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Insmed Incorporated Message Board

checksurshorts 114 posts  |  Last Activity: Jun 23, 2015 7:12 PM Member since: Dec 1, 2006
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  • Google: "IGFBP-3 reduces eNOS and PKCzeta phosphorylation, leading to lowered VEGF levels"

    May 20 2015

    "Results: Our results suggest that 1) IGFBP-3 inhibits the endothelial nitric oxide synthase (eNOS) and protein kinase C zeta (PKCzeta) pathway, which in turn inhibits VEGF production, and 2) that eNOS plays a role in activating PKCzeta to increase VEGF levels in diabetic retinopathy."

    "Conclusions: In conclusion, IGFBP-3 may be a novel treatment for macular edema through the inhibition of eNOS and PKCzeta activation, leading to reduced VEGF levels."

    Sentiment: Strong Buy

  • Reply to

    August

    by biowatchdog May 9, 2015 10:30 AM
    checksurshorts checksurshorts Jun 22, 2015 11:08 AM Flag

    Thanks BWD. It's always better to under promise and over deliver:)

    Sentiment: Strong Buy

  • Reply to

    New Post on NTM Forum

    by checksurshorts Jun 17, 2015 7:49 PM
    checksurshorts checksurshorts Jun 19, 2015 7:43 PM Flag

    Bump

    Sentiment: Strong Buy

  • Reply to

    Doctors can now put drugs straight into brains

    by checksurshorts May 14, 2015 10:20 AM
    checksurshorts checksurshorts Jun 18, 2015 12:55 PM Flag

    Since iPLEX is being discussed

    Sentiment: Strong Buy

  • checksurshorts by checksurshorts Jun 18, 2015 9:48 AM Flag

    Head of Pharmacovigilance

    Job Description

    "SUMMARY: This position is responsible for identifying and assisting in the management of safety concerns with the drug product(s) owned by the company.

    The Head of Pharmacovigilance ensures that any safety signals are appropriately evaluated, communicated and managed with guidance from supervisor. This role is also responsible for writing documents required for assessment and communication of product safety information for core safety documents.

    RESPONSIBILITIES:
    •Manage the relationship with Pharmacovigilance providers, Clinical Study CROs and internal Medical, Safety and Clinical personnel
    •Contribute to the development, production and maintenance of the appropriate tracking and compliance tools, reports, plans, tasks and activities pertaining to the management of the pharmacovigilance activities
    •Collaborate with safety physicians, medical monitors, toxicology group, and other functional groups in identification, analysis, and reporting of possible trends or concerns
    •Contribute to development & maintenance of product safety profile
    •Support and/or draft regulatory inquiry responses related to pharmacovigilance / safety issues to regulatory agencies, EC/IRB, Investigators and ad hoc inquires
    •Track events of special interest and assist in development and maintenance of standardized queries for events of special interest
    •Provide input and review to key regulatory or clinical documents (i.e. clinical study reports, investigator brochures, integrated summaries of safety, DSUR, etc) related to pharmacovigilance
    •Perform follow-up on pending Corrective and Preventive Actions (CAPAs) and ensure implementation of the same in the Global compliance database
    •Perform compliance data analysis using available tools to identify potential trends
    •Track and communicate on compliance
    •Perform literature search and review and able to effective determine appropriate and relevant literature for the purpose of safety analysis...

    Sentiment: Strong Buy

  • checksurshorts by checksurshorts Jun 17, 2015 7:49 PM Flag

    "Hi Everyone,

    There is such a need for new effective drugs to fight MAC and seem to be so few on the horizon. I was diagnosed with MAC in 2006, and starting in 2007 was on a cocktail of three and four antibiotics until January of this year. I was frustrated having been on these drugs for so many years and still culturing "heavy growth," and my bronchiectasis worsening. Fortunately, I tolerated the drugs. I had heard of the drug Arikayce (Inhaled Liposomal Amikacin) that was being developed and going through trials in Europe. Finally Phase II was started here. I was accepted in the trial starting in May of 2013 finishing in October. Along the way I had several cultures done (outside of the clinical study) I cultured negative each time and have ever since. I had a bronchoscopy done last November to be sure and again cultured negative. We need more drugs in our arsenal to beat MAC and the only way they will become available is for us to participate. I am copying the information for Phase III Inhaled Liposomal Amikacin for anyone who is not responding to their current treatment and would be interested in learning more about this trial.

    Insmed Incorporated is recruiting patients diagnosed with Nontuberculous Mycobacterial (NTM) lung infection that is caused by Mycobacterium avium complex (MAC) to enroll in a Phase 3 study..."

    Sentiment: Strong Buy

  • Reply to

    I Still like IGFBP3 for Asthma

    by checksurshorts Mar 8, 2015 12:42 PM
    checksurshorts checksurshorts Jun 16, 2015 7:38 PM Flag

    Bump

    Sentiment: Strong Buy

  • Reply to

    Citigroup eases into position...

    by jsblvbjb Jun 9, 2015 9:40 AM
    checksurshorts checksurshorts Jun 10, 2015 2:35 PM Flag

    Spot on Jad!!!

    Sentiment: Strong Buy

  • Reply to

    Anyone?

    by justarook04 Jun 5, 2015 8:03 AM
    checksurshorts checksurshorts Jun 5, 2015 8:53 AM Flag

    The domain had expired but has now be renewed.

