Monthly Archives: October 2013

October 29 ,2013 | By Márcio Barra

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Tecfidera (dymethil Fumarate), Biogen Idec’s prized multiple sclerosis drug, is fast approaching blockbuster status according to the recently released third-quarter numbers of Biogen Idec’s, beating along the way analyst expectation and pushing Biogen Idec’s net profit up 22%.

For Q3, Tecfidera sales garnered $286.4 million, far higher than the $217.2 million that analysts expected. It is now expected that Tecfidera will reach $3.5 billion in annual revenue by 2016, a no doubt impressive number for a drug that, in its first quarter in the market (the drug was launched in March 2013 in the US), posted $192.1 million in sales. This revenue mark pushed Biogen’s net profit up 22% to $488 million, up from $398 million last year.

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October 28 ,2013 | By Márcio Barra

Tafamidis (vyndaqel), from Pfizer, sold in Portugal since 05 May 2012

What follows is a list of Orphan Drugs available in Portugal. This data has been compiled from two different databases, the INFOMED database, managed by the Portuguese National Competent Authrority on Medicines, INFARMED, and the OrphaNet database, from which sales numbers from Portugal were obtained, when available (note, sales numbers were, according to the Orphanet Website, last updated in September 28, 2013). The Portuguese Marketing approval date was also provided,

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October 28, 2013 | By Anabela Farrica

Last Friday, FDA approved Vizamyl (flutemetamol F 18), a radioactive agent to be used with PET to help evaluate the brain of patients for Alzheimer’s disease or dementia. Vyzamil works by binding to beta-amyloid plaques, which can be found in the brain of people with Alzheimer’s disease or other dementias, as well as in the brain of elderly people who do not have neurological problems.

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October 26, 2013 | By Anabela Farrica

Abbott’s MitraClip Percutaneous Mitral Valve Repair System

The U.S. Food and Drug Administration has approved Abbot’s MitraClip, a device intended for patients with mitral valve regurgitation and for whom open-heart surgery for valve repair is deemed inadequate. Patients who find themselves in a too fragile state to endure such complex surgeries are generally treated with the available medicines and experience high rates of heart failure and rehospitalization.

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October 25, 2013 | By Anabela Farrica

Medica device maker Boston Scientific is under the limelight again. On Wednesday, the Massachusetts-based company announced its plans of eliminating between 1.100 and 1.500 jobs in the next two years all around the world. This restructuring move – the company’s third since 2011 – will allow the company to save between $150 million and $200 million until 2015. Amongst the laid off employees is Jeffrey Capello, Boston’s CFO, who will leave at the end of year.

CEO Mike Mahoney said that cutting this number of jobs is part of the company’s plan to boost operating income margins from 19% to 25%. In spite of the fact that the latest quarter’s revenue ($1.74 billion) has not matched the value obtained in the same quarter of last year, the company’s EPS were higher than predicted. Some of the highlights of this quarter include a growth of 4% in the endoscopy division, 5% in the women’s health division and 1% in CRM. In addition, several analysts consider the medical device maker’s quarter, and overall growth, to be quite positive.

Thus, these job cuts arise not as defensive measure (something that has happened in the past), but as a part of an offensive strategy. With the cuts, Boston Sci will be able to allocate more resources towards the development of new products and other initiatives.

The company said CFO Jeffrey Capello will leave because he wants to find a broader management position outside the company. Daniel Brennan, Boston Scientific’s corporate controller and senior vice president, will become its new CFO.



Medical Device and Diagnostic Industry




October 24 ,2013 | By Márcio Barra

Back in June this year, The European Medicines Agency (EMA) released for consultation a draft policy on access and transparency of clinical-trial data, detailing three different levels of access according to the type of data, alongside rules for publication and use.

This new draft policy came under fire from elements of the pharmaceutical industry, as the industry felt that, when the policy comes into effect in January 2013, confidential data from their medicines will be released, and harm investment in the development of new drugs. This has put the Agency at odds againts the pharmaceutical industry. This was especially noteworthy earlier this year, when EMA complied with freedom of information requests from UCB for data on AbbVie’s Humira, and from Boehringer Ingelheim for data on InterMune’s Esbriet. In reaction, both AbbVie and InterMune immediately appealed to the European court against the decisions, and at the same time sought – and won – injunctions granting them relief on a temporary basis, pending a final court decision.

In a personal response, EMA’s boss Guido Rasi, writing in the New England Journal of Medicine, has come out with an article entitled “Access to patient-level trial data – a boon to drug developers”, defending greater transparency for clinical trials. The article argues that EMA’s controversial policy to end data secrecy will “benefit the research-based biopharmaceutical industry…increase the efficiency of drug development, improve cost-effectiveness, improve comparative-effectiveness analysis, and reduce duplication of effort among trial sponsors”

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