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Crucell « Terug naar discussie overzicht

Draadje OT, bijzaken & geleuter in de marge! - Deel 2

1.200 Posts, Pagina: « 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 ... 56 57 58 59 60 » | Laatste

Omlaag ↓

[verwijderd] 19 december 2006 14:01

Wanneer gaan ze deze produkten eindelijk eens met STAR produceren?

Dat kan toch volgens hr. Kruimer.

12/19/2006

ZURICH (Dow Jones)--Drugmaker Roche Holding AG (RHHBY) said Monday an intermediate study showed that combining two of its targeted cancer drugs showed promise in the treatment of an aggressive form of breast cancer.

Combining Avastin, a drug that hinders the growth of tumors by starving them of blood supply, and Herceptin, which blocks a protein responsible for tumor growth, caused tumors to shrink in more than half of the 37 patients participating in the study.

"These positive results confirm that adding Avastin to Herceptin could provide extra benefit for patients with this particularly aggressive form of breast cancer," said Andreas Abt, business director for Roche oncology, in a statement.

The study was presented at the San Antonio Breast Cancer Symposium.

Scientists believe that targeted drugs are the way forward in cancer treatment and increasingly companies are starting to investigate the benefits of combining two such drugs compared to the combination with a traditional chemotherapy agent.

Targeted cancer drugs work by killing cancer cells specifically, or by hindering their proliferation, while traditional chemotherapy often kills healthy as well as unhealthy cells, leading to troublesome side effects.

Roche plans to study the combination further in a large trial, which is required before the combination could be submitted for regulatory approval. Analysts expect results from this larger study by 2008.

HER2-positive breast cancer affects around 20% to 30% of women with breast cancer. It demands special attention because the tumors are typically fast-growing and there is a high likelihood of relapse.

At 1505 GMT, Roche shares were up CHF3.50, or 1.6%, at CHF221.20, in a higher broader market. Shares of Genentech Inc. (DNA), which is selling both drugs in the U.S. were up $0.52, or 0.6%, at $81.31.

"This study is part of Roche's strategy to expand the overall market for Avastin," said Karl Heinz Koch, pharmaceutical analyst at private bank Vontobel in Zurich, who has a buy rating on the stock. "If these very promising results can be upheld in a phase III trial, this could add CHF3 billion to our estimates for Avastin."

Avastin, approved in the U.S. in 2004 and in Europe in 2005 for the treatment of colorectal cancer, has recently received U.S. marketing approval for the treatment of advanced lung cancer. The drug has also been shown to work as a breast and kidney cancer treatment.

Herceptin has been on the U.S. market since 1998, and was launched in Europe six years ago. Sales have risen sharply since last year, when a study showed that giving the drug early significantly extended the time patients lived without their disease worsening, while also reducing the number of women who died from the disease.

The drug is today considered the preferred treatment for women who suffer from this particular form of breast cancer.

However, a rival emerged recently in GlaxoSmithKline Plc's (GSK) Tykerb, which targets the same protein and has been shown to work in patients who don't respond to treatment with Herceptin.

Both Avastin and Herceptin were developed jointly with Genentech, the U.S. biotechnology company, which is majority-owned by Roche.

Genentech is selling both drugs in the U.S., while Roche is selling them in Europe. Chugai Pharmaceutical Co. (4519.TO), another Roche affiliate, is selling Herceptin in Japan. Japanese approval for Avastin is pending.

In 2005, Herceptin generated sales of CHF2.15 billion, while Avastin sales amounted to CHF1.67 billion.

Company Web Site: www.roche.com

[verwijderd] 20 december 2006 08:47

Published online: 19 December 2006; | doi:10.1038/news061218-3

Medics sentenced to death in Libya

Health workers accused of deliberate HIV infection found guilty.
A Libyan court today condemned to death six foreign health professionals accused of infecting over 400 children with HIV in 1998. The court refused to take into account a swathe of independent scientific evidence indicating that the outbreak had begun several years before the accused began working there and was caused by poor hygiene at the hospital.

The defence say they intend to appeal to the Supreme Court, which would be the last chance that the medics would have of being acquitted. Emmanuel Altit, the head of the international defence team, says the international community can help by insisting that scientific evidence be taken into account.

Behind-the-scenes discussions are also ongoing between the European Union, Bulgaria, the United States and Libya to find a diplomatic solution (under Islamic law, victims' relatives may withdraw death sentences in return for compensation) but so far this has proved elusive.

The verdict has prompted widespread international condemnation. "We are appalled by the decision of the Libyan court to sentence the five Bulgarian nurses and the Palestinian doctor to death," says a statement from The World Medical Association and the International Council of Nurses. They emphasize that the denial of health problems that can promote the accidental spread of HIV, such as the use of dirty needles, is an ongoing, dangerous situation in Libya. "How many children will go on dying in Libyan hospitals while the Government ignores the root of the problem?"

Denial of evidence

This is not the first time that the five Bulgarian nurses and Palestinian doctor have faced the firing squad. The group were previously condemned to death in May 2004 after an earlier trial in the same court. But the Supreme Court overturned the verdict on 25 December 2005 and ordered a retrial. The retrial began in May this year, and ended on 4 November.

In the retrial, the court denied requests by the defence to hear evidence from international experts. It did hear the opinions of five Libyan physicians, who testified that they stood by the conclusions of their 2003 report, which had been commissioned by the court's earlier trial. Their report claimed that HIV and hospital hygiene were not a problem in Libya (the prosecution describes the Al-Fateh Hospital as a "model" facility), and that the outbreak was so large that deliberate, malicious infection of HIV could not be excluded.

