Latest News in the pharma Industry

Policy & Regulation

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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FDA approves new antibacterial drug

FDA approves new antibacterial drug

30 Aug 2017

First carbapenem-based combination product – combination of meropenem with a new class of beta-lactamase inhibitor.

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Acordia's NDA generates Refusal to File letter from FDA

Acordia's NDA generates Refusal to File letter from FDA

29 Aug 2017

FDA cites two manufacturing concerns.

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Biogen’s adalimumab biosimilar referencing Humira, is approved in the EU

Biogen’s adalimumab biosimilar referencing Humira, is approved in the EU

28 Aug 2017

Biogen becomes the first company with approved biosimilars for the three most prescribed anti-TNF biologic treatments in Europe.

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Boehringer Ingelheim receives FDA approval for its Humira biosimilar

Boehringer Ingelheim receives FDA approval for its Humira biosimilar

29 Aug 2017

Cyltezo approved for the treatment of multiple chronic inflammatory diseases.

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EC approves first oral short-course treatment for highly active relapsing multiple sclerosis

EC approves first oral short-course treatment for highly active relapsing multiple sclerosis

27 Aug 2017

Mavenclad has shown sustained clinical efficacy for up to 4 years with a maximum of 20 days of oral treatment over 2 years.

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FDA grants Priority Review to Genentech's emicizumab for Hemophilia A with inhibitors

FDA grants Priority Review to Genentech's emicizumab for Hemophilia A with inhibitors

24 Aug 2017

Application based on positive results of Phase III study in adults and adolescents with hemophilia A with inhibitors and interim Phase III results in children.

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Hikma statement on generic Advair Diskus

Hikma statement on generic Advair Diskus

18 Aug 2017

Company been able to clarify and resolve a number of the questions raised by the FDA.

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Shire submits lifitegrast MAA for treatment of dry eye disease in Europe

Shire submits lifitegrast MAA for treatment of dry eye disease in Europe

15 Aug 2017

Lifitegrast, if approved, would be the first and only new class treatment to address the signs and symptoms of dry eye disease in adults in Europe.

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FDA removes clinical hold on CEL-SCI’s Phase III head & neck cancer trial

FDA removes clinical hold on CEL-SCI’s Phase III head & neck cancer trial

14 Aug 2017

The last FDA approved treatment for advanced primary head and neck cancer was over 50 years ago.

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