DIABETES CIES SEARCH ENGINE [SELECTED WEBSITES]

Showing posts with label Insulin. Show all posts
Showing posts with label Insulin. Show all posts

Thursday, January 25, 2024

Modular Medical Announces 510(k) Submission of MODD1 Insulin Pump

SAN DIEGO, CA / January 19, 2024 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company"), a development-stage, insulin delivery technology company seeking to launch the next generation of user-friendly and affordable insulin pump technology, announced the premarket submission of its MODD1 next-generation insulin pump to the FDA for 510(k) clearance.

Modular Medical

"This is an exciting milestone for the Company, as we seek to change the diabetes market. Almost 30 years after the introduction of the first insulin pump, more than three quarters of those who could benefit from wearing a pump do not wear one. It is our belief that our simplified design will encourage many "almost-pumpers" to adopt technology to aid in their diabetes management, without the complexity and expense required by many of the current solutions," said Paul DiPerna, Chairman and CTO of Modular Medical.

Modular Medical's MODD1 Insulin Pump

Jeb Besser, CEO of Modular Medical, stated "Getting a person who requires daily insulin to adopt a pump instead of multiple daily injections can reduce healthcare costs and improve long-term patient outcomes. Pump adoption has been impeded by the ‘three-Cs:' they are too complex, cumbersome and costly. The MODD1 was designed to be simple and affordable with an attractive form factor. We believe our two-part patch pump design, easy to learn interface and scalable manufacturing will all contribute to a differentiated and lower cost marketing approach."... Modular Medical's Press Release -

Tuesday, May 22, 2012

Midatech and MonoSol Rx : Positive Phase 1 Clinical Results for their Novel Transbuccal Oral Insulin Film Product

Midatech
3 May 2012 – Midatech Ltd., a global leader in the design, synthesis and manufacture of nanomedicines based on its passivated gold-nanoparticle technology, and MonoSol Rx LLC, the developer of PharmFilm® drug delivery technology, announced positive bioavailability and pharmacokinetic results from a first-in-human Phase 1 clinical study of their Midaform™ Insulin PharmFilm product in 27 healthy volunteers. The companies have licensed to their joint venture company, MidaSol Therapeutics LLC, a proprietary nanoformulated transbuccal insulin film product, which delivers monomeric insulin through the use of a rapidly dissolving mucoadhesive film that is placed onto the inside of the cheek.

MonoSol Rx

Insulin, stabilized on a nanoparticle and delivered transbuccally, has the potential to offer diabetic patients a viable oral alternative to injectable insulin. The Phase 1 study established Midaform Insulin PharmFilm as a safe, novel, non-injectable insulin delivery system, which closely mimicked the delivery characteristics of monomeric insulin from the pancreas. Importantly, MidaSol’s product showed a faster onset of action compared to subcutaneous insulin. Top-line results, including PK and bioavailability elements, from the study will be presented at the European Summit for Clinical Nanomedicine (CLINAM) in Basel, Switzerland by Prof.Dr. med. Fritz R. Bühler, Chief Medical Officer and member of the Board of Midatech Ltd... [PDF] Midatech's Press Release - MonoSol Rx's Press Release -

Thursday, April 26, 2012

Orgenesis : Agreement to Commence Advanced Studies for Proposed Diabetes Treatment

Orgenesis
Apr 11, 2012 - Orgenesis Inc. (OTCBB: ORGS), a development stage company with a novel therapeutic technology dedicated to convert a patient's own liver cells into functional insulin-producing cells as a treatment for diabetes, is pleased to announce entry into an agreement to commence a comprehensive research study into the efficacy of its treatment in order to more efficiently move the technology towards future human clinical trials.

Effective March 22, 2012, Orgenesis Inc. has entered into an agreement with Tel Hashomer - Medical Research, Infrastructure and Services Ltd. ("THM"). In exchange for certain fees, licensing rights and other considerations, THM is to perform a study at the facilities and using the equipment and personnel of the Chaim Sheba Medical Center of Israel under the direct supervision of Orgenesis Chief Science Officer, Prof. Sarah Ferber.

