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Sanofi Insulin Pens

Sanofi Secures Us Regulatory Approval For New Insulin Pen

Sanofi Secures Us Regulatory Approval For New Insulin Pen

Sanofi secures US regulatory approval for new insulin pen The new Max SoloStar pen holds 900 units of Toujeo, more than any other long-acting insulin pen in the US. Credit: Sanofi. Sanofi has secured approval from the US Food and Drug Administration (FDA) for its new long-acting insulin pen, Toujeo Max SoloStar, for diabetes patients. Toujeo is 300units/ml of insulin glargine. The new high capacity device has the ability to hold 900 units of Toujeo and can dispense up to 160units/ml of the insulin glargine in one injection. The company expects that Max SoloStars higher capacity will result in a decrease in the number of pens prescribed to adults for Toujeo use. This will lead to reduced refills and associated copays. In certain patients, the maximum 160units/ml dose is expected to minimise the number of injections required to deliver the necessary Toujeo dosage. The new high capacity device has the ability to hold 900 units of Toujeo and can dispense up to 160units/ml of the insulin glargine in one injection. Sanofi North America Diabetes and Cardiovascular head Michelle Carnahan said: This new high capacity pen has a broader range of doses than the original SoloStar, delivering Toujeo, long-acting insulin with established safety and efficacy. By reducing the number of injections for people who need more long-acting insulin and lowering copay costs both of which are important to patients Toujeo Max SoloStar underscores Sanofis continued commitment to help those living with diabetes. Toujeo Max SoloStar will be introduced in retail pharmacies across the US in the third quarter of 2018. To what extent do you think a lack of widespread access to diagnostic testing has exacerbated the spread of Covid-19 (coronavirus)? Continue reading >>

Sanofi Files Patent Infringement Suit Against Mylan Over Insulin Pen

Sanofi Files Patent Infringement Suit Against Mylan Over Insulin Pen

Sanofi files patent infringement suit against Mylan over insulin pen Sanofi (NYSE: SNY ) filed a patent infringement suit against Mylan (NSDQ: MYL ) yesterday in the U.S. District Court of New Jersey, alleging that the EpiPen-maker infringed upon 18 patents covering Sanofis Lantus insulin glargine injection and SoloStar pen. The suit was triggered by a notice from Mylan in mid-September, Sanofi said. Mylan told the insulin-maker that it had filed an NDA for an insulin glargine pre-filled pen, which challenged all of the patents listed for Sanofis Lantus products. Mylan is not the only company that Sanofi is tangling with in court over the Lantus patents. In August, the company filed another patent lawsuit against Merck Sharp & Dohme Corp. (NYSE: MRK ), alleging that Mercks product infringes upon two patents covering Lantus. In July, Merck won tentative approval for its follow-on biologic version of Sanofis Lantus. The agencys final regulatory nod is contingent upon the resolution of these patent infringement suits, according to Reuters . Sanofi said its most recent suit was triggered by a notification received by Merck in June. Merck reportedly told the company that its the application for regulatory approval included a section challenging all of the Sanofi patents listed for its Lantus and Lantus SoloStar products. The Paris-based company filed its latest suit in the U.S. District Court of New Jersey. Late last year, Sanofi brought a lawsuit against Merck, alleging infringement of 10 patents covering its Lantus products, in the U.S. District Court of Delaware. Continue reading >>

Haselmeier Announces Launch Of Sanofi Half-unit Insulin Pen

Haselmeier Announces Launch Of Sanofi Half-unit Insulin Pen

Suitable for all Sanofi insulin types, the new and reusable half-unit insulin pen JuniorSTAR is now available in Germany. It provides individual dosage, which can be corrected easily. Furthermore, it has a large display to ensure the correct dosage and is a lightweight companion during the day, especially for young people with diabetes. “The launch of JuniorSTAR marks another milestone of a long-term partnership with Sanofi," said Sandra de Haan, director project management at Haselmeier and project manager responsible for the JuniorSTAR. "After the single unit pen TactiPen, the portfolio is now complete with the half-unit pen JuniorSTAR. The JuniorSTAR delivers 1 to 30 units in steps of 0.5. Thanks to the close cooperation of both teams, we were able to develop an excellent pen that meets current, very high quality requirements.” “The JuniorSTAR expands our portfolio for people suffering from diabetes,” said Hamit Oualali, global device manager for reusable pens at Sanofi. “Being flexible and easy to handle, it is especially suitable for young people with type 1 diabetes. The close and excellent cooperation with Haselmeier was an important part for the successful development of the JuniorSTAR.” The pen comes in red, blue and silver for easy differentiation of various insulin types. The Chicago Athenaeum Museum of Architecture and Design has already honoured the JuniorSTAR pen for its new and fully developed technology with the Good Design Award. Haselmeier GmbH, www.haselmeier.com. Continue reading >>

Sanofi, Joslin Partner On Clinical Trial Of Common Sensing's Connected Insulin Pen Cap

