Centocor Ortho Biotech Products ha informado a PharmaMar (Grupo Zeltia) de la concesión por parte de las autoridades regulatorias de Brasil, India y Argentina de la autorización de comercialización de Yondelis en combinación con Caelyx (doxorubicina liposomal pegilada) para el tratamiento de cáncer de ovario recurrente platino-sensible.
Tras esta última decisión, Yondelis está aprobado en un total de 63 países, 30 de ellos fuera del Espacio Económico Europeo (EEE). A finales de 2009, la Comisión Europea (CE) aprobó la comercialización de Yondelis administrado con doxorubicina liposomal pegilada para la indicación de cáncer de ovario recurrente platino-sensible. Desde entonces, se han sucedido las aprobaciones en otros territorios para esta indicación y el inicio de la comercialización. En 2007, la CE aprobó Yondelis para el tratamiento del sarcoma de tejidos blandos.
Actualmente desde PharmaMar se están llevando a cabo estudios clínicos para ampliar el uso de Yondelis en sarcoma, tales como un estudio de primera línea en pacientes con tumores asociados a translocaciones, y otro estudio en niños con diagnóstico de sarcoma de Ewing, rabdomiosarcoma y otros sarcomas de tejidos blandos. Yondelis también está siendo estudiado en tumores sólidos como el cáncer de mama.
Yondelis tiene designación de medicamento huérfano para el tratamiento de sarcoma de tejidos blandos y cáncer de ovario en la Unión Europea, Estados Unidos y Suiza, y en Corea del Sur para sarcoma de tejidos blandos.
Según el acuerdo de licencia entre PharmaMar -filial de Zeltia- y Centocor Ortho Biotech Products, PharmaMar tiene los derechos para comercializar Yondelis en Europa, mientras que Centocor Ortho Biotech Products tiene los derechos para comercializar Yondelis en el resto del mundo, salvo Japón, país en el que Pharma Mar y Taiho Pharmaceutical mantienen un acuerdo de licencia para el desarrollo y comercialización de Yondelis.
**Publicado en "PM Farma"
01 October 2010
Modified contraceptive treats cancer of the uterus
A CONTRACEPTIVE device has been adapted to treat a form of cancer of the uterus, avoiding the need for surgery.
Women with endometrial cancer, which affects the lining of the uterus, usually have to have a hysterectomy. Hormone pills may be offered instead, but this can lead to side effects such as nausea, headache and abnormal bleeding.
Lucas Minig, now at the Madrid Sanchinarro University Hospital in Spain, used a hormone-releasing intrauterine device (IUD) to treat 14 women with endometrial cancer (EC) and 20 with atypical endometrial hyperplasia (AEH) - a precursor of EC. The IUD releases a synthetic form of progesterone, thought to cause cell death at high doses. "By acting directly on the tumour, it avoids painful side effects," Minig says. The women also received monthly injections of GnRH, a hormone which halts the production of oestrogen, thought to stimulate tumour growth.
The IUD acts directly on the tumour and avoids the side effects seen with oral hormone therapy
After a year, eight of the women with EC and all but one of those with AEH were cancer-free. Of these 27 women, nine went on to bear children (Annals of Oncology, DOI: 10.1093/annonc/mdq463).
Women with endometrial cancer, which affects the lining of the uterus, usually have to have a hysterectomy. Hormone pills may be offered instead, but this can lead to side effects such as nausea, headache and abnormal bleeding.
Lucas Minig, now at the Madrid Sanchinarro University Hospital in Spain, used a hormone-releasing intrauterine device (IUD) to treat 14 women with endometrial cancer (EC) and 20 with atypical endometrial hyperplasia (AEH) - a precursor of EC. The IUD releases a synthetic form of progesterone, thought to cause cell death at high doses. "By acting directly on the tumour, it avoids painful side effects," Minig says. The women also received monthly injections of GnRH, a hormone which halts the production of oestrogen, thought to stimulate tumour growth.
The IUD acts directly on the tumour and avoids the side effects seen with oral hormone therapy
After a year, eight of the women with EC and all but one of those with AEH were cancer-free. Of these 27 women, nine went on to bear children (Annals of Oncology, DOI: 10.1093/annonc/mdq463).