THM will conduct the study, through the services of the Medical Research Infrastructure Development and Health Services Fund established by the Sheba Medical Center pursuant to the Research Program under the direct supervision of Prof. Ferber, who will conduct and supervise the study with the assistance of the employees, researchers and/or associates of the Hospital and/or the Fund. The study itself shall be performed pursuant to the laws, regulations and guidelines as applicable in Israel with respect to clinical research on human subjects... Orgenesis' Press Release -

Friday, March 23, 2012

ADOCIA : positive phase IIa clinical results on its fast-acting human insulin, HinsBet®

ADOCIA
28th of February 2012 - The first clinical results are confirmed on diabetic patients - The main results of this clinical trial are a rapid reduction of glycemia, an excellent local tolerance and an inter-patient and intra-patient variability, all comparable to NovoLog® (Novo Nordisk) -

ADOCIA (ISIN: FR0011184241, Ticker: ADOC), a biotechnology company specialized in the formulation of therapeutic proteins for treating diabetes and chronic wounds (diabetic foot ulcers, venous ulcers), announces positive results from a Phase IIa clinical trial evaluating the safety and efficacy of HinsBet®, its fast-acting human insulin, in type 1 diabetic patients. This program is supported by OSEO.

This phase IIa study was a single center, double-blinded, randomized, cross-over trial conducted on 20 type 1 diabetic patients under euglycemic clamp procedure. The aim of the study was to compare pharmacokinetics, pharmacodynamics and safety of HinsBet® to the fast-acting insulin analog NovoLog®, after 3 consecutive injections of each study medication to each patient.

The hypoglycemic effect of HinsBet® is as rapid as the one of NovoLog®, one of the modern prandial insulins. Furthermore, neither serious adverse event nor clinically significant change in laboratory safety parameters occurred in this study. On local tolerance, HinsBet® was as good as NovoLog®. Finally, the inter and intra patients variabilities of the two medications after 3 consecutive injections are also similar on pharmacological parameters... [PDF]ADOCIA's Press Release - PDF du communiqué de presse ADOCIA -

Wednesday, February 8, 2012

Actavis and Bioton : new alliance to shake up diabetes market

Actavis
30 JAN 2012 - Global managed-care offering to help bring down treatment costs for 366 million diabetics -

Actavis and Bioton (WSE:BIO) announced today that they have formed a joint venture company for the development and registration of insulins, including analogue insulins. Within the framework of the joint-venture, Bioton will be responsible for the development and manufacture of insulin products, while Actavis will be granted an exclusive licence to commercialise those products under the Actavis brand throughout the European Union and the United States of America, as well as in Albania, Bosnia & Herzegovina, Croatia, Iceland, Japan, Kosovo, Lichtenstein, Macedonia, Montenegro, Norway, Serbia and Switzerland. In Poland, both companies will offer the insulin products under their respective brands, Bioton being a Polish company.

Bioton

The announcement, at a press conference in Warsaw today, was made jointly by Ryszard Krauze, Chairman of the Supervisory Board of Bioton, and Claudio Albrecht, CEO of the Actavis Group and Chairman of the Actavis Board of Directors.

Actavis has agreed to remunerate Bioton with the aggregate amount of EUR 55.5 million, of which EUR 22.25 million at signing today. The remainder (EUR 33.25 million) will be paid in instalments in accordance with agreed milestones relating to the registration process involving recombined human insulin (RHI)...Actavis' Press Release -

Wednesday, November 23, 2011

Tandem Diabetes Care : FDA Clearance of the t:slim™ Insulin Delivery System

Tandem Diabetes Care
November 16, 2011 - Tandem Diabetes Care Announces FDA Clearance of the t:slim™ Insulin Delivery System -


Smallest Insulin Pump System and First-Ever with a Touch Screen -

Tandem Diabetes Care, Inc. announced that the U.S. Food and Drug Administration has granted the Company clearance to market the t:slim™ Insulin Delivery System.—

Tandem Diabetes Care, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to market the t:slim™ Insulin Delivery System (t:slim). This new full-featured pump is the first-ever with a color touch screen, and is the smallest insulin pump system currently available. The t:slim is one of the first insulin pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative.

“With the clearance of t:slim, Tandem Diabetes Care has an opportunity to set a new standard in insulin infusion therapy,” said Kim Blickenstaff, president and CEO, Tandem Diabetes Care. “In creating t:slim, we spoke with more than 4,000 healthcare professionals and people with diabetes, and the clear message we heard was, ‘make it cool and make it uncomplicated to use. Give us access to the most advanced features without extra effort.’ The t:slim’s touch screen interface has been proven in extensive user studies to be easy to learn and to use by new and experienced pump users alike.”