Sanofi, Joslin Partner On Clinical Trial Of Common Sensing's Connected Insulin Pen Cap

Sanofi, Joslin partner on clinical trial of Common Sensing's connected insulin pen cap Common Sensing , a Cambridge-based company developing a smart connected insulin pen cap, announced that it will test its device in a clinical trial in collaboration with Joslin Diabetes Center, Sanofi, and Dexcom. The study of 125 subjects will be conducted by Joslin and funded by Sanofi. Patients will be given a Gocap from Common Sensing, a cap that fits on to a disposable insulin pen and can detect data on when the injector is used and how much insulin is left in it. They will also have a Dexcom CGM. In the Joslin study, [our device is] being given out with a CGM, James White, president and cofounder of Common Sensing, told MobiHealthNews. So youll be able to see someone injecting a dose and, for every minute after that, see how their glucose changes, measured by that CGM. No ones ever seen that before for disposables, so were really excited. Gocap can send data about adherence to the patients smartphone and allow them to monitor trends, but it can also send that data out to a doctor or health coach, which is where White expects to see most of the value. Right now, people go home from the doctor after being given insulin for the first time and they dont have another touchpoint for three months with anything, White said. Their data is theirs, theyre looking at it, but they often dont know how to interpret it because they werent taught at the doctor, and more than half of those people, in those first three months, drop off. They come back and theyre not using it. With Gocap, however, the patients care team can intervene the moment they dont take an injection, rather than waiting three weeks. So if Im using an insulin pen and I drop off that first week, someone from the clinic or coac Continue reading >>

Re-usable Insulin Pen From Sanofi

Re-usable Insulin Pen From Sanofi

Sanofi India, on Tuesday, announced the launch of AllStar, its first indigenously-manufactured reusable insulin pen. We have launched AllStar, an indigenously-manufactured reusable insulin pen at an affordable price of Rs.650 a unit. It is developed for Indian patients by Sanofis medical device development team in Frankfurt, company Managing Director Shailesh Ayyangar told reporters here. AllStar was custom-made for patients in India. It would help improve insulin initiation and compliance and bring ease and reassurance to the lives of patents, giving them the convenience of international standards at an affordable price, he said. Incidentally, India has the second highest number of diabetics in the world estimated at 62 million. The company had also received enquiries from other emerging markets in Asia and Africa, Mr. Ayyangar said. Shashank Joshi, President, Indian Academy of Diabetes, said: In India, on an average, doctors prescribe insulin therapy to about one-third of the countrys diabetes patients. Close to 75 per cent patients are on vials with syringes and 25 per cent on insulin pens. Insulin pens definitely offered greater advantage than vials and syringes in terms of ease of usage, thereby increasing patient initiation and compliance to therapy, Mr. Joshi said. Continue reading >>

Sanofi-aventis' Solostar Lantus Insulin Pen Marketed In Us

Sanofi-aventis' Solostar Lantus Insulin Pen Marketed In Us

Sanofi-aventis' SoloSTAR Lantus insulin pen marketed in US Sanofi-aventis launches Lantus SoloSTAR, a disposable insulin pen, on the US market Sanofi-aventis has launched its Lantus SoloSTAR, a disposable insulin pen, on the US market. SoloSTAR pre-filled with Lantus (insulin glargine [rDNA origin]), the only 24-hour insulin approved exclusively for use once a day, for the treatment of hyperglycaemia in people with type 1 or type 2 diabetes. The product is also the only prefilled disposable insulin pen which permits patients to administer doses from one to 80 units, in one injection and offers a 25 per cent greater maximum capacity than other insulin pens. Equivalence studies have revealed that the product operates with a lower injection force and requires 31 per cent less injection force than the Novo Nordisk FlexPen and 54 per cent less force than the Eli Lilly Humulin/Humalog pen. Lantus SoloSTAR is also available in Australia. Previously, it was introduced in France and Germany in 2007 and is expected to be introduced in other countries in the near future. Angela Moskow, associate vice president of diabetes marketing at sanofi-aventis, said: "Insulin pens are underutilised in the US, compared with other countries, even though they may offer more convenience and flexibility for people with diabetes. Lantus SoloSTAR demonstrates sanofi-aventis' commitment to designing devices based on insights from people with diabetes, to help meet their lifestyle demands. We are excited to offer this new device." Continue reading >>

