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Research & Development

Eli Lilly and AstraZeneca announce continuation of pivotal clinical trial for people with early Alzheimer's disease

Eli Lilly and AstraZeneca announce continuation of pivotal clinical trial for people with early Alzheimer's disease

8 Apr 2016

Phase II/III trial of AZD3293, an oral potent small molecule BACE inhibitor, will continue to Phase III after positive interim safety data.

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Cambridge, UK, workshop to discuss accelerated preclinical drug development and readying molecules for Phase I

Cambridge, UK, workshop to discuss accelerated preclinical drug development and readying molecules for Phase I

7 Apr 2016

The event content will include API and formulation development, clinical study design and regulatory requirements.

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Novartis receives EU approval for Revolade as first-in-class therapy for children aged 1 year and above with chronic ITP

Novartis receives EU approval for Revolade as first-in-class therapy for children aged 1 year and above with chronic ITP

7 Apr 2016

Two formulations approved: once-daily tablet and oral suspension formulation designed for younger children who may not be able to swallow tablets.

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Engineers develop a pill for long-term drug release

Engineers develop a pill for long-term drug release

6 Apr 2016

New tablet attaches to the lining of the GI tract, resists being pulled away.

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MRC Technology and Institut Pasteur of Shanghai, Chinese Academy of Sciences collaborate on antibody drug development

MRC Technology and Institut Pasteur of Shanghai, Chinese Academy of Sciences collaborate on antibody drug development

6 Apr 2016

The parties created IPS-MRCT Joint Centre for Therapeutic Antibodies to combine their expertise in research and development, intellectual property (IP) protection and management, and commercial acumen for more precise and efficient technology transfer.

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Merck and Pfizer announce first patient treated in Phase III combination study

Merck and Pfizer announce first patient treated in Phase III combination study

5 Apr 2016

First-line study evaluating avelumab in combination with Inlyta (axitinib) compared with Sutent (sunitinib malate) monotherapy in renal cell carcinoma.

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NDA Group releases data comparing FDA and EMA ahead of annual DIA EuroMeeting in Hamburg

NDA Group releases data comparing FDA and EMA ahead of annual DIA EuroMeeting in Hamburg

5 Apr 2016

In spite of similar approval numbers, the US continue to outpace Europe.

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Regeneron and Sanofi announce positive dupilumab topline results from two Phase III trials

Regeneron and Sanofi announce positive dupilumab topline results from two Phase III trials

5 Apr 2016

Dupilumab is first systemic therapy to show positive Phase III results in patients with moderate-to-severe atopic dermatitis, a serious, chronic inflammatory skin disease marked by widespread rash, itching and associated psychosocial comorbidities.

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GSK receives positive CHMP opinion in Europe for Strimvelis, the first gene therapy to treat very rare disease, ADA-SCID

GSK receives positive CHMP opinion in Europe for Strimvelis, the first gene therapy to treat very rare disease, ADA-SCID

4 Apr 2016

The medicine is a stem cell gene therapy created for an individual patient from their own cells which is intended to correct the root cause of the disease.

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RedHill Biopharma's interim results from Phase IIa PoC study supporting therapeutic potential of RHB-104 in multiple sclerosis

RedHill Biopharma's interim results from Phase IIa PoC study supporting therapeutic potential of RHB-104 in multiple sclerosis

4 Apr 2016

RedHill Biopharma's interim results from Phase IIa proof-of-concept study supporting therapeutic potential of RHB-104 in multiple sclerosis

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Janssen receives CHMP Positive Opinion for Trevicta recommending approval in EU for maintenance treatment of schizophrenia

Janssen receives CHMP Positive Opinion for Trevicta recommending approval in EU for maintenance treatment of schizophrenia

3 Apr 2016

If approved, Trevica will be the first treatment for schizophrenia to be administered four times a year and will provide the longest dosing interval available for an antipsychotic medication in the EU.

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Flixabi, an infliximab biosimilar candidate referencing Remicade, receives positive CHMP opinion

Flixabi, an infliximab biosimilar candidate referencing Remicade, receives positive CHMP opinion

2 Apr 2016

Flixabi to be the second anti-TNF biosimilar commercialized and manufactured by Biogen in the EU.

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