DeBeurs.nl

lucas D 30 mei 2012 20:29

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Ruconest (conestat alfa) in Europa.
En straks ook in Amerika.;~)

[verwijderd] 30 mei 2012 20:59

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marketpublishers.com/report/company_r...

Zou er nog echt nieuws in staan?

[verwijderd] 31 mei 2012 11:11

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www.sobi.com/en/Investors--Media/News...

voda 5 juni 2012 16:41

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Galapagos: medicijn GLPG0634 zeer actief tegen reuma

AMSTERDAM (Dow Jones)--Galapagos nv (GLPG.BT) meldt dinsdag dat medicijn GLPG0634 zeer actief is tegen reuma, een snelle werking heeft en een heel goede veiligheidsscore geeft.

Het Belgische biotechbedrijf zal op 9 juni tijdens het EULAR Annual European Congress of Rheumatology de resultaten presenteren van de fase II Proof-of-Concept studie met JAK1-remmer GLPG0634 in reumapatienten.

In de klinische studie werden 36 reumapatienten betrokken die onvoldoende reageren op de standaard behandeling met methotrexaat. Het doel van de studie was om de werkzaamheid en veiligheid van GLPG0634 bij patienten met actieve reuma aan te tonen.

Het molecuul is ontwikkeld door Galapagos. Bij succesvolle afronding van de Fase IIb studies voor reuma, zal Abbott Laboratories (ABT) het programma licenseren en is daarna verantwoordelijk voor de Fase III klinische ontwikkeling en de wereldwijde productie.

Door Ben Zwirs; Dow Jones Nieuwsdienst; +31 20 571 52 00; ben.zwirs@dowjones.com

konijnenmelkertbaan 6 juni 2012 07:20

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fd.nl/beleggen/682649-1206/stamcellen...

Het Vaticaan heeft ook een stap genomen in de moderne geneeskunde. Het lijkt me een stap richting de "tricks on life" die Pharming uitvoert.

[verwijderd] 6 juni 2012 11:52

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Sobi to refinance existing credit facility
Sobi has decided to refinance its existing credit facility either by issuing a SEK denominated bond up to SEK 500 M or by entering into a new revolving credit facility with SEB and Nordea.

The purpose of the refinancing is to improve the financial flexibility and to extend the maturity profile. The refinancing will replace existing bank debt and will not increase Sobi's total debt.

Sobi has appointed Nordea as Joint Bookrunner and Co-ordinator together with SEB as Joint Bookrunner to investigate a bond issue. The lead banks Nordea and SEB have committed to provide a credit facility in a corresponding amount in the event that Sobi does not proceed with the bond issue.

[verwijderd] 7 juni 2012 13:45

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Lead product on track for market launch in 2014

LEIDEN, The Netherlands & SEATTLE, Jun. 06, 2012 -- (BUSINESS WIRE) -- ProFibrix B.V., a leader in the development of innovative bioactive products to stop bleeding (hemostasis), today announced the start of its pivotal Phase III clinical trial with Fibrocaps (FINISH-3) in spine, liver, vascular and soft tissue surgery.

FINISH-3 is a multicenter, randomized, single-blind, controlled Phase III trial of Fibrocaps in 672 surgical patients with mild to moderate surgical bleeding. The main objectives of the study are to demonstrate superior efficacy of Fibrocaps vs. gelatin sponge within each surgical indication, and to confirm the overall safety results from the Phase II Fibrocaps trials completed in 2011.

Dr. Paul Frohna, Chief Medical Officer of ProFibrix said: “We are very pleased to announce the randomization and treatment of the first patients in the international FINISH-3 trial less than 4 months after completing our End-of-Phase II meeting with the U.S. FDA. Based on the excellent Phase II study results, the investigators are very eager to enroll their patients into our study and we remain on track for regulatory filings in the U.S. and EU in 2013. Based on the product’s unique properties, and the overwhelmingly positive feedback we are receiving from the surgical community, we believe Fibrocaps should be able to capture a substantial share of the US$ 1 billion topical hemostat market.”

The Fibrocaps used in the pivotal Phase III clinical trial has been manufactured by ProFibrix’s commercial manufacturing partner Nova Laboratories Limited (Leicester, UK). Peter White, Managing Director of Nova Laboratories said: “It is great to be part of this exciting project and to manufacture the Phase III product and I am looking forward to our long term collaboration.”

About Fibrocaps

Fibrocaps is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, and is stable at room temperature.

About the FINISH-3 trial

FINISH-3 is a prospective, randomized (2:1), single-blind, controlled, pivotal Phase III trial of Fibrocaps vs. active control in 672 subjects undergoing spinal (n=168), liver (n=168), vascular (n=168) and soft tissue surgery (n=168). The study will be conducted at 65 sites across Europe and the U.S. Estimated completion date is May 2013.

