Click
Chat
 
Du kan vedhæfte PDF, JPG, PNG, DOC(X), XLS(X) og TXT-filer. Klik på ikonet, vælg fil og vent til upload er færdig før du indsender eller uploader endnu en fil.
60
Vedhæft Send
Historik

Vælg chat via ovenstående menu
Luk reklame

      

Er der mere i Genmab


7343 tumult 8/4 2009 13:08
Oversigt

Her op til Påske?
Jeg tror det ikke, så derfor har jeg solgt 1/3 del og tager nu på påskeferie.
Så nu skal det da nok gå sådan, at den stiger helt vildt.

God Påske.



8/4 2009 13:20 JørgenVarnæs 07345



Det er under MEGET beskeden volumen, at den stiger. Det tyder ikke på, at der er epokegørende nyheder på vej.

Men jeg håber da stadig på at min 400% opkøbspremium snart tikker ind på kontoen, så vi kan komme igang med nogle af alle de fantastiske slagtilbud, der er i markedet!



8/4 2009 13:30 Solsen 07347



Jeg tror på et tradingrange på 210-240 i de næste måneder - men også at 180 evt. skal testes, hvis markederne falder fuldstændigt sammen.

Så lidt svingtrading kan være interessant

Vi har ikke set massive udsalg de sneste uger så "en kan håbe på" at der er så mange der skal akummulere de næste måneder, at tilbagefald undgås.

God påske til alle !



8/4 2009 13:36 JørgenVarnæs 07348



I et sjældent anfald af optimisme, så tror jeg faktisk at vi vil se en støt stigende tendens over de næste månder. Der kommer en periode med stilhed og stabilitet for GEN indtil FDA/Arzerra - det tror jeg vil være tilstrækkeligt til at berolige og tiltrække investorerne



8/4 2009 14:12 Stinker 07354



Volumen er virkelig ikke imponerende. Mens vi spændt venter på den dag, hvor Genmab atter er en aktie, som købes, er det dog rart, at kunne glæde sig over, at Genmab allerede er en aktie, som ikke sælges.



8/4 2009 13:49 alpehue 07350



Vi er (tror jeg) i toppen af et bear market rally, som vi ikke har set mange af - længe.

Nu vender bøtten, (sidste 2 dage) og I vil se søgning mod defensive aktier.

Genmab er ikke bare defensiv, den er skul passiv, men den bliver stille mere og mere offensiv.

At være ude - helt eller delvist, turde jeg ikke !

Tag nu denne lille kurve, se så på hvor vi er lige nu !
http://social.stocktock.com/profiles/blogs/1937-vs-20..



8/4 2009 14:02 Solsen 07351



Ja ligheden er slående.

Jeg kan ikke se hvorfor masserne skulle købe Genmab de næste par måneder.

De vil ikke tage risiko for markedets udsving og venter derfor til tæt på afgørelsen med at tage posistion.....gætter jeg.

Men den lave volumen kan jo måske gøre interesserede købere nervøse for, om der kan købes tilstrækkelige mængder genmab indtil juli.

Jeg er overrasket over, at vi holder den nuværende kurs - så måske har jeg heller ikke ret i mine antagelser denne gang.



8/4 2009 16:36 akademikeren 07388



Investtech siger: Genmab har brudt den faldende trend, hvilket i første omgang indikerer svagere faldende takt. Er steget kraftigt efter købssignal fra en omvendt-hovede-og-skuldre-formation ved bruddet op gennem modstanden ved 215. Objektivet ved 221 er nu opnået, men formationen signalerer fortsat udvikling i samme retning. Aktien nærmer sig modstanden ved ca. 228 kroner, noget der kan give en reaktion ned. Aktien anses samlet set teknisk neutral på kort sigt.



8/4 2009 16:50 Solsen 07391



Det er første gang i lang tid at investtech er positiv på Genmab

Så må vi holde op med at shorte.....

Luk i 225 - de er smarte nok dem der køber.



8/4 2009 20:59 akademikeren 07411



Vi fik så lukket over 228, så nu er det påske.....og i næste uge GF.



9/4 2009 02:40 akademikeren 07447



New Report Defines Challenges for New Entrants in Key Rheumatology Markets

MedPredict's Rheumatology Thought Leader Panel Creates a 'Fantasy Formulary' For 2015

SCOTTSDALE, Ariz., April 7 /PRNewswire/ -- MedPredict Market Research, a global provider of pharmaceutical competitive intelligence and market research, has published a new report providing critical strategic insight for companies with a stake in the market for rheumatology therapies, including rheumatoid arthritis, lupus, gout and psoriatic arthritis.

