Daily Pharmer Countdown 10-03-08 (28)

1. aldel 10 maart 2008 10:55

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   De uitslag, wannneer en hoe laat.
2. [verwijderd] 10 maart 2008 10:59

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   quote:

   trott schreef:

   [quote=NBeets]
   "Ik weet wel dat is aangegeven dat de her-beoordeling gedaan wordt door een nieuw team en niet alleen een nieuwe rapporteur en co-rapporteur."
   
   Dan moet ik daarover iets gemist hebben.
   Heb je een link of waar kan ik dat terug vinden.
   
   groet Camobs
   [/quote]
   
   Re-examination of opinions
   Article 11
   1. For the implementation of the procedures for the re-examination of opinions mentioned in Article
   9(2) of Regulation (EC) No 726/2004, in Article 32(4) of Directive 2001/83/EC, as amended, a
   different rapporteur and where previously appointed, a different co-rapporteur from those appointed
   for the initial evaluation, will be appointed to assess the grounds for the re-examination of opinions.
   This re-examination shall be made by using the best endeavours to ensure a new examination,
   independent from the first opinion.
   2. The re-examination may deal only with the points of the opinion initially identified by the applicant
   and is based only on the scientific data available when the Committee adopted the initial opinion. The
   applicant may request that the Committee consult a scientific advisory group (if and when established)
   in connection with the re-examination. In this case, the Committee shall request the advice of
   additional available expertise.
   
   

   Dat weet Nbeets wel joh.
   immers de rapporteur en co worden uit de groep gekozen.
   Er is een heel nieuw team !
   die het volgende opnieuw gaan aanvoeren of er anders over gaan denken!
   
   What documentation did the company present to support its application to the CHMP?
   The effects of Rhucin were first tested in experimental models before being studied in humans.
   Rhucin was studied in two main studies involving a total of 48 adults with C1 inhibitor deficiency. In both studies, patients were given Rhucin if they had an attack of angioedema. In total, 17 attacks were treated in a total of 12 patients, but both studies were still ongoing at the time of the medicine’s initial assessment. The main measure of effectiveness was how long it took for the patient’s symptoms to improve. During the evaluation procedure, the company also supplied the initial results of a study comparing the effects of Rhucin with those of placebo (a dummy treatment). This included results from 25 patients.
   The CHMP also took safety data from studies on healthy volunteers and patients without symptoms who were treated with Rhucin into account.
   ©EMEA 2007 Page 2/2
   What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
   The CHMP was concerned that there was insufficient evidence to show the benefits and risks of Rhucin.
   In particular, the available studies were too small to show how effective Rhucin is in treating more severe forms of the disease, such as swelling in the larynx (voice box), or how safe and effective the medicine is when given to a patient more than once.
   There was also insufficient information over the likelihood of patients developing antibodies following repeated doses of Rhucin. The Committee was also concerned over the possible presence of impurities in Rhucin, which could come from the rabbit milk from which the active substance is extracted and could affect the medicine’s safety. The company had not demonstrated that the levels of the impurities or the antibodies could be measured in a reliable manner.
   In addition, there were concerns that the choice of the dose of Rhucin had not been sufficiently justified.
   At that point in time, the CHMP was of the opinion that the benefits of Rhucin in the treatment of acute attacks of angioedema did not outweigh its risks. Hence, the CHMP recommended that Rhucin be refused marketing authorisation.
   What are the consequences of the refusal for patients in clinical trials or compassionate use
   
   En ik denk dat er best wel een erg zeer erg nauw contact is tussen de beide!
   
   Pharming provides Update on Rhucin®
   
   Leiden, The Netherlands, January 29, 2008. Biotech company PharmingGroup NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) todayprovided an update on the development of Rhucin® and its efforts tohave the product registered in the European Union and the UnitedStates of America through the European Medicines Agency (EMEA) andthe US Food and Drug Administration (FDA) respectively.In accordance with European regulation (EC) No 726/2004, Pharmingrequested a re-examination of the grounds for refusal that led to anegative opinion by the Committee for Medicinal Products for HumanUse (CHMP), regarding the granting of Market Authorization of Rhucin®for treatment of attacks of Hereditary Angioedema (HAE) in theEuropean Union. Based on these grounds for refusal, the Company willsubmit detailed grounds for this re-examination request to the EMEAno later than February 11, 2008 (within sixty calendar days afterreceipt of the negative opinion).In the re-examination procedure, the CHMP has appointed a newRapporteur and co-Rapporteur, who will assess the dossier, inparticular the elements that form the basis of Pharming's grounds forthe request.
   