For more details on the study, please go to www.clinicaltrials.gov.

en aanvullend... :-)

Jaap Koopman, PhD

Chief Scientific Officer
Dr. Koopman founded ProFibrix in 2004 and led the company through a seed financing round in January 2005 and the first round of venture funding in February 2007. He has over 20 years experience in biomedical research focusing on various aspects of haemostasis, particularly fibrinogen and fibrin formation. Dr. Koopman is a member of the Counsel of the International Fibrinogen society and is co-chairman of the ISTH sub-committee for fibrinogen standardization. From 1998 to 2003 he was scientific director and project manager Pharming Group N.V., Leiden, the Netherlands.

konijnenmelkertbaan 7 juni 2012 15:25

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Waarom konijnen gebruiken als je ook planten kan gebruiken?
Voor proteinen schijnt het al te werken:

www.permies.com/t/15160/medicinal-her...

[verwijderd] 8 juni 2012 16:16

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June 7, 2012 (Tokyo) - Chugai Pharmaceutical Co., Ltd. [Main Office: Chuo-ku, Tokyo. Chairman & CEO: Osamu Nagayama (hereafter, “Chugai”)] announced today that it will launch on June 8, 2012, Pulmozyme® Inhalation Solution 2.5mg (hereafter, “Pulmozyme®”)[recombinant human deoxyribonuclease I (rhDNase), generic name: dornase alfa] for “improvement of pulmonary function in patients with cystic fibrosis.” Pulmozyme® received a manufacturing and marketing approval on March 30, 2012 and was listed on the National Health Insurance (NHI) reimbursement price list on May 29, 2012. Pulmozyme® is designated as an orphan drug for this indication by the Ministry of Health, Labour and Welfare (MHLW).

As a result of the evaluation by the “Review Committee on Unapproved Drugs and Indications with High Medical Needs*” held on April 18, 2011, it was concluded that it is reasonable that dornase alfa be filed for approval in this indication based on available data, and on July 15, 2011, the filing was made using overseas data. In overseas clinical studies, administration of dornase alfa by inhalation is confirmed to be effective for the improvement of pulmonary function and reduction of the risk of serious infection of the respiratory tract in cystic fibrosis patients, compared to placebo.

In Japan, the incidence of cystic fibrosis is only about one in 1.87 million, and according to MHLW-supported research done in 2009, “Investigational study on refractory pancreatic disease,” there were 15 patients estimated in Japan in 2009. Cystic fibrosis is caused by genetic mutation of CFTR, a chloride ion-channel. There is no curative treatment for this disease, and typically, expectorants and bronchodilators are administered for respiratory tract disturbances, and antibiotics by inhalation or systemic treatment are used to treat infection.

Pulmozyme® cleaves extracellular DNA in the mucus of cystic fibrosis patients, reducing the adhesiveness and viscoelasticity of the mucus. Overseas, it is approved in approximately 70 countries including the U.S. and Europe, and is administered to around 50 thousand patients per year, as one of the standard treatments for cystic fibrosis.

[verwijderd] 13 juni 2012 19:50

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Icatibant treatment for acquired C1-inhibitor deficiency: a real-world observational study

Abstract

Icatibant, a bradykinin B2 receptor antagonist, is an established treatment for acute attacks of hereditary angioedema (HAE) with C1-inhibitor (C1-INH) deficiency. We describe our experience with icatibant in eight patients with angioedema because of acquired C1-INH deficiency (AAE). Forty-eight moderate-to-severe attacks were treated with subcutaneous icatibant 30 mg; two moderate attacks resolved without treatment. The median (range) duration of treated attacks (onset to complete resolution) was 9.33 (1.67–39.00) h; durations of the untreated attacks were 72 and 96 h. Symptom improvement following icatibant treatment occurred in 0.5 (0.25–2.10) h and complete resolution in 6.75 (0.50–30.75) h. A single icatibant injection achieved complete symptom resolution in 47 attacks; one facial attack required a second injection. One peripheral attack responded less quickly than other treated attacks. Five patients reported transient injection site reactions. Icatibant appeared to provide effective symptom relief and was generally well tolerated.

voda 18 juni 2012 16:21

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Grote productieorder voor farmatak DSM

Gepubliceerd op 18 jun 2012 om 08:43 | Views: 861

PARSIPPANY (AFN) - DSM Pharmaceutical Products heeft een omvangrijke productieorder in de wacht gesleept van een groot farmaceutisch bedrijf. Dat maakte DSM maandag bekend, zonder financiële details of de naam van de opdrachtgever te vermelden.