To develop this analysis, entitled "Thought Leader Insight & Analysis: Rheumatology," MedPredict conducted a thought exercise with four North American and four European rheumatologists. The purpose was to identify their "must have" branded and generic drugs for their real-world practices in the year 2015. This report outlines each panelist's "Fantasy Formulary," and the strengths, weaknesses and product news for each pharmacotherapy that is mentioned.

"It is essential that drug developers consider the entire rheumatology practice when establishing their strategies going forward," according to Dr. Jeffrey Berk, MedPredict's president and one of the report's authors. "One key insight from our research is that drugs which will be beneficial across multiple indications are going to have an easier time getting on formulary."

The report will answer the following questions:

What are these thought leaders' top ten choices for their rheumatology practice in 2015?
How do their choices differ by geography, and why?
How will the availability of biosimilars for substitution of first generation biologics impact the environment for new entrants?
What is the preferred anti-TNF drug, and why?
Where will new mechanistic approaches, such as Jak and Syk inhibitors, IL-17, anti-B-cell, and others fit in the rheumatologist's armamentarium?
Companies/Partnerships mentioned in this report include: Abbott, Alder, Amgen, Amgen/Wyeth, Biogen Idec, Bristol-Myers Squibb, Can-Fite, Centocor, Centocor/Schering-Plough, Chelsea, GlaxoSmithKline/Genmab, Human Genome Sciences, Incyte, J&J/Alza, Lilly, Medarex, Merck, Merck Serono/ZymoGenetics, Mitsubishi Tanabe, Neovacs, Nitec/SkyePharma, Novartis, Pozen/AstraZeneca, Rigel, Roche, Roche/Chugai, Roche/Genentech/Biogen Idec, Sanofi-Aventis, Savient, Takeda, UCB, Vertex, and Wyeth/Trubion.



9/4 2009 02:45 akademikeren 07448



Jeg lægger vægt på denne formulering : "One key insight from our research is that drugs which will be beneficial across multiple indications are going to have an easier time getting on formulary."

Det er jo vores lille baby der kan det der....



14/4 2009 15:46 Solsen 07862



Sunday, April 12 2009

FDA’s Next Accelerated Approval Process: “Targeted Cancer Drugs”
By Cole Werble

Two former FDA Commissioners are working on development of new regulatory pathway for approval of oncologics rooted in the principles of accelerated approval.


Former FDA Commissioners David Kessler and Mark McClellan are urging the agency to develop a new process for accelerated cancer drug approval to take advantage of biomarker identification of specific patient populations and drug activity.

Kessler has been talking publicly about a new approval process for cancer drugs for over a year (The RPM Report, March 2008). He raised the issue as the centerpiece of an address to the Pharmaceutical Research and Manufacturers of America annual meeting in San Antonio on April 4.

“We need to identify the most significant opportunities and develop pathways to improve the rapid availability of more effective, targeted cancer therapies – and outline specific steps in the development and regulatory process for acceleration of targeted cancer development while continuing to assure safety and effectiveness,” Kessler declared.

In his view, one of the highlights of his six-plus years at the top of FDA was the agency’s aggressive participation in helping to define an accelerated approval pathway for HIV therapeutics.

He still likes to recount the joint work by the National Institute of Allergy and Infectious Diseases and FDA reviewers to speed the assessment of raw clinical trial data generated by companies developing the first protease inhibitors and to use that information to develop a foreshortened route to approval.

Using the data from companies and analyzed by FDA and NIH scientists, FDA “set out a roadmap and industry followed it to a T,” Kessler said.

FDA should again step in proactively into the development process for cancer drugs, Kessler believes. “We need to create such roadmaps, a next generation of accelerated approval. We’ll see what it ends up looking like but one that possibly could be called something like ‘targeted approvals.’”

Noting that McClellan, FDA commissioner from late 2002 to early 2004 and now the head of the Engelberg Institute at Brookings, has “been doing a lot of thinking on this.” Kessler said that the new process “should be based on pre-specified markers, both positive and negative.”

A targeted cancer approval process would include five basic elements, Kessler said.

1) It would be designated for a specific cancer or stage of disease that does not have an existing standard therapy.

2) Biomarkers would have to be identified to judge patient response in disease models.

3) Studies would be conducted on biomarker positive or biomarker-enriched positive populations to show clinical benefit.

4) Steps would be in place to provide reimbursement for patients who are biomarker positive.

5) FDA approval would be conditioned on post-marketing studies to test broader populations and to confirm clinical benefit.

“Obviously,” he said, “there needs to be a lot of work on the details.” For example, concepts such as “clinical benefit” would need more precise definitions.

