|
|
Post by lakers on Oct 31, 2015 1:35:08 GMT -5
www.investorvillage.com/smbd.asp?mb=1492&mn=8031&pt=msg&mid=14102357%C2%A0online Russian Jewish news - Afrezza karman.zahav.ru/Articles/6714/sanofiInhaled insulin AFREZZA may soon appear in IsraelInhaled insulin AFREZZA may soon appear in Israel08/14/2014 10:44 Pharmaceutical company Sanofi and American biopharmaceutical corporation MannKind, engaged in research of cancer and diabetes, as well as the development of therapeutic drugs against these diseases, have signed an agreement for the distribution of the first of its kind inhaled insulin AFREZZA. A new form of insulin for the treatment of type 1 and type 2, has received considerable support from the FDA (FDA Office of the Food and Drug Administration in the United States), for now, the use of insulin by diabetic patients of the first and the second type is much easier and painless . AFREZZA is a revolutionary innovation: human insulin analog, equal in potency of human insulin and charged into the cartridge (inhaler) for inhalation. AFREZZA - a rapid-acting insulin, which, like their counterparts (eg, insulin Apidra), simulates the response of the body to increase blood sugar levels after a meal, soaked in parallel with the highest food. Such insulin necessarily used in addition to basal insulin (for example, Lantus). The use of rapid-acting insulin as a food insulin has the following advantages: * Rapid onset of action allows you to inject insulin just before eating, when we already know the amount of food that will be eaten now, * In some cases when it is difficult to determine in advance the amount of food, including young children, the injection can be made after a meal by the dose depending on the amount of food, * Due to the fact that the duration of ultrashort insulin roughly corresponds to the time increase in blood sugar after a meal, you can not snack between meals. However, one disadvantage of using such are part of the daily insulin injections. Roni Birinboym, CEO of Sanofi in Israel: "Inhaled insulin AFREZZA save diabetics from having to do injections and greatly facilitate their lives. This is a real revolution in the world of pharmacology. Our company will do everything necessary to deliver as soon as possible this insulin in Israel. " AFREZZA go on sale in America in early 2015.
|
|
|
|
Post by vestful on Oct 31, 2015 1:59:09 GMT -5
No injection here...let's go Israel
|
|
|
|
Post by liane on Oct 31, 2015 5:20:48 GMT -5
Love the translation  |
|
|
|
Post by peppy on Oct 31, 2015 7:31:31 GMT -5
The requirement to obtain a preliminary approval for every pharmaceutical product in order to allow its regular distribution is an accepted practice worldwide. In Israel, the preliminary approval is known as registration in the national drug registry. The mechanism of drug registration has been in place since 1964, and is now based on Article 47A(b) of the Pharmacists Ordinance [New Version], 1981.
meitar.com/files/downloads/pharmaceutical%20advertising%202009.pdf
===============================================================================================
Under the Pharmacists Ordinance, it is not possible to manufacture,
market or order use of a preparation that has not been authorised in
Israel. However, the Minister of Health may set down rules under
which the Director General of the Ministry of Health may permit
manufacture, marketing or use of an unauthorised preparation
where such is required in order to provide vital treatment or for the
purpose of research, provided that he is persuaded that such will not
harm the public health (section 47A(b) of the Pharmacists
Ordinance). The Preparations Regulations set out exceptions
where, with the consent of the Director General of the Ministry of
Health, a preparation that has not been authorised in Israel may be
advertised in professional journals, in cases such as the following:
a preparation intended for medicinal follow-up treatment, for
medical or other scientific research, or a registered preparation that
is intended for medicinal treatment other than in accordance with
the conditions of registration (section 29 of the Preparations
Regulations).
meitar.com/files/downloads/pharmaceutical%20advertising%202009.pdf
==================================================================================================== Reading this, it is possible that Afrezza could be prescribed in Israel?