**Published in "New Scientist"
Ban all tobacco advertising, say US paediatricians
THE American Academy of Pediatrics is calling for a ban on all tobacco advertising in the US, plus restrictions on alcohol and prescription drug-related ads. Smoking and drinking are also glamorised in movies and TV programmes, it says, and this should be reduced (Pediatrics, DOI: 10.1542/peds.2010-1635).
The authors of the policy statement argue that while parents and teachers are urging kids to stay away from smoking and drinking, the $25 billion spent each year in advertising glamorises it - sending confusing messages to children.
The AAP refers to various studies in its report. One suggests advertising could be responsible for nearly a third of all teen alcohol and tobacco use. Another reveals that the Budweiser frog is almost as familiar to 9 and 10-year-olds as Bugs Bunny.
**Published in "New Scientist"
The authors of the policy statement argue that while parents and teachers are urging kids to stay away from smoking and drinking, the $25 billion spent each year in advertising glamorises it - sending confusing messages to children.
The AAP refers to various studies in its report. One suggests advertising could be responsible for nearly a third of all teen alcohol and tobacco use. Another reveals that the Budweiser frog is almost as familiar to 9 and 10-year-olds as Bugs Bunny.
**Published in "New Scientist"
Welcome breather for US stem cell research
On Tuesday an appeals court gave US stem cell researchers a boost by permanently lifting a ban imposed on their work in August by a federal judge, reports CNN.
The decision by the three appeals court judges following oral evidence from both sides on Monday means that, for now, federally funded researchers can continue their work on human embryonic stem cells (hESCs), which have the potential to turn into all tissues of the body.
The decision lifts the uncertainty facing many researchers affected by the ruling.
The ban in August, announced by district court judge Royce Lamberth, brought all federally funded projects involving hESCs to a grinding halt. Lamberth reasoned that because extraction of hESCs involves destruction of human embryos, work on them violates a legal amendment in 1995 forbidding funding of any research involving destruction of embryos.
After two weeks of uncertainty, the ban was temporarily lifted, but it took today's appeal court decision to lift Lamberth's ban completely.
But the reprieve may yet prove to be temporary. The future of government-funded hESC research in the US won't be fully resolved until a fully fledged court case in which the US government appeals to have the ban on funding of hESC research completely lifted.
**Published in "New Scientist"
The decision by the three appeals court judges following oral evidence from both sides on Monday means that, for now, federally funded researchers can continue their work on human embryonic stem cells (hESCs), which have the potential to turn into all tissues of the body.
The decision lifts the uncertainty facing many researchers affected by the ruling.
The ban in August, announced by district court judge Royce Lamberth, brought all federally funded projects involving hESCs to a grinding halt. Lamberth reasoned that because extraction of hESCs involves destruction of human embryos, work on them violates a legal amendment in 1995 forbidding funding of any research involving destruction of embryos.
After two weeks of uncertainty, the ban was temporarily lifted, but it took today's appeal court decision to lift Lamberth's ban completely.
But the reprieve may yet prove to be temporary. The future of government-funded hESC research in the US won't be fully resolved until a fully fledged court case in which the US government appeals to have the ban on funding of hESC research completely lifted.
**Published in "New Scientist"
Una llamada a la solidaridad, Madrid acoge la I Gambia Race
Bajo el lema “Tu pequeño esfuerzo, su gran recompensa” se celebrará el domingo, 3 de octubre, la primera edición de la “Gambia Race”, una carrera solidaria organizada para recaudar fondos que irán destinados a mejorar las instalaciones y medios del principal centro sanitario de este pequeño país africano, el Hospital Royal Victoria Banjul.
En total la organización de la “Gambia Race”, la asociación sin ánimo de lucro Daniel Jiménez de los Galanes, ha logrado reunir a través de las inscripciones solidarias 15.000 euros que irán destinados íntegramente a contribuir a la mejora del sistema de salud gambiano.
Deportistas como Nuria Fernández, Chema Martínez o Rubén de la Red acudirán el domingo, a partir de las 10.00 horas, a la Casa de Campo de Madrid para respaldar con su presencia a esta carrera.