   The Rapporteur and co-Rapporteur will report theirfindings to the CHMP, to which the Company can respond. The CHMP will issue their final opinion at a CHMP meeting within sixty calendardays following receipt of the grounds for the request. This opinionwill form the basis of a decision on the Market Authorization ofRhucin® within the EU. Therefore, such a final decision can beexpected in the second quarter of 2008.Pharming believes that the results obtained in clinical studies formthe basis for a positive risk benefit ratio for Rhucin® in treatmentof acute HAE-attacks. In a randomized placebo-controlled study,Rhucin® showed statistically significant superiority over placebo intime to first relief of the attack and in time to minimal symptoms.Efficacy was shown earlier in open-label clinical trials. No patientexperienced a relapse of the HAE attack or any treatment-relatedadverse event. Once authorized to enter the market, Rhucin® wouldmake an additional replacement therapy available throughout the EU.In the US, a double-blinded randomized placebo-controlled clinicaltrial was completed in the fourth quarter of 2007. When the lastpatients complete their follow-up visits, the data will be analyzedby an independent statistician. The Company expects to have summarydata available later this quarter. The US open-label study is stillongoing. Depending on the outcome of the placebo-controlled study anda pre-BLA (Biologic License Application) meeting with the FDA, theCompany anticipates to file the application for a US market approvalin 2008.While the regulatory process of Rhucin® is still ongoing, Pharmingcontinues its preparations for the commercialization of the product.The clinical database is being expanded by continued inclusion ofpatients in open label studies, of which the resulting data shouldeventually support marketing efforts. In addition, the commercialprotection of Rhucin® has been further strengthened by the recentissuance of European Patent 1252184 entitled "C1 inhibitor producedin the milk of transgenic mammals". The claims of this patent coverproduction, purification and the use of C1 inhibitor (the scientificname of Rhucin®) in pharmaceutical preparations.About Rhucin® and HAERhucin® (recombinant human C1 esterase inhibitor) is a human proteindeveloped through Pharming's proprietary technology where the humanprotein is expr
3. [verwijderd] 10 maart 2008 11:05

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   Het is maar wat je een nieuw team noemt?
   
   Het CHMP heeft een nieuwe Rapporteur en co-Rapporteur benoemd. Hun bevindingen worden door het “oude” CHMP team verder beoordeeld.
   
   groet Camobs
   
4. [verwijderd] 10 maart 2008 11:20

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   quote:

   NBeets schreef:

   Het is maar wat je een nieuw team noemt?
   
   Het CHMP heeft een nieuwe Rapporteur en co-Rapporteur benoemd. Hun bevindingen worden door het “oude” CHMP team verder beoordeeld.
   
   groet Camobs
   
   

   Volgende stukje blijf ik uiterst belangrijk vinden!
   
   Pharming submits request for re-examination of CHMP opinion for European marketing authorization application for RHUCIN(R)
   Friday, December 21, 2007; Posted: 06:21 AM
   
   
   
   
   
   Dec 21, 2007 (Hugin via COMTEX) -- PHGUF | charts | news | PowerRating -- Leiden, The Netherlands, December 21, 2007. Biotech company Pharming Group NV ("Pharming") (NYSE Euronext: PHARM) announced today that, in accordance with European regulations No 726/2004, it has given written notice to the European Medicines Agency (EMEA) for re-examination of the opinion of the CHMP (Committee for Medicinal Products for Human Use) issued last week.
   
