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Sanofi-aventis
21 января 2015, 01:06

Sanofi and Boehringer Ingelheim Ink Strategic Deal - Analyst Blog

Sanofi (SNY) announced that it has entered into a strategic agreement with Boehringer Ingelheim

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29 марта 2013, 01:52

Sanofi/Transgene Inks Immunotherapy Deal - Analyst Blog

Sanofi entered into a collaboration Transgene for the production of immunotherapy products

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28 марта 2013, 01:15

FDA Approves What Is Expected To Be Top Oral Treatment For Multiple Sclerosis

* Tecfidera expected to become dominant oral MS treatment * Sales of Tecfidera expected to top $3 billion by 2017 * Tecfidera expected to be launched within days * Stock rises 3.2 percent to $182.68 (Adds analyst comment, background, stock price) By Toni Clarke WASHINGTON, March 27 (Reuters) - U.S. regulators on Wednesday approved a new multiple sclerosis drug made by Biogen Idec Inc that is widely expected to become the No. 1 oral treatment for the disease, with annual sales topping $3 billion. The drug, Tecfidera, activates a chemical pathway in the body known as Nrf2 that helps protect nerve cells from damage and inflammation. Following Wednesday's approval by the Food and Drug Administration, Biogen said it will launch the drug within the coming days. Multiple sclerosis is a chronic condition that attacks the central nervous system and can lead to numbness, weakness, paralysis and blindness. It affects more than 2.1 million people worldwide, according to the National Multiple Sclerosis Society. "We expect a solid launch of Tecfidera, and our sense is that there is a bolus of patients in the queue ready to transition to therapy," Geoff Meacham, an analyst at J.P. Morgan, said in a research note. "However, we believe that Street expectations likely already account for this and then some." Shares of Weston, Massachusetts-based Biogen rose 3.2 percent to close at $182.68 on Wednesday. The shares have more than tripled over the past three years, mainly driven by high hopes for Tecfidera, known chemically as dimethyl fumarate. Biogen already sells the MS drugs Avonex and Tysabri, which together account for about 30 percent of the market. Teva Pharmaceutical Industries Ltd's drug Copaxone is the current market leader, with a roughly 29 percent share and annual sales last year of more than $4 billion. Unlike Copaxone, Avonex and Tysabri, which are injected or infused, Tecfidera comes in the more convenient form of a pill. As such, it will compete with Novartis AG's MS pill Gilenya, which, though first to market, has been dogged by heart safety concerns. Gilenya holds an 8.5 percent share of the market and generated worldwide sales of $1.2 billion last year. Tecfidera will also compete with Sanofi's recently approved MS pill Aubagio. Aubagio's label carries a boxed warning -- the most serious kind of warning -- alerting physicians to a potentially heightened risk of liver problems. Novartis said in a statement that it welcomed additional treatment options for people with MS, but warned that Tecfidera may not perform as well in the market as in clinical trials. "As with any new medication, real-world experience is critical to gain an accurate understanding of a therapy's full clinical profile," the company said. "It will be important to see the clinical profile of dimethyl fumarate -- including efficacy, safety, tolerability and adherence with its twice-a-day dosing -- as it gains real-world experience." Michael Yee, an analyst at RBC Capital Markets, said the overall profile of Tecfidera looks "significantly better than Gilenya." Tecfidera's side effects appear relatively benign, consisting mainly of flushing, diarrhea and nausea. And its label contains no boxed warnings. The FDA recommended only that physicians monitor patients' infection-fighting white blood cell count once a year. "That's an excellent label," said Yee. "I expect the drug to meet consensus of $300 million this year, and over five years it can achieve greater than $3 billion in sales based on its convenience and efficacy profile." Tecfidera will be used to treat patients with relapsing-remitting MS, a form of the disease in which flare-ups are followed by periods of remission. About 85 percent of people with MS are initially diagnosed with this form of the disease. Combined clinical trial data showed Tecfidera cut the average relapse rate by 49 percent after two years compared to patients taking a placebo. The drug is expected to generate sales of about $3 billion in 2017, according to data compiled by Thomson Reuters Cortellis. Last week European regulators recommended approval for Tecfidera and Aubagio, but they declined to give Aubagio a "new active substance" designation because it is similar to an older drug. Without this designation, generic copies of the drug could be launched in Europe in as little as three years. That could hurt sales of most other MS drugs on the market. Sanofi said it was disappointed by the decision and plans to request a re-examination of the case. (Reporting By Toni Clarke in Washington; additional reporting by Bill Berkrot in New York; Editing by Tim Dobbyn, Bernard Orr and Leslie Adler)

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28 марта 2013, 00:24

Sanofi Reports Lemtrada Data - Analyst Blog

Sanofi's subsidiary, Genzyme, announced interim data on Lemtrada.

