Latest News in the pharma Industry

Policy & Regulation

MAA submitted to EMA for patisiran for the treatment of hereditary ATTR amyloidosis

MAA submitted to EMA for patisiran for the treatment of hereditary ATTR amyloidosis

27 Dec 2017

Sanofi and Alnylam's patisiran MAA to be reviewed under accelerated assessment.

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FDA approves the only OTC eye drop with low-dose Brimonidine to treat eye redness

FDA approves the only OTC eye drop with low-dose Brimonidine to treat eye redness

27 Dec 2017

Clinical studies showed 95% symptom improvement at one minute and reduced redness for up t 8 hours.

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Allergan acknowledges Appeals Court decision for Combigan

Allergan acknowledges Appeals Court decision for Combigan

27 Dec 2017

Allergan plans to file petitions for rehearing of the appeals court decision and has asserted a new Orange Book patent against Sandoz's generic version of Combigan.

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Acerus receives Notice of Deficiency from Health Canada for Gynoflor

Acerus receives Notice of Deficiency from Health Canada for Gynoflor

27 Dec 2017

Health Canada requests additional technical information on Gynoflor to complete its assessment of the product.

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FDA clears myPKFiT for ADVATE to help personalize care for hemophilia A

FDA clears myPKFiT for ADVATE to help personalize care for hemophilia A

19 Dec 2017

First and only FDA-cleared PK dosing software to support healthcare professionals in creating personalized dosing regimens for patients 16 and older with hemophilia A.

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New formulation of Oncaspar receives Marketing Authorization in Europe for patients with ALL

New formulation of Oncaspar receives Marketing Authorization in Europe for patients with ALL

14 Dec 2017

Freeze-dried, or lyophilized, formulation aims to improve supply management by providing the same dosing regimen as liquid Oncaspar but with a three-times longer shelf life of up to 24 months.

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Recipharm equips a further three facilities for US serialisation

Recipharm equips a further three facilities for US serialisation

27 Nov 2017

CDMO's serialisation capabilities in place ahead of US deadline to avoid potential problems for our customers.

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FDA approves Zelboraf for Erdheim-Chester Disease

FDA approves Zelboraf for Erdheim-Chester Disease

6 Nov 2017

Zelboraf is the first FDA-approved treatment for Erdheim-Chester disease ECD, a rare blood disease.

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RedHill Biopharma and IntelGenx submit NDA to FDA for Rizaport for migraines

RedHill Biopharma and IntelGenx submit NDA to FDA for Rizaport for migraines

2 Nov 2017

Rizaport is a proprietary oral thin-film formulation of rizatriptan for the treatment of acute migraines.

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FDA approves AstraZeneca's Calquence for adult patients with mantle cell lymphoma

FDA approves AstraZeneca's Calquence for adult patients with mantle cell lymphoma

31 Oct 2017

Accelerated approval of Bruton tyrosine kinase inhibitor in MCL marks AstraZeneca's entry into the treatment of blood cancers.

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Mylan wins UK court ruling related to Copaxone 40 mg/mL patent

Mylan wins UK court ruling related to Copaxone 40 mg/mL patent

26 Oct 2017

Court finds all claims of Teva's patent relating to Copaxone invalid based on obviousness.

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New European Council of regulatory professionals set to shape and support the profession

New European Council of regulatory professionals set to shape and support the profession

18 Oct 2017

New European Council will support RAPS’ growing member base and volunteer network across Europe to ensure compliance with global regulations and to drive regulatory excellence

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