In October, Nature asked international AIDS experts to review this Libyan report. They concluded that it contained no scientific evidence, and was nothing but conjecture and supposition (see 'A shocking lack of evidence'). The following month, 114 Nobel Laureates wrote to Libya's leader Colonel Gaddafi urging the appropriate authorities to hear independent science-based evidence, and reaffirming the need for a fair trial.

In a paper published online in Nature last week1, an international team led by researchers from Oxford, Edinburgh and Rome showed that the strain of HIV with which the children had been infected was already present and spreading locally in the mid-1990s, long before the medics arrived in Libya in 1998 (see 'Molecular HIV evidence backs medics').

Study support

Over the past few days, Libyan state-controlled media has printed and broadcast statements in support of the medics' guilt, and called for opposition against all those who argued that the six were innocent.

"Skeptics say medical negligence was the cause, but evidence shows that the Bulgarian medics are involved in this crime," reads the website for Libya's main news provider, Jamahiriya Broadcasting corporation, citing the confessions of the medics. Amnesty International and many other groups have reported credible allegations that these confessions were extracted by torture.

Mohammed Daw, one of the authors of the 2003 Libyan expert report saying that deliberate infection could not be ruled out, also held press conferences over the weekend in Geneva and London defending the report's conclusions.

The timing of the appeal and any future re-trial remains uncertain.

"The only just outcome of this trial would be the immediate release of the nurses and physician," says Physicians for Human Rights deputy director Susannah Sirkin.
www.nature.com/news/2006/061218/full/...

'A shocking lack of evidence'
www.nature.com/news/2006/061023/full/...

Molecular HIV evidence backs accused medics
www.nature.com/news/2006/061204/full/...

Death sentences for foreign medical must be withdrawn
web.amnesty.org/library/Index/ENGMDE1...

De vijf verpleegkundigen en de arts zijn vandaag door een Libische rechter ter dood veroordeeld, nadat ze schuldig werden bevonden van het opzettelijk infecteren van honderden Libische kinderen met het HIV-virus in een ziekenhuis in Benghazi.
'Wij betreuren deze straffen en dringen er bij de Libische autoriteiten op aan dat deze straffen nooit uitgevoerd zullen worden. De doodstraf is de wreedste, meest inhumane en vernederende straf, en in dit geval is hij opgelegd na een oneerlijk proces,' aldus Malcolm Smart, hoofd van het Midden-Oosten en Noord-Afrikaprogramma van Amnesty International.
'Dit is de tweede keer dat deze zes mensen ter dood zijn veroordeeld door een Libische rechtbank. Zowel in dit als in het vorige proces zijn de bekentenissen die ze naar verluidt als gevolg van marteling hebben afgelegd, gebruikt als bewijs. Advocaten van de verdediging mochten geen internationale expertise inbrengen, en het bewijs dat door Libische medische deskundigen werd aangeleverd, werd weer betwist door internationale medische experts.'
'Alleen een eerlijk proces kan de waarheid naar boven brengen en recht doen aan de met HIV besmette kinderen en hun ouders.' De doodstraf moet nog worden bekeken door het opperste gerechtshof, en vervolgens goedgekeurd worden door een andere instante. Als dat gebeurd is, rest er alleen nog een eventuele verlening van gratie.
De zes veroordeelden zitten sinds 1999 vast. In mei 2004 werden ze voor de eerste keer ter dood veroordeeld. Op 25 december 2005 werden deze vonnissen echter nietigverklaard door het opperste gerechtshof omdat er "onregelmatigheden" hadden plaatsgevonden tijdens hun detentie en het verhoor dat er op volgde. In mei van dit jaar begon het nieuwe proces.
AIDS-experts concludeerden in het eerste proces al dat de HIV-epidemie waarschijnlijk te wijten valt aan de gebrekkige hygiëne in het ziekenhuis en het hergebruik van injectienaalden. Sinds de arts en de verpleegkundigen in hechtenis zitten zijn 52 van de 426 kinderen gestorven aan AIDS.
www.amnesty.nl/index?w=13484

[verwijderd] 20 december 2006 08:50

RTRS-Middel Organon tegen slapeloosheid in fase drie
ARNHEM (ANP) - Het middel Org 50081 van Organon tegen
slapeloosheid is in de derde fase van klinische ontwikkeling
gekomen. Dat liet het dochterbedrijf van Akzo Nobel woensdag
weten.

Het middel, een zogenaamde serotine-2-blokker, verhelpt
volgens Organon slapeloosheid zonder dat gebruikers afhankelijk
van het middel worden. Het middel werkt mogelijk ook tegen
opvliegers.

((ANP Redactie Economie, email economie(at)anp.nl, +31 20
504 5999))

Opstapelen 20 december 2006 11:41

Dit moet mij toch even van het hart.
Ons gele rakkertje lijkt er vandoor te zijn.

Citaat:
Kan me niet voorstellen dat de Sandoz Foundation daar aan mee werkt. Ook al zijn zij het ook geweest die World-Online naar de beurs brachten. We weten hoe het daar mee is afgelopen.

Maar ik ben verantwoordelijk voor mijn deel. Zag nog wel waarde in de lege huls via net.works. Maar blijkbaar zijn proxy's e.d. ook al niet meer van enige waarde. Weet wel dat dit bedrijf mijn laatste actie op de beurs gaat worden. Wil er het liefst niets meer mee te maken hebben.

Dus ik zal me weer melden als er belangrijk nieuws is. Als dat er al ooit van gaat komen , natuurlijk.