   The re-examination is part of the formal marketing authorization procedure, which still needs to be completed. Pharming believes that the findings of clinical studies have demonstrated clear evidence of Rhucin(R)'s efficacy and safety in treatment of acute HAE attacks. In a randomized placebo-controlled study Rhucin(R) showed statistically significant superiority over placebo in time to first relief of the attack and in time to minimal symptoms.>>>>>>>>>>>>>>> These results have been accepted by the CHMP. No patient experienced a relapse of the HAE-attack or any treatment-related adverse event. Pharming is, therefore, convinced that the available data submitted to the CHMP demonstrate that Rhucin(R) is safe and efficacious in treatment of acute HAE attacks and provide a sound basis for granting a marketing authorisation for Rhucin(R) in the European Union.<<<<<<<<<<<<<<
   
   With respect to the other elements of its business Pharming confirms that its plans have not changed and have not been impacted by the initial opinion of the CHMP. The Company is backed by a sound financial position allowing the further development of its business for several years leading to product approvals, partnerships and other major advances in its portfolio.
   
   Ruud..
   
5. [verwijderd] 10 maart 2008 11:25

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   GUIDELINE ON PROCEDURES FOR RE-EXAMINATION OF CHMP OPINIONS
   
   1. Purpose
   Re-examination procedures are meant to provide a better guarantee for applicants/MAH`s rights
   (Recital 25 of Regulation (EC) No 726/2004).
   This document describes the procedure and gives guidance for the re-examination of different types of
   CHMP opinions, on the timetable for the applicants/MAHs involvement and for the assessment by
   CHMP, rapporteurs, and SAG (Scientific Advisory Group - if deemed necessary), and on the
   documentation to be supplied.
   2. Legal basis for re-examination
   Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying
   down Community procedures for the authorisation and supervision of medicinal products for human
   and veterinary use and establishing a European Medicines Agency (Centralised Procedures)
   • Article 9 (2) of Regulation (EC) No 726/2004 states:
   “Within 15 days after receipt of the opinion referred to in paragraph 1, the applicant may give
   written notice to the Agency that he wishes to request a re-examination of the opinion. In that
   case, the applicant shall forward to the Agency the detailed grounds for the request within 60 days
   after receipt of the opinion.
   Within 60 days following receipt of the grounds for the request, the said Committee shall reexamine
   its opinion in accordance with the conditions laid down in the fourth subparagraph of
   Article 62(1). The reasons for the conclusion reached shall be annexed to the final opinion.”
   • Article 62(1) of Regulation (EC) No 726/2004 states that “ If there is a request for re-examination
   of one of its opinions, the Committee concerned shall appoint a different rapporteur and, where
   necessary, a different co-rapporteur from those appointed for the initial opinion. The reexamination
   procedure may deal only with the points of the opinion initially identified by the
   applicant and may be based only on the scientific data available when the Committee adopted the
   initial opinion. The applicant may request that the committee consult a scientific advisory group in
   connection with the re-examination.”
   Directive 2001/83/EC of the European Parliament and of the Council on the Community Code relating
   to medicinal products for human use, as amended (Referrals)
   Article 32(4) of Directive 2001/83/EC, as amended, states:
   “Within 15 days after receipt of the opinion, the applicant or the marketing authorisation holder may
   notify the Agency in writing of his intention to request a re-examination of the opinion. In that case, he
   shall forward to the Agency the detailed grounds for the request within 60 days after receipt of the
   opinion.
   Within 60 days following receipt of the grounds for the request, the Committee shall re-examine its
   opinion in accordance with the fourth subparagraph of Article 62(1) of Regulation (EC) No 726/2004.
   The reasons for the conclusion reached shall be annexed to the assessment report….”
   Commission Regulation (EC) No 1085/2003 concerning the examination of variations to the terms of
   a marketing authorisation for medicinal products for human use and veterinary medicinal products
   falling within the scope of Council Regulation (EEC) No 2309/93
   • Article 6(9) establishes: “Article 9(1) and (2) of Regulation (EEC) No 2309/93 shall apply to the
   opinion adopted by the competent Committee.” The Articles quoted (which since 20 November
   have been replaced by Article 9(1) and (2) of Regulation (EC) No 726/2004) establish the general
   procedure for the CHMP opinions and re-examination of CHMP opinions.
   ©EMEA 2006 Page 3/6
   • According to Article 2, an application for an extension shall be evaluated in accordance with the
   procedures set out in Articles 6 to 10 of Regulation (EEC) No 2309/93 for medicinal products for
   human use. These Articles cover the re-examination procedure.
   Other references
   • Notice to Applicants
   [The guidance provided in the Notice to Applicants will be reviewed in accordance with the
   revised Regulation and Directive.]
   • Committee for medicinal products for human use rules of procedure (EMEA/CHMP/
   111481/2004).
   • Mandate, Objectives and rules of procedures for the CHMP Scientific Advisory Groups
   (published at the EMEA website: www.emea.eu.int).
   3. Scope
   The re-examination procedure as described in this guideline is applicable to:
   • CHMP opinions on referrals falling within the scope of Article 32.4 of Directive 2001/83/EC, as
   amended.
   • CHMP opinions on applications concerning medicinal products for human use falling within the
   scope of Regulation (EC) No 726/2004:
   o Granting of new marketing authorisations or extensions (Article 9.2)
   o Renewal (Article 14.2)
   o Annual reassessment (Article14.8)
   o Scientific opinions for evaluation of medicinal products outside the Community after
   consulting the WHO (Article 58)
   • CHMP opinions on type II variations and extension applications falling within the scope of
   Commission Regulation (EC) No 1085/2003 (Article 6.9 and Article 2 respectively)
   The re-examination procedure is not applicable to the following procedures:
   - Type 1A and type IB variations.
   - Compassionate use (Article 83.4)
   4. Timing of re-examination procedure
   6.2. Timetable for the applicant/MAH:
   Within 15 calendar days (=sending date by applicant/MAH as documented by fax/ eudralink/registered
   mail) after receipt of the opinion (=receipt date by applicant/MAH as documented by fax/
   eudralink/registered mail), the applicant/MAH may give written notice to the Agency that he wishes to
   request a re-examination of the opinion.
   Within 60 calendar days after receipt of the opinion the applicant/MAH forwards to the Agency
   detailed grounds for requesting re-examination.
6. [verwijderd] 10 maart 2008 11:26