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27 марта 2013, 21:02

The insulin war heats up, as Sanofi ([[SNY]] -0.9%) loses a key pitchman to archrival Novo Nordisk ([[NOVOB.PK]]). Former professional cyclist Phil Southerland, a diabetic whose team was funded by [[SNY]] for the past six years, has jumped ship along with his crew, now calling themselves Team Novo Nordisk. The stakes in this battle are big, as the global diabetes drug market right now runs at around $35B and continues to climb. At present, [[SNY]] dominates the market with Lantus, but its patent expires in 2015, and [[NOVOB]] - despite recent setbacks - continues to draft close behind.

The insulin war heats up, as Sanofi (SNY -0.9%) loses a key pitchman to archrival Novo Nordisk (NOVOB.PK). Former professional cyclist Phil Southerland, a diabetic whose team was funded by SNY for the past six years, has jumped ship along with his crew, now calling themselves Team Novo Nordisk. The stakes in this battle are big, as the global diabetes drug market right now runs at around $35B and continues to climb. At present, SNY dominates the market with Lantus, but its patent expires in 2015, and NOVOB - despite recent setbacks - continues to draft close behind. 1 comment!

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26 марта 2013, 01:12

CHMP in Favor of Sanofi's Aubagio - Analyst Blog

Sanofi received some encouraging news with the CHMP recommending the approval of its drug, Aubagio

26 марта 2013, 00:31

Sanofi ([[SNY]] -1.4%) says it's signed a collaboration agreement with Transgene SA to create a new industrial platform that will produce immunotherapy products including Transgene's therapeutic products. The platform will be established on Genzyme Polyclonals site, costing around ;10M from both partners. The platform will remain Sanofi's exclusive property, and under the agreement, [[SNY]]'s Genzyme will act as contract manufacturer.

Sanofi (SNY -1.4%) says it's signed a collaboration agreement with Transgene SA to create a new industrial platform that will produce immunotherapy products including Transgene's therapeutic products. The platform will be established on Genzyme Polyclonals site, costing around €10M from both partners. The platform will remain Sanofi's exclusive property, and under the agreement, SNY's Genzyme will act as contract manufacturer. Post your comment!

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22 марта 2013, 22:51

Sanofi's ([[SNY]] +1.4%) Genzyme says that the European Medicines Agency has issued a positive opinion for the approval of Aubagio, which is a treatment of relapsing-remitting multiple sclerosis. It did not howvever, recommend the drug receive a new active substance designation, which [[SNY]] believes could have a detrimental impact on future research on MS, as well as other diseases. The drug developer is now planning to request a re-examination of the decision.

Sanofi's (SNY +1.4%) Genzyme says that the European Medicines Agency has issued a positive opinion for the approval of Aubagio, which is a treatment of relapsing-remitting multiple sclerosis. It did not howvever, recommend the drug receive a new active substance designation, which SNY believes could have a detrimental impact on future research on MS, as well as other diseases. The drug developer is now planning to request a re-examination of the decision. Post your comment!

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22 марта 2013, 17:39

Sanofi ([[SNY]] +0.8%) reported positive results for its MS drug Lemtrada late yesterday, saying it remained effective during the first year of an extension study. The data "really speaks to Lemtrada's unique approach to disease modification," says the company's Michael Panzara, speaking at a Neurology conference. An under-the-radar way to play Lemtrada's success is discussed in this SA Pro article.

Sanofi (SNY +0.8%) reported positive results for its MS drug Lemtrada late yesterday, saying it remained effective during the first year of an extension study. The data "really speaks to Lemtrada's unique approach to disease modification," says the company's Michael Panzara, speaking at a Neurology conference. An under-the-radar way to play Lemtrada's success is discussed in this SA Pro article. Post your comment!

21 марта 2013, 05:05

Sanofi investors may sue as a class: Judge

A U.S. judge certified on Wednesday a class of investors who have filed a lawsuit accusing Sanofi of misleading them about the status of regulatory approval for a failed anti-obesity pill. U.S. District ...