Una cita que han apoyado numerosos patrocinadores como Divina Pastora Seguros y rostros conocidos como Iker Casillas, Kaka, David Villa, Raúl Albiol, Anne Igartiburu, Rosi de Palma, Ana de Armas o Juan Ramón Lucas, entre otros.
La carrera, que constará de una 10k y un 5k, congregarán 1.500 personas que se han inscrito en esta prueba y recorrerá distintos puntos de la Casa de Campo. Se espera que familias completas participen en la “I Gambia Race”, como explica la organización, “para ayudar a que el pueblo gambiano tenga, poco a poco, un sistema de salud pública con unas garantías básicas”.
Con más de medio siglo de experiencia, Divina Pastora Seguros es una de las entidades aseguradoras más solventes del país. Cuenta con más de 651.000 pólizas en toda España y una red comercial que ronda el medio centenar de oficinas en todo el territorio nacional.
En total la organización de la “Gambia Race”, la asociación sin ánimo de lucro Daniel Jiménez de los Galanes, ha logrado reunir a través de las inscripciones solidarias 15.000 euros que irán destinados íntegramente a contribuir a la mejora del sistema de salud gambiano.
Deportistas como Nuria Fernández, Chema Martínez o Rubén de la Red acudirán el domingo, a partir de las 10.00 horas, a la Casa de Campo de Madrid para respaldar con su presencia a esta carrera.
Una cita que han apoyado numerosos patrocinadores como Divina Pastora Seguros y rostros conocidos como Iker Casillas, Kaka, David Villa, Raúl Albiol, Anne Igartiburu, Rosi de Palma, Ana de Armas o Juan Ramón Lucas, entre otros.
La carrera, que constará de una 10k y un 5k, congregarán 1.500 personas que se han inscrito en esta prueba y recorrerá distintos puntos de la Casa de Campo. Se espera que familias completas participen en la “I Gambia Race”, como explica la organización, “para ayudar a que el pueblo gambiano tenga, poco a poco, un sistema de salud pública con unas garantías básicas”.
Con más de medio siglo de experiencia, Divina Pastora Seguros es una de las entidades aseguradoras más solventes del país. Cuenta con más de 651.000 pólizas en toda España y una red comercial que ronda el medio centenar de oficinas en todo el territorio nacional.
MEPs reject Euro Commission plan for pharma info
European Parliamentarians have this week rejected proposals by the Commission to allow prescription drugmakers to publish information to consumers about their products in printed media such as newspapers and magazines.
Members of the Parliament’s Environment, Public Health and Food Safety (ENVI) Committee have voted overwhelmingly to delete this proposal from the Commission’s long-delayed package of pharmaceutical legislation, first put forward in December 2008, and to emphasise the rights of patients to receive information rather than giving drugmakers the option of providing it, as the Commission has proposed.
According to the compromise text agreed by a large majority of the Committee, drugmakers should be required to make available the approved and most recent contents of Summaries of Product Characteristics for their product, its labelling and package leaflet, plus a publicly-accessible version of the assessment report. They also introduced a new article into the legislation which would oblige European Union (EU) member states to ensure that this “objective, unbiased information” is publicly-available, along with details of the diseases and conditions which the drug is used to treat and information on how to prevent them.
The new legislative text also states that drugmakers may provide consumers with other “well-defined, non-promotional information” on their products, such as environmental impact details, instructions for use and price or pack changes, although they would need to get regulatory permission first.
Moreover, such information would have to be supplied in electronic and printed form and in formats appropriate for the blind and partially-sighted, while printed material could only be sent to consumers if they had specifically requested it, the MEPs agreed.
A plenary vote in Parliament on the agreed text is due in December.
The Committee’s rapporteur, Swedish MEP Christofer Fjellner, who has long expressed frustration as the pharmaceutical package’s glacial progress, welcomed the compromise agreed by the panel. “Today, anyone but pharmaceutical companies is allowed to inform on prescription drugs, which is unacceptable. The producer has the best knowledge on these products. Now we will allow the industry to spread information, but of course within strict limits and under strict supervision,” the Euractiv news source reports him as saying.
The vote was welcomed by both industry and consumer groups, with the European Federation of Pharmaceutical Industries and Associations (EFPIA) calling it a “step forward in the long-running debate on patients’ access to information.”
