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Post by lakers on Aug 4, 2018 15:57:10 GMT -5
Improving Post-Prandial Blood Glucose Control With Afrezza During Closed-Loop Therapy clinicaltrials.gov/ct2/show/NCT03234491?term=Inhaled+Afrezza&cond=Diabetes&draw=10&rank=98Contacts Contact: Sonali Saxena, MD 203-737-3595 sonali.saxena@yale.edu Contact: Alfonso Galderisi, MD 203-737-3595 alfonso.galderisi@yale.edu Locations United States, Connecticut Yale Diabetes Research Clinic Recruiting New Haven, Connecticut, United States, 06511 Contact: Lori Carria 203-737-3595 lori.carria@yale.edu Contact: Kristen Kraemer kristen.kraemer@yale.edu Sponsors and Collaborators Yale University Brief Summary: The study will be conducted in two phases; an in-patient meal study phase (Phase I) and an outpatient home study (Phase II). The two phase study design is chosen to enhance safety by testing the Afrezza Closed-Loop (CL) system in controlled in-clinic setting under study staff supervision before it could be investigated at the outpatient home setting. Phase II will not begin without the establishment of safety in Phase I. Detailed Description: There are 2 primary study aims that this research will address. The first study aim will be to determine whether use of Afrezza inhaled insulin with ultra-fast kinetics will improve the performance of a closed-loop (CL) system, both with respect to immediate post-prandial hyperglycemia and the subsequent late post-prandial hypoglycemia as compared to hybrid CL (HCL) with subcutaneous (SC) rapid-acting insulin (RAI) pre-meal bolus. The second study aim will be to examine the efficiency and feasibility of Afrezza inhaled insulin as a pre-meal bolus and a missed meal correction bolus on mitigating post-prandial blood glucose control during outpatient CL therapy. This study will test the hypothesis that Afrezza inhaled insulin given before a meal to mimic physiologic first phase insulin release will limit the magnitude and rate of rise of glucose levels following a meal and will achieve greater percent time spent within target blood glucose range as compared to conventional hybrid CL therapy without inhaled insulin both in the in-clinic research and outpatient real-life setting.
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Post by lakers on Aug 4, 2018 15:43:30 GMT -5
Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients Locations United States, Maryland MODEL Clinical Research Recruiting Baltimore, Maryland, United States, 21204 Contact: Karen Klein 443-524-1789 karenklein99@hotmail.com Contact: Lee Bromberger 410-279-0036 lee-model@hotmail.com Sponsors and Collaborators Model Clinical Research LLC Mannkind Corporation Investigators Principal Investigator: Philip Levin, MD Senior Director of MODEL Clinical Research clinicaltrials.gov/ct2/show/NCT03324776?term=Inhaled+Afrezza&cond=Diabetes&rank=5
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Post by lakers on Aug 2, 2018 17:14:51 GMT -5
Brazil quarter 4 first shipment quarter 1 2019. will file with Mexico and Canada. It should be announced shortly. It could shed some lights on some FAQs such as: What publication and when will the STAT result be published? AnsweredWhere and when will be the next international expansion ? Why didn’t we expand in Canada, Mexico due to no NAFTA tariff? AnsweredMENA, China expansion have been often bandied about. When will that happen? Any update on improved coverage? Is TV Ads still going considering the cash crunch? Any near term cash infusion from potential partners? When will phase one pediatric trial complete ? mnkd.proboards.com/thread/10237/next-quarterly-call
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Post by lakers on Jul 28, 2018 14:49:46 GMT -5
Headquartered in the U.S., Tanner’s reach includes Europe, Northeast Asia, Southeast Asia, the Middle East, Australia, Canada and Latin America, including Brazil, Mexico, the Caribbean, Central America and all of South America. Following is a similar deal. Tanner is based in Charlotte, NC, where MC, the CMO had presentation with UNC, Duke recently. www.tannerpharma.com/tanner-pharma-group-signs-distribution-agreement-partner-therapeutics-product-leukine/
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Post by lakers on Jul 18, 2018 12:21:31 GMT -5
It should be announced shortly. It could shed some lights on some FAQs such as:
What publication and when will the STAT result be published? Where and when will be the next international expansion ? Why didn’t we expand in Canada, Mexico due to no NAFTA tariff? MENA, China expansion have been often bandied about. When will that happen? Any update on improved coverage? Is TV Ads still going considering the cash crunch? Any near term cash infusion from potential partners? When will phase one pediatric trial complete ?