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   Jawel Declan,
   
   Je kunt er wel weer grote lappen ` oud nieuws ` bij plakken, maar het blijft toch bij slechts een nieuwe Rapporteur en co-Rapporteur en een `oud` CHMP team.
   
   groet Camobs
7. [verwijderd] 10 maart 2008 11:26

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   4.2. Timetable for the assessment
   General principles:
   Within 60 calendar days following receipt of the grounds for the request, the CHMP shall re-examine
   its opinion. The detailed timetable presented below -as a guidance- will depend on, amongst others,
   the date of receipt of the detailed grounds for the request of re-examination vis-à-vis the CHMP
   meeting dates. However, it will never exceed 60 calendar days (i.e. no clockstop).
   During the CHMP meeting following receipt of the applicant/MAHs written notice to the Agency that
   he wishes to request a re-examination of the opinion, the CHMP appoints a different rapporteur and,
   for opinions where a co-rapporteur was involved in the initial evaluation, a different co-rapporteur
   from those appointed for the initial opinion (these rapporteurs will coordinate the evaluation for the
   duration of the re-examination procedure only). At this meeting the CHMP may have preliminary
   discussions on consultation and composition of the SAG; if possible the CHMP adopts a draft List of
   Questions to SAG at the same meeting.
   Calculation of timetable:
   Day 0: receipt by EMEA of Applicant/MAH`s detailed grounds for the request of re-examination
   Day 1: the next calendar day
   Approx. Day 30: Circulation of rapporteur(s)` assessment report(s) to CHMP (including draft LOQ to
   SAG, if applicable).
   Approx. Day 40: CHMP comments
   Approx. Day 45: Joint assessment report (including revised LOQ to SAG if applicable)
   Approx. Day 50: if applicable, SAG recommendation to CHMP (through SAG meeting or written
   procedure)
   At the latest on Day 60: The applicant/MAH is given the right to an oral explanation to the CHMP;
   CHMP adopts opinion (reasons for the conclusion reached shall be annexed to the final opinion).
   Where the last day of a period is a public holiday/ Saturday/Sunday, the period shall end with the
   expiry of the last hour of the following working day.
   5. Documentation to be supplied.
   5.1. The applicant/MAH shall forward to the Agency the detailed grounds for the request for reexamination
   of the opinion. As stated in Article 62.1 paragraph 4 of Regulation 726/2004 and
   Article 32.4 paragraph 3 of Directive 2001/83/EC, as amended, “the re-examination
   procedure may deal only with the points of the opinion initially identified by the
   applicant/MAH and may be based only on the scientific data available when the Committee
   adopted the initial opinion.” In case the applicant requests that the committee consults a SAG
   in connection with the re-examination, the applicant should inform the CHMP as soon as
   possible of this request. The request should also be mentioned in the notification letter and in
   the cover letter submitted with the grounds for the request for re-examination.
   5.2. Thus the rule for re-examinations in MA applications procedures and referrals is that only
   scientific data available when the Committee adopted the initial opinion is admissible at the
   re-examination stage.
   6. CHMP assessment and final opinion
   The general principles of coordination of the evaluation (i.e. role and interactions of rapporteur, corapporteur,
   CHMP, EMEA) will not be further detailed in this document (please refer to the guidance
   ©EMEA 2006 Page 5/6
   and procedures detailed in NTA vol. 2A, CHMP rules of procedure and Mandate, Objectives and
   Rules of Procedure for CHMP SAGs). However, in view of the particularly strict timetable of reexamination
   procedures (as outlined above), this paragraph will provide some further detail on the
   involvement of SAGs in re-examination procedures.
   6.1. Consultation of the SAG (or ad hoc expert group)
   The decision on consultation of the SAG for a re-examination procedure will amongst others depend
   on the applicant/MAH`s request for consultation of the SAG by CHMP. Preferably the applicant/MAH
