NicOx : Garufi ... e la Rivoluzione Pharma (4 lettori)
- Creatore Discussione Yesod
- Data di Inizio
- Stato
DickSIM
Prima o poi....ci becco!
rimettetevi presto in forma... che sta per salire la febbre ntrica
sarà peggio di una febbre da cavallo............ 
ugotega
Forumer storico
acqua+
ONDA NITRICA
magolibero
..se la sà gira..
io non l'ho richiesta..
DickSIM
Prima o poi....ci becco!
Exelixis, Boehringer enter $354M autoimmune pact
May 8, 2009 — 9:42am ET
South San Francisco-based Exelixis has signed a potential $354 million collaboration agreement with Germany's Boehringer Ingelheim to discover, develop and commercialize autoimmune disease therapies. Exelixis will receive a $15 million upfront payment and up to $339 million in milestone payments.
The deal covers the discovery of sphingosine-1-phosphate type 1 receptor (S1P1) agonists. The S1P1 receptor is a central mediator of multiple pathways implicated in a variety of autoimmune diseases. The two companies will share responsibility and costs for discovery activities; after that, Boehringer Ingelheim will handle all pre-clinical, clinical, regulatory, commercial and manufacturing activities.
"This collaboration highlights Exelixis' ability to leverage our discovery capabilities and early-stage pipeline," said Exelixis CEO George Scangos. "Our S1P1 agonist program has identified multiple analogs with potent in vivo activity. With this collaboration, we have the opportunity to transition the program to a partner with a track record of success in developing and commercializing autoimmune disease therapies while strengthening our financial position."
May 8, 2009 — 9:42am ET
South San Francisco-based Exelixis has signed a potential $354 million collaboration agreement with Germany's Boehringer Ingelheim to discover, develop and commercialize autoimmune disease therapies. Exelixis will receive a $15 million upfront payment and up to $339 million in milestone payments.
The deal covers the discovery of sphingosine-1-phosphate type 1 receptor (S1P1) agonists. The S1P1 receptor is a central mediator of multiple pathways implicated in a variety of autoimmune diseases. The two companies will share responsibility and costs for discovery activities; after that, Boehringer Ingelheim will handle all pre-clinical, clinical, regulatory, commercial and manufacturing activities.
"This collaboration highlights Exelixis' ability to leverage our discovery capabilities and early-stage pipeline," said Exelixis CEO George Scangos. "Our S1P1 agonist program has identified multiple analogs with potent in vivo activity. With this collaboration, we have the opportunity to transition the program to a partner with a track record of success in developing and commercializing autoimmune disease therapies while strengthening our financial position."
DickSIM
Prima o poi....ci becco!
Pfizer is revving up its engines to get those planned R&D changes into high gear. The drugmaker says it's pumping $100 million into its international stem cell development program. The company's new regenerative medicine unit in Cambridge, U.K. will become Pfizer's top stem cell research site, with the headcount expected to increase by 50 percent to 45.
First announced in November of 2008, the independent research unit--Pfizer Renegerative Medicine--is split between the company's Cambridge, MA site and the Cambridge, UK base. Led by Chief Scientific Officer Ruth McKernan, the unit focuses on small molecules and cell therapy. "The important thing is that we will contribute something that will start opening to cell-based therapies. We are attempting to take it to the next stage and make it scaleable and practical," McKernan tells Business Weekly.
Pfizer's cash injection is the single highest funding the stem cell discipline has ever received from the corporate sector, the paper reports. But "it's more than just the money--it's about opening dialogue with the regulators, that's where the money merit is," McKernan explains.
The drugmaker has made collaborations a priority for the new research unit. So far, Pfizer has announced a deal with the University College of London to develop treatments for blindness and a related deal with the U.K.'s struggling Intercytex, which is providing Pfizer with an embryonic stem cell line in exchange for research funding. Earlier this week, the drugmaker also announced a deal week with University of Wisconsin's Alumni Research Foundation for use of their human embryonic stem cells.
