Biotech news
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Cityhunter
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e va beh...
MILANO (MF-DJ)--Pfizer acquisira' la statunitense King Pharmaceuticals
alla somma di 3,6 mld usd, al fine di eliminare una concorrente in un
periodo in cui il settore e' colpito dalla scadenza dei brevetti.
Il deal sopraggiunge un anno dopo che Pfizer ha acquisito Wyeth a 68 mln
usd, in un accordo cui avevano fatto seguito attivita' di fusione tra
societa' farmaceutiche.
La scadenza dei brevetti rappresenta una minaccia per il settore, in
quanto permette alla versione generica e piu' conveniente dei farmaci di
accedere al mercato.
In base ai termini del deal Pfizer versera' la somma di 14,25 usd per
azione a King Pharma, con un premio del 40% sul valore del titolo di ieri.
La societa' prevede di concludere l'accordo entro fine anno e stima che
il takeover aumentera' l'Eps gia' dal prossimo anno e di tagliare costi
con un risparmio di 200 mln usd entro la fine del 2013.
red/est/ac
(fine)
MF-DJ NEWS
1214:52 ott 2010
MILANO (MF-DJ)--Pfizer acquisira' la statunitense King Pharmaceuticals
alla somma di 3,6 mld usd, al fine di eliminare una concorrente in un
periodo in cui il settore e' colpito dalla scadenza dei brevetti.
Il deal sopraggiunge un anno dopo che Pfizer ha acquisito Wyeth a 68 mln
usd, in un accordo cui avevano fatto seguito attivita' di fusione tra
societa' farmaceutiche.
La scadenza dei brevetti rappresenta una minaccia per il settore, in
quanto permette alla versione generica e piu' conveniente dei farmaci di
accedere al mercato.
In base ai termini del deal Pfizer versera' la somma di 14,25 usd per
azione a King Pharma, con un premio del 40% sul valore del titolo di ieri.
La societa' prevede di concludere l'accordo entro fine anno e stima che
il takeover aumentera' l'Eps gia' dal prossimo anno e di tagliare costi
con un risparmio di 200 mln usd entro la fine del 2013.
red/est/ac
(fine)
MF-DJ NEWS
1214:52 ott 2010
Cityhunter
Nuovo forumer
Corrotti e anche ignoranti....
WASHINGTON -- The Food and Drug Administration must update its scientific tools for reviewing prescription drugs, medical devices and tracking food safety, according to a research plan laid out Wednesday by agency leadership.
FDA Commissioner Margaret Hamburg said the agency will spend $25 million in the coming year on collaborations with outside scientists from academia, government and industry. In a speech at the National Press Club, Hamburg said that improved scientific standards will help speed up the approval of important new products and spot safety problems sooner.
"Regulatory science can deliver us better, more targeted therapies, more quickly," Hamburg said.
The FDA oversees the safety of nearly one-fourth of goods sold in the U.S., including many foods, prescription drugs, medical devices and cosmetics.
The federal agency is looking to collaborate on a host of projects, including efforts to predict the side effects of drugs based on the genetic code of individual patients, to reduce or eliminate drug testing on animals and to prevent the spread of salmonella and other bacteria in the food supply.
Modernization is a perennial theme for FDA leadership as the agency struggles to keep up with the evolving science behind the latest drugs, devices and even foods. Last month the agency held a three-day meeting on the safety of a genetically modified salmon that grows twice as fast as the naturally bred fish.
But federal funding for the agency traditionally has lagged behind the agency’s budget requests, giving rise to a series of user fee programs in which drug makers and medical device makers help pay for the agency’s review of their products.
The $25 million investment cited by Hamburg is part of the administration’s proposed $4 billion budget for fiscal year 2011, which began Oct. 1. But congressional lawmakers recently passed a resolution that will continue to fund agencies at 2010 levels, after failing to pass fiscal 2011 appropriations before returning home to campaign.
If Republicans regain control of the House in November, the FDA’s Obama-appointed leadership could face an even tougher time securing funding increases for the agency.
But Hamburg said Wednesday the FDA’s mission of protecting public health should make it a priority no matter which party controls Congress.
"There is no other agency in government that does what we do," Hamburg told reporters. "If we can’t do our job and do it well, there’s no one there to backstop us."
Hamburg, a former health commissioner for New York City, was nominated last year to bolster the agency’s regulatory image after a string of food and drug safety scares under the previous administration. However, the recent recall of more than a half-billion eggs linked to salmonella has underscored the limits of the agency’s powers.
"As in other areas, the effectiveness of FDA’s food safety program depends on the strength and capacity of the science underlying it," the agency paper states.
In 2007, the agency’s outside panel of science advisers said the FDA was in danger of failing in its mission because of a lack of scientific expertise.
Read more: FDA Stresses Need To Modernize Its Science - Drugs.com MedNews
WASHINGTON -- The Food and Drug Administration must update its scientific tools for reviewing prescription drugs, medical devices and tracking food safety, according to a research plan laid out Wednesday by agency leadership.
FDA Commissioner Margaret Hamburg said the agency will spend $25 million in the coming year on collaborations with outside scientists from academia, government and industry. In a speech at the National Press Club, Hamburg said that improved scientific standards will help speed up the approval of important new products and spot safety problems sooner.