|
|
|
|
Post by biotec on Oct 31, 2015 8:05:47 GMT -5
www.investorvillage.com/smbd.asp?mb=1492&mn=8031&pt=msg&mid=14102357%C2%A0online Russian Jewish news - Afrezza karman.zahav.ru/Articles/6714/sanofiInhaled insulin AFREZZA may soon appear in IsraelInhaled insulin AFREZZA may soon appear in Israel08/14/2014 10:44 Pharmaceutical company Sanofi and American biopharmaceutical corporation MannKind, engaged in research of cancer and diabetes, as well as the development of therapeutic drugs against these diseases, have signed an agreement for the distribution of the first of its kind inhaled insulin AFREZZA. A new form of insulin for the treatment of type 1 and type 2, has received considerable support from the FDA (FDA Office of the Food and Drug Administration in the United States), for now, the use of insulin by diabetic patients of the first and the second type is much easier and painless . AFREZZA is a revolutionary innovation: human insulin analog, equal in potency of human insulin and charged into the cartridge (inhaler) for inhalation. AFREZZA - a rapid-acting insulin, which, like their counterparts (eg, insulin Apidra), simulates the response of the body to increase blood sugar levels after a meal, soaked in parallel with the highest food. Such insulin necessarily used in addition to basal insulin (for example, Lantus). The use of rapid-acting insulin as a food insulin has the following advantages: * Rapid onset of action allows you to inject insulin just before eating, when we already know the amount of food that will be eaten now, * In some cases when it is difficult to determine in advance the amount of food, including young children, the injection can be made after a meal by the dose depending on the amount of food, * Due to the fact that the duration of ultrashort insulin roughly corresponds to the time increase in blood sugar after a meal, you can not snack between meals. However, one disadvantage of using such are part of the daily insulin injections. Roni Birinboym, CEO of Sanofi in Israel: "Inhaled insulin AFREZZA save diabetics from having to do injections and greatly facilitate their lives. This is a real revolution in the world of pharmacology. Our company will do everything necessary to deliver as soon as possible this insulin in Israel. " AFREZZA go on sale in America in early 2015. This article is over a year old. |
|
|
|
Post by mnholdem on Oct 31, 2015 9:30:27 GMT -5
Wasn't that around the time that spiro was exiled to Siberia? Perhaps this Zahav character, who wrote the report, was a drinking buddy...  |
|
|
|
Post by rrtzmd on Oct 31, 2015 14:39:20 GMT -5
www.investorvillage.com/smbd.asp?mb=1492&mn=8031&pt=msg&mid=14102357%C2%A0online Russian Jewish news - Afrezza karman.zahav.ru/Articles/6714/sanofiInhaled insulin AFREZZA may soon appear in IsraelInhaled insulin AFREZZA may soon appear in Israel08/14/2014 10:44 Pharmaceutical company Sanofi and American biopharmaceutical corporation MannKind, engaged in research of cancer and diabetes, as well as the development of therapeutic drugs against these diseases, have signed an agreement for the distribution of the first of its kind inhaled insulin AFREZZA. A new form of insulin for the treatment of type 1 and type 2, has received considerable support from the FDA (FDA Office of the Food and Drug Administration in the United States), for now, the use of insulin by diabetic patients of the first and the second type is much easier and painless . AFREZZA is a revolutionary innovation: human insulin analog, equal in potency of human insulin and charged into the cartridge (inhaler) for inhalation. AFREZZA - a rapid-acting insulin, which, like their counterparts (eg, insulin Apidra), simulates the response of the body to increase blood sugar levels after a meal, soaked in parallel with the highest food. Such insulin necessarily used in addition to basal insulin (for example, Lantus). The use of rapid-acting insulin as a food insulin has the following advantages: * Rapid onset of action allows you