Latest News in the pharma Industry

Policy & Regulation

FDA approves Novartis' Kisqali as first-line treatment for HR+/HER2- metastatic breast cancer

FDA approves Novartis' Kisqali as first-line treatment for HR+/HER2- metastatic breast cancer

16 Mar 2017

Kisqali plus letrozole showed treatment benefit across all patient subgroups regardless of disease burden or tumour location.

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Shire receives European approval for label extension of Cinryze

Shire receives European approval for label extension of Cinryze

16 Mar 2017

Cinryze is the first and only Hereditary angioedema treatment approved for routine prevention in paediatrics.

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Merck's Keytruda receives FDA approval to treat patients with refractory classical Hodgkin lymphoma

Merck's Keytruda receives FDA approval to treat patients with refractory classical Hodgkin lymphoma

15 Mar 2017

Only anti-PD-1 therapy approved for the treatment of patients with difficult-to-treat cHL regardless of prior stem cell transplantation or use of brentuximab vedotin

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Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations

Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations

14 Mar 2017

Dietary supplement products "misbranded" and unapproved new drugs being marketed with drug claims despite not being approved for any use.

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Mylan announces global settlement and license Agreements with Genentech and Roche on Herceptin

Mylan announces global settlement and license Agreements with Genentech and Roche on Herceptin

13 Mar 2017

Settlement provides Mylan with global licenses for its trastuzumab product.

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Boehringer's investigational anti-CD33 monoclonal antibody gains orphan drug designation for treatment of myelodysplastic syndromes

Boehringer's investigational anti-CD33 monoclonal antibody gains orphan drug designation for treatment of myelodysplastic syndromes

13 Mar 2017

BI 836858 was previously granted orphan drug designation for the treatment of patients with AML.

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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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