Einde citaat. Aldus Yellowww
Eens kijken hoelang hij dit volhoud.
Erik

voda 20 december 2006 16:53

Hartfalen te ontdekken met een blaaspijpje
Er is een nieuwe, eenvoudige manier om hartfalen aan te tonen: blazen op een afgesloten blaaspijpje. Hierdoor is hartfalen eerder te ontdekken.

Blaaspijpje verraadt hartfalen

Bloeddruk
Bij gezonde mensen daalt de bloeddruk door het blazen op het pijpje, terwijl de bloeddruk bij mensen met hartfalen niet of nauwelijks veranderd. Hartfalen uit zich in klachten als kortademigheid, vermoeidheid en vocht vasthouden.

Diagnose
In Nederland zijn 200.000 mensen die lijden aan hartfalen. Vaak worden de klachten ervan gezien als longproblemen en hoge bloeddruk. Door de verkeerde diagnose overlijdt ongeveer de helft van de patiënten binnen twee jaar.

Onderzoek
De Nijmeegse cardioloog Remmen heeft de nieuwe manier van testen ontdekt. Remmen promoveert morgen op zijn onderzoek naar hartfalen bij oudere mensen.

Bron: RTLZ

[verwijderd] 20 december 2006 19:12

Sanofi pasteur Influenza Vaccine Production Tops 170 Million Doses in 2006

- Record Production Capabilities Strengthen sanofi pasteur's Global
Leadership in the Fight Against Seasonal Influenza and Place the Company at
the Forefront of Pandemic Readiness -

LYON, France, and SWIFTWATER, Pa., Dec. 20 /PRNewswire-FirstCall/ --
Sanofi pasteur, the vaccines business of the sanofi-aventis Group (NYSE:
SNY; EURONEXT: SAN), announced that it completed production of more than
170 million doses of influenza vaccine in 2006. Sanofi pasteur confirmed
its leadership as one of the world's largest manufacturers of seasonal
influenza vaccine, supplying a very significant portion of the estimated
global production of about 350 million doses(1).
As the global influenza vaccine leader, sanofi pasteur has been
steadily increasing its manufacturing capacity. Since 2003, capacity has
increased by more than 40% in line with the company's commitment to serve a
central role in the fight against a disease that causes between three and
five million cases of severe illness and between 300,000 and 500,000
estimated deaths every year around the world according to the Word Health
Organization(1).
In addition, sanofi pasteur's leadership position in developing and
producing influenza vaccines places the company at the forefront of
readiness against the threat of pandemic influenza. The company is
committed to producing as many doses of sanofi pasteur's most advanced
vaccine in the shortest possible timeframe, should a pandemic be declared
by the world's health authorities.
"By producing a record number of doses of seasonal influenza vaccine in
2006, sanofi pasteur demonstrates once again its steadfast commitment to
fight a serious disease that affects the lives of millions of individuals
each year and heavily weighs upon public health systems everywhere," said
Jean-Francois Dehecq, Chairman and CEO of sanofi-aventis. "Sanofi pasteur's
strong industrial capabilities combined with a high-priority pandemic
influenza vaccine research program involving over 100 of our top scientists
is enabling us to provide a meaningful contribution to global pandemic
preparedness," added Mr. Dehecq.
Since 1995, sales volume of sanofi pasteur's influenza virus vaccines
has more than tripled. To keep pace with the world's growing immunization
needs, sanofi pasteur has made significant capital investments in influenza
vaccine production capabilities in the United States and France in order to
reach current levels of more than 170 million doses.
In 2005, sanofi pasteur initiated a USD 160 million investment in the
United States for a new influenza vaccine manufacturing facility, which is
anticipated to double its U.S. production capacity. New production
capacities are planned to come online for the 2008/9 influenza season. A
160 million Euro investment, the largest capital investment to date for
sanofi pasteur in France, has also been approved for a formulation and
filling facility in sanofi pasteur's Val de Reuil facility. The new
state-of-the-industry facility will boost sanofi pasteur filling
capabilities, thus significantly reducing time to market for the vaccine.
Seasonal Influenza Overview
Influenza is a highly infectious virus that spreads easily from person
to person, primarily when an infected individual coughs or sneezes.
According to the World Health Organization (WHO), 5-15% of the population
is affected with upper respiratory tract infections in annual influenza
epidemics. Hospitalization and deaths mainly occur in high-risk groups
(elderly, people with chronic conditions/illness). Although difficult to
assess, these annual epidemics are thought to result in between three and
five million cases of severe illness and between 300,000 and 500,000 deaths
every year around the world(1). Most deaths currently associated with
influenza in industrialized countries occur among the elderly over 65 years
of age.
Pandemic Influenza Overview
Influenza is a disease caused by a highly infectious virus that spreads
easily from person to person, primarily when an infected individual coughs
or sneezes. An influenza pandemic is a global epidemic of an especially
virulent virus, newly infectious for humans, and for which there is no
preexisting immunity. This is why these pandemic strains have such
potential to cause severe morbidity and mortality. According to the World
Health Organization (WHO), the next pandemic is likely to result in 1 to
2.3 million hospitalizations and 280,000 to 650,000 deaths in
industrialized nations alone. Its impact is expected to be even more
devastating in developing countries. In an attempt to minimize the impact
of a pandemic, many countries are developing national and transnational
plans against an eventual influenza pandemic situation.
For information about sanofi pasteur pandemic preparedness program,
please visit: www.sanofipasteur.com/pandemicprepare...
About sanofi-aventis
The sanofi-aventis Group is the world's third-largest pharmaceutical
company, ranking number one in Europe. Backed by a world-class R&D
organization, sanofi-aventis is developing leading positions in seven major
therapeutic areas: cardiovascular disease, thrombosis, oncology, metabolic
diseases, central nervous system, internal medicine, and vaccines. The
sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY). For more information, please visit:
www.sanofi-aventis.com
Sanofi pasteur, the vaccines business of the sanofi-aventis Group, sold
more than a billion doses of vaccine in 2005, making it possible to protect
more than 500 million people across the globe. The company offers the
broadest range of vaccines, providing protection against 20 bacterial and
viral diseases. For more information, please visit:
www.sanofipasteur.com
Reference:
(1) www.who.int/vaccine_research/diseases...

