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ABLYNX NOVEMBER 2016, het vervolg.... (inhoudelijk graag)

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  1. R dayhigh 16 november 2016 12:21
    zakenbank jeffries heeft onlangs zijn koersdoelverhoging verhoogd van 18 naar 21, mede door potentie ALX 0171.

    met dank aan poster sanderus op een ander forum, onderstaand artikel + toelichting.
    onderzoek naar vaccinatie rsv.

    "
    Vaccinating children most effective way to combat RSV

    CAITLIN WESTERFIELD NOV 15, 2016

    Yale researchers have discovered that the most effective way to distribute a vaccine for Respiratory Syncytial Virus is to vaccinate children under five. It is the most common cause of infant hospitalization in the US and is responsible for 10,000 deaths annually among the elderly, according to the study. The researchers analyzed two sets of data about different age groups’ viral loads, which measures the amount of the virus present, and concluded that vaccinating children was not only the most effective technique in reducing the number of children affected with RSV — it was also the most effective way to reduce the number of total people affected with the virus, including the elderly.
    “Regardless of the setting, regardless of the state, what we learned was that the targeting of children is going to be highly beneficial not only for the children themselves but also for the elderly,” said Dan Yamin, a professor at Tel Aviv University and the study’s first author.
    The two main factors analyzed for this model were social behavior and the viral load of each individual, as well as the role of these factors in transmission of RSV. Yamin said that it was important to consider both of these measures because while high viral load within an individual often means that individual is more likely to infect others, it can also mean the person is more likely to stay home, which would be a change in social behavior.
    The study found that children under the age of five had the highest risk of becoming infected as well as the highest risk of transmitting the virus once infected. By targeting children between the ages of six months and five years, the vaccines would likely avert 10 percent to 50 percent of all cases in this age group as well as 10 percent to 40 percent of all cases among adults of age 50 and above — the next most susceptible age group to contracting RSV.
    “This indirect protection that arises from vaccinating children is so substantial that it is even predicted to avert more cases in adults than would a vaccination program that directly targeted the adults,” the study reported.
    While children under five were the most likely to transmit the virus once infected, individuals 50 and older were found to be least likely to cause transmission outside of their age group.
    The study concluded that vaccinating the elderly would therefore have very little effect on reducing the spread of RSV. While each vaccination of a child was predicted to avert 12 percent to 35 percent of cases in children and 3 percent to 7 percent of cases in adults, the vaccination of an adult was predicted to avert only 0.01 percent to 0.14 percent of cases in children and 0.36 percent to 0.86 percent of cases in adults.
    “If you target the elderly, or the adults… above the age of 50, it is not going to be as effective, even for the elderly themselves,” said Yamin. “For the benefit of the children and for the benefit of the adults, it is better that we target the children.”
    The study also looked at four different states across the country in order to consider the way that different states would be affected by different vaccination techniques. Because the RSV vaccine will most likely be distributed at the same time as the influenza vaccine — and different states have different flu seasons and RSV seasons which may not overlap — it is possible that those who are vaccinated may not be vaccinated during the right times.
    Additionally, according to Yamin, states’ differing demographics could cause the model to misrepresent the effect of vaccination on different groups. Still, across all four states in this study, the results were conclusive that vaccinating children was the most effective way to reduce the overall number of RSV cases for all age groups.
    “I would say that no one should be surprised [about these results] because that is what we do for other viral diseases,” said *** Englund, a professor of Pediatrics at the University of Washington School of Medicine who was not associated with this study.
    Englund added that the results from this study reflected similar vaccination procedures for other diseases, such as rotavirus, as doctors also target young children for vaccination.
    However, Englund added that while this model may be the goal, currently there are no RSV vaccines ready for use. Additionally, most ongoing testing of vaccines in clinical trials does not target children under five.
    “We really need to have a vaccine that we are going to use and evaluate it in order to be able to apply it to this modeling. This is a great attempt at trying to study things in advance,” said Englund.
    According to the CDC, those infected with RSV tend to recover within one to two weeks, although young children are contagious for up to three weeks.

    Hetgene in het rood is goed voor alx-171 omdat kleine kinderen de doelgroep zijn.

    Uit de klinische studie met alx-171.

    Ages Eligible for Study: up to 23 Months (Child

    yaledailynews.com/blog/2016/11/15/vac...

    "

    ps: hetgeen dat sanderus aankaart als *in het rood* betreft dit stukje tekst:

    However, Englund added that while this model may be the goal, currently there are no RSV vaccines ready for use. Additionally, most ongoing testing of vaccines in clinical trials does not target children under five

  2. Lauwry 16 november 2016 14:30
    Interessant stuk, ik heb me nogal eens afgevraagd of die vaccins een bedreiging zijn voor behandelingen als ALX 0171

    Ik denk het niet. Zelfs een werkzaam, veilig en kosten effectief vaccin als voor Rota wordt met veel moeite ingevoerd, maar nog niet in Nederland. Het vaccinatie programma wordt ook niet snel uitbreid omdat men bang is voor vaccinatie moeheid en onrust over (vaak niet bewezen) bijwerkingen

    De vaccins voor RSV zijn nog lang niet zo ver. Veel potentieel dus voor Ablynx inderdaad, dat zich op die moeilijke zeer jonge groep richt. Daar komen nu groepen met extra risico bij stamceltransplantatie.