Of approximately 1.5 million people in the U.S. with type 1 diabetes,1 industry estimates indicate that only 20 to 30 percent use an insulin pump, despite clinical evidence that pump use can improve glycemic control and quality of life2. Tandem Diabetes Care believes that enhanced ease of use and attractive design will encourage more patients to consider the clinical benefits of insulin pump therapy... Tandem Diabetes Care's Press Release -

Friday, August 12, 2011

Amarantus BioSciences and Generex Biotechnology : Collaboration on Cell Therapy for Late Stage Diabetes

Amarantus BioSciencesAug. 4, 2011 - Amarantus BioSciences (OTCBB: AMBS), a biotechnology company developing a first-in-class anti-apoptosis therapeutic protein known as MANF, and Generex Biotechnology Corporation (OTCBB: GNBT), a biotechnology company developing a buccal insulin spray technology known as Generex Oral-lyn™, currently in a Phase III trial, are making public the details of their intended third joint diabetes research collaboration. In this third research project, the companies will use Amarantus' proprietary PhenoGuard cell immortalization process to develop beta cell replacement therapies to aid diabetes therapy. The two companies are currently planning to develop a MANF-based diagnostic test to identify a sub-population at risk of developing Type 1 or Type 2 diabetes as well as a MANF-based therapeutic to be administered using the RapidMist™ delivery system for the treatment of diabetes and impaired glucose tolerance.
Generex Biotechnology

"The potential of Amarantus' proprietary PhenoGuard cell immortalization process to create a stable source of representative beta cells that can be used in cell replacement therapy in patients who have lost virtually all beta cell function represents a potential major breakthrough for the treatment of chronic, late-stage diabetes," said Dr. James Anderson, Senior Scientific Advisor and Director of Generex. "Patients whose beta cell function is most impaired are the ones most at-risk of developing life-threatening complications of diabetes. Beta cell replacement therapy taken together with the development of a diagnostic test able to track the progression of beta cell dysfunction, and the ability to administer MANF prophylactically and therapeutically to alter the course of beta cell apoptosis and dysfunction in patients with diabetes and pre-diabetes disorders, these three research collaboration programs represent major research and development initiatives that could dramatically alter the course of treatment in the diabetes space. The breadth and scope of this research collaboration provides Generex with an incredible opportunity to position itself as a long-term market leader in the treatment of diabetes-related metabolic disorders."... [PDF] Amarantus BioSciences' Press Release - Generex Biotechnology 's Press Release -

Tuesday, August 2, 2011

Eli Lilly India and Lupin : Strategic Collaboration to Help Fight the Battle Against Diabetes

LupinJuly 29, 2011 - Eli Lilly India (Lilly) and Lupin Limited (Lupin)announced they have entered into a strategic collaboration to promote and distribute Lilly's Huminsulin range of products, including Huminsulin R(TM), Huminsulin NPH(TM), Huminsulin 50/50(TM), Huminsulin 30/70(TM) and Humapen Ergo II. Lupin's India formulations business will promote and distribute the range of products in India and Nepal, virtually doubling the number of sales representatives behind the diabetes care product. This collaboration will double the current customer base; approximately 45,000 doctors will now be called on as a result of the new partnership.

Eli Lilly
For Lilly, a company whose history in insulin production dates to 1923, caring for diabetes patients in India is clearly a priority. The country has an estimated 51 million people with diabetes currently and will have an estimated 85 million by 2030, or nearly one-fifth of all patients with diabetes globally. Lilly hopes to increase access to Huminsulin(TM) products through its relationship with Lupin India, bringing one of the most basic and proven therapies for diabetes treatment to more patients.

Lupin's India formulation business will deploy a sales force of medical representatives to provide education and resources to physicians and patients. Lupin has a vibrant presence in the Indian pharmaceuticals market and has over the past several years made major strides in expanding its therapy portfolio. Lupin has a robust promotion and distribution setup along with a strong presence in various therapeutic areas, including the fast growing diabetes market. This strategic collaboration will achieve major synergy arising from the strength of the product portfolio of Lilly and the promotion and distribution capabilities of Lupin... Eli Lilly's Press Release - Lupin's Press Release -

Wednesday, June 8, 2011

LCT and Otsuka of Japan : Common DIABECELL ® Vision

 Otsuka Pharmaceutical FactoryApril 12, 2011 ― Otsuka Pharmaceutical Factory, Inc. (head office: Naruto City, Tokushima, Japan; President: Ichiro Otsuka) (“OPF”) entered into a share subscription agreement on April 12, 2011 with Living Cell Technologies Limited (head office: Auckland, New Zealand, Managing Director & CEO:Ross Macdonald) (“LCT”) with respect to subscription for LCT’s new shares.
Under the agreement, OPF will invest AUD3 million in LCT for 25 million ordinary shares (A$0.12 per share). This investment will result in OPF holding 8.2% of LCT’s outstanding shares.
In addition to subscription for LCT’s new shares, OPF has earned an exclusive right to negotiate with LCT for research and development toward commercialization of LCT’s pancreatic islet “DIABECELL” and exclusive license and distribution right in Japan and other Asian countries (except for China).

