May 31, 2013 | By Márcio Barra
France’s health regulator, the National Agency for the Safety of Drugs and Health Products (ANSM), announced yesterday that it would comply with the European Commission if it ruled that Bayer acne pill Diane 35 and its generic versions were safe to use in some cases. Sales of Diane would keep on hold until the final ruling, it said.
The European Commission’s decision is expected to arrive in the coming weeks, following EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) decision back in May, and Thursday’s endorsement of the decision by the The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).
For more on this story, please go here, here, here and here.
May 30, 2013 | By Márcio Barra
NICE, the UK price regulatory agency, gave yesterday their final positive evaluation for Bristol-Myers Squibb and Astrazeneca’s new diabetes drug Forxiga (dapagliflozin), a new, first in class treatment for type II diabetes, allowing it’s commercialization in the UK.
May 29, 2013 | By Márcio Barra
Today, two new drugs from GSK were approved by the FDA, dabrafenib (Tafinlar) and trametinib (Mekinist), for use in certain patients with metastatic or unresectable melanoma, alongside a diagnostic test to identify patients who are most likely to respond to these treatments.
May 28, 2013 | By Márcio Barra
Today, Paulo Macedo, the portuguese Health Minister, in the opening session of the twenty-fifth National Meeting of Pastoral Health, stated that in the first trimester of 2013, the expenses with medicines of the Portuguese population fell 40 million euros, although 200,000 more packages were bought.
“Last year, the Portuguese population spent less 190 million with medication, while buying five million packages. This trend continues in the first quarter of 2013, where the Portuguese spent approximately less 40 million in drugs, while buying 200,000 more packages, “said Paulo Macedo.
The health minister reinforced the position of the Government, which is to have “cheaper” and “more accessible” medicines, while reducing the state’s expenses with medicines.
May 28, 2013 | By Márcio Barra
Astrazeneca announced today that it is to buy Omthera Pharmaceuticals, in an effort to strengthen its cardiovascular drug portfolio.
Following last month’s acquisition of AlphaCore Pharma, a small early-stage U.S. biotechnology company, the acquisition of Omthera Pharmaceuticals brings the drug Epanova to Astrazeneca’s surely needing portfolio. This drug is an ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), two Omega 3 fatty acids from fish oil. Epanova already concluded its final-stage Phase III clinical trials, where it showed its ability to lower non-HDL cholesterol from baseline after 6 months of treatment, and is set to be submitted for U.S. regulatory approval by the middle the year.
May 27, 2013 | By Márcio Barra
Alzheimer’s disease isn’t the only neurologic disease that is hard to find a cure. Parkinson’s disease is an equally tough match, with current treatments, like dopamine agonists, only aimed at symptom relief. In what are sour news for patients, a promising new drug failed to prove successful in treating Parkinson.
Last Thursday, Merck released a press statement declaring that it stopped the development of Preladenant, an investigational Parkinson’s disease medicine which acted as a selective antagonist at the adenosine A2A receptor, responsible for regulating glutamate and dopamine release in the brain.
May 23, 2013 | By Márcio Barra
Antibiotics’ research is very rare nowadays in the industry, as difficult molecular targets and a low profit rate dissuade pharmaceutical companies from investing resources to create new solutions to the growing antibacterial resistance concerns.
In this outlook, GlaxoSmithKline signing an up to $200 deal with the US government to fight antibiotic resistance and bioterrorism is a positive move in the fight against bacterial resistance to antibiotics, and a sign that the US government has made antibiotic resistance a top priority.