[verwijderd] 20 december 2006 22:06

today.reuters.com/news/articleinvesti...

gogogoo 20 december 2006 22:44

quote:
jan941 schreef:
today.reuters.com/news/articleinvesti...

PARIS, Dec 20 (Reuters) - Drug maker Sanofi-Aventis (SASY.PA: Quote, Profile , Research) would be interested in buying a biotechnology company if one available, Chief Executive Jean-Francois Dehecq told French business daily La Tribune.

"If a biotech firm became available, like Genentech (DNA.N: Quote, Profile , Research) with three or four products, we would be buyers. It's not the case," Dehecq said in an interview due for publication on Thursday.

"In clear, one must not rule out anything on the part of Sanofi-Aventis when it comes to buying biotechnology firms, even if it's a complex and often costly process," he said.

-=-=-=-

Market Cap: $84.78B

Da's nie nix.

[verwijderd] 21 december 2006 08:26

Slikker?

Are Your Painkillers Actually Killing You?
abcnews.go.com/Health/story?id=273917...

FDA Proposes Labeling Changes to Over-the-Counter Pain Relievers

The Food and Drug Administration (FDA) today proposed to amend the labeling regulations on over-the-counter (OTC) Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) drug products to include important safety information regarding the potential for stomach bleeding and liver damage and when to consult a doctor. OTC IAAA drug products, commonly known as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, naproxen and ketoprofen, are used to treat pain, fever, headaches, and muscle aches.
www.fda.gov/bbs/topics/NEWS/2006/NEW0...

gogogoo 21 december 2006 12:08

Site met wat rapporten over biotech/vaccines
www.bionest.fr/

Onderstaande rapport (bionest/Exane BNP Paribas: juni 2006) noemt Crucell een paar keer:

www.bionest.fr/publications/VaccinesU...

An oligopoly with room for new players
The vaccines market will remain oligopolistic around Merck, Sanofi-Aventis and GSK, although Novartis (with Chiron) and Wyeth are investing strongly to become part the oligopoly. Behind the majors, many smaller companies are progressing rapidly and
might become major innovation providers, like CSL, Acambis, Crucell or MedImmune.
Local players may also manage to keep, or even increase, their share of the pie (for example in India, Brazil or Japan).
---
– The biotech players are forging stronger links with big pharma and vaccine players,
who lack R&D innovation; some biotech companies will emerge as key players (e.g. CSL, Acambis, Crucell, MedImmune).
---
Vaccine-focused biotech companies: Acambis, Crucell-
Berna, Intercell
This group of companies prospers on the strength of their proprietary technology and
ability to bring forward attractive vaccine candidates in their R&D pipeline. They all
focus on infectious diseases and develop their own business model.

As often with biotechnology companies, the business model is very dependent on the
therapeutic area addressed and on the technology. However, vaccine biotechnology
companies have several common features:
– multiple alliances with big pharma/vaccine majors to enhance the vaccine portfolio:
1) Acambis with Baxter, Sanofi-Pasteur, Chiron; 2) Crucell-Berna with Sanofi-Pasteur,
GSK; 3) Intercell with Novartis, Merck, Kirin Brewery, SciGen, Sanofi-Pasteur;
– strong intellectual property rights allowing the licensing of technology and
generation of significant revenues (e.g. PER.C6 cell line of Crucell, a technology which
uses a human cell line for the production and large scale manufacturing of viral-based
vaccines, monoclonal antibodies, and recombinant proteins);
– a substantial number of vaccine candidates in clinical development: Acambis and Crucell both have five, Intercell has four. Vaccine-focused biotech companies have a number of specific characteristics.
First, the emergence of bio-terrorism risks has created a new market with governments financing the development of specific vaccines in order to stockpile huge quantities against bioterrorism attacks.
Several companies have been fortunate to be selected, including Acambis (smallpox) and Vaxgen (anthrax). The downside is the risk of bottlenecks in manufacturing and resource concentration that could be detrimental to the rest of the activity.
...

[verwijderd] 22 december 2006 07:25

OXFORD BIOMEDICA AND SIGMA-ALDRICH ISSUE JOINT LICENCE FOR LENTIVECTOR® TECHNOLOGY TO GLAXOSMITHKLINE

Oxford, UK – 21 December 2006: Oxford BioMedica (LSE: OXB), a leading gene therapy company, and Sigma-Aldrich, a leading $1.7 billion life science and high technology company, today announced that they have signed a joint licence agreement for the LentiVector technology with GlaxoSmithKline (GSK), which provides GSK with access to the technology for research activities. Sigma-Aldrich is Oxford BioMedica’s strategic partner and exclusive licensee in the commercialisation of the LentiVector technology for research use. Financial details were not disclosed.
Oxford BioMedica’s lentivirus-based gene delivery technology, known as LentiVector, is one of the most powerful technologies for the delivery of genes to a wide range of cell and tissue types. The LentiVector technology has applications both in therapeutic products and as a drug discovery tool for target validation and the creation of targeted disease models. Oxford BioMedica has a comprehensive portfolio of US and European patents and applications that cover the technology. The Company has an active licensing programme providing access to its LentiVector technology on a non-exclusive basis primarily. Licensees include Biogen Idec, Merck & Co and Pfizer.
www.oxfordbiomedica.co.uk/news/2006-o...