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Post by lakers on Jul 17, 2018 23:07:54 GMT -5
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Post by lakers on Jun 29, 2018 8:16:08 GMT -5
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Post by lakers on Jun 8, 2018 2:50:20 GMT -5
Drug Candidates with 505(b)(2) Potential A company may wish to create a new dosage form that is faster acting, combines two active ingredients in a novel way, or provides a route of administration or mechanism of drug delivery that patients or doctors prefer over previous versions. Also, a company may wish to seek approval for a new indication for an already-approved drug or carry out an Rx-to-OTC switch. Such new products often contain well-understood active ingredients that are present in existing, approved drug products (reference drugs); so, companies must only create a bridge between what is already known about the previously approved reference drug and the novel drug product or indication. The 505(b)(2) NDA pathway makes this possible Benefits of 505(b)(2) 505(b)(2) is particularly valuable for pharmaceutical and generics companies looking to alleviate competitive forces in their environments while still wanting to benefit from a development process that eliminates most nonclinical studies as well as extensive safety and efficacy tests. Relatively low risk because of previous drug approval Lower cost, accelerated development due to fewer studies May qualify for three, five or seven years of market exclusivity camargopharma.com/what-is-505b2/
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Post by lakers on May 25, 2018 12:25:54 GMT -5
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Post by lakers on May 22, 2018 13:25:27 GMT -5
PG. Don’t get me wrong. You are well respected. Your idea counts. Solution toward mkt access, cash crunch that has not been thought about. Still waiting for NEJM, Lancet, AJMA.
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Post by lakers on May 22, 2018 12:21:10 GMT -5
Kastanes: I could not agree more with that statement. PG, since you are an employee and an evangelist, what’s your proposed solution? Think out of the box.
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Post by lakers on May 16, 2018 14:57:05 GMT -5
Heidi Soto 3rd degree connection3rd Area Business Manager at Mannkind Corporation MannKind Corporation University of Southern California Greater Los Angeles Area Area Business Manager Company NameMannKind Corporation Dates EmployedFeb 2017 – Present Employment Duration1 yr 4 mos LocationBeverly Hills, California MannKind Corporation (NASDAQ and TASE: MNKD) is a biopharmaceutical company that focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. The company dates back to February 1991, when it was incorporated as Pharmaceutical Discovery Corporation (PDC) in Elmsford, New York. Our Technosphere® formulation technology was developed at PDC shortly after its formation. In the mid-1990s, Alfred Mann – at the time, the CEO of MiniMed Inc. – started working with PDC through a collaborative research effort and eventually became a significant shareholder. In 2001, the company merged with two other companies owned by Alfred Mann (CTL Immunotherapies Corp. and Allecure Corp.) and the surviving company changed its name to MannKind Corporation. As a result of this merger, we relocated the corporate headquarters to Valencia, California while focusing the East coast operations – by this time, located in Danbury, Connecticut – on improving the Technosphere® technology and developing our innovative line of delivery devices. Our Danbury location now houses a state-of-the-art manufacturing facility, where we manufacture Afrezza® (insulin human) inhalation powder, our first FDA-approved product. We are currently commercializing Afrezza in the United States, where it is available by prescription from pharmacies nationwide. Insulet Corporation Territory Manager Company NameInsulet Corporation Dates EmployedMay 2014 – Feb 2017 Employment Duration2 yrs 10 mos LocationGreater Los Angeles Area Responsible and accountable for consistently achieving sales objectives for the OmniPod Tubeless Insulin Pump System and ensuring these sales are profitable and within the guidelines of Insulet Corporation's defined sales and marketing practices. This includes also responsability for the development, management and growth of the healthcare professional recommendation to achieve sales and market share growth. Other key strategies include; expand business and brand loyalty within strategic accounts consisting of