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21 марта 2013, 00:32

Sanofi/MACK Candidate Progresses - Analyst Blog

Merrimack Pharma has completed the enrollment process for a phase II trial on MM-121.

12 марта 2013, 17:46

Bill Gates Continues ‘God’s Work’, Third World Vaccine Workers Shot Dead

Bill Gates promotes more vaccines, not nutrition or clean water for children in Third World countries.Christina EnglandActivist Post In January 2013, Bill Gates told the world in an interview that he had no need for money and that he believed the global vaccination program was God’s work. [1] “It’s not going to stop us succeeding,” says Gates. “It does force us to sit down with the Pakistan government to renew their commitments, see what they’re going to do in security and make changes to protect the women who are doing God’s work and getting out to these children and delivering the vaccine.” His words came after several vaccine workers administering the polio vaccination in Pakistan were shot dead in January. [2] It appears that although Gates wants to carry on with what he calls ‘God’s work,’ people living in the Third World are beginning to make their feelings abundantly clear. It appears that they don’t want his vaccines or his charity, as more shootings were reported in Nigeria.On February 8, 2013, The Guardian reported that at least nine health workers administering the polio vaccinations in Nigeria were shot dead by gunmen thought to belong to radical an Islamist sect. The Guardian wrote:The killings drew comparisons with a series of incidents in Pakistan last December where five female polio vaccinators were gunned down, apparently by Islamist militants. It also signalled a fresh wave of hostility towards immunisation drives in Nigeria, where some clerics have claimed the vaccines are part of a western plot to sterilise young girls and eliminate the Muslim population. [3] google_ad_client = "pub-1897954795849722"; /* 468x60, created 6/30/10 */ google_ad_slot = "8230781418"; google_ad_width = 468; google_ad_height = 60; DO YOU KNOW WHAT’S IN THAT NEEDLE? They are right to be suspicious because it would not be the first time that vaccines were given with the intention of sterilizing women in the Third World. In 1995, many Third World countries were given a tetanus vaccine containing a birth control drug by the World Health Organization. An organization known as The Comite became suspicious of the protocols surrounding the vaccines and obtained several vials for testing. It was discovered that some of the vials contained human chorionic gonadotrophin (hCG), a naturally occurring hormone essential for maintaining a pregnancy. However, when combined with a tetanus toxoid carrier, this vaccine essentially causes a woman’s body to produce antibodies against pregnancy, forcing her body to abort her unborn baby, as reported by ThinkTwice Global Vaccine Institute:In nature the hCG hormone alerts the woman’s body that she is pregnant and causes the release of other hormones to prepare the uterine lining for the implantation of the fertilized egg. The rapid rise in hCG levels after conception makes it an excellent marker for confirmation of pregnancy: when a woman takes a pregnancy test she is not tested for the pregnancy itself, but for the elevated presence of hCG. However, when introduced into the body coupled with a tetanus toxoid carrier, antibodies will be formed not only against tetanus but also against hCG. In this case the body fails to recognize hCG as a friend and will produce anti-hCG antibodies. The antibodies will attack subsequent pregnancies by killing the hCG which naturally sustains a pregnancy; when a woman has sufficient anti-hCG antibodies in her system, she is rendered incapable of maintaining a pregnancy. [4]Curiously, no men, boys or babies were vaccinated during the program. The only people vaccinated with this particular vaccine were women aged between 15 and 45. Was it a coincidence that these vaccines were only given to women of childbearing age? After all, anyone can contract tetanus, can’t they?THE ADVERSE EVENT YOU MIGHT NOT EXPECT Polio vaccine workers are not the only health workers who have been attacked during the last few months. In December 2012, La Voix reported that parents of vaccine-damaged children in Chad, Northern Africa, took out their anger and frustration by torching a car belonging to a hospital worker. [5] VacTruth has since been informed by Chadian contacts that the people of Chad are boycotting all vaccinations, while the parents of the vaccine damaged children stoned the school’s headmaster who had forced pupils to take the MenAfriVac Meningitis A vaccine. The parents have since announced that they have no choice but to take government and its international organizations to court. This is probably because whether Gates believes he is doing ‘God’s work’ or not, dumping severely vaccine-damaged children in a remote village in Africa without a doctor on site is almost certainly not God’s work, and this is exactly what Gates has allowed to happen to the children adversely affected by the MenAfriVac Meningitis A vaccine. Over the last few months I have written four articles covering recent events in Chad, Northern Africa, where 106 children became ill after receiving the meningitis vaccine, 40 of which were left paralyzed and suffering from convulsions. [6,7,8,9] This week, VacTruth received word from a Chadian contact that said:Last night the Chadian minister of health evacuated all children paralyzed from MenAfriVac meningitis A vaccine, including very ill children, to Faya. I have just spoken to one person, who told me that seven girls and a boy are seriously ill with convulsions. Please, help