[verwijderd] 22 december 2006 07:51

22/12/2006, 2006, 07.15 AM CET

Exforge® receives US regulatory approval as a new and highly effective treatment option for patients with high blood pressure

Exforge offers in one tablet the complementary actions of valsartan and amlodipine besylate, two of the most prescribed branded antihypertensive medicines[1],[2],[3]
Approval based on clinical data showing improved efficacy and side effect profile compared to amlodipine alone[4],[5]
Clinical trials show Exforge helped up to 9 out of 10 patients get to goal*[4]
US Food and Drug Administration grants tentative approval pending expiration of market exclusivity and patent protection for amlodipine besylate in September 2007
Basel, December 22, 2006 - Novartis announced today the US regulatory approval of Exforge as a new treatment option for patients with high blood pressure. Exforge combines in one tablet the two most commonly prescribed hypertension medicines in their categories - Diovan® (valsartan) and Norvasc®# (amlodipine besylate).
The US Food and Drug Administration (FDA) issued this tentative approval because Exforge has met all the required standards for safety, efficacy and manufacturing quality.[6] Exforge is expected to be available to patients in the US in late September 2007, pending the expiration of market exclusivity and patent protection for amlodipine besylate.
In an extensive clinical program involving over 5,000 patients, Exforge helped up to nine out of 10 patients reach their treatment goal (diastolic blood pressure under 90 mmHg or more than a 10 mmHg reduction in diastolic blood pressure from baseline).[4]
"The combination of these two well-known and powerful antihypertensive medications in one tablet will now give patients additional blood pressure control with favorable tolerability," said Bertram Pitt, MD, FACC, Professor of Medicine Emeritus at the University of Michigan School of Medicine Division of Cardiology in Ann Arbor, Michigan, USA.
The need for new antihypertensive medicines is urgent, as seven out of 10 patients are not at their target blood pressure goal.[7],[8] High blood pressure is a leading risk factor for cardiovascular disease, which is the world's leading cause of death.[9]
Exforge is appropriate for patients whose blood pressure is not adequately controlled on any dihydropyridine calcium channel blocker (CCB) or angiotensin receptor blocker (ARB). Also, it is appropriate for patients who experience dose-limiting side effects on either component, such as amlodipine- induced edema, dizziness and flushing.[6]
Diovan blocks angiotensin II, a hormone that causes blood vessels to tighten and narrow[5], while amlodipine blocks the entrance of calcium into the blood vessel walls. Both allow blood vessels to relax so blood can flow more easily.[2],[3] Exforge also provides the convenience of a single once-daily tablet, which could reduce the overall number of pills a patient may need to take.[10]
"Most patients need two or more medicines to control their blood pressure and achieve guideline targets,"[6] said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "Exforge promises to be an attractive therapy option because it brings together two of the most powerful mechanisms of action in a single pill."
In November, Exforge was granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), the regulatory agency that reviews European Union submissions for new medicines. Novartis expects to receive approval from the European Commission and to make Exforge available in the EU during the first half of 2007.
www.novartis.com/

[verwijderd] 22 december 2006 08:16

Je was mij net voor Flosz:

