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Monthly Archives: January 2016

By Márcio Barra

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Six people were hospitalized in the Hospital of Rennes, France in serious condition, and one is brain dead, following a Phase I first-in-man clinical trial with a new drug  from the Portuguese pharmaceutical company BIAL.  The clinical trial was being conducted by French company Biotrial.

The French Health Minister, Marisol Touraine said on Friday that it is a “serious accident”. The minister added that the accident happened on Thursday and that the trial was suspended, with all previous volunteers called to undergo tests.

There are several reports online describing the drug as an analgesic product based on cannabis, but little to new additional details are being reported. Looking at BIAL´s R&D pipeline, the agent appears to be BIAL´s BIA 10-2474. BIA 10-2474 is described as a new small molecule drug that acts on the Central Nervous System as a painkiller, and currently undergoing Phase I trials.

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Reports state that a total of 8 participants were participating in the trial, with two taking placebo. A message on Biotrial´s website reads:

During a FIM study which was being conducted for a sponsor, serious adverse events related to the test drug  have occurred in some subjects at our CPU. The trial has been conducted in full compliance with the international regulations and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital. We are in close and regular contact with the Health Authorities and Ministry in France. The priority at Biotrial remains the safety of our subjects. We are very grateful for the support we have been receiving from our clients and partners today.

BIAL is still verifying the occurrence, since the drug has been used successfully in other subjects with no issues.

By Márcio Barra

savaysa

Savaysa, a novel anti-clotting agent made by Tokyo-based Daiichi Sankyo, and the first new molecular entity to be approved by the FDA in 2015

Novel drug approvals in the US reached a new high in 2015, with 45 new medicines containing new molecular entities approved by the Food and Drug Administration, above the 2014 figure of 41, the record held since 1996. Moreover, of the 45 new approved drugs, more than 40% of new approvals were for rare disease therapies.

IMS Health expects this rising trend of approvals to continue in the coming years, with with 225 new drugs expected to receive clearance between 2016 and 2020, compared to 184 for the 2011-2015 period.  Cancer treatments are expected to be the largest category of new drug approvals.

The full list (still under construction) is provided below:

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By Márcio Barra

FILE - This undated file photo provided by Gilead Sciences shows the hepatitis C medication Sovaldi. Gilead Sciences says it has reached a deal with several generic drugmakers to produce cheaper versions of its popular, expensive hepatitis C drug Sovaldi for use in developing countries. (AP Photo/Courtesy of Gilead Sciences, File)

Sofosbuvir, Gilead´s Hepatitis C drug which is making waves due to its high cure rate (approximately 90%) and high treatment cost, has already cured 651 Hepatitis C patients in Portugal since it was made available, according to the National Competent Authority INFARMED to Diário de Notícias.

The drug (marketed as Sovaldi for the Sofosbuvir-only formulation, and as Harvoni for the combination of Ledipasvir and Sofosbuvir) was made available following an agreement between the Ministry of Health, INFARMED and Gilead Sciences to treat 13,000 hepatitis C patients. The agreement was concluded on February 2015 following weeks of negotiations. So far, 5322 patients are currently undergoing treatment, with 683 reaching the end of treatment. 32 patients were not cured of Hepatitis C, and hospitals have not reported the causes for the non-response to treatment. As for the total cost of payment per patient, the amount remains undisclosed.

In Portugal, it is estimated about 100,000 people are living with hepatitis C and a large proportion of them have developed cirrhosis. The prices of Sofosbuvir across European member states- in excess of €50,000- make Sobusfuvir a heated topic of discussion among healthcare regulators.