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INSM - Insmed - Deel 15

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  1. [verwijderd] 27 maart 2007 15:51
    FDA Cites Challenges of Generic Biotech
    Monday March 26, 5:52 pm ET
    By Matthew Perrone, AP Business Writer
    FDA Official Says Science to Quickly Approve Generic Biotech Drugs Could Be a Decade Away

    WASHINGTON (AP) -- A top drug regulator told lawmakers Monday it could be a decade or more before science is available to safely approve generic versions of biotech drugs in the way the agency approves knockoffs of traditional drugs.
    Food and Drug Administration deputy commissioner Janet Woodcock's testimony could benefit companies such as Amgen Inc. and Genentech Inc., which have never faced generic competition in the U.S. for their products, some of the most complex and expensive on the market.

    That lack of competition would change under a bill recently introduced by Rep. Henry Waxman, D-Calif. The bill would task FDA with approving knockoff versions of biotech medicines, many of which cost tens of thousands of dollars for a year's supply.

    Waxman, who chairs the House Committee on Oversight, helped launch the generic drug industry more than 20 years ago when he co-wrote legislation allowing generic manufacturers such as Barr Pharmaceutical Inc. and Mylan Laboratories Inc. to market cheaper versions of traditional drugs after the originals loose patent protection. Waxman's new legislation would give generic drug makers access to an estimated $12 billion worth of biotech patents that have already expired.

    Unlike traditional chemical-based pharmaceuticals, biotech pharmaceuticals are made from living cells and proteins. The biotech industry has long argued that because these proteins are more prone to minor differences when mass produced, it will be more difficult for generic drug companies to safely reproduce them.

    Woodcock said that while FDA can currently establish the safety between versions of simple protein-based drugs, it will likely "be a stepwise progression over a decade or so," before the agency can scientifically verify that a knockoff version of a complex biotech drug is similar to the original. Woodcock testified before The House oversight committee along with representatives from the drug industry and consumer groups.

    Ranking member Tom Davis, R-Virginia, argued that the complexity of biotech drugs makes it essential that would-be generic biotech makers be required to conduct clinical trials of their products.

    A vice president from Denmark-based Novo Nordisk, a biotech company that makes diabetes therapies, agreed. Nordisk's Inger Mollerup said that if Congress creates a system to approve cheaper protein-based drugs it should be similar to one already used by the European Union.

    Under the EU system, generic biotech companies have to conduct extensive studies to show the safety of their versions. Even after these studies are completed and the product is approved, knockoff biotech drugs are not considered interchangeable with the original product, meaning a patient has to get doctor approval before switching from the original drug to a generic.

    Waxman's bill would allow the FDA to require clinical safety studies, though it wouldn't make it mandatory.

    The question of whether generic drug companies would have to conduct safety trials is critical in determining how much lower generic biotech drugs would be priced than their brand name counterparts. Currently, generic drug companies are able to sell their existing treatments at 20 to 60 percent below the original's price because they are not required to spend time and money conducting safety studies.

    Last month, pharmacy benefit manager Express Scripts Inc. issued a report saying generic biotech drugs could save patients and insurance providers $71 billion over 10 years.

    The Biotechnology Industry Organization called the study flawed, saying it is impossible to forecast savings from generic biotech drugs without knowing how much testing regulators will require. Even as the industry lobbying group tries to head off Waxman's legislation, several original biotech manufacturers say they support the proposal.

    Momenta Pharmaceutical's Vice President Ganesh Venkataraman said his company hopes to develop ways to manufacture protein-based drugs that are interchangeable with the original manufacturer's. To date Momenta's research has focused on developing medicines from complex sugar chains, which are different from proteins.

    Insmed Inc.'s Geoffrey Allan went one step further, telling committee members that the generic biotech business "is a business in which we would like to specialize."

    "The science has reached a level of sophistication to make this endeavor entirely possible," Allan said. "All we need now is the regulatory go ahead."

