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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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Fire at Ashland facility suspends production of BDO, THF and formaldehyde

Fire at Ashland facility suspends production of BDO, THF and formaldehyde

29 Aug 2017

Volume expected to remain somewhat constrained into the first quarter of fiscal 2018.

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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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Krystal microplate enables development of drug testing assay

Krystal microplate enables development of drug testing assay

29 Aug 2017

Scientists at the NCBS using Krystal 384-well black microplates to produce a standard drug testing assay for Plasmodium vivax infection.

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Berg and AstraZeneca collaborate to identify new therapeutic targets to treat neurological disorders

Berg and AstraZeneca collaborate to identify new therapeutic targets to treat neurological disorders

28 Aug 2017

Collaboration to focus on a disease target in Parkinson's disease with Berg's Interrogative Biology technology.

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New Repatha data support lower LDL-C levels for high-risk cardiovascular patients

New Repatha data support lower LDL-C levels for high-risk cardiovascular patients

28 Aug 2017

No evidence of a leveling off of effect and no new safety concerns were identified in this analysis.

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Sanofi completes the acquisition of Protein Sciences

Sanofi completes the acquisition of Protein Sciences

28 Aug 2017

An innovative quadrivalent influenza vaccine will complement Sanofi Pasteur vaccine portfolio.

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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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Class action lawsuit filed on behalf of investors in Teva

Class action lawsuit filed on behalf of investors in Teva

28 Aug 2017

Complaint alleges Teva failed to disclose the poor performance of its US generics business and the subsequent goodwill impairment charge stemming from the company’s purchase of Actavis Generics.

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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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