    Sentiment: Strong Buy

  • checksurshorts checksurshorts Jun 4, 2015 9:28 AM Flag

    I think most of do know how to read and thanks to Biowatchdog's post on the contents of the CHIMP minutes (5/22) on May 27th, we know what was requested.

    Sentiment: Strong Buy

  • Reply to

    New post on NTM forum

    by checksurshorts Mar 17, 2015 1:05 AM
    checksurshorts checksurshorts May 31, 2015 12:22 PM Flag

    Bump

    Sentiment: Strong Buy

  • Reply to

    What happened to the P-II people?

    by fmjtfb May 29, 2015 7:34 PM
    checksurshorts checksurshorts May 30, 2015 4:27 PM Flag

    More: "Fortunately, very well. I was diagnosed at age 46, started medications at 47. I was in good health to start (minus MAC!) so I did fine. The problem is the meds did not get rid of the MAC for me. I think they controlled it somewhat but I still did have some progression. It was after the inhaled Arikace that I finally cultured negative and have for over a year. I had a bronch last November to make sure that I was negative before going off the meds. I don't get the best sputum samples. I also have Alpha1 Antitrypsin Deficiency which probably is the reason I got MAC. For the last three years I have worked in the pulmonary field and I see research physicians frequently. At this point, I am convinced that inhaled antibiotics are the way to go when trying to reach deep down in the lungs to erradicate an infection. There are several in clinical trials, including Arikace."

    Sentiment: Strong Buy

  • Reply to

    What happened to the P-II people?

    by fmjtfb May 29, 2015 7:34 PM
    checksurshorts checksurshorts May 30, 2015 4:22 PM Flag

    Some have posted on NTM forums. This is from NTMir:

    "I participated in the Phase 2 trial in 2013. I have cultured negative ever since. I know another MAC patient who also participated and is also culturing negative for MAC. I highly recommend giving it a try. I was on the big 3 plus Clofazamine for over 5 years and still culturing heavy growth. If we don't particpate in these trials, we are NOT going to get the effective medications which we desperately need!"

    Sentiment: Strong Buy

  • Reply to

    New job opening

    by checksurshorts May 22, 2015 3:01 PM
    checksurshorts checksurshorts May 22, 2015 3:04 PM Flag

    SUMMARY:

    Reporting to the Global Head of Program Management, this position will be accountable for all necessary project planning, scheduling, tracking, managing and project direction required for the successful and timely completion of projects within Technical Operations including:

    • Technology Transfer

    • New Product Launches

    • Assay Transfer

    • Packaging/labeling

    • Process Scale-up

    • Process Improvements

    Sentiment: Strong Buy

  • checksurshorts by checksurshorts May 22, 2015 3:01 PM Flag

    Project Manager - Technical Operations

    Sentiment: Strong Buy

  • Vertex in Talks With Other Cystic Fibrosis Drugmakers on Combos
    2015-05-19 15:59:21.268 GMT

    By Catherine Larkin
    (Bloomberg) -- Vertex in talks with “most if not all”
    smaller cos. that are also developing drugs to treat cystic fibrosis about potential combination therapies, CEO Jeff Leiden says at UBS health conf. in New York.

    * VRTX has become “partner of choice” for many small cos.

    with only one drug, pretty clear that one component alone
    isn’t going to be enough

    * Pleased with how these talks are progressing, says may be
    more news on this later this yr

    * NOTE: Other cos. developing cystic fibrosis drugs include
    Corbus Pharmaceuticals, Galapagos, Insmed, Protalix, PTC
    Therapeutics

    Sentiment: Strong Buy

  • Reply to

    How sweet it is!!!

    by jsblvbjb May 20, 2015 4:10 PM
    checksurshorts checksurshorts May 20, 2015 8:56 PM Flag

    No wonder WL was "excited" to present these posters. Thanks!!!

    Sentiment: Strong Buy

  • checksurshorts checksurshorts May 20, 2015 1:06 PM Flag

    I personally think insmed will get to file early with FDA when early good data comes out. This trial is recruiting only those that are most responsive to the treatment and conversion happened fairly quickly. Duplicating the results of the previous trial under the "proper" endpoint would allow the FDA to remain within process. Remember, insmed was approached by the gov to do NTM. Just my opinion.

    Sentiment: Strong Buy

  • Reply to

    Frankfort Germany

    by justarook04 Apr 9, 2015 7:22 AM
    checksurshorts checksurshorts May 19, 2015 12:56 PM Flag

    Yes, all good.

    He just mentioned the Tobi for CF at 15-20 EU per 6 months and Arykace would match. He then said for NTM would be 30-40 EU per year but I don't think he meant Tobi was used for NTM just that there would be a similar price point.

    Good luck.

    Sentiment: Strong Buy

  • Reply to

    Frankfort Germany

    by justarook04 Apr 9, 2015 7:22 AM
    checksurshorts checksurshorts May 19, 2015 12:12 PM Flag

    Will had said $50-$100K in US and he believes there is very good support at the upper end of the range. They would push value for the money but didn't want to hurt uptake by pricing too high.

    In Europe he said they would match other treatments such as Tobi which is 15-20 EU per 6 months and NTM would be 30-40 EU per year.

    Sentiment: Strong Buy

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