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By Jean-Michel Coumes On August 25, 2005, AstraZeneca appealed to the European Court of First Instance CFI ; against a decision of the European Commission fining the company 60 million for abuse of a dominant position, contrary to Article 82 of the EC Treaty. The Commission considered that AstraZeneca misused the EU patent process in order to block or delay generic competition to its Losec stomach ulcers medication. Alleged methods of this abuse consisted of i ; providing misleading information to national patent offices in order to obtain supplementary protection certificates and ii ; withdrawing marketing authorization for one type of medication Losec capsules ; in order to replace them with Losec tablets, since, without a marketing authorization on the original product, third parties had no possibilities to produce generics. The CFI judgment will be of particular interest. It is the first time that the alleged misuse of a regulatory process has been considered as an abuse of dominance under Article 82 of the EC Treaty. In that particular context, the CFI should also be called to consider whether and in which circumstances the withdrawal of a marketing authorization may constitute abusive behavior on the part of pharmaceutical companies. |
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Effectively. The program is also built on research that shows that teenage leaders 11th and 12th graders in this program ; produce greater and more lasting effects on other teens' behavior than do adults." These peer role models present factual information, identify pressures, role-play responses to pressures, teach assertiveness skills and discuss problem situations. BUT, says Howard and McCabe, "because young people also need the detailed information about reproduction, family planning and sexually transmitted diseases contained in the original curriculum, `Postponing Sexual Involvement' was added to the existing program. The PSI program covers four main areas: an emphasis on abstinence from or delay of sexual activity, life-skills training, sexuality education, and contraceptive education. Abstinence is presented as the best way to prevent unintended pregnancy and sexually transmitted diseases. The lifeskills component includes activities that help students build decision-making skills, set goals for their lives, learn how to say no to sex and negotiate within relationships. Sexuality education refers to a broad-based curriculum covering physical growth and the development of healthy sexual attitudes and values. Contraceptive education covers methods of contraception, how such methods are used, and their effectiveness in preventing pregnancy and sexually transmitted diseases. Although PSI does not directly provide access to contraceptives, some of the Atlanta staff members were from a nearby family planning clinic and therefore provided indirect access to contraceptives." The complete 10-period sexuality education program, 5 periods devoted to the abstinence curriculum and 5 to reproduction, family planning or contraceptives and sexually transmitted diseases with the 5th period of the abstinence curriculum delivered 1-3 months later to reinforce program content, is presented each year to all eighth grade students in 19 separate schools-approximately 4, 500 students each year. So, the sex-education curriculum under review in Family Planning Perspectives January February 1990, is an abstinence-based comprehensive or safe-sex program NOT an abstinence-only till marriage sex education curriculum such as the Alpha Center provides. But the Alpha Center isn't the only promoter of abstinence-only till marriage sex education programs playing foot-loose with the truth about Howard and McCabe's evaluation of the Grady Memorial Hospital's Revised Human Sexuality program. Virginia State Department of Health's Office of Family Health Services said on their Web Site page titled Virginia Abstinence Education Initiative Data and Statistics on March 25, 2003, "An evaluation of the Postponing Sexual Involvement PSI ; curriculum showed that its participants were five times less likely to become sexually active than those not involved in the program." They cite Howard and McCabe's article in Family Planning Perspectives, however, the conclusion the reader of that statement is left to draw; the insinuation, is that this was a typical abstinence-only till marriage curriculum which references contraceptives and condoms only in terms of their "alleged" failure rates; that no other sex education curriculum was in play, which isn't just misleading, it too is flat out on its face untrue. Moreover, this particular statement is more general in its conclusion than the true statement made by Howard and McCabe in their evaluation of the Grady Memorial Hospital's Revised Human Sexuality program. In addressing the issue of success, of, this abstinence-based comprehensive program, Howard and McCabe said, "To evaluate the revised program, a prospective study was designed to determine whether adding Postponing Sexual Involvement to the existing human sexuality program would reduce the rate of sexual involvement among young people." The authors concluded the following: "The major goal of Grady Memorial Hospital's Postponing Sexual Involvement program given in eighth grade was to assist young people in postponing sexual intercourse. Overall, nearly threequarters of the students in the program group had not had sexual intercourse before participating in the program. Based on the reports of these students, the study found that almost all 95 percent ; who had not had sexual intercourse and who participated in the hospital's program felt the information personally would be helpful in saying no to sexual involvement. By the end of eighth grade, students who had not participated in the program were as much as five times more likely to and psilocybin.
