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23/9 2009 17:58 1
18810 Genmab er det eneste uafhængige antibody firma tilbage
9/23 15:34
af akademikeren arzerra is pending approval
9/23 15:34
af Solsen Hehe samme slagstale som tidligere
9/23 15:34
af Solsen salgstale
9/23 15:35
af jobono men mere upbeat?
9/23 15:35
af akademikeren emea processen er langsommere med godkendelse kommer i 1. halvår 2010
9/23 15:36
af akademikeren Store muligheder for arzerra
9/23 15:36
af akademikeren mere upbeat
9/23 15:36
af akademikeren Egfr nu
9/23 15:36
af akademikeren Individuel dosering, rash satuaration tyder på rigtig dosering
9/23 15:37
af akademikeren Vi har et hard endpoint, survival
9/23 15:37
af akademikeren filing af bla på egfr i løbet af 2010
9/23 15:37
af akademikeren Ingen data endnu! Super godt
9/23 15:38
af akademikeren Hun forklarer lidt om Biobetter. De laver antistoffer med valideret molekyler
9/23 15:39
af akademikeren Roche partnerskab
9/23 15:39
af akademikeren Highlight ved asco tidligere i år og vi får pivotal study snart
9/23 15:39
af akademikeren De skylder os milestones
9/23 15:39
af akademikeren Nice potential revenuestream in the not too distant future
9/23 15:40
af Solsen Hun har tidligere påstået at det var pivotal study
9/23 15:40
af akademikeren Arzerra har potentiale i RA og MS
9/23 15:41
af akademikeren Og kører VIDERE I NHL 1st line
9/23 15:41
af akademikeren Nu riuxiamab head to head preclinical data
9/23 15:41
af akademikeren Vi ser at arzerra er bedre på de kendte måder
9/23 15:42
af akademikeren Hun virker skarp idag
9/23 15:42
af Solsen Har hun drukket
9/23 15:42
af akademikeren Hun refererrer til de gamle slides...
9/23 15:43
af akademikeren Der er en god grund til Arzerrra virker bedre end ritux i CLL
9/23 15:43
af akademikeren Unprecedented responserate i refrac og veltolereret
9/23 15:44
af akademikeren kan ikke lige fange om vi får moget nyt survival data. Men responders har længere overlevelsestid
9/23 15:44
af akademikeren Nu nhl fase 3
9/23 15:45
af akademikeren ORR på 10%
9/23 15:45
af akademikeren Over 20% ORR på rituxian refrac
9/23 15:46
af CHjort Vil det sige at de raske forsøgskaniner viser tegn på bedring???
9/23 15:46
af akademikeren 50% Stable disease og det er nok hvad man kan vente af denne gruppe, siger hun
9/23 15:46
af akademikeren det kunne så godt være meldt ud til markedet skulle man mene
9/23 15:47
af akademikeren Hun tror meget på CLL i 1st line
9/23 15:47
af akademikeren fordi patienterne ofte er gamle og ikke kan tåle aggressiv kemo
9/23 15:47
af akademikeren Nu zalutumab, resultater skal komme inden year end
9/23 15:48
af akademikeren Vi har worldwide rights, kigger på partnerskab, når resultaterne foreligger
9/23 15:49
af akademikeren Upcoming milestones
9/23 15:50
af akademikeren Ash mere data på CLL og NHL
9/23 15:50
af akademikeren Big milestones på Approval
9/23 15:50
af akademikeren We are building for the future!
9/23 15:51
af akademikeren Vi håber at lave partnerskab på EGFR når data kommer
9/23 15:52
af akademikeren Enten er der ingen spørgsmål, eller også var der ingen.
9/23 15:34
af akademikeren arzerra is pending approval
9/23 15:34
af Solsen Hehe samme slagstale som tidligere
9/23 15:34
af Solsen salgstale
9/23 15:35
af jobono men mere upbeat?