Living Cell Technologies Limited lct
It is OPF’s objective, through obtaining the rights for development and commercialization of this pancreatic islet DIABECELL, to offer additional therapeutic options for patients with diabetes, and to strengthen its R&D in the field of regenerative medicine and further actively expand its business not only in Japan but also on the international stage... [PDF] Otsuka Pharmaceutical Factory's Press Release - [PDF] Living Cell Technologies' Press Release -

Monday, April 18, 2011

Asante Solutions : CE Mark for Pearl™ Insulin Pump

asante solutions.April 12, 2011 – Asante Solutions, Inc. (Asante), a medical device company focused on diabetes care, announced it received the CE mark for its Pearl Insulin Pump, the only insulin pump that uses a pre-filled insulin cartridge. The CE mark is a European proof of conformity that certifies the product meets EU safety, health and environmental requirements. Asante has begun discussions with potential distribution partners in Europe.
“This important regulatory milestone brings us one step closer to our goal of delivering a sensible solution to the growing but underserved insulin pump market,” said Phil Hopper, Asante CEO and President. “Once available, we believe the small and sleek Pearl will be the simplest-to-operate pump on the market. The Pearl is a fully featured insulin pump addressing the imperatives of safety, reliability, and ease of use required to meet the needs of people with diabetes using intensive insulin therapy.”

The Pearl Insulin Pump is designed to simplify diabetes care for the more than 500,000 people worldwide who use an insulin pump and those considering insulin pump therapy. Unlike the insulin pumps currently available, which require users to manually fill an insulin reservoir using a vial of insulin and syringe, the Pearl Insulin Pump uses a 300-unit, pre-filled insulin cartridge that simplifies the process of loading the pump and filling the infusion set by reducing the number of steps required and thereby creating a less time-consuming and more convenient process... [PDF] Asante Solutions' Press Release -

Wednesday, March 9, 2011

Sanofi-aventis Acquires from Ascendis Pharma Worldwide Rights on Drug-Delivery Technology in Diabetes and Related Disorders

Ascendis PharmaDecember 21, 2010 – Innovative technology designed for sustained release of peptides and proteins – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Ascendis Pharma (Ascendis) announced a global licensing and patent transfer agreement on Ascendis’ proprietary TransCon Linker and Hydrogel carrier technology, which allows for a drug compound to be released in the body in a precise, time-controlled fashion, creating a long-acting effect.
The technology creates transient bonds between larger molecules such as proteins and peptides, including insulin, and a carrier. This allows for tailor-made release profiles, with no initial burst and high drug load formulations. The TransCon Linker technology has shown promising results in preclinical studies in delivering insulin.

Sanofi-aventis
“We are excited about this promising technology to create next-generation products in the field of diabetes and related disorders,” commented Pierre Chancel, Senior Vice-President, Head of the Global Diabetes Division, sanofi-aventis. “Building on our achievements with Lantus®, our 24-hour insulin approved for use once a day, we hope to further improve the lives of people with diabetes by developing this innovative technology to offer biologicals that present an extended and controlled release of unmodified parent drugs, including insulin."... [PDF] Ascendis Pharma's Press Release - [PDF] Sanofi-aventis' Press Release -

Tuesday, March 1, 2011

Evotec : Metabolic disease alliance with MedImmune

Evotec15 December 2010 - Focus on innovative diabetes therapy - €5 million upfront payment, up to €254 million milestones and royalties - Evotec's first commercial agreement in the field of beta cell regeneration - Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX) announced that via its subsidiary Develogen AG it has entered into a license and collaboration agreement with MedImmune (the global biologics unit of AstraZeneca), in the diabetes therapeutic area, with a particular focus on the regeneration of insulin producing beta cells. The license gives MedImmune exclusive access to a portfolio of research programs and represents the first deal executed by Evotec on beta cell regeneration assets and capabilities.

Develogen
The agreement triggers an upfront payment of € 5 million. Further on, additional deferred payments including potential milestone payments of up to € 254 million as well as royalties are agreed. The milestone payments will be due upon achievement of certain clinical as well as regulatory and commercial events.