us. This forced evacuation of very ill and paralyzed children on a military plan, to a destination where there is not even basic medical personnel and equipment, is deliberately sending vulnerable children to a place where they are likely to die.Faya is a small town surrounded by desert at least 100 miles away from the children’s home village of Gouro. This is extremely worrying, especially after VacTruth received several medical records confirming that these children did indeed suffer vaccine injuries.MEDICAL RECORDS AS EVIDENCE Over the past three months, members of the community of Gouro have reached out to VacTruth with desperate pleas for assistance as they helplessly watch their children suffer. We received a copy of one of the children’s medical records from their parent, which was written in French and translated on our behalf by Desiree Rover, an activist and avid campaigner from the Netherlands. According to the record of treatment, the child was admitted to the hospital for an “undesirable post-vaccinal manifestation” and “intoxication by meningitis A vaccine.” Over the course of the hospital stay, the child suffered from headaches, shaking, vomiting, intense abdominal pain, and “contractions,” which likely refers to seizures. Sadly, this child was prescribed Largactil, a psychiatric drug used to treat schizophrenia, probably due to the fact that members of the government have insisted that the paralyzed children’s afflictions were all in their heads. There is no mention in the clinical records of any prescription or treatment for pain relief or seizures. This medical record, as well as the others sent to VacTruth by parents, demonstrates that these children need continued medical care. Yet, the ill children have been returned to an isolated, poorly equipped village far from sufficient available help!It has since been reported by Ecoterra International that the conditions of at least ten children have deteriorated since being evacuated. [10]POLIO RATES SKYROCKET IN THE MIDST OF VACCINATION CAMPAIGNS As if the poorest regions of Africa has not had enough problems, GlaxoSmithKline has decided that they would get in on the act. Ethan A. Huff from Natural News reported on Feburary 19, 2013, that GlaxoSmithKline has teamed up with the company Biological E Ltd. and together they have decided that is a great idea to give the children of Africa a six-in-one vaccine. This is a single-dose vaccine for polio, diphtheria, tetanus, whooping cough (pertussis), hepatitis B, and Haemophilus influenzae type B. This vaccine will be specifically designed for the poorest children of world. Natural News says:According to reports, GSK will add the contents of its injectable polio shot to a pentavalent vaccine already being manufactured by Biological E Ltd. that contains the other five vaccines. Together, as part of a 50-50 joint venture, the two companies will manufacture the hexavalent vaccine, which will rival similar combination vaccines for polio currently being developed and administered by rival drug companies in India such as Serum Institute of India Ltd. and Sanofi Pasteur. [11]According to Natural News, a study published in the Indian Journal of Medical Ethics (IJME) found that cases of polio-related paralysis have skyrocketed as a result of widespread polio vaccine campaigns throughout India, which means the populations of India are not benefiting from existing polio vaccines as the vaccine industry claims they are. So the two companies decided to put their heads together and come up with a new vaccine to boost their own economy. In other words if at first you do not succeed, try, try, try again! Dr. Rebecca Carley made her feelings abundantly clear about vaccines being used as bioweapons in an article recently, while the resulting damage is hidden from the public. She wrote:As I continue to follow the ongoing vaccine induced genocide of the indigenous Tibu children in Chad, Africa, it has become obvious that the totality of the documents I have accrued over the years has now reached critical mass for the purpose of going on the offensive against the psychopaths orchestrating the depopulation agenda. This was the topic of my RBN show on 2/10/13; you can access the archive for free by going to http://thelightofdayradioshow.com/archives/RBN-BACKUP/New-RBN-Dr-Carley-Archives.html. [12]Dr. Carley is right, as there is no better way of covering up adverse events than dumping sick children in the middle of nowhere and leaving them to die, is there? The saying ‘out of sight, out of mind’ springs to mind. google_ad_client = "ca-pub-1897954795849722"; /* 468x60, created 7/28/12 */ google_ad_slot = "9833874419"; google_ad_width = 468; google_ad_height = 60; CONCLUSION It appears that Mr. Gates will go to any lengths to vaccinate the world, even if the world makes it very clear that they do not want his vaccines. Rather than vaccinating more children, if he was such a humanitarian, why has he allowed vulnerable, sick children to be dumped in the middle of nowhere to die? Surely the world would applaud him far more loudly if he spent his millions making sure that any vaccine casualties were sufficiently cared for.RELATED ACTIVIST POST ARTICLE:Gates Foundation Partner in Malawi Vaccinates 131 Children At GunpointReferences: 1. http://www.telegraph.co.uk/technology/bill-gates/9812672/… 2. http://www.guardian.co.uk/world/2012/dec/18/polio… 3. http://www.guardian.co.uk/world/2013/feb/08/gunmen-nigeria-kill-polio-workers 4. http://thinktwice.com/birthcon.htm 5. http://www.tolerance.ca/Article.aspx?ID=157421&L=en 6. http://vactruth.com/2013/01/06/paralyzed-after-meningitis-vaccine/ 7. http://vactruth.com/2013/01/13/children-paralyzed-by-vaccine/ 