    Insmed's lead product is a first-of-a-kind biological for children who lack certain growth hormones.

    biz.yahoo.com/ap/070326/congress_gene...
  2. [verwijderd] 27 maart 2007 17:30
    TiGenix NV (BRU)
    Heb dit gekocht en zit midden in de stijging ;-)))

    Laatste 6,97
    Laatste volume 500
    Tijd 17:24
    +/- 0,86 14,08%
    Volume 688.017

    Bied 6,92 17:24
    Biedvolume 350
    Laat 6,97 17:24
    Laatvolume 1.000

    Slot 6,11 26/3
    Open 6,49 09:00
    Hoog 6,98 17:19
    Laag 6,30 09:01

  3. [verwijderd] 27 maart 2007 17:39
    Gefeliciteerd maaruhh..

    Nuvelo was nog beter geweest :

    Nuvelo Inc.

    3,85 ( 17:37 ) 0,76 / 24,60%
    Laatste volume 200
    Volume 16.291.767
    Slot 3,09 26-3-2007
    Open 4,01 15:30
    Hoog 4,12 15:35
    Laag 3,80 15:55
  4. [verwijderd] 27 maart 2007 18:05
    Short interest Insmed :

    Mar. 15, 2007 4,316,745 6,661,746 1.00
    Feb. 15, 2007 2,917,904 2,086,510 1.40
    Jan. 12, 2007 2,072,313 2,316,052 1.00
    Dec. 15, 2006 2,800,640 3,933,147 1.00
    Nov. 15, 2006 1,872,589 1,078,200 1.74
    Oct. 13, 2006 1,961,944 1,037,387 1.89
    Sep. 15, 2006 1,851,513 382,568 4.84
  5. [verwijderd] 27 maart 2007 22:36
    quote:

    ramon72 schreef:

    Short interest Insmed :

    Mar. 15, 2007 4,316,745 6,661,746 1.00
    Feb. 15, 2007 2,917,904 2,086,510 1.40
    Jan. 12, 2007 2,072,313 2,316,052 1.00
    Dec. 15, 2006 2,800,640 3,933,147 1.00
    Nov. 15, 2006 1,872,589 1,078,200 1.74
    Oct. 13, 2006 1,961,944 1,037,387 1.89
    Sep. 15, 2006 1,851,513 382,568 4.84

    Oef.Blurp.Thx.
  6. [verwijderd] 28 maart 2007 11:02


    Gisteren Tigenix gekocht, eindelijk na veel staren toch in durven stappen. Bij opening ging het gelijk 6 % hoger open dan de vorige koers.

    Gisteren dus ingestapt aan 6.45, Ik denk nu toch een tijdje te blijven zitten, waarom, ik vermoed dat dit fonds nog goed gaat door stijgen de komende tijd, heb dit ook al eerder aangegeven, met Thrombogenix. gaat volgens mij de zelfde kant op.

    Zal hier even info plaatsen over Tigenix

    www.tigenix.com/

    www.baekelandfonds.be/conten t/view/37/1/

    tinyurl.com/2kbojo

    tinyurl.com/2wtnew

    www.tigenix.com/key/htm/01.h tml

    tinyurl.com/2kbojo

    tinyurl.com/2wtnew

    www.tigenix.com/key/htm/01.h tml
  7. [verwijderd] 28 maart 2007 17:50
    quote:

    marieke2 schreef:

    Ik kan geen aanmaken bij de bio forums, wie wel?
    onder de Belgische aandelen kijkt geen kat naar

    Wat is er met Insmed rt 0.94

    iex.nl/forum/forum.asp?forum=215
    rechts bovenaan boven laatste bericht:
    "nieuw bericht"

    en INSM=gebrek aan nieuws en dus kopers..
    shorters in control nu, die proberen hem behoedzaam omlaag te manouvreren

    0,89/90 support
  8. [verwijderd] 28 maart 2007 20:01
    quote:

    crackedtooth schreef:

    [quote=bertvv]
    Op 0.92 weer wat aangeschaft.
    [/quote]

    wat is je TA steunnivo's?
    Steun op 0.86 maar zegt de laatste tijd weinig bij INSM.
  9. [verwijderd] 28 maart 2007 20:09
    quote:

    crackedtooth schreef:

    0,92 dan ivm laag volume?
    vroeg me gewoon je afwegingen af...