MedImmune
Further milestone payments may be achieved with the approval of additional indications and programs. Evotec will also receive research payments to support further in vivo and in vitro pharmacology efforts conducted in collaboration with MedImmune... Evotec's Press Release -

Saturday, December 11, 2010

Valeritas FDA 510(k) Clearance for the V-Go™ Disposable Insulin Delivery Device

Valeritas, Inc.December 8, 2010 - V-Go provides Type 2 diabetic patients a simple option for basal-bolus insulin therapy - Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, announced that the US Food and Drug Administration has cleared the company's V-Go Disposable Insulin Delivery Device for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing for adult patients requiring insulin. V-Go devices will be available in a preset basal rate to deliver 20, 30 or 40 Units of insulin in one 24-hour period (0.83 U/hr, 1.25U/hr or 1.67U/hr respectively) and on-demand bolus dosing in 2 Unit increments (up to 36 Units per one 24-hour time period).

"The V-Go Disposable Insulin Delivery Device is the first fully disposable, non-electronic basal-bolus device that is specifically designed with the Type 2 population in mind," said Valeritas CEO Kristine Peterson. "We believe that the simple user features of the V-Go will allow more patients with diabetes to adhere to their insulin regimen, which ultimately may lead to better control." ... Valeritas' Press Release -

Tuesday, October 19, 2010

Biocon and Pfizer : Global Commercialization Agreement

BioconOct. 18, 2010 - Creates Global Alliance Well Positioned to Deliver Essential Insulin Treatments to Diabetes Patients Worldwide - Biocon, Asia's premier biotechnology company, and Pfizer Inc. (NYSE: PFE), the world's leading biopharmaceutical company, announced that they have entered into a strategic global agreement for the worldwide commercialization of Biocon's biosimilar versions of Insulin and Insulin analog products: Recombinant Human Insulin, Glargine, Aspart and Lispro. Pfizer will have exclusive rights to commercialize these products globally, with certain exceptions, including co-exclusive rights for all of the products with Biocon in Germany, India and Malaysia. Pfizer will also have co-exclusive rights with existing Biocon licensees with respect to some of the products, primarily in a number of developing markets.

Pfizer Inc.

Biocon will remain responsible for the clinical development, manufacture and supply of these biosimilar Insulin products, as well as for regulatory activities to secure approval for these products in various geographies. Biocon's Recombinant Human Insulin formulations are approved in 27 countries in developing markets, and commercialized in 23, while Glargine has been launched in its first market, India... Pfizer's Press Release - [PDF] Biocon's Press Release -

Wednesday, September 1, 2010

ZenBio : Awarded Phase I SBIR Grant to Develop Adipose Stem Cells into Insulin Producing Cells

ZenBioJuly 1, 2010 - ZenBio, Inc. announced that it has been awarded a Phase I SBIR grant to identify and characterize an adult stem cell population from human fat stroma that has the therapeutic potential to differentiate into insulin-secreting “beta-like” cells.
Human adult stem cells derived from adipose tissue are a practical source of stem cells from which to launch work on deriving beta-like cells for autologous transplantation. The medical need for new therapies to manage type 1 and type 2 diabetes is well known and appreciated by physicians and patients alike. A plentiful and convenient source of cells that release appropriate amounts of insulin in response to changes in glucose would be a major advancement for diabetes therapy, particularly if the cells were provided by the patient (i.e. autologous transplantation). “In type 1 and long-term type 2 diabetes, the failure of the beta cells in the pancreas to produce sufficient insulin results in eventual insulin dependence for survival.”... [PDF] ZenBio's Press Release -

Wednesday, July 21, 2010

Prodigy : syringe-filling system for blind and low-vision diabetics

Prodigy Diabetes CareMarch 16, 2010 – Prodigy Diabetes Care, LLC, is launching its new Prodigy® Count-a dose™ April 1, a precise and safe syringe-filling device for the blind and visually impaired.
The Prodigy® Count-a-dose™ offers diabetics a device which can easily measure and mix two insulins at one time. The device had been pulled from the market a year ago by another company, prompting an outcry from blind and low-vision diabetics. Prodigy® is coming to their rescue as of April 1.
The initial version uses touch and sound to allow diabetics to measure out dosages. Prodigy® plans to release a fully audible version in the future, which mirrors the company’s commitment to providing audible medical devices.
“We’ve perfected the device to make it simple for the blind or low-vision patient to easily and, above all, safely fill their own insulin syringes,”... [PDF] Prodigy Diabetes Care's Press Release -