Kessler sees a clear opening for a change in approval criteria: either from the new leadership at FDA under Commissioner-designate Margaret (“Peggy”) Hamburg or Deputy Commissioner Josh Sharfstein or from congressional activity to revamp the effort against cancer.

Kessler suggests that he will have access to the new FDA topside team and that they will be receptive to taking an active role on cancer approvals. Not many FDA commissioners seek out the advice of their predecessors. Kessler, however, believes his previous experience with Hamburg and Sharfstein may make this team different.

Kessler also has ties to a former Obama health transition team member, Greg Simon, the head of Faster Cures, who is actively lobbying to get Kessler a position in the health establishment, perhaps at NIH. If Simon is successful in helping Kessler find a place in the administration, that could increase his access to the FDA management team.

Kessler left the position of dean of the University of California San Francisco medical school in late 2007. He is still affiliated with the medical school.

“I know and have worked with each one over the last decade,” Kessler observed. “Josh was my intern; Peggy and I worked together when she was commissioner of health in New York City and there were not drugs for tuberculosis readily available.”

Sharfstein worked at FDA in the Office of the Commissioner while in medical school. He worked on the addiction analysis that was central to Kessler’s argument for FDA to have more control over tobacco. Kessler describes Sharfstein’s contributions as brilliant.

If personal connections and his previous FDA experience do not get attention at FDA, Kessler can ride increased pressure on FDA from Congress to the same purpose.

Congress Pushing For Cancer Changes Also

A Senate bill, S. 717, introduced on March 26 by the Sens. Ted Kennedy, D-Mass., and Kay Bailey Hutchinson, R-Texas, calls for changes in FDA’s efforts to help develop cancer biomarkers and use them in the approval process. The bill’s discussion of biomarker development suggests that an accelerated approval as described by Kessler would fit right in with the intended objectives of the proposed legislation. (“The Pink Sheet”, April 6).

The bill, for example, calls for a combined FDA, Centers for Medicare and Medicaid Services and National Cancer Institute effort to “develop guidelines for the conduct of clinical studies designed to generate clinical data relating to cancer care and treatment biomarkers that is adequate for review by each Federal agency.”

The bill would also state the “Sense of the Senate” that FDA would place high priority on the use of biomarkers to establish effective strategies for selecting patients for treatment with specific drugs.

The legislation is expected to go to markup in the Senate HELP committee, chaired by Kennedy, in late April. In the House, Lois Capps, D-Calif., is taking the lead on corresponding legislation. Capps is vice chair of the Energy and Commerce Committee’s Health Subcommittee.

Kessler is keeping up with activity on the Capitol Hill and told PhRMA that he had been visiting Congress prior to his speech to the association. He further noted that President Obama’s aggressive statements on cancer research further help the climate for adoption of new approval processes.

One of the major hurdles weighing against an innovative effort to overhaul part of the cancer approval process will be simply the number of competing priorities facing Hamburg and Sharfstein. Food safety will clearly take up management time. Kessler, who started his tenure at FDA taking on food labeling claims, noted that food safety “has emerged on the Hill and in the public mind along with health reform as one of the defining issues” in the health arena.

“Peggy and Josh understand that their legacy will be determined in many ways by how well they handle food safety,” Kessler observed. He noted that the intense attention to food safety brings with it the debate over whether to split the agency into two separate regulatory entities – which will further hinder the management team’s ability to deal with issues like the cancer drug approval process.

Kessler tried to put food safety and cancer therapies into a broader perspective. “If we want to have an impact on public health, moves on food safety are important – but there are, what, 5,000 deaths a year from food-borne pathogens.”

That is “certainly too many” deaths from food safety problems, “but,” Kessler noted, the effect of cancer is more widespread and threatening: “one in two men and one in three women will develop one form of cancer in their lifetimes.”

The public health backgrounds of Hamburg and Sharfstein should lead them to keep an “eye on where is the path of greatest impact in people’s lives.” Kessler also noted that FDA will be under close scrutiny from Congress to deal with medical device approvals (and the aging 510(k) device approval process and the more fundamental issue of whether drug and device sponsors are providing accurate and honest data to the agency.

Kessler believes that naming a pair of FDA top managers simultaneously is a good move. “The administration deserves a lot of credit” for coming up with the solution, Kessler said.

