Latest News in the pharma Industry

Research & Development

JAMA publishes Mylan and Biocon's proposed biosimilar trastuzumab Phase III data

JAMA publishes Mylan and Biocon's proposed biosimilar trastuzumab Phase III data

27 Dec 2016

Published study results showed an overall response rate of 69.6% for MYL-1401O compared to 64% for branded trastuzumab.

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Recursion receives industry awards for drug discovery platform

Recursion receives industry awards for drug discovery platform

27 Dec 2016

Computationally intelligent drug discovery platform receives two Fierce Innovation awards for Biotech Innovation and Best New Product.

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FDA approves first drug for spinal muscular atrophy

FDA approves first drug for spinal muscular atrophy

26 Dec 2016

Spinraza improved motor function in SMA patients.

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Vectura and Mundipharma sign global development programme

Vectura and Mundipharma sign global development programme

26 Dec 2016

Development and licence agreement is for pMDI inhaled triple therapy (VR2076) for asthma and COPD.

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New formulation of linaclotide may produce additional relief of abdominal pain in patients with IBS-C

New formulation of linaclotide may produce additional relief of abdominal pain in patients with IBS-C

22 Dec 2016

Abdominal pain improved 56% with CR1 300 mcg relative to placebo in Phase IIb trial.

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FDA extends review of application for Ocrevus

FDA extends review of application for Ocrevus

21 Dec 2016

Extension is the result of the submission of additional data regarding the commercial manufacturing process of the biologic.

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FDA grants accelerated approval to Rubraca for the treatment of advanced ovarian cancer

FDA grants accelerated approval to Rubraca for the treatment of advanced ovarian cancer

20 Dec 2016

First and only PARP inhibitor in the US indicated t.o treat advanced ovarian cancer patients who have been treated with two or more chemotherapies and who have deleterious germline or somatic BRCA mutations.

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Ionis and AstraZeneca advance first generation 2.5 LICA drug into preclinical development to treat CV disease

Ionis and AstraZeneca advance first generation 2.5 LICA drug into preclinical development to treat CV disease

20 Dec 2016

Ionis earns $25 million milestone payment.

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AmpliPhi Biosciences reports favorable final results from Phase I trial of AB-SA01 in CRS patients

AmpliPhi Biosciences reports favorable final results from Phase I trial of AB-SA01 in CRS patients

19 Dec 2016

AB-SA01 meets primary endpoints of safety and tolerability and reduces S. aureus bacterial load in all patients.

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FDA approves removal of boxed warning regarding serious neuropsychiatric events from Chantix labeling

FDA approves removal of boxed warning regarding serious neuropsychiatric events from Chantix labeling

19 Dec 2016

Labeling revisions also include updates to corresponding warning and addition of clinical data on superior efficacy of Chantix compared with bupropion or nicotine patch.

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Oxford Genetics secures £1.61m grant to establish next-generation bioproduction technologies

Oxford Genetics secures £1.61m grant to establish next-generation bioproduction technologies

15 Dec 2016

The project aims to create a step-change in the capabilities of current bioproduction methods, meeting unmet needs in the field of viral vector production.

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Catalent Biologics to collaborate with PATH Malaria Vaccine Initiative

Catalent Biologics to collaborate with PATH Malaria Vaccine Initiative

15 Dec 2016

Catalent Biologics will employ its proprietary GPEx cell line technology and ambr workstation to develop, optimize the process for expression, and manufacture antibodies for further investigation by MVI and its partners.

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