9/23 15:35
af akademikeren emea processen er langsommere med godkendelse kommer i 1. halvår 2010
9/23 15:36
af akademikeren Store muligheder for arzerra
9/23 15:36
af akademikeren mere upbeat
9/23 15:36
af akademikeren Egfr nu
9/23 15:36
af akademikeren Individuel dosering, rash satuaration tyder på rigtig dosering
9/23 15:37
af akademikeren Vi har et hard endpoint, survival
9/23 15:37
af akademikeren filing af bla på egfr i løbet af 2010
9/23 15:37
af akademikeren Ingen data endnu! Super godt
9/23 15:38
af akademikeren Hun forklarer lidt om Biobetter. De laver antistoffer med valideret molekyler
9/23 15:39
af akademikeren Roche partnerskab
9/23 15:39
af akademikeren Highlight ved asco tidligere i år og vi får pivotal study snart
9/23 15:39
af akademikeren De skylder os milestones
9/23 15:39
af akademikeren Nice potential revenuestream in the not too distant future
9/23 15:40
af Solsen Hun har tidligere påstået at det var pivotal study
9/23 15:40
af akademikeren Arzerra har potentiale i RA og MS
9/23 15:41
af akademikeren Og kører VIDERE I NHL 1st line
9/23 15:41
af akademikeren Nu riuxiamab head to head preclinical data
9/23 15:41
af akademikeren Vi ser at arzerra er bedre på de kendte måder
9/23 15:42
af akademikeren Hun virker skarp idag
9/23 15:42
af Solsen Har hun drukket
9/23 15:42
af akademikeren Hun refererrer til de gamle slides...
9/23 15:43
af akademikeren Der er en god grund til Arzerrra virker bedre end ritux i CLL
9/23 15:43
af akademikeren Unprecedented responserate i refrac og veltolereret
9/23 15:44
af akademikeren kan ikke lige fange om vi får moget nyt survival data. Men responders har længere overlevelsestid
9/23 15:44
af akademikeren Nu nhl fase 3
9/23 15:45
af akademikeren ORR på 10%
9/23 15:45
af akademikeren Over 20% ORR på rituxian refrac
9/23 15:46
af CHjort Vil det sige at de raske forsøgskaniner viser tegn på bedring???
9/23 15:46
af akademikeren 50% Stable disease og det er nok hvad man kan vente af denne gruppe, siger hun
9/23 15:46
af akademikeren det kunne så godt være meldt ud til markedet skulle man mene
9/23 15:47
af akademikeren Hun tror meget på CLL i 1st line
9/23 15:47
af akademikeren fordi patienterne ofte er gamle og ikke kan tåle aggressiv kemo
9/23 15:47
af akademikeren Nu zalutumab, resultater skal komme inden year end
9/23 15:48
af akademikeren Vi har worldwide rights, kigger på partnerskab, når resultaterne foreligger
9/23 15:49
af akademikeren Upcoming milestones
9/23 15:50
af akademikeren Ash mere data på CLL og NHL
9/23 15:50
af akademikeren Big milestones på Approval
9/23 15:50
af akademikeren We are building for the future!
9/23 15:51
af akademikeren Vi håber at lave partnerskab på EGFR når data kommer
9/23 15:52
af akademikeren Enten er der ingen spørgsmål, eller også var der ingen.
23/9 2009 19:51 tumult 018811 FDA har bare at godkende Arzerra ellers.....
Wyeth (WYE) has filed a lawsuit against the U.S. Food and Drug Administration
seeking to reverse the agencys recent approval of a generic version of the
companys blockbuster antibiotic Zosyn.
Wyeth claims the generic product cant be safely used in the same manner as
the branded product, due to interactivity with an intravenous solution
sometimes used in conjunction with Zosyn, and would seriously endanger
patients health. The suit was filed in U.S. District Court for the District of
Columbia.
The FDA last week approved a generic version of Zosyn from Orchid Chemicals &
Pharmaceuticals Ltd. (524372.BY) of India. Orchid is to have a 180-day period
of generic market exclusivity, and has joined with Apotex Inc. of Canada to
sell the drug.
Wyeth, Madison, N.J., had previously asked FDA not to approve proposed
generic versions of Zosyn because they were based on an earlier formulation of
the drug, and Wyeth changed the formulation in 2005. Orchids generic product
is based on the old formulation.
The effects of the old formulation of Zosyn can be diminished when its given
along with an I.V. solution known as Ringers lactate, Joseph Camardo, senior
vice president of Wyeths global medical affairs, said in an interview
Wednesday. Wyeths newer formulation of Zosyn, however, doesnt have this
issue, he said.
Wyeth fears that medical errors will result if health-care professionals
assume that generic Zosyn is identical to branded Zosyn and give it with
Ringers lactate, Camardo said.