EFPIA director general Brian Ager commended the ENVI panel for its “pragmatic approach” which, he said: “contrasts with the situation in a number of member states, where there has been a reluctance to even discuss options for providing citizens and patients with improved access to information about their illnesses and treatments.”
“Such an approach ignores the reality of the modern information society, and perpetuates inequalities of access to information that currently exists between member states,” he said.
The Commission’s proposal had not sought to overturn the current ban on manufacturers providing prescription drug information to the public through broadcast media, and Mr Ager emphasized that EFPIA and its member companies have already made clear that they do not wish to see any “push” of information on specific medicines via television, radio or print mass-media. However, he added: “those citizens seeking information on their disease or therapy should be able to access it in both user-friendly formats and in their own language.”
The European Consumers’ Organisation (BEUC) - which had slammed the Commission’s original proposal as “designed in the interests of the pharmaceutical companies” and warned that it would have “opened the door” to prescription drug advertising - said the vote was “a relief for European consumers.”
The work done by the ENVI panel “more adequately reflects consumers’ needs,” said BEUC director general Monique Goyens, adding: “while the pharmaceutical industry can still decide on which particular medicines and on which diseases they communicate, the European Parliament obliges public authorities to provide for more and better information on health, diseases and medicines.”
However, Ms Goyens also urged the MEPs to “continue their work so as to avoid introducing a bias in favour of ‘blockbuster’ medicines and against non-drug therapies. European patients should have the right to receive non-promotional and user-friendly information on prescription medicines from independent sources,” she said.
www.europarl.europa.eu
Links
www.euractiv.com
www.efpia.org
www.beuc.org
**Published in "Pharma Times"
Members of the Parliament’s Environment, Public Health and Food Safety (ENVI) Committee have voted overwhelmingly to delete this proposal from the Commission’s long-delayed package of pharmaceutical legislation, first put forward in December 2008, and to emphasise the rights of patients to receive information rather than giving drugmakers the option of providing it, as the Commission has proposed.
According to the compromise text agreed by a large majority of the Committee, drugmakers should be required to make available the approved and most recent contents of Summaries of Product Characteristics for their product, its labelling and package leaflet, plus a publicly-accessible version of the assessment report. They also introduced a new article into the legislation which would oblige European Union (EU) member states to ensure that this “objective, unbiased information” is publicly-available, along with details of the diseases and conditions which the drug is used to treat and information on how to prevent them.
The new legislative text also states that drugmakers may provide consumers with other “well-defined, non-promotional information” on their products, such as environmental impact details, instructions for use and price or pack changes, although they would need to get regulatory permission first.
Moreover, such information would have to be supplied in electronic and printed form and in formats appropriate for the blind and partially-sighted, while printed material could only be sent to consumers if they had specifically requested it, the MEPs agreed.
A plenary vote in Parliament on the agreed text is due in December.
The Committee’s rapporteur, Swedish MEP Christofer Fjellner, who has long expressed frustration as the pharmaceutical package’s glacial progress, welcomed the compromise agreed by the panel. “Today, anyone but pharmaceutical companies is allowed to inform on prescription drugs, which is unacceptable. The producer has the best knowledge on these products. Now we will allow the industry to spread information, but of course within strict limits and under strict supervision,” the Euractiv news source reports him as saying.
The vote was welcomed by both industry and consumer groups, with the European Federation of Pharmaceutical Industries and Associations (EFPIA) calling it a “step forward in the long-running debate on patients’ access to information.”
EFPIA director general Brian Ager commended the ENVI panel for its “pragmatic approach” which, he said: “contrasts with the situation in a number of member states, where there has been a reluctance to even discuss options for providing citizens and patients with improved access to information about their illnesses and treatments.”
“Such an approach ignores the reality of the modern information society, and perpetuates inequalities of access to information that currently exists between member states,” he said.
The Commission’s proposal had not sought to overturn the current ban on manufacturers providing prescription drug information to the public through broadcast media, and Mr Ager emphasized that EFPIA and its member companies have already made clear that they do not wish to see any “push” of information on specific medicines via television, radio or print mass-media. However, he added: “those citizens seeking information on their disease or therapy should be able to access it in both user-friendly formats and in their own language.”