DSM neemt de procesontwikkeling en commerciële productie van drie antistoffen voor zijn rekening. Het werk zal plaatsvinden in Groningen en in de nieuwe productiefaciliteit voor medicijnen van het speciaalchemiebedrijf in Brisbane, Australië.

[verwijderd] 18 juni 2012 16:29

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En toch weer dumps...de vraag is....daghandelaren of...?
Gezien het feit dat ze steeds met een klein aantal weer hoger worden gezet denk ik geen daghandelaren...

[verwijderd] 19 juni 2012 16:59

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Activation of the complement system has been associated with tissue injury after hemorrhage and resuscitation in animals. We investigated whether administration of recombinant human C1-esterase inhibitor (rhC1-INH), a regulator of complement and contact activation systems, reduces tissue damage and cytokine release and improves metabolic acidosis in a porcine model of hemorrhagic shock. Male Yorkshire swine were assigned to experimental groups and subjected to controlled, isobaric hemorrhage to a target mean arterial pressure of 35 mmHg. Hypotension was maintained for 20 min followed by a bolus intravenous injection of rhC1-INH or vehicle; animals were then observed for 3 h. Blood chemistry and physiologic parameters were recorded. Lung and small intestine tissue samples were subjected to histopathologic evaluation and immunohistochemistry to determine the extent of injury and deposition of complement proteins. Cytokine levels and quantitative assessment of renal and hepatic function were measured via enzyme-linked immunosorbent assay and chemistry analyzer, respectively. Pharmacokinetics of rhC1-INH revealed dose proportionality for maximum concentration, half-life, and the time span in which the functional C1-INH level was greater than 1 IU/mL. Recombinant human C1-INH significantly reduced renal, intestinal, and lung tissue damage in a dose-dependent manner (100 and 250 IU/kg). In addition, rhC1-INH (250 IU/kg) markedly improved hemorrhage-induced metabolic acidosis and circulating tumor necrosis factor a. The tissue-protective effects of rhC1-INH appear to be related to its ability to reduce tissue complement activation and deposition. Recombinant human C1-INH decreased tissue complement activation and deposition in hemorrhaged animals, improved metabolic acidosis, reduced circulating tumor necrosis factor a, and attenuated tissue damage in this model. The observed beneficial effects of rhC1-INH treatment on tissue injury 20 min into severe hypotension present an attractive model of low-volume resuscitation, particularly in situations with a restrictive medical logistical footprint.

voda 20 juni 2012 15:57

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Van Herk vergroot belang in OctoPlus

Gepubliceerd op 20 jun 2012 om 08:47 | Views: 625

AMSTERDAM (AFN) - A. Van Herk heeft zijn kapitaalbelang en stemrecht in OctoPlus vergroot naar 19,75 procent. Dat blijkt uit een woensdag gepubliceerde melding bij de Autoriteit Financiële Markten (AFM).

Bij een eerdere melding van de AFM bedroegen het kapitaalbelang en stemrecht van Van Herk in OctoPlus nog 11,47 procent.

Aandeelhouders zijn verplicht hun belang bij de AFM te melden als dit 5 procent, of een veelvoud daarvan, overschrijdt.

[verwijderd] 21 juni 2012 16:17

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blogs.nature.com/news/2012/06/intelle...

Ruud..

[verwijderd] 27 juni 2012 17:16

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Beetje vergelijkbaar verhaal...

With positive phase IIb data for its novel dual action SGLT1 and SGLT2 diabetes drug in the bag, Lexicon Pharmaceuticals will now start the inevitable hunt for a partner. Shares in the Texas-based group rose by 16% on yesterday to $2.26 after it reported impressive results in blood sugar reductions for LX4211 and more importantly a good safety profile. Today the stock, which had risen by over 70% in the last six months, was 3% lower, indicating profit taking.
As the laggard in the race to the US market for this approach to diabetes, launch is still not expected until 2016, LX4211 needed some clear blue water in terms of efficacy or safety. So results showing that the drug was effective and had apparently avoided the urinary and yeast infections that have blighted others in the field will help to differentiate it from the current crop of SGLT2 inhibitors in development

[verwijderd] 29 juni 2012 09:03

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Published: 08:30 CEST 29-06-2012 /Thomson Reuters /Source: Swedish Orphan Biovitrum AB (publ) /XSTO: SOBI /ISIN: SE0000872095

Change in number of shares and votes in Swedish Orphan Biovitrum AB

The total number of shares in Swedish Orphan Biovitrum AB (publ) as per 29 June 2012 amounts to 267,979,722 shares, of which 265,226,598 common shares and 2,753,124 class C shares*, corresponding to in total 265,501,910.4 votes.

The increase in the number of shares and votes is due to an issue of 684,590 class C shares under the company's long-term incentive programs. The class C shares are intended to ensure fulfillment of commitments under the programs.