8. http://vactruth.com/2013/01/25/paralyzed-symptoms-in-head/ 9. http://vactruth.com/2013/02/12/vaccine-cover-up/ 10. http://www.groundreport.com/World/Do-to-them-what-they-are… 11. http://www.naturalnews.com039160_glaxosmithkline_vaccines_developing… 12. http://thelightofdayradioshow.com/archives/RBN-BACKUP/…This article originally appeared at VacTruth.com http://vactruth.com/2013/02/26/rebels-shooting-vaccine-workers/Christina was born and educated in London, U.K. She left school to work in a children's library, specializing in story telling and book buying. In 1978 Christina changed her career path to dedicate her time to caring for the elderly and was awarded the title of Care Giver of the Year for her work with the elderly in 1980. In1990 she adopted the first of two disabled boys, both with challenging behavior, complex disabilities and medical needs. In 1999 she was accused of Munchausen by Proxy after many failed attempts to get the boys’ complex needs met. Finally, she was cleared of all accusations after the independent psychologist Lisa Blakemore-Brown gave both boys the diagnosis of Autism Spectrum Disorder and ADHD as part of what she described to be a complex tapestry of disorders. During the assessments Ms Blakemore-Brown discovered through the foster care diaries that the eldest boy had reacted adversely to the MMR vaccine. After taking an A Level in Psychology and a BTEC in Learning Disabilities Ms. England spent many years researching vaccines and adverse reactions. She went on to gain a Higher National Diploma in journalism and media and currently writes for the American Chronicle, the Weekly Blitz, VacTruth and Namaste Publishing UK on immunization safety and efficacy whilst continuing to study for a BA Honors degree in English Literature and Humanities. England’s main areas of expertise are researching false allegations of child abuse and adverse reactions to vaccines. Her work is read internationally and has been translated into many languages. Ms England has been a guest on many radio shows and has spoken at seminars worldwide. She is the co author to the book ‘Shaken Baby Syndrome or Vaccine Induced Encephalitis – Are Parents Being Falsely Accused?’ with Dr Harold Buttram. var linkwithin_site_id = 557381; linkwithin_text='Related Articles:' Enter Your Email To Receive Our Daily Newsletter Close var fnames = new Array();var ftypes = new Array();fnames[0]='EMAIL';ftypes[0]='email';fnames[1]='FNAME';ftypes[1]='text';fnames[2]='LNAME';ftypes[2]='text';var err_style = ''; try{ err_style = mc_custom_error_style; } catch(e){ err_style = 'margin: 1em 0 0 0; padding: 1em 0.5em 0.5em 0.5em; background: FFEEEE none repeat scroll 0% 0%; font- weight: bold; float: left; z-index: 1; width: 80%; -moz-background-clip: -moz-initial; -moz-background-origin: -moz- initial; -moz-background-inline-policy: -moz-initial; color: FF0000;'; } var mce_jQuery = jQuery.noConflict(); mce_jQuery(document).ready( function($) { var options = { errorClass: 'mce_inline_error', errorElement: 'div', errorStyle: err_style, onkeyup: function(){}, onfocusout:function(){}, onblur:function(){} }; var mce_validator = mce_jQuery("#mc-embedded-subscribe-form").validate(options); options = { url: 'http://activistpost.us1.list-manage.com/subscribe/post-json? u=3ac8bebe085f73ea3503bbda3&id=b0c7fb76bd&c=?', type: 'GET', dataType: 'json', contentType: "application/json; charset=utf-8", beforeSubmit: function(){ mce_jQuery('#mce_tmp_error_msg').remove(); mce_jQuery('.datefield','#mc_embed_signup').each( function(){ var txt = 'filled'; var fields = new Array(); var i = 0; mce_jQuery(':text', this).each( function(){ fields[i] = this; i++; }); mce_jQuery(':hidden', this).each( function(){ if ( fields[0].value=='MM' && fields[1].value=='DD' && fields[2].value=='YYYY' ){ this.value = ''; } else if ( fields[0].value=='' && fields [1].value=='' && fields[2].value=='' ){ this.value = ''; } else { this.value = fields[0].value+'/'+fields[1].value+'/'+fields[2].value; } }); }); return mce_validator.form(); }, success: mce_success_cb }; mce_jQuery('#mc-embedded-subscribe-form').ajaxForm(options); }); function mce_success_cb(resp){ mce_jQuery('#mce-success-response').hide(); mce_jQuery('#mce-error-response').hide(); if (resp.result=="success"){ mce_jQuery('#mce-'+resp.result+'-response').show(); mce_jQuery('#mce-'+resp.result+'-response').html(resp.msg); mce_jQuery('#mc-embedded-subscribe-form').each(function(){ this.reset(); }); } else { var index = -1; var msg; try { var parts = resp.msg.split(' - ',2); if (parts[1]==undefined){ msg = resp.msg; } else { i = parseInt(parts[0]); if (i.toString() == parts[0]){ index = parts[0]; msg = parts[1]; } else { index = -1; msg = resp.msg; } } } catch(e){ index = -1; msg = resp.msg; } try{ if (index== -1){ mce_jQuery('#mce-'+resp.result+'-response').show(); mce_jQuery('#mce-'+resp.result+'-response').html(msg); } else { err_id = 'mce_tmp_error_msg'; html = ' '+msg+''; var input_id = '#mc_embed_signup'; var f = mce_jQuery(input_id); if (ftypes[index]=='address'){ input_id = '#mce-'+fnames[index]+'-addr1'; f = mce_jQuery(input_id).parent().parent().get(0); } else if (ftypes[index]=='date'){ input_id = '#mce-'+fnames[index]+'-month'; f = mce_jQuery(input_id).parent().parent().get(0); } else { input_id = '#mce-'+fnames[index]; f = mce_jQuery().parent(input_id).get(0); } if (f){ mce_jQuery(f).append(html); mce_jQuery(input_id).focus(); } else { mce_jQuery('#mce-'+resp.result+'-response').show(); mce_jQuery('#mce-'+resp.result+'-response').html(msg); } } } catch(e){ mce_jQuery('#mce-'+resp.result+'-response').show(); mce_jQuery('#mce-'+resp.result+'-response').html(msg); } } } BE THE CHANGE! 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11 марта 2013, 22:55