private practice, large diabetes clinics, hospital teaching institutions, and other major medical centers. Calling on customers to raise their level of awareness and increase the demand of the Insulet Corporation product line within the defined geographic territory. And correlating any professional contact needed within the above mentioned accounts with the operational, quality or customer service teams of Insulet Corporation. Eli Lilly and Company Senior Specialty Sales Representative, Diabetes & Endocrine Business Unit Company NameEli Lilly and Company Dates EmployedNov 2008 – Apr 2014 Employment Duration5 yrs 6 mos LocationGreater Los Angeles Area Responsible for developing relationships with all practicing endocrinologists and pediatric endocrinologists who are prescribers/influencers for diabetes and growth hormone disorders. This includes selling the diabetes portfolio (Humalog, Tradjenta, Jentadueto & Humatrope) in key hospital accounts: including interactions with attending endocrinologists, endocrine fellows, diabetes educators, chief internal medicine residents, chief family practice residents, and residents involved in endocrine rotations. * Lilly is the 5th largest pharmaceutical company in the country and the 10th largest pharmaceutical company in the world and has remained dedicated to creating medicines that help improve peoples' quality of life for more than 135 years.
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Post by lakers on May 16, 2018 12:59:23 GMT -5
Most cost effective, Expect articles on
Journal Impact Factor Year NEJM 72.406 2016 Lancet 47.831 2017 JAMA 44.405 2016
NEJM is a weekly medical journal published by the Massachusetts Medical Society. It is among the most prestigious peer-reviewed medical journals[1] as well as the oldest continuously published one.
The journal usually has the highest impact factor of the journals of internal medicine. According to the Journal Citation Reports, NEJM had a 2014 impact factor of 55.873,[24] ranking it first of 153 journals in the category "General & Internal Medicine".[25] It was the only journal in the category with an impact factor of more than 50. By comparison, the second and third ranked journals in the category (The Lancet and JAMA) had impact factors of 45.217 and 35.289 respectively.
Lancet The Lancet is a weekly peer-reviewed general medical journal. It is one of the world's oldest and best known general medical journals.
The Lancet publishes original research articles, review articles ("seminars" and "reviews"), editorials, book reviews, correspondence, as well as news features and case reports.
JAMA is a peer-reviewed medical journal published 48 times a year by the American Medical Association. It publishes original research, reviews, and editorials covering all aspects of the biomedical sciences.
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Post by lakers on May 15, 2018 20:21:55 GMT -5
I only recognize the famous Sports. Kindly educate me from left to right please.
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Post by lakers on May 12, 2018 1:19:33 GMT -5
Interesting exchange between Kastanes and OS. Thoughts?
Kastanes
Comments (2311) |+ Follow |Send Message |
The troubling aspect of the India deal is it indicates very little upfront money will be generated through Afrezza partnerships; MannKind's only option to raise money is through the authorized shares. Castagna needs to consider selling the entire Afrezza franchise.
11 May 2018, 03:09 PM
Spencer Osborne, Contributor
Comments (14450) |+ Follow |Send Message |
Author’s reply » Kastanes.....
"Castagna needs to consider selling the entire Afrezza franchise."
I happen to agree that a shift to a pipeline could be the best path forward. Sell off Afrezza for a royalty and a manufacturing contract, and then raise additional capital to get a robust pipeline.
That being said, it appears that such a move will get more difficult. With Brazil and India out of the mix, a buyer is getting less than the whole enchilada. With another term sheet in the works, that could get even more complex.
Funny anecdote.....
2 years ago there was an "offer" at the annual shareholder meeting by Henry Orlosky proposing $500 million cash for a 51% stake for rights to China (if I recall). At the time many passionate longs scoffed at the idea of "such a low offer". Fast forward to today, and those same people seem to be celebrating $2.2 million for India. Imagine what a $500 million cash infusion would have done over the last 2 years.
11 May 2018, 03:30 PM
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