For further information, please contact:
Åsa Stenqvist, Head of Communications and Investor Relations
Tel.: +46 8 697 21 88

Swedish Orphan Biovitrum (Sobi)
Sobi is a leading integrated biopharmaceutical company dedicated to bringing innovative therapies and services to improve the health of rare disease patients and their families. The product portfolio comprises about 45 marketed products as well as projects in the late clinical phase. Key therapeutic areas are Inflammation and Genetics & Metabolism. In 2011, Sobi had revenues of SEK 1.9 billion and around 500 employees. The share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.

*All class C shares are held by the company.

The information above has been published pursuant to the Swedish Securities Market Act and/or the Financial Instruments Trading Act. The information was released for public distribution on 29 June 2012 at 08.30 CET.

[verwijderd] 29 juni 2012 11:42

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Liverpool, UK, June 27, 2012 – Inspiration Biopharmaceuticals today presented the results of a non-clinical study evaluating the precision and accuracy of an assay used to monitor the development of inhibitory antibodies to porcine factor VIII. The in vitro study, which involved fifteen of the international sites participating in Inspiration’s Phase 3 Accur8 clinical trial program, found that the degree of variability in results obtained from assays used to monitor for porcine factor VIII inhibitors is similar to that seen with assays for human factor VIII inhibitors. The results were presented in a poster presentation today at the 58th Annual Meeting of the Scientific and Standardization Committee (SSC) of the International Society on Thrombosis and Haemostasis (ISTH) in Liverpool, UK.

Inspiration is developing an investigational recombinant porcine factor VIII, OBI-1, for the treatment of bleeding in people with congenital hemophilia A with inhibitors, or acquired hemophilia.

“The ability to accurately monitor development of anti-porcine antibodies is a key component of our ongoing safety and efficacy studies with OBI-1,” said Howard Levy, MD, Chief Medical Officer at Inspiration and a co-author on the study. “We are pleased with these findings, which suggest that labs around the world who already monitor inhibitors to human factor VIII can successfully adapt their monitoring procedures to assess inhibitors to porcine factor VIII. These study results support the validation of our ability to accurately monitor factor VIII as an indicator of the response to OBI-1 as we continue to advance the OBI-1 clinical development program.”

Study Design and Results

Centers participating in the OBI-1 Phase 3 Accur8 Auto-antibody study tested a set of inhibitor samples of a human anti-C1 factor VIII antibody with strong cross-reactivity to porcine factor VIII. Local laboratories performed a regular Bethesda assay (the assay commonly used to monitor inhibitors to human factor VIII in people resistant to treatment with clotting factor concentrate), substituting a standard OBI-1 preparation pre-diluted in human factor VIII deficient plasma creating a “normal porcine plasma”.

Fifteen laboratories in five countries participated in the study. The inter-laboratory coefficient of variation (CV) ranged from 29.5% to 56.8% for the various samples, comparable to the CV seen with the Bethesda assay measuring inhibitors to human factor VIII.

i“OBI-1 is being developed as a potential treatment option for people with congenital hemophilia A, and acquired hemophilia who have developed inhibitors to human factor VIII, which can render some existing treatments ineffective at controlling their bleeds.

For these inhibitor patients, accurate monitoring of anti-porcine inhibitors is important to determine the overall safety and efficacy profile of this investigational product,” said Edward D. Gomperts, MD, Director of Clinical Research, Clinical Investigation Center, Children’s Hospital Los Angeles and Consultant to Inspiration Biopharmaceuticals. About Inhibitor Development in Hemophilia A and Acquired Hemophilia People with hemophilia A can develop inhibitors (also called antibodies) against the coagulation factor VIII concentrates that are commonly used to treat or prevent bleeding. This can make treatment of bleeds very difficult. People with acquired hemophilia develop antibodies, in their case, to the native factor VIII their bodies produce. The antibodies make them unable to effectively use their native factor VIII or respond to human factor VIII concentrate.

[verwijderd] 29 juni 2012 11:50

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www.nasdaq.com/article/do-you-have-th...

voda 3 juli 2012 16:30

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Farmaciereus krijgt boete van drie miljard wegens fraude

Het farmaceutisch bedrijf GlaxoSmithKline (GSK) heeft voor 3 miljard dollar een schikking getroffen in een van de grootste fraudezaken in de Amerikaanse farmaceutische sector. Dat is vandaag bekend geworden.

GSK zou onder meer de antidepressiva Paxil en Wellbutrin hebben aanbevolen aan patiënten voor wie de medicijnen oorspronkelijk niet waren bedoeld, onder meer kinderen en pubers.

Daarnaast zou de onderneming frauduleus hebben gehandeld rond het diabetesmedicijn Avandia.

www.ad.nl/ad/nl/5597/Economie/article...

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