U.S. Probes Sanofi Over Blockbuster Drug Plavix

The U.S. Justice Department is investigating drug maker Sanofi's disclosures to the Food and Drug Administration about different responses to its blockbuster blood thinner Plavix.The French company said ...

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11 марта 2013, 21:06

China’s Breakneck Auto Sales and Why the DOJ is Probing Sanofi

Headlines you need to know this morning...

11 марта 2013, 15:07

The DOJ is probing disclosures to the FDA about different responses that patients had to the blood-thinning drug Plavix, which is developed by Bristol-Myers Squibb (BMY) and Sanofi (SNY). The investigation is looking at how Plavix is less effective in patients who metabolize the drug poorly. State AGs in Mississippi and West Virginia have sued the companies, saying they should have known about the problem since 2003 and that they didn't disclose it in a timely manner.

The DOJ is probing disclosures to the FDA about different responses that patients had to the blood-thinning drug Plavix, which is developed by Bristol-Myers Squibb (BMY) and Sanofi (SNY). The investigation is looking at how Plavix is less effective in patients who metabolize the drug poorly. State AGs in Mississippi and West Virginia have sued the companies, saying they should have known about the problem since 2003 and that they didn't disclose it in a timely manner. Post your comment!

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08 марта 2013, 19:43

Merck's Big Vytorin Study Could Change Rules For New Cholesterol Drugs

Sometime this month, a group of independent experts will look at the data for the key study testing Merck's blockbuster cholesterol pills, Zetia and Vytorin. They could decide that the active ingredient in both is effective – or that it is unsafe.

