MILAN, 23 Aug (APM) - Médecins Sans Frontières (MSF) has called on TB Alliance to make its new treatment for drug-resistant tuberculosis affordable and accessible to everyone that needs it, La Repubblica reported on Monday.
The U.S. Food and Drug Administration (FDA) approved the combination regimen consisting of the new drug, pretomanid, with linezolid and Johnson & Johnson's bedaquiline for the treatment of extensively drug-resistant tuberculosis (XDR-TB) last week (APMHE 64058
TB Alliance is a not-for-profit organisation, funded by governments (including Australia, Germany, UK and U.S.) and from other philanthropic sources, La Repubblica explained. It is committed to the discovery, development and delivery of better, faster-acting and affordable tuberculosis drugs so that they are available to those who need them.
The organisation is expected to be granted a tropical disease priority review voter (PRV) which it will be able to sell. Previous sales have brought in between $67-$350 million, the paper said. TB Alliance suggested that proceeds should be used to register pretomanid and set an affordable price, La Repubblica explained.
TB Alliance has granted a licence to Mylan to manufacture and supply pretomanid. But neither organisation has disclosed the price of the drug. According to MSF, a generic version could be produced and sold at a profit at between $0.36 and $1.14.
MSF has called on TB Alliance to abide by its promise to provide the drug at an affordable price.
Parallel trade still driving drug shortages in Italy
Parallel trade is still driving drug shortages in Italy, Il Gazzettino reported on Thursday.
It cited a post on the Facebook page of a Belluno pharmacy as evidence that the problem is continuing despite action by the authorities.
Farmacia Boco said that the shortages are determined by the pharma market not the pharmacies. The outlet make extra orders for the drugs identified as having supply problems. It is also in direct contact with producers to manage supplies of therapies on behalf of doctors so that it can provide alternatives if a drug runs short.
Roberto Grubissa, an official in the trade association Federfarma, warned that Belluno is an example of difficulties occurring all over Italy. He said shortages have been going on for years. The health ministry has taken action but no solution has been found yet, he added.
The paper noted that medicines agency AIFA publishes regular updates of which drugs which are not available and contacts the producers to find out why. The paper said that one of the most recent cases involved UCB’s epilepsy drug Keppra (levetiracetam).
"It seems that sometimes drugs are being exported abroad where they can have higher prices. On other occasions production is halted and when it restarts it can take several months for the product to be available on the market again," Grubissa explained.
ASL patient victim of Brainstorm stem cell scam
An Italian patient with amyotrophic lateral sclerosis (ALS) has been the victim of a scam which led him to believe he would be treated with an experimental stem cell therapy being developed by Brainstorm Cell Therapeutics, La Stampa reported on Tuesday.
Paolo Palumbo is known on social media as the youngest person with the disease in Europe at just 22 years old. He was contacted by an "intermediary" who offered him the chance to be treated with Brainstorm's NurOwn stem cells in Israel.
Palumbo paid several hundred thousand euros to the medical professional, who claimed to be working on behalf of Brainstorm. But it turned out to be a scam and the intermediary disappeared along with the money.
Police are confident they will catch him and Palumbo's search for a treatment will go on despite the experience, the paper said.
Lilly planning €100 million insulin production site expansion
Lilly will soon be able to start a €100 million expansion of its insulin production site just outside Florence after the land around its existing plant is freed up, Il Sole 24 Ore reported on Thursday.
The centre at Sesto Fiorentino has already seen several phases of expansion including the construction of new production lines. But the most recent plans have been more problematic because they encroach on an area occupied by a school, the paper said.
Now a metropolitan authority has published the tender for the construction of a new high school building in another location, to be financed with public funding and the proceeds of the sale of the area to Lilly.
The work is to be completed in 540 days so that it is ready for start of the 2021/2022 school year. Once the students have moved into the new school, Lilly will take ownership of the area and start its expansion which is expected to create 100 new jobs, the paper said.