Latest News in the pharma Industry

Policy & Regulation

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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FDA warns Pfizer company about cGMP violations associated with the manufacture of EpiPen

FDA warns Pfizer company about cGMP violations associated with the manufacture of EpiPen

10 Sep 2017

Warning letter cites Meridian Medical Technologies' failure to thoroughly investigate multiple serious component and product failures of EpiPen products.

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Research reveals costly implementation is the biggest barrier to serialization compliance

Research reveals costly implementation is the biggest barrier to serialization compliance

7 Sep 2017

The time it takes to develop a solution has been gravely underestimated by a large part of the industry.

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Novo Nordisk settles US federal investigation of marketing practices

Novo Nordisk settles US federal investigation of marketing practices

7 Sep 2017

In connection with the $60 million settlement, the company has also resolved several private whistle-blower cases related to the government's investigation.

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Life-extending pancreatic cancer medicine recommended by NICE in final guidance

Life-extending pancreatic cancer medicine recommended by NICE in final guidance

6 Sep 2017

The pivotal Phase III study demonstrated that treatment with Abraxane in combination with gemcitabine can offer patients a median overall survival improvement of 1.8 months.

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