Cristiana Bernini, Autore a NCF International

Latam means M&A

Global report

Cristiana Bernini

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4 April 2014

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The Latin American countries are about to host a forthcoming wave of merger and acquisition operations in the pharmaceutical sector, where today local producers in the bio-similar sector are still playing a prominent role. Foreign investments can instead give the industry an additional boost

Roberto Carminati

The multi-national research and consulting company GlobalData has recently released a new report about the Latin American pharmaceutical market and industry. Dubbed Pharmasphere: pharmaceutical and healthcare deal trends in Latin America 2008-2012 the document pointed out how a new wave of merger and acquisition or M&A operation has been shaking the continent all across the last five or six years.

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Bio-similar, the Italian job

Global report

Cristiana Bernini

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4 April 2014

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Despite the fact that this kind of drugs is about to increase its popularity and market share worldwide, sales in the Peninsula are today expected to climb up to previously unexperienced peaks in the next five years, as stated in a recent report released by the consultancy firm Frost & Sullivan

Roberto Carminati

As a new wave of mergers and acquisitions is taking the global pharmaceutical markets by storm, experts say a number of them could actually impact on the bio-similar or generic drugs sector, the reason being that this industry is growing at a dramatic pace and is poised to keep on rocketing.

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Mitochondrial-DNA related diseases and genetic manipulation

R&D

Cristiana Bernini

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4 April 2014

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Mitochondrial-DNA related diseases and genetic manipulation

FDA has recently audited experts in the field of artificial fertilisation and mitochondrial DNA replacement in order to better evaluate whether a new technique might be used to generate healthy progeny from mothers carrying mitochondrial DNA’s mutations. The debate is still open

Giuliana Miglierini

The technique is ready to be transferred to humans, claims Dr. Shoukhrat Mitalipov – the scientific team leader working at the Oregon Health & Science University in Portland (US). Nevertheless, deep scientific, ethic, social and regulatory scrutiny still need to be performed before it might be transferred in the clinical practice.

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Medicines shortages: an European overview?

Global report

Cristiana Bernini

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4 April 2014

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Medicines shortages: an European overview?

A clear definition of the terms shortages and a measurable scope of the problem are required to prevent patient’s discomforts

Caterina Lucchini

Medicine shortages have consistently been in the media over the past few years and have seemingly, with the economic crisis and austerity programme, become a crisis in their own right. Independent researchers Birgli recently published a study on the causes of medicines shortages, commissioned by the EAEPC (European Association of Euro-Pharmaceutical Companies).

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Dolutegravir, an integrase inibitor, to prevent HIV spread in patients

Drug Delivery

Cristiana Bernini

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4 April 2014

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The European Commission granted a marketing authorization valid throughout the European Union for Dolutegravir on 16 January 2014. Tivicay, the commercial name, is an antiviral medicine approved to treat adults and adolescents from 12 years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

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Antiviral treatment for chronic hepatitis C in adults

Drug Delivery

Cristiana Bernini

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4 April 2014

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On 21 November 2013, after an accelerated examination of the dossier, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Sovaldi (sofosbuvir) 400 mg film-coated tablet intended for the treatment of Chronic Hepatitis C (CHC).

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Dimethyl fumarate to treat multiple sclerosis

Drug Delivery

Cristiana Bernini

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4 April 2014

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The European Commission granted a marketing authorization valid throughout the European Union for Tecfidera (dimethyl fumarate) on 30 January 2014. Dimethyl fumarate is a nervous system drug (N07XX09), that primarily acts by triggering the activation of the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway

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Bitopertin misses primary endpoints in two phase III trials

Trials

Cristiana Bernini

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4 April 2014

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Against schizophrenia, Bitopertin, the first of a new class of medicines known as glycine reuptake inhibitors, has been proposed. Aim of Bitopertin, to treat the negative symptoms of schizophrenia, such as social withdrawal and lack of motivation.

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An HIV vaccine trial will start during springtime 2014

Trials

Cristiana Bernini

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4 April 2014

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Finnish biotechnology firm FIT Biotech focused in the development and commercialization of its Gene Transport Unit (GTU) technology and GTU product applications in DNA vaccination as well as in immuno – and gene therapies, has developed a new vaccine for the treatment of HIV.

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Placental expanded cells in the treatment of muscle injury

Trials

Cristiana Bernini

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4 April 2014

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The results from a randomized, placebo-controlled, double-blinded Phase 1/2 clinical trial on PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury have presented. Aim of the study to assess safety and efficacy of the treatment.

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Cristiana Bernini

The Latin American countries are about to host a forthcoming wave of merger and acquisition operations in the pharmaceutical sector, where today local producers in the bio-similar sector are still playing a prominent role. Foreign investments can instead give the industry an additional boost

Despite the fact that this kind of drugs is about to increase its popularity and market share worldwide, sales in the Peninsula are today expected to climb up to previously unexperienced peaks in the next five years, as stated in a recent report released by the consultancy firm Frost & Sullivan

FDA has recently audited experts in the field of artificial fertilisation and mitochondrial DNA replacement in order to better evaluate whether a new technique might be used to generate healthy progeny from mothers carrying mitochondrial DNA’s mutations. The debate is still open

A clear definition of the terms shortages and a measurable scope of the problem are required to prevent patient’s discomforts

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