First announced in November of 2008, the independent research unit--Pfizer Renegerative Medicine--is split between the company's Cambridge, MA site and the Cambridge, UK base. Led by Chief Scientific Officer Ruth McKernan, the unit focuses on small molecules and cell therapy. "The important thing is that we will contribute something that will start opening to cell-based therapies. We are attempting to take it to the next stage and make it scaleable and practical," McKernan tells Business Weekly.
Pfizer's cash injection is the single highest funding the stem cell discipline has ever received from the corporate sector, the paper reports. But "it's more than just the money--it's about opening dialogue with the regulators, that's where the money merit is," McKernan explains.
The drugmaker has made collaborations a priority for the new research unit. So far, Pfizer has announced a deal with the University College of London to develop treatments for blindness and a related deal with the U.K.'s struggling Intercytex, which is providing Pfizer with an embryonic stem cell line in exchange for research funding. Earlier this week, the drugmaker also announced a deal week with University of Wisconsin's Alumni Research Foundation for use of their human embryonic stem cells.
DickSIM
Prima o poi....ci becco!
FDA nominee sees need for confidence boost
May 7, 2009 — 11:46am ET | By John Carroll
FDA nominee director Dr. Margaret Hamburg will tell lawmakers today that the agency is in need of a boost in public confidence and will come down hard on the side of food and drug safety--areas that the agency has fallen short on in recent years. But her prepared remarks also underscore a commitment to innovation. Drug makers will be watching closely to see whether the FDA's emphasis on safety will trump its desire to usher in a new generation of therapeutics.
May 7, 2009 — 11:46am ET | By John Carroll
FDA nominee director Dr. Margaret Hamburg will tell lawmakers today that the agency is in need of a boost in public confidence and will come down hard on the side of food and drug safety--areas that the agency has fallen short on in recent years. But her prepared remarks also underscore a commitment to innovation. Drug makers will be watching closely to see whether the FDA's emphasis on safety will trump its desire to usher in a new generation of therapeutics.
DickSIM
Prima o poi....ci becco!
Obama wants to boost FDA budget 19%
May 8, 2009 — 10:34am
The Obama administration wants to hike the FDA's budget by 19 percent to $3.2 billion for fiscal 2010. That's a whopping increase: In dollar terms, it amounts to about half a billion, Reuters reports. A good billion or so of the total comes from industry via user fees.
More than half of that amount would go to the "F" in FDA, however, as the administration seeks to follow through on promises to better regulate the food supply. And part of the "D"-in-FDA increase would come from levying additional fees on generic drugmakers, about $36 million worth. But given that the fees would help break the approvals logjam in FDA's generics office, the drugmakers aren't balking.
Will those many millions be enough? William Hubbard, a former FDA associate commissioner, told the Wall Street Journal that the boost--coupled with an emergency funding increase of $172 million last year--will help the FDA "begin to solve some problems." That's partly because the budget will allow hiring of more inspectors and scientists, both of which are sorely needed at the FDA, observers say.
Still, those numbers only allow enough hiring to take FDA back up to the same level as 1994, WSJ notes, the year before FDA's budget started lagging. As you know, the Agency has watched its funding shrink repeatedly since the mid-1990s, so there's a lot of ground to make up.
May 8, 2009 — 10:34am
The Obama administration wants to hike the FDA's budget by 19 percent to $3.2 billion for fiscal 2010. That's a whopping increase: In dollar terms, it amounts to about half a billion, Reuters reports. A good billion or so of the total comes from industry via user fees.
More than half of that amount would go to the "F" in FDA, however, as the administration seeks to follow through on promises to better regulate the food supply. And part of the "D"-in-FDA increase would come from levying additional fees on generic drugmakers, about $36 million worth. But given that the fees would help break the approvals logjam in FDA's generics office, the drugmakers aren't balking.
Will those many millions be enough? William Hubbard, a former FDA associate commissioner, told the Wall Street Journal that the boost--coupled with an emergency funding increase of $172 million last year--will help the FDA "begin to solve some problems." That's partly because the budget will allow hiring of more inspectors and scientists, both of which are sorely needed at the FDA, observers say.
