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Licensing New Drugs – The Final Piece of the Puzzle for Drug Companies

October 10, 2011 By Leave a Comment

Article by Tim Bisley

The discovery and creation of a new drug will be an exciting time for everyone involved in the process from the pharmacologists and chemists involved in researching and refining the particular drug or cure to the actual patients and sufferers who have been waiting for either a breakthrough cure or a new and improved drug or treatment that makes their lives much more comfortable and stress-free.

The final stage of any new drug being made available will be the licensing or pharmalicensing stage of development. This is the stage where a drug and all of its related documentation are submitted before a licensing authority to determine whether the drug is safe and effective to be made readily available to the public. Information relating to what the drug is made up of, the testing results and other factors will all need to be presented to allow the relevant authority to approve and allow the drug to be released.

Licensing differs in each country, each country’s government and health authority will have different requirements and procedures which a drug company has to follow and measure up to. If a company wishes to market their drug in different countries they then have to go through this whole process again, unless they apply for a European license which can help get the drug approved for a larger number of countries at once. This may not always be the case though as some countries will want additional information or further testing before they approve it for release in their own country.

Pharmalicensing isn’t black and white either, sometimes licensing authorities will approve a drug for release in a particular country but with certain provisos such as the drug only being available for certain age groups or strains of the disease. As there are many different factors that could contribute towards the effects of the drug in that one country it is sometimes the case that drug companies will have to go back to the drawing board for some countries and it isn’t uncommon for them to have to produce two or more variants of their drug based on this.

When it comes to pharmalicensing companies will spend a large chunk of time on ensuring their drug’s abilities and background are 100% clear to the licensing board, not only to make sure it is clear to see that the drug is in fact safe but also to help speed the process up as there will be less need for additional testing to be carried out and slow the time taken to get the drug on the market and available to patients that desperately need them.

Pharmaceutical drug development can be helped along with the help of additional research and resources that make it quicker to find the right cure.










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Leukaemia sufferer in remission thanks to drug

October 10, 2011 By 8 Comments

A Northern Irish man who was diagnosed with leukaemia is now in remission thanks to a new drug which significantly improves the chance of survival, according to research carried out.

William Nelson from Co Londonderry was diagnosed in November 2008 with chronic lymphocytic leukaemia (CLL), a blood cancer caused by a type of abnormal blood cell but now, thanks to the administering of MabThera (rituximab) he is now in remission.

And his daughter Diane Johnston has spoken to me about his remarkable recovery which has been attributed to the drug used in conjunction with chemotherapy.

It comes as data presented at the American Society of Haematology (ASH) annual meeting shows that the addition of MabThera to chemotherapy in previously untreated patients with CLL significantly improves chances of survival.

“My dad discovered an enlargement on his left side, and to be honest, it came as quite a surprise because he is a very fit and healthy man and had been a lorry driver all his life,” said Diane. “He never had any other health problems so it arrived completely out of the blue.”

Mr Nelson visited his GP to assess the enlargement and was then referred to the a cancer unit.

“At the start of December it was confirmed that he had CLL with an enlarged spleen. I don’t think the doctor had seen such an enlargement before. It was really tough because it was Christmas,” said Diane. “But the doctor said that being healthy had stood to Dad and it would allow him to cope with this.”

For the family, especially wife Marjorie, the news of an uncertain future was worrying and the family was desperate for more information about the newly-diagnosed condition.

Mr Nelson received his first treatment in December 2008, starting with steroid treatment. At that point his blood count was dangerously low and the treatment generally had little or no effect, according to Diane.

“Dad just felt the steroids gave him some sort of boost. Then in January he was given two drugs to target the spleen – Fludarabine and Cyclophosphamide – and he was on these until September,” said Diane.

It was at this point Mr Nelson was given a glimmer of hope with the offer of the new drug MabThera to be combined with his chemotherapy. This was administered slowly via a drip during the course of one day.

“Initially Dad had a reaction to it and we believed he wasn’t going to be able to continue on with it, but thankfully once the drug got into his system, the side-effects disappeared,” said Diane.

Commenting on the findings presented at the AHA annual meeting, Professor Peter Hillmen, Consultant Haematologist at Leeds Teaching Hospital, said these results are extremely significant.

