Latest News in the pharma Industry

Policy & Regulation

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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Takeda disappointed as NICE issue second negative draft decision for ixazomib

Takeda disappointed as NICE issue second negative draft decision for ixazomib

5 Sep 2017

Company says it is determined to work collaboratively to find a solution.

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Bayer submits BLA in the for BAY94-9027 – a long-acting factor VIII for the treatment of hemophilia A

Bayer submits BLA in the for BAY94-9027 – a long-acting factor VIII for the treatment of hemophilia A

3 Sep 2017

Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervals.

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FDA approves Pfizer's Mylotarg for treatment of AML

FDA approves Pfizer's Mylotarg for treatment of AML

1 Sep 2017

Only approved antibody-drug conjugate for newly diagnosed and relapsed or refractory CD33-positive AML.

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Lilly to file baricitinib resubmission to FDA before end of January 2018

Lilly to file baricitinib resubmission to FDA before end of January 2018

30 Aug 2017

Resubmission package will include new safety and efficacy data.

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Novartis receives first ever FDA approval for a CAR-T cell therapy

Novartis receives first ever FDA approval for a CAR-T cell therapy

30 Aug 2017

Kymriah approvaed for children and young adults with B-cell ALL that is refractory or has relapsed at least twice.

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