Still, those numbers only allow enough hiring to take FDA back up to the same level as 1994, WSJ notes, the year before FDA's budget started lagging. As you know, the Agency has watched its funding shrink repeatedly since the mid-1990s, so there's a lot of ground to make up.
DickSIM
Prima o poi....ci becco!
Glaxo says its HPV shot outperforms Merck's
May 8, 2009 — 11:16am ET | By Tracy Staton
When GlaxoSmithKline announced that it would unveil head-to-head trial data on its HPV vaccine long after the fact and at a lesser-known meeting, folks speculated that the drugmaker might be embarrassed of the trial's outcome. Not so--emphatically not so. The company trumpeted the comparative study, saying that its Cervarix vaccine prompted a much stronger immune-system response than Merck's Gardasil did.
The Glaxo shot generated two times as many antibodies for one HPV strain than Gardasil did, the data showed, and more than six times as many for another. Plus, Cervarix patients produced 2.7 times more memory B cells for HPV than patients who received the Merck vaccine. Another study due to be presented at the same conference found that Cervarix provided sustained antibodies against HPV through more than seven years of follow-up, the company said.
"The presence of neutralising antibodies at the location of the infection (the cervix) appears to be an important part of vaccine-induced protection against HPV," said Glaxo's R&D chief Thomas Breuer in a statement. "This study offers the first evidence that these two vaccines do not generate the same immune response."
Merck was ready to rumble though; the Gardasil maker said that the comparative data isn't clinically relevant because there's no evidence a higher immune response actually made much difference to the long-term risk of developing cancer, Reuters reports. Sanofi Pasteur MSD, a joint venture between Merck and Sanofi that sells Gardasil in Europe, also got into the act: "We see no clinical relevance in the results of this study ... and we don't see the point of doing such a comparison," Bennett Lee, medical director, told the wire service. "If you want to compare vaccines, you compare clinical efficacy."
Nonetheless, it's something of a coup for Glaxo, which was betting the farm on Cervarix when it chose to pit its HPV shot against Merck's. Now if only Glaxo can get Cervarix past the FDA, then it will really have a fight with Merck on its hands.
May 8, 2009 — 11:16am ET | By Tracy Staton
When GlaxoSmithKline announced that it would unveil head-to-head trial data on its HPV vaccine long after the fact and at a lesser-known meeting, folks speculated that the drugmaker might be embarrassed of the trial's outcome. Not so--emphatically not so. The company trumpeted the comparative study, saying that its Cervarix vaccine prompted a much stronger immune-system response than Merck's Gardasil did.
The Glaxo shot generated two times as many antibodies for one HPV strain than Gardasil did, the data showed, and more than six times as many for another. Plus, Cervarix patients produced 2.7 times more memory B cells for HPV than patients who received the Merck vaccine. Another study due to be presented at the same conference found that Cervarix provided sustained antibodies against HPV through more than seven years of follow-up, the company said.
"The presence of neutralising antibodies at the location of the infection (the cervix) appears to be an important part of vaccine-induced protection against HPV," said Glaxo's R&D chief Thomas Breuer in a statement. "This study offers the first evidence that these two vaccines do not generate the same immune response."
Merck was ready to rumble though; the Gardasil maker said that the comparative data isn't clinically relevant because there's no evidence a higher immune response actually made much difference to the long-term risk of developing cancer, Reuters reports. Sanofi Pasteur MSD, a joint venture between Merck and Sanofi that sells Gardasil in Europe, also got into the act: "We see no clinical relevance in the results of this study ... and we don't see the point of doing such a comparison," Bennett Lee, medical director, told the wire service. "If you want to compare vaccines, you compare clinical efficacy."
Nonetheless, it's something of a coup for Glaxo, which was betting the farm on Cervarix when it chose to pit its HPV shot against Merck's. Now if only Glaxo can get Cervarix past the FDA, then it will really have a fight with Merck on its hands.
- Stato