At 50-60 mm Hg systolic for rest of the surgery. In the last 2 episodes of air embolism no arrythmia was noticed, only patient had hypotension and decrease in EtCO2. Pupils became semidilated and non reacting to light, no respiratory effort was present. Patient was put on ventilator on CMV mode in the postoperative period. The patient remained in the same condition post operatively and died on the 2nd day of the operation. Discussion Along with a number problems of sitting posture, air embolism remains a great hazard of this posture. The incidence is as high as 45-50% in posterior fossa surgery.2, 3 While a large share of VAE occurs at the commencement of surgery - 78.7%, still 18% of embolic phenomena are reported at the end of surgery, probably associated with reopening of injured vein when retractors are removed.4 For the prevention of VAE various methods are being described as use of MAST suits, application of PEEP, 5 inflatable cervical torniquet and positive pressure at the end of procedure6 but none seems to be a full proof method. In our case it was catastrophic presentation of VAE which proved fatal. Despite early detection by a high pitched sound on doppler and with immediate intervention in the form of putting off the N2O, maintenance of PEEP, change of posture, air aspiration through CVP catheter we were unable to save the patient. Reports of catastrophic presentation of VAE are rare and variable.7, 8, 9, 10, But to our knowledge none presented as severe hypertension and brain oedema which lead to herniation of cerebeller tonsils and fatal outcome of patient. In our case a large rent was present in the venous sinus which when exposed after removal of retractor was the cause of aspiration of large amount of air. This air probably blocks the cerebral venous drainage and causes raised ICT which in turn gives rise to dangerous level of hypertension and brain oedema cushing reflex.
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If a patent expires before the first generic applicant has final approval of its ANDA, the applicant must amend its certification from a paragraph IV to a paragraph II and will no longer be entitled to 180 days of exclusivity when finally approved. On October 14, 2003, a federal district court in New Jersey found that Dr. Reddy's Laboratories was not entitled to share Andrx's 180-day exclusivity for generic copies of Prllosec omeprazole ; .105 Although Andrx was the first to file a paragraph IV certification to the 40 mg version on ten of the eleven patents listed by AstraZeneca, Dr. Reddy's was the first to file a paragraph IV for the 40 mg version on the other patent.106 Andrx filed a paragraph III. ; The patent expired after both ANDAs were tentatively approved, but before either was finally approved. FDA concluded that Dr. Reddy's lost its eligibility for exclusivity when the patent expired, on the theory that the company was required at that time to amend its ANDA to convert the paragraph IV certification to a paragraph II certification.107 Dr. Reddy's sued FDA in the District of New Jersey. The court noted that the agency had set forth its interpretation of the statute at least twice prior to its decision on Dr. Reddy's application.108 Dr. Reddy's argued that FDA may not require generic applicants to amend their certifications prior to final ANDA approval, and that an ANDA is eligible for exclusivity if it contains the appropriate paragraph IV certification at the time of filing. The court found the statute ambiguous on both points, however, and upheld the agency's decision.109 For new ANDAs, the first applicant forfeits exclusivity if all of the patents as to which it filed a paragraph IV certification qualifying it for exclusivity have expired.110 and relafen and prilosec. Opticrom fiorinal prescriptions with codine opticrom discount pharmaceuticals opticrom opticrom fiorinal prescriptions with codine opticrom discount pharmaceuticals opticrom stimulants adderall concerta provigil ritalin strattera anti depressants amitriptyline celexa effexor xr elavil lexapro lithium paxil prozac remeron wellbutrin zoloft bacterial infection treatments amoxicillin augmentin bactrim biaxin cephalexin cipro doxycycline erythromycin keflex levaquin penicillin zithromax antiviral treatment acyclovir amantadine tamiflu valtrex anxiety panic attack medications alprazolam ativan buspar clonazepam diazepam klonopin lorazepam oxazepam rivotril valium xanax arthritis treatments bextra lodine voltaren asthma medications foradil birth control