priority Review

FDA accepts BLA for avelumab for the treatment of metastatic urothelial carcinoma for Priority Review

28 Feb 2017

Second Biologics License Application accepted by the FDA for avelumab.

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CHMP recommends EU Conditional Marketing Authorisation for Natpar for patients with chronic hypoparathyroidism

CHMP recommends EU Conditional Marketing Authorisation for Natpar for patients with chronic hypoparathyroidism

27 Feb 2017

If approved, Natpar would be the first licensed recombinant parathyroid hormone in Europe for the management of chronic hypoparathyroidism, the only endocrine-deficiency disorder with no hormone treatment.

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FDA expands approval of Spiriva Respimat inhalation spray

FDA expands approval of Spiriva Respimat inhalation spray

16 Feb 2017

Steroid-free Spiriva Respimat now approved as asthma treatment for age 6 and older.

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FDA accepts BLA for Mylan and Biocon's proposed biosimilar pegfilgrastim for review

FDA accepts BLA for Mylan and Biocon's proposed biosimilar pegfilgrastim for review

16 Feb 2017

The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.

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Valeant's treatment for plaque psoriasis gets FDA thumbs up for Siliq

Valeant's treatment for plaque psoriasis gets FDA thumbs up for Siliq

16 Feb 2017

More than 50% of patients in three clinical studies who used Siliq achieved total skin clearance within a year.

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EC approves once-daily Olumiant tablets for treatment of adults with active RA

EC approves once-daily Olumiant tablets for treatment of adults with active RA

14 Feb 2017

Baricitinib, marketed as Olumiant, is the first JAK inhibitor approved to treat RA in the EU.

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Appeals Court grants stay of permanent injunction for Praluent during appeals process

Appeals Court grants stay of permanent injunction for Praluent during appeals process

9 Feb 2017

Praluent continues to be available to patients in the US.

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Lilly's Trulicity label updated to include use in combination with basal insulin for adults with type 2 diabetes

Lilly's Trulicity label updated to include use in combination with basal insulin for adults with type 2 diabetes

8 Feb 2017

Trulicity is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist injectable prescription medicine.

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FDA approves first new treatment in more than a decade for secondary HPT in adults on hemodialysis

FDA approves first new treatment in more than a decade for secondary HPT in adults on hemodialysis

8 Feb 2017

Intravenous administration puts delivery in hands of healthcare provider.

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