The European Consumers’ Organisation (BEUC) - which had slammed the Commission’s original proposal as “designed in the interests of the pharmaceutical companies” and warned that it would have “opened the door” to prescription drug advertising - said the vote was “a relief for European consumers.”
The work done by the ENVI panel “more adequately reflects consumers’ needs,” said BEUC director general Monique Goyens, adding: “while the pharmaceutical industry can still decide on which particular medicines and on which diseases they communicate, the European Parliament obliges public authorities to provide for more and better information on health, diseases and medicines.”
However, Ms Goyens also urged the MEPs to “continue their work so as to avoid introducing a bias in favour of ‘blockbuster’ medicines and against non-drug therapies. European patients should have the right to receive non-promotional and user-friendly information on prescription medicines from independent sources,” she said.
www.europarl.europa.eu
Links
www.euractiv.com
www.efpia.org
www.beuc.org
**Published in "Pharma Times"
Data published showing survival benefit for sanofi-aventis' prostate cancer drug Jevtana
Late-stage study results that formed the basis of the FDA's decision to approve sanofi-aventis' Jevtana (cabazitaxel) for advanced prostate cancer have been published in The Lancet, the drugmaker announced. The previously released data from the TROPIC trial are "the first to demonstrate an overall survival advantage in patients with hormone refractory prostate cancer whose disease has progressed following treatment with a docetaxel-containing treatment regimen," noted Debasish Roychowdhury, sanofi-aventis' head of oncology.
In the study, 755 men with advanced prostate cancer were randomised to receive either Jevtana or mitoxantrone, both in combination with prednisone. Results showed that sanofi-aventis' drug reduced the risk of death by 30 percent compared to mitoxantrone, while an improvement in median overall survival of 15.1 months was seen with Jevtana, compared with 12.7 months in the mitoxantrone arm. Further, Jevtana slowed development of the cancer, with median progression-free survival with the drug of 2.8 months, versus 1.4 months for mitoxantrone.
However, the drugmaker noted that 18 percent of patients who received Jevtana discontinued treatment due to adverse events, which included neutropenia and renal failure, compared to 8 percent of those who took mitoxantrone. In addition, the number of deaths not related to disease progression were higher in the group of patients receiving Jevtana, sanofi-aventis said, with 18 deaths, compared to 3 in the mitoxantrone group.
A regulatory application for the drug is currently being reviewed by the European Medicines Agency.
Reference Articles
Prostate cancer drug could provide two precious extra months of life to men in advanced stages of the disease - (Daily Mail)
Sanofi says Jevtana improves prostate cancer survival - (Forexpros)
New chemo offers chance of longer life - (The Scotsman)
Drug extends lives of advanced prostate cancer patients - (The Telegraph)
Jevtana improves survival in advanced prostate cancer patients - (sanofi-aventis)
**Published in "First Word"
In the study, 755 men with advanced prostate cancer were randomised to receive either Jevtana or mitoxantrone, both in combination with prednisone. Results showed that sanofi-aventis' drug reduced the risk of death by 30 percent compared to mitoxantrone, while an improvement in median overall survival of 15.1 months was seen with Jevtana, compared with 12.7 months in the mitoxantrone arm. Further, Jevtana slowed development of the cancer, with median progression-free survival with the drug of 2.8 months, versus 1.4 months for mitoxantrone.
However, the drugmaker noted that 18 percent of patients who received Jevtana discontinued treatment due to adverse events, which included neutropenia and renal failure, compared to 8 percent of those who took mitoxantrone. In addition, the number of deaths not related to disease progression were higher in the group of patients receiving Jevtana, sanofi-aventis said, with 18 deaths, compared to 3 in the mitoxantrone group.
A regulatory application for the drug is currently being reviewed by the European Medicines Agency.
Reference Articles
Prostate cancer drug could provide two precious extra months of life to men in advanced stages of the disease - (Daily Mail)
Sanofi says Jevtana improves prostate cancer survival - (Forexpros)
New chemo offers chance of longer life - (The Scotsman)
Drug extends lives of advanced prostate cancer patients - (The Telegraph)
Jevtana improves survival in advanced prostate cancer patients - (sanofi-aventis)
**Published in "First Word"
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