   will inform the CHMP of this request as early as possible. When there is no request from the
   applicant/MAH the CHMP will decide on the need for additional expertise. In case of a request for
   consultation of the SAG coming from the applicant, the CHMP will systematically consult the SAG.
   In a therapeutic area where no SAG is established, the advice of additional available expertise will be
   requested in the form of consultation of an ad hoc expert group meeting.
   During the CHMP meeting following receipt of the applicant/MAHs written notice to the Agency or
   detailed grounds for requesting a re-examination of the opinion, the CHMP decides on consultation of
   the SAG and its composition (with regard to experts other than the SAG core group), and the CHMP
   adopts a List of Questions to the SAG.
   If the LOQ to the SAG has not yet been adopted during a CHMP meeting, it will be adopted by
   written procedure.
   EMEA will provide to the involved members of the SAG a copy of the List of Questions to the SAG.
   The CHMP/rapporteurs and the SAG secretary will decide on the additional documents given to the
   SAG/ad hoc experts, e.g. the applicant/MAH`s detailed grounds, the rapporteur(s)` draft assessment
   report on the re-examination, the CHMP`s initial opinion.
   The rapporteur`s assessment report on the re-examination and the (relevant sections of the) LOQ for
   the SAG is also sent for information to the applicant/MAH. The CHMP will decide whether the
   applicant/MAH will be invited for an oral presentation to the SAG.
   The SAG recommendation will be reflected in the CHMP assessment report.
   The MAH/ applicant in any case has the right to be heard by the CHMP.
   6.2. CHMP final opinion on re-examination
   Within 15 calendar days after its adoption, the Agency shall send the final CHMP opinion to the
   Commission, to the Member States and to the applicant/MAH.
   If an opinion is favourable to the granting/maintaining of the MA, the following documents shall be
   annexed to the opinion:
   • Annex A
   • Draft SPC, PL and labelling
   • Details of conditions affecting the authorisation (supply)
   • Details of recommended conditions or restrictions with regard to the safe and effective use of
   the medicinal product
   The CHMP assessment report is appended to the CHMP opinion.
8. [verwijderd] 10 maart 2008 11:26

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   If an opinion is not favourable to the granting/maintaining of the MA, the following document shall be
   annexed to the opinion:
   • Scientific conclusions and grounds for the refusal of the granting of the Marketing
   authorisation.
   The CHMP assessment report is appended to the CHMP opinion.
   6.3. Special situations
   In case of re-examination request by 1 of several parties, the final CHMP opinion will be delayed for
   all parties involved in the referral.
   In case of withdrawal (by applicant/MAH) of the request for re-examination, the initial CHMP opinion
   will immediately become the final CHMP opinion.
   7. Transparency/communication
   At the time of the initial CHMP opinion, a Summary of Opinion (SmOp) will be published for positive
   opinions, and a Question & Answer document for the negative opinions.
   At the time the Agency receives written notice from the applicant/MAH requesting a re-examination
   of an opinion, it will make this information public.
   After receipt by the Agency of the applicant/MAHs’ detailed grounds for re-examination of an
   opinion, this information will be mentioned in the next CHMP press release/CHMP Monthly Report.
   At the end of the re-examination procedure, the SmOp/Questions & Answer document of the initial
   opinion will be revised to reflect the outcome of the re-examination procedure, and will be published
   at the time of the CHMP press release/CHMP Monthly Report.
   In case of positive outcome, the EPAR will be published once the Commission Decision has been
   issued.
   In case of withdrawal by the applicant/MAH during the re-examination process, information about the
   withdrawal will be published by the EMEA.
   In case of refusal following the re-examination process, information about the refusal will be
   published.
   