to inject insulin just before eating, when we already know the amount of food that will be eaten now, * In some cases when it is difficult to determine in advance the amount of food, including young children, the injection can be made after a meal by the dose depending on the amount of food, * Due to the fact that the duration of ultrashort insulin roughly corresponds to the time increase in blood sugar after a meal, you can not snack between meals. However, one disadvantage of using such are part of the daily insulin injections. Roni Birinboym, CEO of Sanofi in Israel: "Inhaled insulin AFREZZA save diabetics from having to do injections and greatly facilitate their lives. This is a real revolution in the world of pharmacology. Our company will do everything necessary to deliver as soon as possible this insulin in Israel. " AFREZZA go on sale in America in early 2015. Of course, the problem is that Sanofi is responsible for international approval, sales, and distribution. So far they haven't expressed much interest in attempting approval in other countries. |
|
|
|
Post by EveningOfTheDay on Oct 31, 2015 14:56:18 GMT -5
I won't go and find it for you, but there is an announced road map for approval in Europe and Japan, and we are not there yet. Therefore your statements seems clearly premature and somewhat malicious, or if you prefer simply wrong
|
|
|
|
Post by kdaddyfresh2000 on Oct 31, 2015 15:07:59 GMT -5
www.investorvillage.com/smbd.asp?mb=1492&mn=8031&pt=msg&mid=14102357%C2%A0online Russian Jewish news - Afrezza karman.zahav.ru/Articles/6714/sanofiInhaled insulin AFREZZA may soon appear in IsraelInhaled insulin AFREZZA may soon appear in Israel08/14/2014 10:44 Pharmaceutical company Sanofi and American biopharmaceutical corporation MannKind, engaged in research of cancer and diabetes, as well as the development of therapeutic drugs against these diseases, have signed an agreement for the distribution of the first of its kind inhaled insulin AFREZZA. A new form of insulin for the treatment of type 1 and type 2, has received considerable support from the FDA (FDA Office of the Food and Drug Administration in the United States), for now, the use of insulin by diabetic patients of the first and the second type is much easier and painless . AFREZZA is a revolutionary innovation: human insulin analog, equal in potency of human insulin and charged into the cartridge (inhaler) for inhalation. AFREZZA - a rapid-acting insulin, which, like their counterparts (eg, insulin Apidra), simulates the response of the body to increase blood sugar levels after a meal, soaked in parallel with the highest food. Such insulin necessarily used in addition to basal insulin (for example, Lantus). The use of rapid-acting insulin as a food insulin has the following advantages: * Rapid onset of action allows you to inject insulin just before eating, when we already know the amount of food that will be eaten now, * In some cases when it is difficult to determine in advance the amount of food, including young children, the injection can be made after a meal by the dose depending on the amount of food, * Due to the fact that the duration of ultrashort insulin roughly corresponds to the time increase in blood sugar after a meal, you can not snack between meals. However, one disadvantage of using such are part of the daily insulin injections. Roni Birinboym, CEO of Sanofi in Israel: "Inhaled insulin AFREZZA save diabetics from having to do injections and greatly facilitate their lives. This is a real revolution in the world of pharmacology. Our company will do everything necessary to deliver as soon as possible this insulin in Israel. " AFREZZA go on sale in America in early 2015. This article is over a year old. Exactly. My observation also. |
|
|
|
Post by EveningOfTheDay on Oct 31, 2015 15:58:55 GMT -5
Does that mean we should expect to be one year closer to see it happening? or we just dismissed as too old to hold value.
Common! It is a bit over one year old, not one decade old.