We believe [the FDA] came to the wrong conclusion based on the scientific
evidence, Camardo said. Thats why were asking the court to force them to
reconsider. We think the law is very clear - if a formulation is different and
the ingredients in the formulation have an impact on the safety and efficacy of
the drug, then you cant consider them identical.
But the FDA said in a letter last week thatthe prescribing label for Orchids
generic Zosyn will note its incompatibility with Ringers lactate. The FDA also
stated that the generic is as safe and effective as Wyeths reformulated Zosyn
when used in accordance with prescribing labels.
Zosyn had $1.3 billion in sales last year. Wyeth has agreed to be acquired by
Pfizer Inc. (PFE); the deal is expected to close by the end of the year.
An FDA spokeswoman said the agency doesnt comment on lawsuits. Zosyn is one
of several big-selling branded drugs that have enjoyed continued market
exclusivity even after key patents expired, largely because their manufacturers
had filed citizen petitions with the FDA asking them not to approve generics.
Critics have accused branded drug makers of abusing the citizen-petition
process to maintain their monopolies, but branded drug makers have said the
petitions were filed for valid safety or efficacy reasons.
Johnson & Johnsons (JNJ) Concerta drug for attention deficit disorder and
Sanofi-Aventis SAs (SNY) Lovenox anti-clotting drug also have avoided generic
competition partly due to ongoing citizen-petition reviews by the FDA.
Wyeth (WYE) has filed a lawsuit against the U.S. Food and Drug Administration
seeking to reverse the agencys recent approval of a generic version of the
companys blockbuster antibiotic Zosyn.
Wyeth claims the generic product cant be safely used in the same manner as
the branded product, due to interactivity with an intravenous solution
sometimes used in conjunction with Zosyn, and would seriously endanger
patients health. The suit was filed in U.S. District Court for the District of
Columbia.
The FDA last week approved a generic version of Zosyn from Orchid Chemicals &
Pharmaceuticals Ltd. (524372.BY) of India. Orchid is to have a 180-day period
of generic market exclusivity, and has joined with Apotex Inc. of Canada to
sell the drug.
Wyeth, Madison, N.J., had previously asked FDA not to approve proposed
generic versions of Zosyn because they were based on an earlier formulation of
the drug, and Wyeth changed the formulation in 2005. Orchids generic product
is based on the old formulation.
The effects of the old formulation of Zosyn can be diminished when its given
along with an I.V. solution known as Ringers lactate, Joseph Camardo, senior
vice president of Wyeths global medical affairs, said in an interview
Wednesday. Wyeths newer formulation of Zosyn, however, doesnt have this
issue, he said.
Wyeth fears that medical errors will result if health-care professionals
assume that generic Zosyn is identical to branded Zosyn and give it with
Ringers lactate, Camardo said.
We believe [the FDA] came to the wrong conclusion based on the scientific
evidence, Camardo said. Thats why were asking the court to force them to
reconsider. We think the law is very clear - if a formulation is different and
the ingredients in the formulation have an impact on the safety and efficacy of
the drug, then you cant consider them identical.
But the FDA said in a letter last week thatthe prescribing label for Orchids
generic Zosyn will note its incompatibility with Ringers lactate. The FDA also
stated that the generic is as safe and effective as Wyeths reformulated Zosyn
when used in accordance with prescribing labels.
Zosyn had $1.3 billion in sales last year. Wyeth has agreed to be acquired by
Pfizer Inc. (PFE); the deal is expected to close by the end of the year.
An FDA spokeswoman said the agency doesnt comment on lawsuits. Zosyn is one
of several big-selling branded drugs that have enjoyed continued market
exclusivity even after key patents expired, largely because their manufacturers
had filed citizen petitions with the FDA asking them not to approve generics.
Critics have accused branded drug makers of abusing the citizen-petition
process to maintain their monopolies, but branded drug makers have said the
petitions were filed for valid safety or efficacy reasons.
Johnson & Johnsons (JNJ) Concerta drug for attention deficit disorder and
Sanofi-Aventis SAs (SNY) Lovenox anti-clotting drug also have avoided generic
competition partly due to ongoing citizen-petition reviews by the FDA.
23/9 2009 23:00 tumult 018812 Det er nu mulig at genhøre dagens webcast for dem der ikke var med direkte.
http://cc.talkpoint.com/ubsx001/092109a_ke/?entity=24_GHKV01E
http://cc.talkpoint.com/ubsx001/092109a_ke/?entity=24_GHKV01E