   Zo hier is de procedure voor de XXX maal
   
   Ruud..
9. [verwijderd] 10 maart 2008 11:29

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   quote:

   NBeets schreef:

   Jawel Declan,
   
   Je kunt er wel weer grote lappen ` oud nieuws ` bij plakken, maar het blijft toch bij slechts een nieuwe Rapporteur en co-Rapporteur en een `oud` CHMP team.
   
   groet Camobs
   

   Inderdaad brengen deze rapporteurs hun bevindingen bij de EMEA !
   En waar geen nieuws is doen we het met oude gegevens toch?
   Want wij hebben geen nieuwe data ;-)
   
   Ruud..
10. [verwijderd] 10 maart 2008 11:31

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    quote:

    Filasoft schreef:

    De afwegingen:
    De EMEA heeft aangegeven o.a. bedenkingen te hebben over de effecten bij veelvuldig toedienen. Nieuwe feiten mogen niet worden meegenomen dus bij de herkeuring kan het bijna niet anders of men komt tot dezelfde conclusie.
    
    Uit het "assessment report" (EPAR) van Atryn:
    
    The CHMP sought input from an ad-hoc expert group on the issue of limited safety data, especially with regard to concerns for possible immunogenicity of antithrombin alfa and of remaining goat proteins in the product. The vast majority of the (over 200) individuals tested for IgG and IgM antibodies to ATryn were given a single Atryn dose. Immunodot Blot Assay (for remaining goat proteins) has only been carried out in 24 subjects. To the experts,
    
    !!!the concerns raised related to possible immunogenicity of ATryn would not be an issue precluding clinical use, provided appropriate surveillance would be in place. !!!
    
    The lack of clinical experience in the patient population with the nanofiltered product was identified as an element of uncertainty (please refer to the discussion on Efficacy).
    
    !!! CHMP therefore considers the potential problem with immunogenicity does not preclude granting a marketing authorisation, provided that the applicant addresses these points as part of post-authorisation activities. This also includes questions raised during the expert meeting regarding test methodology (the positive controls used, and IgE testing). !!!
    
    Ze hoeven helemaal niet tot dezelfde conclusie te komen Men kan meer eisen stellen aan "monitoring" terwijl het product op de markt is.
    
    Het moet maar weer eens gezegd worden.
    
    Link naar het hele document:
    
    www.emea.europa.eu/humandocs/PDFs/EPA...
    
    Goed leesvoer hoor :)
    
    

11. [verwijderd] 10 maart 2008 11:34

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    Juist saf en aanbevolen!
    
    Onderstaande bericht is ook totaal niet door gekomen lijkt het.
    Terwijl het een stukje mooi progressie laat zien!
    
    Pharming concludes license agreement with Advanced Cell Technology
    Company further strengthens transgenic technology platform
    Biotech company Pharming Group NV ("Pharming") (NYSE Euronext: PHARM) announced today that it has concluded a license agreement with Advanced Cell Technology Inc to obtain exclusive rights on patents in the field of transgenic technology, to which it already had non-exclusive rights. Financial details of the agreement were not disclosed.
    
    These patents were previously owned by Infigen Inc and cover a wide range of technologies including for Pharming relevant elements of nuclear transfer, which is an essential step in generating transgenic cattle. The agreement provides Pharming strict control over the generation of its transgenic cattle, while, at the same time, increasing the barriers of entry for others.
    
    Protecting its technology platforms via patents and licenses is an essential element of Pharming's strategy. This is done not only to maintain 'freedom to operate', but also to limit others in using the technology without a license, thereby protecting the investments that Pharming has made in developing its technology.
    