i j l
Persbericht 22 december 2006
Galapagos neemt ProSkelia over van ProStrakan
en plaatst €31 miljoen bij institutionele beleggers
Uneke positie in medicinontwikkeing voor bot en gewrichtziekten
Webcast persconferentie gepland voor 10.30 uur CET op 22 december 2006
• Preklinische programma’s in botziekten verbreden Galapagos’ pijplijn
• Galapagos start klinisch fase II onderzoek met menopauze product
• Overnameprijs €12,5 miljoen in nieuwe Galapagos aandelen plus mogelijke toekomstige uitkeringen tot max. €14,5 miljoen
• Galapagos haalt €31 miljoen op in private plaatsing
• Dit kapitaal zal worden geïnvesteerd in de klinische ontwikkeling van de gecombineerde portefeuille van kandidaat-geneesmiddelen
Mechelen, België, 22 december, 2006; Galapagos NV (Euronext & Londen AiM: GLPG), een geïntegreerde drug discovery onderneming, kondigt vandaag aan dat zij een overeenkomst is aangegaan met de Engelse ProStrakan Groep plc (LSE: PSK) voor de overname door Galapagos van ProSkelia SASU, de Franse dochtermaatschappij van ProStrakan.
ProSkelia ontwikkelt geneesmiddelen voor botziekten. Het bedrijf werd in 2002 verzelfstandigd vanuit de divisie Botziekten van Aventis, en werd in 2004 overgenomen door de Strakan Groep, wat resulteerde in het huidige ProStrakan.
Galapagos verkrijgt met de acquisitie alle ProSkelia R&D-activiteiten, inclusief drie preklinische producten in botziekten (osteoporose en botmetastase) en een preklinisch product in cachexia (spierafbraak en gewichtsverlies). De gecombineerde portefeuille aan R&D-programma’s zal in sterke mate bijdragen aan Galapagos’ doelstelling om meerdere kandidaat-geneesmiddelen voor bot- en gewrichtsziekten in de kliniek te hebben in 2008.
De overname omvat ook een exclusieve optie en licentie op het product oestradiol glucoside (“E2G”), wat reeds met succes klinische fase IIa doorlopen heeft, voor behandeling van symptomen die kunnen optreden in de menopauze (‘opvliegers’). Hiermee start Galapagos haar eerste klinische ontwikkelingsprogramma. De lopende samenwerkingen van ProSkelia met farmaceutisch concern Novartis, en met Amgen en Genentech (de twee grootste biotech bedrijven wereldwijd), worden ook aan Galapagos overgedragen. Galapagos zal alle jaarlijkse inkomsten uit deze samenwerkingen ontvangen alsmede 25% van toekomstige succesbetalingen en royalty’s.
De overnameprijs
De overnameprijs voor ProSkelia is €12,5 miljoen in nieuwe Galapagos aandelen. Dit wordt voor een aanzienlijk deel gecompenseerd door een geschatte netto
belastingteruggave van €9 miljoen over de komende 4 jaar. ProStrakan komt in aanmerking voor mogelijke betalingen tot maximaal €14,5 miljoen, als onderdeel van toekomstige inkomsten die Galapagos zal ontvangen uit de verkregen preklinische programma’s. ProStrakan komt ook in aanmerking voor een betaling van €5 miljoen, een vast bedrag aan licentie-inkomsten die door Galapagos ontvangen worden en single-digit royalty’s op productverkopen. De betalingen aan ProStrakan voor het E2G programma zijn afhankelijk van het succesvol afronden van de klinische fase IIb en het uitlicenseren van het product. ProStrakan heeft tevens het eerste recht van weigering op het cachexia programma, mocht Galapagos besluiten dit uit te licenseren.
Financiering
In het kader van deze acquisitie heeft Galapagos €31 miljoen opgehaald via een private plaatsing van nieuwe aandelen bij institutionele beleggers in de VS en Europa. Het aangetrokken kapitaal zal worden geïnvesteerd in de klinische ontwikkeling van de gecombineerde portefeuille van kandidaat-geneesmiddelen in bot- en gewrichtsziekten.
“Met onze programma’s in reuma, de GSK-alliantie in artrose, en de uitstekende portefeuille van ProSkelia in botziekten, wordt Galapagos een leider op gebied van ontwikkeling van orale geneesmiddelen voor bot- en gewrichtsziekten,” zegt Onno van de Stolpe, CEO van Galapagos. “Met het inlicenseren van ProStrakan’s E2G product kunnen we een klinisch fase IIb traject starten en alle benodigde infrastructuur opbouwen om onze overige producten met succes in klinisch onderzoek te kunnen testen. Galapagos breidt met de overname ook het aantal samenwerkingsverbanden met farma en biotech bedrijven uit. De substantiële inbreng van kapitaal door de plaatsing van nieuwe aandelen bij institutionele beleggers in de VS en Europa levert Galapagos naar verwachting de benodigde financiering op om onze programma’s in bot- en gewrichtsziekten in de kliniek te brengen in 2008 en 2009. Het is goed om te zien dat de beleggers onze plannen voor klinisch onderzoek steunen.”
ProSkelia, gevestigd in Romainville bij Parijs, heeft moderne laboratoria voor geneesmiddelenontwikkeling, het bedrijf telt nu 64 werknemers. ProSkelia zal onderdeel gaan uitmaken van Galapagos’ drug discovery divisie, gevestigd in Mechelen. De vandaag aangeworven expertise met preklinische ontwikkeling en in vivo farmacologie zal alle drugdiscovery programma’s van Galapagos ten goede komen. De onderneming verwacht dan ook directe kostenbesparingen in de orde van €2,5 miljoen per jaar, met name omdat de noodzaak wegvalt tot het uitbesteden van geneesmiddelenontwikkeling bij derden, maar deels ook door te verwachten besparingen uit bedrijfssynergie.
De overname past ook zeer goed in de strategie van Galapagos om turn-key allianties aan te gaan met farma en biotech bedrijven, juist omdat de overname de portefeuille met kandidaat-geneesmiddelen versterkt. Galapagos is in juni 2006 zo’n turn-key alliantie gestart met GlaxoSmithKline in artrose, en het is van plan om nog twee van dergelijke samenwerkingsverbanden aan te gaan in de komende drie jaar.
Galapagos zal 4.860.331 nieuwe aandelen uitgeven als onderdeel van de private plaatsing en de acquisitie van ProSkelia, op basis van €8,95 per aandeel (de gemiddelde Galapagos slotkoers op Euronext Amsterdam over de afgelopen dertig dagen tot aan 22 december 2006). De nieuwe aandelen die aan ProStrakan worden uitgegeven, zullen onder normale omstandigheden onderworpen zijn aan een zgn. lock-up overeenkomst voor een periode van 12 maanden. Galapagos zal notering van de nieuw uitgegeven aandelen aanvragen
op Euronext Brussel en Euronext Amsterdam, afhankelijk van goedkeuring door de Centrale Belgische Financiële Autoriteit (BFIC-CBFA) van een prospectus zoals vereist onder de Belgische wetgeving, alsmede op de AiM in Londen. De nieuw geplaatste aandelen die zijn uitgegeven in het kader van de kapitaalsverhoging, zullen niet eerder verhandelbaar zijn via Euronext and AiM dan na goedkeuring van het prospectus door BFIC-CBFA. Naar verwachting zullen deze aandelen in april 2007 genoteerd worden.
Kempen & Co adviseerde Galapagos bij de acquisitie van ProSkelia, en Kempen & Co, Fortis en Whitaker Securities hebben gezamenlijk als Joint Lead Managers opgetreden bij de private plaatsing.
Webcast persconferentie details
Galapagos zal een persconferentie en webcast houden die begint om 10.30 AM CET. Voor deelname aan de teleconferentie, kunt u +32 2290 1608 bellen, minimaal tien minuten voor aanvang. Na de presentatie zal een vraag- en antwoordsessie volgen. De audio webcast is live te volgen via Galapagos’ website www.glpg.com en zal na de uitzending een maand beschikbaar blijven op de website.
Over Galapagos
Galapagos is een beursgenoteerde onderneming die zich richt op innovatief gentechnologisch geneesmiddelenonderzoek (Euronext Brussel, GLPG; Euronext Amsterdam, GLPGA; Londen AiM: GLPG) dat programm