“Never before have we seen proof that any treatment has led directly to improved overall survival in CLL. The combination of rituximab and fludarabine-based chemotherapy has proven to be a formidable partnership, sending more patients into remission, extending the period before their leukaemia returns and now increasing the length of time people survive overall,” he said.

And he added: “This is certainly one of the most significant steps forward we have seen for a long time.”

Diane told me medics are pleased with her dad’s progress to date and everyone is optimistic about his future.

“We were told with all cases of cancer they can’t say for sure whether it is cured – they can treat it, and at the moment, he’s in remission. The doctors are really pleased with Dad’s progress and he’s in really good form,” she said.

“We’re so thankful to the staff at the cancer unit who were fantastic and we’re pleased to have this opportunity to be able to speak about how this drug has helped Dad. It’s opened up a new chapter on our lives.”

Mr Nelson, meanwhile, keeps busy with his three grown-up children and nine grandchildren.

“He just loves spending time with the grandchildren and we’re delighted he has been given the chance to do this. Family times are always precious,” she added.

Mr Nelson said he was very thankful for the power of prayer and God’s healing hand upon him.

Written by GFMcDade

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New drugs to target cancer

October 10, 2011 By Leave a Comment

New drugs to target cancer

 

A NEW range of drugs is being developed to target specific cancer cells, bringing fresh hope to millions of families blighted by the nation’s No 1 killer.

A “phenomenal” advance means experts understand more about tumours than ever before.

Following a major genetic breakthrough a decade ago, it has been possible to unravel genes that fuel cancers which kill more than 150,000 people a year in Britain.last night Professor Ghulam Mufti, a leukaemia expert at King’s College London, said that understanding the genetics of cancer will soon lead to new, more targeted treatments for many patients. He believes that if the progress continues as quickly as it has done the drug ­treatments could be widely available within the next decade.

He said: “The genetics of cancers are being rapidly unraveled. We are soon going to have a library of what genetic abnormalities lead to which cancers. If these are specific, we can target these abnormalities using new treatments.”

The research is moving forward so quickly that over the past two years scientists have begun to ­create detailed “maps” of the genetic glitches that occur in certain types of tumors.

They have found that cancers in different parts of the body may be triggered by the same genetic faults and could therefore be treated using the same drug. They have also found that breast cancer patients, for example, may have different triggers for their disease and so require very different treatments. This will allow doctors to offer patients tailor-made drugs.

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Some of these drugs are already available in Britain. Women with breast cancer can get treatment based on whether their tumors were triggered by their genes.

But the British experts are now looking at other ways to tackle cancer based on genetics. A drug undergoing trials at London’s Breakthrough Breast Cancer Research Centre works by attacking cancer cells’ inability to repair their own damaged genetic structure.

Project leader Professor Alan Ashworth tells tonight’s BBC2′s Horizon program: “Some tumor cells can’t repair their DNA properly.’

“They just carry on growing fast. So we’ve worked out a way of trying to exploit that to treat cancer.”

The drug in development, which has no side effects, given at a low concentration lets healthy cells survive but destroys cancer cells. Prof Ashworth said: “All mutant cells are killed but normal cells are not touched. So potentially that translates into much more powerful treatments with fewer side effects as we’re not killing normal cells.”

Prof Ashworth said: “We are in the 21st century. We’ve got the human genome sequence and yet we’re still treating cancer with medieval treatments. We cut it out with a big knife or burn it with radiation or poison it with chemotherapy.”

“There is nothing clever about it at all. What we’re trying to do is use the genome information to develop new ways of treating the cancer itself, the genetic defects of the cancer, not the normal cells.”

Understanding the genetics of cancer was made possible 10 years ago when scientists first mapped all three billion “letters” that comprise the entire human genetic sequence.

Scientists are now comparing “healthy” genomes to those of cancer and pinpointing what genetic faults cause these tumors to grow.

Tonight’s Horizon program also features a medical trial of a drug to cure cystic fibrosis using a similar method of gene therapy that could be available on the NHS in just five years. It works by replacing the faulty gene that causes cystic fibrosis with a healthy man-made version, inhaled via a nebulizer.

Professor Eric Alton, of the Cystic Fibrosis Gene Therapy Consortium and Imperial College London, said the research would be completed by the end of 2012.

He said: “If this first trial looks good then we can move it quite rapidly into the NHS and within two or three years might be able to put it into regular treatment.”

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