    Zou het een tactiek kunnen zijn om eerste approval voor de moeilijke patientpopulaties te krijgen om op basis daarvan verdere toestemming voor algemene populatie te krijgen?

    quote:

    R dayhigh schreef op 16 november 2016 12:21:

    zakenbank jeffries heeft onlangs zijn koersdoelverhoging verhoogd van 18 naar 21, mede door potentie ALX 0171.

    met dank aan poster sanderus op een ander forum, onderstaand artikel + toelichting.
    onderzoek naar vaccinatie rsv.

    "
    Vaccinating children most effective way to combat RSV

    CAITLIN WESTERFIELD NOV 15, 2016

    "

    ps: hetgeen dat sanderus aankaart als *in het rood* betreft dit stukje tekst:

    However, Englund added that while this model may be the goal, currently there are no RSV vaccines ready for use. Additionally, most ongoing testing of vaccines in clinical trials does not target children under five

  3. Lauwry 16 november 2016 14:44
    www.ncbi.nlm.nih.gov/pubmed/21139081

    Respiratory syncytial virus (RSV) is a common cause (up to 10%) of seasonal respiratory viral infection in patients who have undergone hematopoietic stem cell transplantation. RSV usually presents as an upper respiratory tract infection in this patient population but may progress rapidly to lower respiratory tract infection. Available therapies that have been used for the treatment of RSV infections are limited to ribavirin, intravenous immunoglobulin, and palivizumab. The use of aerosolized ribavirin, alone or in combination with either palivizumab or intravenous immunoglobulin, remains controversial.
    On average, almost one-third to one-half of patients with RSV LRI had RSV-related or attributable mortality. We can assume that RSV infection has a substantial impact on our HSCT recipients by causing significant morbidity and mortality, especially when contracted in the first few months after HSCT.

  4. Joho 2.0 16 november 2016 17:31
    Deze notie van begin dit jaar, heb ik nog in mijn agenda staan voor Ablynx:
    4Q16 ALX-0171 Start dose finding infant Phase IIb (RSV) – Wholly-owned
    1H17 Caplacizumab MAA filing EU (TTP) – Wholly-owned

    Ik verwacht dus nog meer nieuws dit jaar. Of heb ik wat gemist (muv Jefferies,vandaag) ?
  5. Spreidstand 18 november 2016 07:29

    FMR LLC MELDEN 9,10% AANDELENBELANG IN ABLYNX

    GEREGLEMENTEERDE INFORMATIE

    GENT, België, 18 november 2016 - Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] maakte vandaag bekend, in overeenstemming met artikel 14 van de Belgische wet van 2 mei 2007 betreffende de openbaarmaking van belangrijke deelnemingen in emittenten van wie aandelen zijn toegelaten tot verhandeling op een gereglementeerde markt (de "Transparantiewet"), dat zij een kennisgeving van deelneming heeft ontvangen van FMR LLC.

    FMR LLC hebben Ablynx bericht dat het aandelenbelang in Ablynx gehouden via financiële instrumenten door FMR Co., Inc., een dochteronderneming van Fidelity Management & Research Company, dat op zich een dochteronderneming is van FMR LLC (de uiteindelijke moedermaatschappij), de drempel van 3% aandelenbelang heeft overschreden op 10 november 2016.

    Volgens de transparantieverklaring is het aandelenbelang van FMR Co., Inc. in Ablynx aandelen en stemrechten via financiële instrumenten gestegen tot 1.888.006 aandelen, wat overeenkomst met 3,10% van de huidige 60.921.732 uitstaande Ablynx aandelen (tegenover 1,92% in de vorige transparantieverklaring van 3 oktober 2016).

    FMR LLC (rekening houdend met de deelnemingen van haar dochterondernemingen) bezitten momenteel een totaal van 5.543.898 Ablynx aandelen, wat 9,10% van de huidige 60.921.732 uitstaande aandelen van Ablynx vertegenwoordigt.

    De bedrijven toegeschreven aan FMR LLC komen voort uit bedrijven van diverse instellingen voor collectieve beleggingen die beheerd worden door FMR Co., Inc., Fidelity Institutional Asset Management Trust Company en FIAM LLC, die elk op zich entiteiten zijn van dochterondernemingen, en gecontroleerd door, FMR LLC. Deze instellingen voor collectieve beleggingen hebben FMR LLC toegekende discretionaire bevoegdheid gegeven om te stemmen namens al hun effecten in overeenstemming met de FMR LLC board proxy voting policy. FMR LLC is geen gecontroleerde onderneming.

    De volledige versie van alle transparantiekennisgevingen is beschikbaar op de website van Ablynx onder de rubriek Investeerders.
  6. Spreidstand 18 november 2016 10:52
    Van het Beursig forum (met dank aan "ture"). Wilde ik jullie hier niet onthouden:

    Ablynx in talks with partners for RA drug
    Richard Staines Richard Staines
    November 17, 2016

    Ablynx is looking for new partners to take its rheumatoid arthritis drug vobarilizumab into phase 3 development, after AbbVie turned down an option to license the drug.

