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Wednesday, November 2nd, 2011
The European Commission (EC) has granted approval to Eli Lilly for it’s drug Alimta as a single agent to act as maintenance therapy for those suffering from advanced nonsquamous non-small cell lung cancer (NSCLC) reports pharmaceutical-business-review.com.
Progression free survival was indicated to have improved in clinical trials conducted by Eli Lilly when the patients were treated with Alimta alone and this is what convinced the EC to grant approval to the drug. Continuation maintenance therapy will help those who have reacted positively to first line treatments of Alimta coupled with cisplatin designed to stabilize the disease.
Allen Melemed, senior director of Lilly’s Oncology department believes the approval will see distinct advancements in lung cancer treatments. Also, following first line treatments, patients have the opportunity to now continue treatments with the chance of “a better clinical outcome.”
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Friday, September 2nd, 2011
Pharmaceutical-business-review.com has reported that French pharmaceutical company Roche has received approval from the European Commission (EC) for lung cancer drug Tarceva.
The drug can now be used as a treatment on it’s own to treat patients with locally advanced or metastatic lung cancer. Prior studies have shown that Tarceva nearly doubles the amount of time patients survive without their cancer progressing when compared to chemotherapy.
Hal Barron, Roche’s head of Global Product Development and chief medical officer believes the European approval to be good news for those with genetically distinct forms of the cancer because they can receive a greater benefit when the medicine is used as an initial treatment.
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Tuesday, August 16th, 2011
Pharmaceutical giant GlaxoSmithKline’s new Parkinson’s drug has been seen to help patients retain their motor skills following the medication wearing off, reports inpharm.com.
In a phase III trial, the drug significantly increased patients’ time without needing to use the drugs whilst their motor skills did not decline any further. The drug decreased patients off time, where they suffer from Parkinson’s symptoms, by 33.5% from the standard baseline. This represents over two hours more time that patients report that they are symptom free following taking their medication.
Impax Pharmaceuticals, who developed the drug with GSK, said they are “excited to report these positive results.” Under the agreement between the companies, Impax holds the rights to the drug in the US and Taiwan, with GSK holding the rights in every other market. GSK plans to apply for marketing rights in the EU early in 2012.
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Friday, July 29th, 2011
Samarind RMS has been released in its fourth version by Samarind Limited, a provider of software to the regulatory affairs profession, reports PharmiWeb.com.
The new software is designed for worldwide usage rather than a solely European venture. Many companies are showing interest in the EudraVigilance Medicinal Product Dictionary software update, needed to fall in line with EMA regulations and are looking to submit their information to be included before the July 2012 deadline.
Samarind’s Phil Turner comments “Our objective remains to ensure that we align our software with the current and future needs of the regulatory affairs profession.” Samarind RMS reduces costs of managing licences and also increases profitability of said licences.
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Thursday, July 28th, 2011
Pharmaceutical giant Eisai has been granted an extended European licence for the drug Zonegran, reports Pharmaceutical Business Review.
Zonegran, an antiepileptic drug, has been accepted as an adjunctive therapy for epilepsy treatment and Eisai are applying to have the drug used as a stand alone therapy for epilepsy patients with partial seizures.
The application for a mono-therapy was given following a blind, random trial comparing Zonegran to another treatment and involved nearly 600 newly diagnosed patients. The trial showed that those who used Zonegran as a mono-therapy tolerated the drug well and found it was effective in controlling symptoms.
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Monday, July 25th, 2011
The Committee for Medicinal Products for Human Use has given a positive opinion of Orion’s intensive care sedative drug dexdor, reports Pharmaceutical Business Review.
Orion expects to get the European Medicines Agency’s approval for the drug soon, which means they will be given marketing authorization for dexdor in the EU. The drug will be available in all member states of the EU once fully approved.
Dexdor has been available in over 30 countries outside the EU, including the US since 2000 and Japan.
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Tuesday, July 19th, 2011
Nektar has been given a positive review of its ovarian cancer drug, reports the Pharmaceutical Business Review.
The Committee for Orphan Medicinal Products, a branch of the European Medical Association, has responded positively in relation to Nektar’s attempt to have its ovarian cancer drug granted orphan medicinal product status, which can lead to extended exclusivity. A phase II study is currently recruiting patients with ovarian cancer, whilst the company are looking to begin a phase III study later this year.
Nektar Drug Development and Regulatory Affairs vice president Carlo DiFonzo has said that the news of the positive opinion is welcome following the recent designation of orphan drug status in the US in April.
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Monday, July 18th, 2011
Amgen’s bone cancer drug Xgeva has been granted European approval, reports inpharm.com.
The drug, used to prevent serious bone problems in cancer patients, is expected to make $1 billion in oncology and can now be used to help with skeletal issues relating from tumours, such as bone metastases.
The drug was approved after phase III trials on 5,700 patients were positive. Bone metastases occur in 1.5 million cancer patients worldwide, and the “approval makes a real advance” according to professor Ingo J. Diel at the Institute for Gynaecological Oncology in Germany. The trials gave increased protection against skeletal problems and slowed the rate at which pain spread throughout the body of cancer patients.
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Thursday, July 14th, 2011
CK Regulatory has recently launched a new Facebook page for people to stay up to date on all that’s happening in the world of Regulatory Affairs.
If you’re looking to start a career, or looking for someone to fill a role withing your company, then the CK team can help as we have access to some of the best Regulatory jobs in the industry, an enviable track record of providing high quality recruitment to pharmaceutical companies and we aim to make the job hunting process as easy and enjoyable as possible for both clients and candidates.
For regular updates, make sure to ‘like’ us here
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