|
|
|
|
Post by ricguy on Oct 31, 2015 17:18:03 GMT -5
Does that mean we should expect to be one year closer to see it happening? or we just dismissed as too old to hold value. Common! It is a bit over one year old, not one decade old. I take biotech's comment at face value. It's a year old, old but good news. |
|
|
|
Post by rrtzmd on Oct 31, 2015 20:37:35 GMT -5
I won't go and find it for you, but there is an announced road map for approval in Europe and Japan, and we are not there yet. Therefore your statements seems clearly premature and somewhat malicious, or if you prefer simply wrong Sanofi says they'll be sharing their latest "roadmap" on November 6: roadmap announcement coming up"Despite headwinds in our diabetes business, we are confident in Sanofi's long-term prospects and we look forward to sharing our roadmap for the Group on November 6, 2015." I noticed they were aggressive about pushing praluent: "In September, the European Commission (EC) granted marketing authorization for Praluent® (alirocumab, collaboration with Regeneron) for the treatment in certain adult patients of hypercholesterolemia characterized by high level of low-density lipoprotein (LDL) cholesterol. This approval follows the FDA approval received on July 24th. In August, Praluent® was also submitted to Japanese health authorities." But I still can't find anything regarding efforts to gain foreign approval for afrezza. |
|
|
|
Post by lakers on Oct 31, 2015 21:36:48 GMT -5
I won't go and find it for you, but there is an announced road map for approval in Europe and Japan, and we are not there yet. Therefore your statements seems clearly premature and somewhat malicious, or if you prefer simply wrong Sanofi says they'll be sharing their latest "roadmap" on November 6: roadmap announcement coming up"Despite headwinds in our diabetes business, we are confident in Sanofi's long-term prospects and we look forward to sharing our roadmap for the Group on November 6, 2015." I noticed they were aggressive about pushing praluent: "In September, the European Commission (EC) granted marketing authorization for Praluent® (alirocumab, collaboration with Regeneron) for the treatment in certain adult patients of hypercholesterolemia characterized by high level of low-density lipoprotein (LDL) cholesterol. This approval follows the FDA approval received on July 24th. In August, Praluent® was also submitted to Japanese health authorities." But I still can't find anything regarding efforts to gain foreign approval for afrezza. This will change in 1Q16 as a result of 9/22 JAC. Multiple new fronts will be opened simultaneously in the Diabetes War when the Allies fight back in EU and ME. Olivier was fed up. He will declare war on Nov 6. 'Nuff is 'Nuff. The 3rd, 4th indicator might be autoimmune disease TS drugs Rheumatoid arthritis (RA) is an autoimmune disease that causes chronic inflammation of the joints. Autoimmune diseases are illnesses that occur when the body's tissues are mistakenly attacked by their own immune system. AbbVie's Humira and Amgen's Enbrel together hold more than 80% of the inflammatory condition market share. Enbrel is currently on pace for $5 billion in sales, whereas Humira could be on pace for a record year of more than $13 billion. With little in the way of established competition, these two titans can raise their prices on an almost as-needed basis. Something worth watching here is the imminent loss of patent exclusivity on Humira at the end of 2016 and the eventual introduction of non-branded competition. It's possible that the inflammatory condition class could see cost cuts in the near future with Humira's dominance ending, but we're still a little more than a year away from that happening. Can we say AbbVie's inhaled Humira? Multiple sclerosis (MS) is a potentially disabling disease of the brain and spinal cord (central nervous system). In MS, the immune system attacks the protective sheath (myelin) that covers nerve fibers and causes communication problems between your brain and the rest of your body. There are a number of big players in MS, such as Teva Pharmaceutical (NYSE:TEVA) with its new longer-acting version of Copaxone. It'll be interesting to see how successful Teva is in transitioning patients over to the new extended formulation considering the prior-generation formulation is now off patent. For now, Copaxone maintains a commanding lead with nearly 30% market share, but expect this share to shift when Express Scripts updates the data next year. Inhaled Copaxone by Teva? |
|
|
|
Post by rrtzmd on Oct 31, 2015 22:55:13 GMT -5
Sanofi says they'll be sharing their latest "roadmap" on November 6: roadmap announcement coming up"Despite headwinds in our diabetes business, we are confident in Sanofi's long-term prospects and we look forward to sharing our roadmap for the Group on November 6, 2015." I noticed they were aggressive about pushing praluent: "In September, the European Commission (EC) granted marketing authorization for Praluent® (alirocumab, collaboration with Regeneron) for the treatment in certain adult patients of hypercholesterolemia characterized by high level of low-density lipoprotein (LDL) cholesterol. This approval follows the FDA approval received on July 24th. In August, Praluent® was also submitted to Japanese health authorities." But I still can't find anything regarding efforts to gain foreign approval for afrezza. This will change in 1Q16 as a result of 9/22 JAC. Multiple new fronts will be opened simultaneously in the Diabetes War when the Allies fight back in EU and ME. Olivier was fed up. He will declare war on Nov 6. 