"Regulatory science can deliver us better, more targeted therapies, more quickly," Hamburg said.
The FDA oversees the safety of nearly one-fourth of goods sold in the U.S., including many foods, prescription drugs, medical devices and cosmetics.
The federal agency is looking to collaborate on a host of projects, including efforts to predict the side effects of drugs based on the genetic code of individual patients, to reduce or eliminate drug testing on animals and to prevent the spread of salmonella and other bacteria in the food supply.
Modernization is a perennial theme for FDA leadership as the agency struggles to keep up with the evolving science behind the latest drugs, devices and even foods. Last month the agency held a three-day meeting on the safety of a genetically modified salmon that grows twice as fast as the naturally bred fish.
But federal funding for the agency traditionally has lagged behind the agency’s budget requests, giving rise to a series of user fee programs in which drug makers and medical device makers help pay for the agency’s review of their products.
The $25 million investment cited by Hamburg is part of the administration’s proposed $4 billion budget for fiscal year 2011, which began Oct. 1. But congressional lawmakers recently passed a resolution that will continue to fund agencies at 2010 levels, after failing to pass fiscal 2011 appropriations before returning home to campaign.
If Republicans regain control of the House in November, the FDA’s Obama-appointed leadership could face an even tougher time securing funding increases for the agency.
But Hamburg said Wednesday the FDA’s mission of protecting public health should make it a priority no matter which party controls Congress.
"There is no other agency in government that does what we do," Hamburg told reporters. "If we can’t do our job and do it well, there’s no one there to backstop us."
Hamburg, a former health commissioner for New York City, was nominated last year to bolster the agency’s regulatory image after a string of food and drug safety scares under the previous administration. However, the recent recall of more than a half-billion eggs linked to salmonella has underscored the limits of the agency’s powers.
"As in other areas, the effectiveness of FDA’s food safety program depends on the strength and capacity of the science underlying it," the agency paper states.
In 2007, the agency’s outside panel of science advisers said the FDA was in danger of failing in its mission because of a lack of scientific expertise.
Read more: FDA Stresses Need To Modernize Its Science - Drugs.com MedNews
Cityhunter
Nuovo forumer
ogni tanto....
Alkermes Announces FDA Approval of VIVITROL® for Prevention of Relapse to Opioid Dependence
Alkermes Announces FDA Approval of VIVITROL® for Prevention of Relapse to Opioid Dependence
Zohar
Forumer storico
Alkermes Announces FDA Approval of VIVITROL® for Prevention of Relapse to Opioid Dependence
E' salita pochissimo ... per la notizia ... almeno fino ad ora ... come al solito i soliti, sapevano tutto prima ...
Cityhunter
Nuovo forumer
è vero... ma non so perchè, me lo aspettavo
non si è mossa nemmeno quando c'è stato il panel favorevole...
non so, occorreranno le vendite?
Zohar
Forumer storico
Ormai le buone news tendono ad essere scontate prima dell'AdCOm così poi si ricomprano più basse e si attendono gli introiti da commercializzazione ... certo non è sempre così, ma spesso sì.
Comunque tra pre-AdCom > AdCom > PDUFA ormai non me la sentirei più di rischiare ... la FDA ormai è impazzita ... e non sempre l'approvazione in AdCom è sicurezza di una successiva PDUFA positivo.
Cityhunter
Nuovo forumer
CONCORDO PIENAMENTEci sono dei titoli tra quelli segnalati in questo e altri forum che stanno dando ottimi risultati. Vedi ad esempio EXAS, OGXI, PSVD, CVM, anche OREX.
Tutti più o meno distanti da scadenze di sorta (quelle che tu hai riportato) a breve, insomma... in piena aspettativa... e si vede... performance da 10% a 30% anche in pochi giorni, tali da aggirare anche il problema tasso di cambio..
Ho provato ALKS perchè mi sentivo forte del panel, per fortuna senza danni. Sembra un titolo da long...
Ho provato ALXA perchè.... non so perchè, con danni..
Adesso viaggio sui titoli indicati sopra.
CVM su tutti...
guly
Forumer storico
ci sono dei titoli tra quelli segnalati in questo e altri forum che stanno dando ottimi risultati. Vedi ad esempio EXAS, OGXI, PSVD, CVM, anche OREX.
Tutti più o meno distanti da scadenze di sorta (quelle che tu hai riportato) a breve, insomma... in piena aspettativa... e si vede... performance da 10% a 30% anche in pochi giorni, tali da aggirare anche il problema tasso di cambio..
Ho provato ALKS perchè mi sentivo forte del panel, per fortuna senza danni. Sembra un titolo da long...
Ho provato ALXA perchè.... non so perchè, con danni..
Adesso viaggio sui titoli indicati sopra.
CVM su tutti...
psvd e' ottimo come lo e' KERYX.per me sono due titoli sicuri su cui puntare.daranno ottime soddisfazioni nel 2011.CVm NON LO CONOSCO.MA SUI PRIMI DUE CI METTEREI LA MANO SUL FUOCO.