[verwijderd] 22 december 2006 13:29

Galapagos verwacht komende tijd geen acquisities22 dec 2006, 13:25 uur
Amsterdam (BETTEN BEURSMEDIA NEWS) - Galapagos zal de komende maanden geen acquisities plegen. Dat gaf bestuursvoorzitter Onno van de Stolpe vrijdag aan in een gesprek met Betten. 'We moeten eerst de vandaag aangekondigde overname maar eens rustig doorvoeren.'

Van de Stolpe deed zijn uitspraken na afkomst van de persbijeenkomst vanwege de acquisitie van ProSkelia, dat geneesmiddelen ontwikkelt voor botziekten. Biotechbedrijf Galapagos neemt deze Franse overneming over voor EUR 12,5 miljoen in nieuwe Galapagos-aandelen, plus mogelijke toekomstige uitkeringen tot maximaal EUR 14,5 miljoen.

Galapagos maakte vanmorgen ook bekend dat het middels een private plaatsing van aandelen in totaal EUR 31 miljoen heeft opgehaald. 'Dit kapitaal zal worden geinvesteerd in de klinische ontwikkeling van de gecombineerde portefeuille van kandidaat-geneesmiddelen', zo meldt het bedrijf in het persbericht.

Financieel bestuurder David Smith zei vanmorgen al in de komende drie jaar circa EUR 15 tot 20 miljoen aan kosten te verwachten om de pijplijn van de onderneming aan te vullen.

Galapagos gaf tijdens de persbijeenkomst overigens ook aan dat ProSkelia in de afgelopen vier maanden een omzet zag van EUR 800.000. Financieel bestuurder David Smith schat de volledige omzet van het bedrijf in 2006 op EUR 2,4 miljoen.

Het afgelopen jaar nam Galapagos onder meer het Engelse Inpharmatica over voor EUR 12,5 miljoen in aandelen. Ook verkreeg het alle drug discovery activiteiten van het Amerikaanse Discovery Partners International (DPI), voor EUR 4,25 miljoen in contanten. De onderneming ging ook verregaande samenwerkingsverbanden aan met LEO Pharma en OneWorld Health.

(c) BETTEN BEURSMEDIA NEWS (tel: +31 20 710 1756; fax: +31 20 710 1875)

[verwijderd] 27 december 2006 08:55

Europe Releases $750 Million for Research in Coming Year

By Peter O'Donnell

BioWorld International Correspondent
BRUSSELS, Belgium - The European Union's Christmas present to the biotechnology industry was a Dec. 22 announcement of €628 million ($750 million) funding for health research in 2007. Individual grants of up to €12 million are being made available for projects across a broad range of biotechnology and human health.

The long list of eligible fields is headed by large-scale collaborations, such as unifying genetic variation databases or networking biobanking initiatives across Europe, and developing standards and norms for human sample biobanks. Other large-scale areas of inquiry include temporal and spatial proteomics studies in biological processes, ground-breaking techniques for DNA sequencing and genotyping and in-vivo image-guidance for cell therapy.

There also are possibilities in integrating biological data and processes for large-scale data gathering, such as structure-function analysis of membrane transporters and channels for the identification of potential drug target sites; molecular epidemiological studies in well-characterized population cohorts; studies of genetic variation in humans aimed at characterizing a reference population in Europe; and characterization and variability of microbial communities in the human body. Also eligible for funding are genome-wide association studies in mammalian non-rodent models for the identification of genes relevant to human health and disease, modelling of T-cell activation and fundamental approaches to stem cell differentiation.

Provision also is made for smaller-scale research focused on alternative testing strategies for assessing the toxicological profile of nanoparticles used in medical diagnostics, or the development and production of new generation antibodies.

Translational research in major diseases will be supported with projects such as deriving novel diagnosis and therapy strategies from knowledge of non-coding RNAs linked to the aetiology of cancer, translating technology in genomics, proteomics, metabolomics into innovative cancer biomarkers, or studying genomic instability and genomic alterations in pre-cancerous lesions or the genetic factors of osteoporosis.

Research project proposals will be evaluated in mid-2007, and negotiations will be conducted on shortlisted proposals in July or August.

Published December 27, 2006

[verwijderd] 28 december 2006 12:18

DJ US FDA Clears Several Generic Versions Of Merck's Zocor

12/28/2006
Dow Jones News Services
(Copyright © 2006 Dow Jones & Company, Inc.)

ZURICH (Dow Jones)--The U.S. drug regulator is allowing generic competition to Merck & Co.'s (MRK) cholesterol drug Zocor by approving several companies' cheaper versions of the drug.

The U.S. Food and Drug Administration, or FDA, has posted on its Web site clearances for simvastatin, as the generic version is known. The clearances have been given to drug makers Cobalt Pharma, Aurobindo Pharma (524804.BY), Zydus Pharma, Novartis AG's (NVS) generic unit Sandoz and Dr. Reddy's Laboratories (500124.BY).