    Ruud..
12. [verwijderd] 10 maart 2008 11:38

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    quote:

    Declan. schreef:

    [quote=NBeets]
    Jawel Declan,
    
    Je kunt er wel weer grote lappen ` oud nieuws ` bij plakken, maar het blijft toch bij slechts een nieuwe Rapporteur en co-Rapporteur en een `oud` CHMP team.
    
    groet Camobs
    [/quote]
    
    Inderdaad brengen deze rapporteurs hun bevindingen bij de EMEA !
    En waar geen nieuws is doen we het met oude gegevens toch?
    Want wij hebben geen nieuwe data ;-)
    
    Ruud..
    

    Bij het CHMP Declan. Bij het CHMP.
    
    groet Camobs
13. [verwijderd] 10 maart 2008 11:44

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    `Pharming concludes license agreement with Advanced Cell Technology
    Company further strengthens transgenic technology platform`
    
    Kunnen ze over 1 1-2 week mooi dumpen bij een of ander luguber laboratoriumpje diep in Azie.
    
    groet Camobs
14. [verwijderd] 10 maart 2008 11:50

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    quote:

    NBeets schreef:

    [quote=Declan.]
    [quote=NBeets]
    Jawel Declan,
    
    Je kunt er wel weer grote lappen ` oud nieuws ` bij plakken, maar het blijft toch bij slechts een nieuwe Rapporteur en co-Rapporteur en een `oud` CHMP team.
    
    groet Camobs
    [/quote]
    
    Inderdaad brengen deze rapporteurs hun bevindingen bij de EMEA !
    En waar geen nieuws is doen we het met oude gegevens toch?
    Want wij hebben geen nieuwe data ;-)
    
    Ruud..
    [/quote]
    
    Bij het CHMP Declan. Bij het CHMP.
    
    groet Camobs
    

    JAja haha als dan alles tien keer moet worden verteld dan dat ook maar he Beets Bij de CHMP welke dan goedkeuring gaan verstrekken.
    Ja men is nog steeds geschrokken dat de nieuwe leden hun ogen niet open hadden en wakker schrokken tijdens de telling!
    Ze moeten nu naar een hokje lopen en daar hun ..
    Juist je begrijpt het goedkeuring melden!
    
    Ruud.. ;-)
15. [verwijderd] 10 maart 2008 11:53

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    `Bij de CHMP welke dan goedkeuring gaan verstrekken.`
    
    Nee, het CHMP geeft advies aan de Europese Commissie, en die geven toestemming om het op de markt te brengen.
    Maar zover komt Rhucin niet.
    
    groet Camobs
    
16. [verwijderd] 10 maart 2008 11:55

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    Hahahahahahaha
    
    Die Ruud.
    
    Hahahahahahahahaha
17. [verwijderd] 10 maart 2008 12:01

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    quote:

    NBeets schreef:

    Hahahahahahaha
    
    Die Ruud.
    
    Hahahahahahahahaha
    

    Kijk zo brengen we het goed onder de aandacht.
    Met een volle lach!
    
    Beter als een Pharmer met kiespijn.
    O BTW hoe was je weekend?
    
    Ruud..
18. [verwijderd] 10 maart 2008 12:17

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    Rt Bied €1.21 laat €1.23
    
    Laten we er het gas maar een opzetten vanmiddag.
    Alles groen dan ook ons aller Pharmpje.
    
    Ruud..
19. [verwijderd] 10 maart 2008 12:41

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    Eigenlijk wordt het wel de hoogste tijd al zal men liever zien dat er een grote stijging zal plaatsvinden in 1 of 2 dagen.
    Maar dat het omhoog zal gaan lijkt me een kwestie van tijd!
    Of dat dan ook gegrond is ?
    
    Ruud.. Rt 1.23
    
20. [verwijderd] 10 maart 2008 13:00

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    Ik heb even gezocht naar het document waarin staat dat de hele commissie wordt vervangen, maar ik kan het niet vinden. Ik weet zeker dat ik het gelezen heb, maar daar heb je weinig aan. Wellicht dat iemand anders nog even kan zoeken.
    
    Mvgr,
    
    BB