    Portie verkocht op 1.02 op de dag dat de koers op 0.71 opende (pre market dinsdag?)
    Nu weer terug gekocht.
    De koers is zonder reden in dunne markt toch nog 10 % gezakt deze week.
    Verwacht geen verdere daling.
    Is en blijft een speelbal maar ik verwacht dat de koers komende maanden weer naar de 1.20- 1.50 gaat.

  10. [verwijderd] 28 maart 2007 20:18
    quote:

    bertvv schreef:

    [quote=crackedtooth]
    0,92 dan ivm laag volume?
    vroeg me gewoon je afwegingen af...

    [/quote]

    Portie verkocht op 1.02 op de dag dat de koers op 0.71 opende (pre market dinsdag?)
    Nu weer terug gekocht.
    De koers is zonder reden in dunne markt toch nog 10 % gezakt deze week.
    Verwacht geen verdere daling.
    Is en blijft een speelbal maar ik verwacht dat de koers komende maanden weer naar de 1.20- 1.50 gaat.

    van gtcb wel geleerd..op grote dipdagen proberen rond de bodem te kopen en dan ook flink kopen voor bounce binnen diezelfde dag

    is met met insm toen niet gelukt ivm te druk met werk
  11. [verwijderd] 29 maart 2007 21:51
    quote:

    ludwig mack schreef:

    dit is dan een dipdag ?
    gr
    1,50->0,68 met hoog volume is een dipdag

    maar ik heb gister wat gekocht ja wat er rond 1$ uit was gegaan op een trigger

    lt holding intact
  12. [verwijderd] 30 maart 2007 11:27
    Van IHub:

    www.abstracts2view.com/sabcs06/view.p...

    4077 Synergistic interaction between recombinant human insulin-like growth factor-binding protein 3 (rhIGFBP-3), rapamycin and letrozole in estrogen positive breast cancer.

    sabcs.org/ProgramSchedule/PosterSessi...

    December 13-16, 2007
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Aalberts 466 7.001
AB InBev 2 5.481
Abionyx Pharma 2 29
Ablynx 43 13.356
ABN AMRO 1.582 51.192
ABO-Group 1 22
Acacia Pharma 9 24.692
Accell Group 151 4.132
Accentis 2 264
Accsys Technologies 23 10.501
ACCSYS TECHNOLOGIES PLC 218 11.686
Ackermans & van Haaren 1 188
ADMA Biologics 1 34
Adomos 1 126
AdUX 2 457
Adyen 14 17.647
Aedifica 3 901
Aegon 3.258 322.647
AFC Ajax 538 7.086
Affimed NV 2 6.287
ageas 5.844 109.884
Agfa-Gevaert 14 2.048
Ahold 3.538 74.292
Air France - KLM 1.025 34.991
AIRBUS 1 11
Airspray 511 1.258
Akka Technologies 1 18
AkzoNobel 467 13.035
Alfen 16 24.319
Allfunds Group 4 1.468
Almunda Professionals (vh Novisource) 651 4.251
Alpha Pro Tech 1 17
Alphabet Inc. 1 405
Altice 106 51.198
Alumexx ((Voorheen Phelix (voorheen Inverko)) 8.486 114.812
AM 228 684
Amarin Corporation 1 133
Amerikaanse aandelen 3.835 242.709
AMG 971 133.042
AMS 3 73
Amsterdam Commodities 305 6.686
AMT Holding 199 7.047
Anavex Life Sciences Corp 2 482
Antonov 22.632 153.605
Aperam 92 14.900
Apollo Alternative Assets 1 17
Apple 5 380
Arcadis 252 8.731
Arcelor Mittal 2.033 320.549
Archos 1 1
Arcona Property Fund 1 286
arGEN-X 17 10.288
Aroundtown SA 1 219
Arrowhead Research 5 9.715
Ascencio 1 26
ASIT biotech 2 697
ASMI 4.108 39.078
ASML 1.766 105.976
ASR Nederland 21 4.451
ATAI Life Sciences 1 7
Atenor Group 1 469
Athlon Group 121 176
Atrium European Real Estate 2 199
Auplata 1 55
Avantium 32 13.609
Axsome Therapeutics 1 177
Azelis Group 1 64
Azerion 7 3.390