    AbbVie has already paid the Belgian biotech $175 million to develop the anti-IL-6R drug vobarilizumab (pictured) in phase 2 trials, and was waiting on further data before deciding to take the partnership further.

    But AbbVie was unconvinced with data published last month and decided against progressing the partnership any further.

    AbbVie’s rheumatoid arthritis blockbuster Humira is set for $15 billion in revenues this year, but the first biosimilars could be on the US market as early as next year.

    The US company had pinned its hopes on the Ablynx drug being a strong successor to Humira, but AbbVie got spooked by data from a second phase 2b trial. The results showed vobarilizumab missed its primary endpoint after a high percentage of patients in a placebo arm saw their symptoms improve.

    The drug also failed to show superiority to Actemra in a recent head-to-head study, with these combined results persuading AbbVie to not exercise its option to license the drug.

    Ablynx missed out on a $75 million milestone payment, and further payments worth up to $665 million, plus sales royalties.

    However chief executive Edwin Moses told the Jefferies London Healthcare Conference that Ablynx will continue to develop the drug and seek a new partner. He says its advantages compared to Actemra include less frequent dosing (once every two weeks or even monthly, rather than weekly) and a potentially superior side-effect profile.

    Dr Edwin Moses
    The Ghent-based biotech is also talking to regulators about further clinical development of vobarilizumab, which like Ablynx’s other products, is a smaller monoclonal antibody derived from camel or llama immune systems.

    Ablynx is talking with regulators about design of phase 3 trials, said Moses. He added that Ablynx is “talking now with potential new partners, exploring the future.”

    He also referred to data showing that 50% of patients on vobarilizumab in a 24 week study achieved remission in rheumatoid arthritis, which compared favourably, based on data from other trials, with UCB’s Cimzia (certolizumab) and AbbVie’s Humira (adalimumab).

    “We think we have a very efficacious product, we showed a very positive safety profile, we have two weeks administration and data to show monthly administration is possible,” he added.

    Anti-drug antibodies were produced at similar levels to Humira, but with no impact on safety and pharmacokinetics, Moses added.

    Ablynx noted that the placebo effect was highest in a group of mainly eastern European countries, where there is limited access to biologicals.

    The effect was “clearly related to trial design and location,” Ablynx said.

    The FDA has approved Amgen’s cheaper Humira biosimilar, Amjevita, but launch could be delayed by up to three years after AbbVie launched a legal challenge earlier this month.
  7. [verwijderd] 18 november 2016 11:17
    quote:

    Spreidstand schreef op 18 november 2016 10:52:

    Van het Beursig forum (met dank aan "ture"). Wilde ik jullie hier niet onthouden:

    Ablynx in talks with partners for RA drug
    Richard Staines Richard Staines
    November 17, 2016

    Etc. etc.
    Wellicht dit forum ook wat beter lezen, een link naar dit artikel was vanochtend al door mij op dit forum geplaatst
  8. Spreidstand 18 november 2016 12:08
    quote:

    jan941 schreef op 18 november 2016 11:17:

    [...]

    Wellicht dit forum ook wat beter lezen, een link naar dit artikel was vanochtend al door mij op dit forum geplaatst
    Sorry. En dank voor het posten uiteraard!

    Niet opgevallen (niet op geklikt). M.i. is het beter om in elk geval de essentie van het artikel waar je naartoe linkt hier even te posten. Voor de snelle scanners van het forum tussen andere bezigheden door ;-). Bovendien: als linkjes vervallen dan staat hier in elk geval de informatie nog.
  9. aossa 18 november 2016 13:05
    quote:

    Spreidstand schreef op 18 november 2016 07:29:

    FMR LLC MELDEN 9,10% AANDELENBELANG IN ABLYNX
    Wanneer je de tabelletjes naast (of boven) elkaar zet, zie je dat het aantal aandelen is afgenomen, en het aantal aandelen "via financiële instrumenten" is toegenomen. Dat zouden dan opties of(?) de converteerbare obligaties kunnen zijn.

    hugin.info/137912/R/2047967/765606.pdf

    hugin.info/137912/R/2057802/771108.pdf

    Credits to Hoebeet (beursig forum)
  10. Masiquodo 18 november 2016 13:56
    quote:

    aossa schreef op 18 november 2016 13:05:

    [...]

    Wanneer je de tabelletjes naast (of boven) elkaar zet, zie je dat het aantal aandelen is afgenomen, en het aantal aandelen "via financiële instrumenten" is toegenomen. Dat zouden dan opties of(?) de converteerbare obligaties kunnen zijn.

    hugin.info/137912/R/2047967/765606.pdf

    hugin.info/137912/R/2057802/771108.pdf

    Credits to Hoebeet (beursig forum)
    Is dat een goede ontwikkeling voor de gewone aandeelhouder of niet?
307 Posts
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