'Nuff is 'Nuff. The 3rd, 4th indicator might be autoimmune disease TS drugs Rheumatoid arthritis (RA) is an autoimmune disease that causes chronic inflammation of the joints. Autoimmune diseases are illnesses that occur when the body's tissues are mistakenly attacked by their own immune system. AbbVie's Humira and Amgen's Enbrel together hold more than 80% of the inflammatory condition market share. Enbrel is currently on pace for $5 billion in sales, whereas Humira could be on pace for a record year of more than $13 billion. With little in the way of established competition, these two titans can raise their prices on an almost as-needed basis. Something worth watching here is the imminent loss of patent exclusivity on Humira at the end of 2016 and the eventual introduction of non-branded competition. It's possible that the inflammatory condition class could see cost cuts in the near future with Humira's dominance ending, but we're still a little more than a year away from that happening. Can we say AbbVie's inhaled Humira? Multiple sclerosis (MS) is a potentially disabling disease of the brain and spinal cord (central nervous system). In MS, the immune system attacks the protective sheath (myelin) that covers nerve fibers and causes communication problems between your brain and the rest of your body. There are a number of big players in MS, such as Teva Pharmaceutical (NYSE:TEVA) with its new longer-acting version of Copaxone. It'll be interesting to see how successful Teva is in transitioning patients over to the new extended formulation considering the prior-generation formulation is now off patent. For now, Copaxone maintains a commanding lead with nearly 30% market share, but expect this share to shift when Express Scripts updates the data next year. Inhaled Copaxone by Teva? Per the license agreement: SNY/MNKD license agreement"JAC Decision-Making. All decisions within the authority of the JAC shall be made by unanimous vote or written consent, with the MannKind members of the JAC collectively having one vote and the Sanofi members of the JAC collectively having one vote in all decisions of the JAC. The members of the JAC shall use reasonable efforts to reach agreement on all matters. If, despite such efforts, agreement on a particular matter cannot be reached by the JAC within 15 days after the JAC first considers such matter (or such shorter or longer time as may be agreed by the Parties), then either Party may, by written notice to the other Party, have such matter referred to, on behalf of MannKind, the President of MannKind and, on behalf of Sanofi, the Senior Vice President – Global Diabetes of Sanofi. Such executives shall use reasonable efforts to resolve the matter referred to them within 10 days after such referral. If, despite such efforts, such executives are unable to resolve such matter within 10 days after such referral (or such shorter or longer time as may be agreed by the Parties), then the Sanofi co-chair on the JAC shall have the right to make the final decision with regard to the disputed matter following good faith consideration of MannKind’s comments, subject to Section 3.4 and provided that the Sanofi co-chair on the JAC shall not have power to resolve a dispute: (i) in a manner that would require MannKind to perform activities (A) for which Sanofi will not reimburse MannKind’s costs (except as expressly set forth in this Agreement or the Supply Agreement) or (B) which MannKind has not agreed to perform as set forth in this Agreement or otherwise in writing; (ii) in a manner that would conflict with the terms of this Agreement or the Supply Agreement, including all Exhibits and Schedules hereto and thereto; (iii) by unilaterally determining that it has fulfilled any diligence obligations hereunder; (iv) in a manner that would modify or increase MannKind’s responsibilities under the Development Plan; or (v) regarding changes to any Budget, except as may be required to reflect activities required by a Regulatory Authority or Applicable Laws. For all purposes under this Agreement, any decision made pursuant to this Section 3.1(f) shall be deemed to be the decision of the JAC." In other words, while MNKD can "plead" its case, the SNY "co-chair" is the final judge and jury. Now, the recent Sanofi earnings report and conference call obviously didn't suggest much in the way of enthusiasm about afrezza and didn't offer any info about the latest JAC meeting or info about any "new fronts" in the "diabetes wars." Given SNY's "oligarchy," I don't see any reason to expect the "kingdom" to change management strategy from the one it has been following. Perhaps SNY's November 6 presentation will offer further insight, but about the only thing the CEO could announce significant for afrezza would be a trial demonstrating that's it's more than "non-inferior." |
|
|
|
Post by biotec on Nov 1, 2015 9:32:20 GMT -5
Does that mean we should expect to be one year closer to see it happening? or we just dismissed as too old to hold value. Common! It is a bit over one year old, not one decade old. Maybe only 1 year old, but its also 2 new CEO's and low script count old also. Plans could of changed a little no? We shall find out Friday. |
|