Monday, June 21, 2010

Home Diagnostics and Nipro Diabetes Systems : Plans to Merge to Become Nipro Diagnostics

Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. become Nipro Diagnostics, Inc.June 9, 2010 –– Home Diagnostics, Inc. and Nipro Diabetes Systems, Inc. announced that the two companies will merge to become Nipro Diagnostics, Inc. Both companies are wholly-owned by Nipro Corporation, a multi-billion dollar company headquartered in Osaka, Japan and a world leader in providing medical products to the healthcare community.
Home Diagnostics, Inc., based in Fort Lauderdale, Florida, manufactures and markets the TRUE brand of quality, high-performance blood glucose monitoring systems. Home Diagnostics is the co-brand supplier of blood glucose monitoring systems for leading national retail pharmacies, pharmacy wholesalers, medical products distributors and mail-order suppliers. Nipro Diabetes Systems, located in Miramar, Florida, is the manufacturer and marketer of the Amigo® Insulin Pump.
The merger of the two companies results in a comprehensive diabetes monitoring and insulin management product portfolio, which few companies offer. This portfolio will help to ensure that patients and their healthcare professionals have easy access to the high-quality diabetes monitoring and management tools they need to improve quality of life... [PDF] Nipro Diagnostics Press Release -

Thursday, May 27, 2010

Home Diagnostics, Inc. and Cellnovo : Strategic Alliance

CellnovoMay 6, 2010 – Building on a shared vision to simplify diabetes management worldwide, Cellnovo, a London-based medical device company, and Home Diagnostics, Inc., a leader in diabetes products, announced a strategic alliance that involves integrating technologies and developing distribution opportunities for Cellnovo’s insulin patch pumps.

Home Diagnostics, Inc.The partnership allows both companies to accelerate their growth and has the potential to transform the pump industry. The first phase of the agreement calls for the inclusion of Home Diagnostics TRUE™ blood glucose technology in the Cellnovo wireless mobile handset. The companies will also begin exploring ways to leverage Home Diagnostics’ distribution network to expand Cellnovo’s presence in the United States and other countries... [PDF] Home Diagnostics' Press Release -

Tuesday, April 27, 2010

MannKind Corporation : Follow-up Safety Data Show AFREZZA(TM) Comparable to Standard Antidiabetic Therapy in Lung Function Tests

MannKind CorporationApr 23, 2010 - Follow-up Study with Investigational Diabetes Therapy Presented at the American Association of Clinical Endocrinologists 19th Annual Meeting -Pulmonary function test results (PFTs) in patients treated with AFREZZA TM (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, ultra rapid acting insulin, at follow-up measurements were similar to PFT results observed in patients receiving standard antidiabetic therapy, according to data presented today at the American Association of Clinical Endocrinologists 19th Annual Meeting (Poster #267). Results from the follow-up study suggest that the pattern and magnitude of changes in lung function associated with the use of AFREZZA in patients with Type 1 and Type 2 diabetes are not likely due to any structural alterations in the lungs and are not clinically meaningful.

"Our findings add to the growing body of clinical evidence that indicates AFREZZA is comparable to standard of care insulin therapy in terms of lung safety," ...

...

...AFREZZA is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corporation for the treatment of adult patients with Type 1 and Type 2 diabetes for the control of hyperglycemia. It is a drug-device combination product, consisting of AFREZZA Inhalation Powder pre-metered into single use dose cartridges and the light, discreet and easy-to-use AFREZZA Inhaler. Administered at the start of a meal, AFREZZA dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of meal-time insulin observed in healthy individuals. To date, the AFREZZA clinical program has involved 49 different studies and over 5,000 adult patients... MannKind's Press Release -

Tuesday, April 13, 2010

Roche acquires Medingo Ltd. and expands its position in the growing insulin delivery systems market

Roche13 April 2010 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Elron Electronics Ltd. (TASE:ELRN) announced that they have signed an agreement under which Roche will acquire 100% of Medingo Ltd., a majority-owned subsidiary of the Elron group. Medingo Ltd. is engaged in the development of a semi-disposable insulin patch pump.

Medingo Ltd.
Under the terms of the agreement, Roche will pay Medingo Ltd.’s shareholders an upfront payment of US$ 160 million as well as up to 25% of the upfront payment in performance related milestones... Roche's Press Release - [PDF] Elron Electronics' Press Release -