08 марта 2013, 03:14

FDA Weighs Approval Of Narcolepsy-Linked Flu Vaccine In US

By Toni Clarke March 7 (Reuters) - Growing evidence of a link between GlaxoSmithKline Plc's pandemic flu vaccine and an increase in narcolepsy cases among children who received it in Europe, is giving pause to health regulators weighing approval of a similar vaccine in the United States. Data published recently in the British Medical Journal found that children in England who received GSK's Pandemrix vaccine during the 2009-10 H1N1 swine flu pandemic had a 14-fold heightened risk of developing narcolepsy, a chronic and potentially debilitating sleep disorder that can cause hallucinations, daytime sleepiness and cataplexy, a form of muscle weakness precipitated by strong emotion. Authors of the study - whose results echo those of similar studies in Sweden, Finland and Ireland - said the data had implications for the approval and use of future vaccines that, like Pandemrix, contain AS03, a new adjuvant, or booster, that turbo-charges the body's immune response to the vaccine. Scientists believe AS03 may be the culprit in the narcolepsy cases though they have yet to decipher the precise nature of the association. That uncertainty poses a challenge for the U.S. Food and Drug Administration, which is considering an AS03-containing vaccine for use in the event of an H5N1 bird flu epidemic. Like Pandemrix, which has not been approved in the United States, it is made by GSK and is almost identical in structure. A 14-member panel of advisors to the FDA voted unanimously in November to recommend the vaccine to protect against bird flu. The panel considered early studies from Europe showing an increase in the number of narcolepsy cases but concluded that the potential benefit of the vaccine outweighed the risk. WORSE THAN THOUGHT? Since then, however, new data, including the study results from Britain, suggest the scale and strength of the narcolepsy link could be greater than first thought. At least one committee member would like the FDA to reconvene the panel. "I personally think the panel should be reconvened now that we have new data," said Dr. Ambrose Cheung, professor of Microbiology and Immunology at Geisel School of Medicine at Dartmouth College in New Hampshire. "This is an issue worth re-examining." According to GSK, some 30 million doses of the vaccine were administered across Europe and 800 people, mostly children, developed narcolepsy. While acknowledging an association, the company says there is insufficient evidence to prove Pandemrix is the cause. A new meeting of the advisory committee would not necessarily lead panelists to change their vote. Bird flu kills nearly 60 percent of those it infects. As a result, the imperative to find a vaccine is high. "This is an evolving situation so there will continue to be more information to inform the decision making process," said advisory committee member Dr. Melinda Wharton, acting director of the National Center for Immunization and Respiratory Diseases at the U.S. Centers for Disease Control and Prevention (CDC). "Given that, I think this is a situation where the risk/benefit assessment could still favor the use of the vaccine, particularly in adults, as we are looking at a disease with an extremely high mortality rate." The CDC is sponsoring an international study on the links between adjuvanted flu vaccines and narcolepsy, which is expected to be completed in 2014. HIGHER MORTALITY RATE The H5N1 bird flu virus was first isolated in a human in Hong Kong in 1997 and it began to spread throughout Southeast Asia in 2003. A 2011 report by the World Health Organization showed only 566 people have been infected with bird flu worldwide, against the millions infected with the 2009 H1N1 swine flu virus. However, bird flu has a significantly higher mortality rate; of those infected, 59 percent died, according to WHO. That compares with fewer than 1 percent of those infected with H1N1 who have lost their lives, which alters the equation for the FDA versus the European regulators who authorized Pandemrix for the H1N1 virus. "We gave a favorable vote to a vaccine that we hope will never be used and to protect the public against a disease that has a better than 50 percent mortality rate," said Dr. Robert Daum, chairman of the FDA's advisory committee and a professor of pediatrics, microbiology and molecular medicine at the University of Chicago. "That is a very special situation." Still, Daum said he welcomed the opportunity to discuss any new information if the FDA were to reconvene the panel. "I have had several discussions with FDA personnel about the issue of adjuvanted vaccines and there are many unanswered questions," he said. "If they came to us and said we would like you to reconvene and consider the new data, I'd be in favor." FDA officials declined to be interviewed. A spokeswoman, Rita Chappelle, said in a statement that the FDA "will continue to monitor the situation, and consider regulatory options as needed." The FDA is not obliged to follow the recommendation of its advisory panel, though it typically does. NEW ADJUVANTS Regardless of whether the bird flu vaccine is approved for use in the United States, the narcolepsy issue has raised concerns within the broader scientific community about the future of novel adjuvants. "We are taking this very seriously," said Dr. Kathryn Edwards, director of the vaccine research program at Vanderbilt University, who did not sit on the bird flu vaccine panel though she has served on FDA advisory panels in the past. "We would like to understand this." Adjuvants have been used in vaccines for diseases such as diphtheria and tetanus for decades. A new, more powerful generation of adjuvants, including AS03, is being developed whose safety is relatively untested, which is why the Pandemrix experience could be pivotal. "The whole adjuvant story is an important one because there are going to be vaccines that we may be able to use to prevent diseases, if we are able to use adjuvants, that we could not prevent otherwise," Edwards said. Edwards said U.S. experts felt that traditional, non-adjuvanted H1N1 vaccines made by Sanofi SA and others offered enough protection against the virus. A study by the CDC showed traditional vaccines have not been associated with any spike in the number of people with narcolepsy. In the case of bird flu, however, regulators currently have no other choices as scientists have not developed a vaccine capable of protecting against bird flu. GSK's super-charged vaccine is the first to show it can confer protection and could potentially save countless lives in the event of a pandemic. European regulators have approved it under the brand name Pumarix. Assessing the relative risk versus benefit is a complex task and the calculation can change over time. Scientists are only just beginning to investigate the long-term effects of Pandemrix. Narcolepsy is widely considered to be an autoimmune disease, in which the body's immune system mistakenly attacks its own organs. One question now being raised by scientists is whether Pandemrix may be associated over the long term with an increase in other autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, psoriasis and lupus. Indeed, the FDA panel, which looked to the Pandemrix data for clues on the safety of the bird flu vaccine, noted a slightly elevated number of cases of irritable bowel syndrome and rheumatoid arthritis, said Cheung. But the panel felt these events could easily have been due to chance. "These kind of events," Cheung said, "can only be addressed after a longer period of time."