The approvals clear the way for generic drug makers to undercut Merck's best-selling Zocor with cheaper versions.

Two other drug companies, Teva Pharmaceutical Industries Ltd. (TEVA) of Israel and India's Ranbaxy Laboratories Ltd. (500359.BY), already market a generic version of Zocor in the U.S., after a key U.S. patent expired in June.

Regulator Web site: www.fda.gov

-By Katharina Bart, Dow Jones Newswires; +41 43 443 8043; katharina.bart@dowjones.com

[verwijderd] 28 december 2006 18:43

P06-215
December 28, 2006
FDA Issues Draft Documents on the Safety of Animal Clones
Agency Continues to Ask Producers and Breeders Not to Introduce Food from Clones into Food Supply
The U.S. Food and Drug Administration (FDA) today issued three documents on the safety of animal cloning -- a draft risk assessment; a proposed risk management plan; and a draft guidance for industry.
Draft risk assessment
The draft risk assessment finds that meat and milk from clones of adult cattle, pigs and goats, and their offspring, are as safe to eat as food from conventionally bred animals. The assessment was peer-reviewed by a group of independent scientific experts in cloning and animal health. They agreed with the methods FDA used to evaluate the data and the conclusions set out in the document.
The draft risk assessment presents an overview of assisted reproductive methods widely used in animal agriculture, the extensive scientific information available on animal health and food consumption risks, and draws science-based conclusions. These conclusions agree with those of the National Academies of Sciences, released in a 2002 report. Due to limited data on sheep clones, in the draft guidance FDA recommends that sheep clones not be used for human food.
"Based on FDA's analysis of hundreds of peer-reviewed publications and other studies on the health and food composition of clones and their offspring, the draft risk assessment has determined that meat and milk from clones and their offspring are as safe as food we eat every day," said Stephen F. Sundlof, D.V.M., Ph.D., director of FDA's Center for Veterinary Medicine. "Cloning poses no unique risks to animal health when compared to other assisted reproductive technologies currently in use in U.S. agriculture."
An animal clone is a genetic copy of a donor animal, similar to identical twins but born at different times. Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA; cloning does not change the gene sequence.

www.fda.gov/cvm/CloneRiskAssessment.htm

[verwijderd] 28 december 2006 18:51

Stocks Will Keep Rollin' in '07

4 bladzijden vandaar alleen de link

www.thestreet.com/_dm/markets/marketf...

[verwijderd] 28 december 2006 19:50

MedImmune In-Licenses Novel Inflammatory Disease Target

GAITHERSBURG, Md., Dec. 28 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI) announced today that it intends to develop a monoclonal antibody (MAb) targeting pathways within the CD28 receptor family for treatment of certain inflammatory diseases under a recently signed license agreement with Japan Tobacco, Inc. (JT). MedImmune's initial efforts will focus on developing the current lead antibody, which aims to inhibit a receptor believed to play a key role in controlling adaptive immune responses, called inducible-costimulator (ICOS), and thereby regulate T-cell dependent activation of B cells. Inappropriate activation of T cells resulting in B-cell activation is implicated in a variety of autoimmune disorders.

"The addition of this novel target to MedImmune's inflammatory disease pipeline underscores our commitment to developing innovative therapies for the treatment of unmet medical needs, such as systemic lupus erythematosus (SLE or lupus), Sjogrens syndrome and rheumatoid arthritis," said Anthony J. Coyle, Ph.D., MedImmune senior director, research, and head, inflammation biology. "As we work to develop the anti-ICOS MAb as a potential treatment for such immune system disorders, we also hope to continue to collect scientific knowledge related to the role of signaling pathways in regulating immune response outcomes."

Under the terms of the agreement, JT will receive an undisclosed upfront payment, milestone payments and royalties on any future marketed products. JT retains exclusive development and marketing rights for the current lead antibody in Japan. MedImmune has exclusive development and marketing rights to this antibody for the rest of world and certain rights worldwide for other antibodies developed as a result of the agreement.

About Anti-ICOS MAbs

Preclinical study results indicate that ICOS is only expressed on a subset of T cells and is essential for T-cell dependent B-cell activation. In addition, ICOS is required for IL-17 secretion from activated T cells. IL-17 is a T-cell derived cytokine that is implicated in the development of various inflammatory diseases, including rheumatoid arthritis. In preclinical studies, ICOS-inhibition with MAbs was shown to be effective in models of rheumatoid arthritis, asthma, multiple sclerosis and lupus.
phx.corporate-ir.net/phoenix.zhtml?c=...

[verwijderd] 28 december 2006 20:00

Het moet mijn inziens toch niet gekker worden.
Alhoewel, wel terug te vinden in het donker.

Chinese scientists develop first green fluorescent transgenic pigs

Chinese scientists have successfully bred partially green fluorescent pigs which they hope will boost stem cell research, a leading scientist said.

By injecting fluorescent green protein into embryonic pigs, a research team at the Northeast Agricultural University managed to breed three transgenic pigs, said professor Liu Zhonghua of the university's College of Life Sciences.

"The mouth, trotters and tongue of the pigs are green under ultraviolet light," said Liu.

Genetic material from jellyfish was injected into the womb of a sow which gave birth to the three pigs 114 days later in Harbin, he said.

Researchers will be able to monitor changes in the tissues of the transgenic pigs, commonly used to study human diseases, during their physical development, said Liu.

The Chinese scientists bred this kind of pigs successfully with somatic cell nuclear transfer technology following their counterparts in the United States, South Korea and Japan.

Source: Xinhua

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