The two-person team offers the agency the “priceless gift [of] the possibility of stability of leadership for the next four years if not the next eight years.” Kessler’s own tenure of six-plus years is the longest that the agency has had since the 1950’s. When he left, the agency had an interim commissioner for almost two years. The new team has “the potential for succession built in.” Kessler said Hamburg and Sharfstein are a team “that potentially can be in place for a significant period of time,” Kessler declared.

http://therpmreport.com/Free/firsttake.aspx



14/4 2009 15:53 akademikeren 07866



Det lyder faneme godt Lad os da få Azerra på markedet med det samme



14/4 2009 16:04 Stinker 07867



Vi har vel passeret det stadium, hvor Arzerra kunne nyde godt af nye regler for accelerated approval (i hvert fald i CLL). Desuden er det jo ikke givet at vedtagelsen af de nye regler selv nyder nogen form for acceleration...



14/4 2009 16:57 Solsen 07878



Sikkert - men det kan vel få dem til at tage fingeren ud lidt tidligere

Vi har jo Zalutumumab lige om hjørnet !

Monoclonal antibodies primed to become potent immune weapons against cancer
March 20th, 2009 New research suggests that monoclonal antibody therapy of cancer can be improved to be much more powerful than it is today, says a researcher at Georgetown University Medical Center's Lombardi Comprehensive Cancer Center in the March 21 issue of the Lancet.

Ads by Google
Antibody Humanization - www.BioAtla.com
Guaranteed Affinity San Diego and Beijing

NeuroMab - www.neuromab.org
High quality, low cost monoclonal antibodies-neuroscience research



"We believe that antibody therapy has the capacity to immunize people against cancer," says Louis Weiner, MD, director of the cancer center at GUMC and an internationally recognized expert in development and use of monoclonal antibodies. "Treatment modifications might be able to prolong, amplify, and shape a continuous immune response to cancer cells."

Weiner was asked by Lancet editors to write a review article discussing the newest research in this field. His co-authors are Madhav Dhodapkar, MD, of Yale University and Soldano Ferrone, MD, of the University of Pittsburgh.

Their analysis, based on reviewing the last eight years of research on monoclonal antibody treatment, suggests that a new era in use of these therapies is just around the corner. "Scientists have been able to use new tools to measure effectiveness of these therapies, and have found that antibodies are capable of stimulating the immune system in ways that had not been appreciated to date, and which we can now take advantage of," Weiner says.

Antibodies are immune system proteins that seek out and neutralize molecules they recognize as foreign to a body, such as viruses and bacteria. Monoclonal antibodies are proteins crafted in a laboratory to recognize specific receptors, or antigens, on cancer cells; some antigens promote uncontrolled growth. These antibodies are designed to both attach to cancer receptors to inhibit their function and to alert and activate the immune system to the presence of these receptor proteins.

Monoclonal antibodies already offer effective treatment for a wide range of cancers, including breast cancer (Herceptin®, Avastin®), colorectal cancer (Erbitux®, Avastin), lung cancer (Avastin), and blood cancers (Rituxan®, Campath®), but they have appeared to primarily work by forcing tumor related receptors to shut down pro-growth signals, Weiner says.


Ads by Google
New Cancer Treatments - Ultimate-Cancer-Breakthroughs.com
Discover The 12 Most Effective Cancer Treatments In Existence!

Antibody Humanization - www.BioAtla.com
Guaranteed Affinity; Fast Global Services; Highest Quality



"For years it has been presumed that the ability of antibodies to interfere with malignant cell-related signaling is the dominant mechanism of anticancer activity, but we have also known that the normal job of an antibody is to deliver an antigen to the body's immune system which then destroys the target," Weiner says.

Recent research by Weiner and others, however, now shows that antibodies can inhibit function not only as signaling manipulators but also as initiators of immune responses that leads to control of cancer, the authors say.

"We believe that Herceptin and Rituxan, as examples, work in part by immunizing people against cancer, but at this point, the magnitude of that response is variable and is frequently very small," Weiner says.

Scientists now believe that it will be possible to alter the antibodies so that they induce both kinds of human immunity - the innate immune response that is short-lasting and which directly kills tumor cells, and a long-lasting "memory" response that comes from the adaptive immune response. "We have long thought that monoclonal antibodies are capable of stimulating the innate immune system, but we now have evidence that the therapy can prime an adaptive response as well. Such responses would make the treatment much more powerful, capable of keeping cancer under control," he says.

"For the first time we are using technology that can measure the immune response that is occurring in monoclonal antibody treatment, and which will help us build better antibodies that amplify and shape that immune response to become more powerful," Weiner says.

And in the future, it may be possible to build antibodies that are targeted to existing targets on a patient's tumor, as well as to targets that may appear as the cancer mutates. "This one-two punch would anticipate how the tumor changes over time and cut off the cancer's escape route," Weiner says. "These new directions are very exciting."

Source: Georgetown University Medical Center


http://www.physorg.com/news156772110.html




TRÅDOVERSIGT