Выбор редакции
05 марта 2013, 01:00

Sanofi/REGN Present Dupilumab Data - Analyst Blog

Sanofi and Regeneron Pharmaceuticals presented data from two phase Ib trials evaluating dupilumab.

28 февраля 2013, 18:48

Фармацевтический кризис разразился в Греции

В аптеках Греции появилась нехватка сотен лекарств: компании приостановили поставки медикаментов в страну из-за низких цен и неуплаты партнеров по счетам, сообщили в четверг зарубежные СМИ. Ситуация с лекарствами может усугубиться, сообщает «Вести.Ру» со ссылкой на материалы Guardian. Цены на лекарства в Греции ниже, чем в других странах Европы, а многие партнеры не платят по своим счетам, так что зарубежные поставщики приостанавливают сотрудничество. Правительство Греции опубликовало список из 50 фармацевтических компаний, которые планируют приостановить поставки. В него вошли крупнейшие корпорации, например Pfizer, Roche, Sanofi и GlaxoSmithKline. Более 200 лекарственных препаратов пострадало, среди них – лекарства от артрита, гепатита С, антибиотики, антипсихотропные препараты, иммуномодуляторы и другие. В результате греки обходят местные аптеки в поисках лекарств, которых нет в больницах. «Красный крест» также собирается снижать поставки крови в Грецию, так как она не платит по своим счетам. Закладки:

28 февраля 2013, 14:42

В Греции разразился фармацевтический кризис

В Греции может начаться фармацевтический кризис, связанный с тем, что компании приостановили поставки лекарств в страну вследствие низких цен и неуплаты партнеров по счетам. Грекам придется обходиться без лекарств Уже сейчас в аптеках Греции не хватает сотен лекарств, и вскоре ситуация усугубится, пишет британское издание Guardian. Цены на лекарства в Греции ниже, чем в других странах Европы, а многие партнеры не платят по своим счетам, так что многие зарубежные поставщики приостанавливают сотрудничество. Правительство Греции опубликовало список из 50 фармацевтических компаний, которые планируют приостановить поставки. В него вошли крупнейшие корпорации, например Pfizer, Roche, Sanofi и GlaxoSmithKline.Более 200 лекарственных препаратов пострадало - среди них лекарства от артрита, гепатита С, антибиотики, антипсихотропные препараты, иммуномодуляторы и другие. В результате греки обходят местные аптеки в поисках лекарств, которых нет в больницах."Красный крест" также собирается снижать поставки крови в Грецию, так как она не платит по своим счетам.