medication alesse mircette ortho evra ortho tricyclen ortho tricyclen lo plan b triphasil yasmin blood pressure treatment aceon atenolol norvasc cancer medication femara cholesterol meds crestor lipitor vytorin zocor diabetic medication avandamet insulin metformin stomach medication aciphex bentyl detrol la prevacid prilosrc protonix ranitidine hcl hair losstreatments propecia blood thinner coumadin plavix eerectile dysfunction medication cialis levitra viagra migraines headache treatments butalbital esgic plus fioricet imitrex imitrex oral muscle relaxant carisoprodol flexeril skelaxin soma zanaflex pain meds codeine darvocet hydrocodone lorcet lortab norco oxycodone percocet tramadol ultram vicodin vicoprofen zydone anti psychotic abilify zyprexa seizures medications neurontin topamax sexual disease medications acyclovir aldara condylox famvir valtrex skin care treatments accutane aphthasol atarax lamisil metronidazole nizoral protopic renova retin-a sumycin tretinoin insomnia treatment ambien rozerem sonata smoking cessation zyban thyroid hormonal treatments levothyroxine synthroid appetite suppressant adipex bontril didrex diethylpropion ionamin meridia phendimetrazine phentermine tenuate xenical best results a current page: 1 next cromolyn ophthalmic ; cromolyn kroe-moe-lin ; ophthalmic solution is used in the eye to treat certain disorders of the eye caused by allergies.
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There are a number of controversies about NABs, such as the lack of standardized testing and the best way to measure them. But overall, NABs are believed to develop in up to 31-45% of people taking Betaseron, in 12-24% in people on Rebif, and in 3-5% of people on Avonex Giovannoni 2002 ; . NABs typically appear earlier in people on Betaseron: most people who develop NABs do so within 3-6 months after starting therapy, although NABs may develop over the first 18 months of treatment Rice G. Archives of Neurology, vol. 58, pp. 1297-1298, 2001 ; . With Avonex or Rebif, most people who will develop NABs do so about 9-15 months after starting therapy so many of the two-year studies of these medications are not helpful in assessing NAB development ; Ross and colleagues. Annals of Neurology, vol. 48, pp. 706-712, 2000 ; . Are NABs important or are they simply a scientific curiosity? In a large trial of Betaseron, treatment was very effective in reducing the frequency of MS relapses -- but only if people were NAB-negative. NAB-positive people had the same relapse rate as people on placebo no treatment ; IFNB MS Study Group. Neurology, vol. 47, pp. 889-894, 1996 ; . In the main study involving Rebif PRISMS, for Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in MS; Lancet, vol. 352, pp. 1491-1497, 1998 ; , NABs did not appear to be detrimental during the initial two-year study. However, at four years, NABs were having a significant effect PRISMS-4. Neurology, vol. 56, pp. 1628-1636, 2001 ; . The NAB-positive group had significantly more relapses and more flare-ups detectable on magnetic resonance imaging MRI ; than people who were NABnegative. So it is quite clear that NABs are important: if they develop, they have the potential to neutralize the benefits of therapy despite your regular injections and attempts to remain well. There are now plans in some regions to introduce regular NAB testing in people with MS who are taking a beta-interferon. However, it isn't clear what to do if person is NABpositive. NABs typically go away in the majority of people who stay on treatment, although therapy may well be ineffective during the period when NABs are present -- which has been reported to be as long as eight years Rice and colleagues. Neurology, vol. 52, pp. 1277-1279, 1999 ; . Switching from one betainterferon to another is not advised since NAB development with one will stimulate NAB development with another Khan and Dhib-Jalbut. Neurology, vol. 51, pp. 1698-1702, 1998 ; . Some NAB-positive people may decide to continue with treatment if they still feel they are doing well. Others will stop therapy altogether. Others may opt to switch to another type of treatment, such as glatiramer acetate. The best approach, determined by the person with MS in consultation with their neurologist, will depend on the individual's circumstances. Such decisions lie in the future. At the moment, what is needed is routine, standardized testing of neutralizing antibodies in everyone who is receiving a beta-interferon. I.
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