Fda Approves New Maximum-unit Insulin Pen

Fda Approves New Maximum-unit Insulin Pen

FDA Approves New Maximum-Unit Insulin Pen The US Food and Drug Administration (FDA) has approved glargine 300 units/mL insulin pen (Toujeo Max SoloStar) as the newest device for insulin injection therapy. With the approval, the pen from Sanofi became the largest pen carrier of insulin units on the market designed to hold 900 units/mL, and provide up to 160 units/mL per single injection. The greater capacity of the Max SoloStar leads Sanofi to believe its newly-approved device could reduce the amount of pens adults prescribed to Toujeo use, thereby affecting their rate of refills and related copays. The maximum dosage rate may also reduce the number of necessary injections for some adults with diabetes. The preceding SoloStar device for Toujeo injectios contained 450 units of insulin glargine, and a maximum single injection dose of 80 units/mL. At the time of its approval, Sanofi reported that this dosage met the vast majority of patients on basal insulin in the US, who require 80 IU or less per day. Michelle Carnahan, North America Diabetes and Cardiovascular Head of Sanofi, highlighted the pens new capacity and dose range compared to the original SoloStar device. By reducing the number of injections for people who need more long-acting insulin and lowering copay costs both of which are important to patients Toujeo Max SoloStar underscores Sanofi's continued commitment to help those living with diabetes, Carnahan said in a statement. Toujeo, the once-daily long-acting basal insulin therapy, was approved by the FDA to treat glycemic control in adult patients with type 1 and type 2 diabetes in February 2015. In clinical trials included in its FDA application, the therapy was compared to 100 unit/mL once-daily insulin glargine injection (Lantus) in open-label, randomized, Continue reading >>

Sanofi Gets Fda Approval For Toujeo Max Solostar Insulin Pen Device

Sanofi Gets Fda Approval For Toujeo Max Solostar Insulin Pen Device

Sanofi gets FDA approval for Toujeo Max SoloStar insulin pen device MDBR Staff Writer Published 28 March 2018 Sanofi has secured approval from the US Food and Drug Administration (FDA) for its new insulin pen device, Toujeo (insulin glargine 300units/mL) Max SoloStar. The new Max SoloStar pen accommodates 900 units of Toujeo, and can deliver up to 160units/mL of Toujeo in a single injection. Its higher capacity will help to reduce the number of pens adults prescribed Toujeo use, allowing for fewer refills and related copays. The maximum dose of up to 160units/mL will also allow to reduce the number of injections needed to deliver the required Toujeo dosage for some diabetes patients. Sanofi is planning to launch the Toujeo Max SoloStar in retail pharmacies across the US in the third quarter of this year. Toujeo is a long-acting insulin developed to control blood sugar in adults with diabetes mellitus. It contains three times more insulin in 1mL compared to standard insulin (100units/mL). Toujeo cannot be used for the treatment of diabetic ketoacidosis, and should be avoided to treat children. According to Sanofi, Toujeo SoloStar and Toujeo Max SoloStar are disposable prefilled insulin pens, and required to carry out a safety test when using a new pen for the first time. Toujeo should not be diluted or mixed with any other insulin or solution, which will result in drop of blood sugar control and not work as intended. It should be used only if the solution is clear and colorless with no particles visible. Sanofi North America diabetes and cardiovascular head Michelle Carnahan said: "This new high capacity pen has a broader range of doses than the original SoloStar, delivering Toujeo, a long-acting insulin with established safety and efficacy. "By reducing the number of i Continue reading >>

Sanofi Aims To Lower Copay Costs With Higher-capacity Toujeo Pen

Sanofi Aims To Lower Copay Costs With Higher-capacity Toujeo Pen

Sanofi aims to lower copay costs with higher-capacity Toujeo pen The Food and Drug Administration on Tuesday cleared Sanofi SA's Toujeo Max SoloStar, a delivery device for the long-acting insulin that the French drugmaker characterized as the highest-capacity pen on the U.S. market. Toujeo Max SoloStar holds 900 units of product, significantly more medication per pen that a typical insulin pen holds. Sanofi said the move to cram more product into the disposable prefilled pens may cut down on out-of-pocket costs by potentially lowering the number of times patients need to refill their prescriptions at a pharmacy. For many patients, going to the pharmacy regularly can seem like a chore and in the case of procuring insulin, sometimes an expensive one. In what Sanofi says is an effort to help patients reduce drug costs and boost convenience, the company introduced Toujeo (insulin glargine 300 units/mL) Max SoloStar. The new device holds more insulin than standard pen, so patients theoretically would have to pay a copay less frequently than they might otherwise when picking up refills of a standard insulin pen. Sanofiwill also offer a copay card to patients. Eligible, commercially insured patients wouldn't have copay costs for their first three prescription renewals provided they are new to Toujeo. After that, they would have $10 copays for the next 12 refills, the French pharma said. Sanofi spokesperson Ashleigh Koss said the company chose to keep the unit price the same to align with its pledge to boost transparency and keep patient costs under control. Last year, Sanofi announced it would keep price increases for its medicines at or below the national health expenditure growth projection calculated by the Centers for Medicare and Medicaid Services. For Toujeo, the wholes Continue reading >>

Sanofi’s Allstar Pro Reusable Insulin Pen Now Available In Australia

Sanofi’s Allstar Pro Reusable Insulin Pen Now Available In Australia

Sanofi has developed the AllStar PRO, a reusable insulin pen for use with Lantus (insulin glargine 100 units/mL) and Apidra (insulin glulisine) cartridges. It replaces the longstanding ClikSTAR pen. The AllStar PRO has the same functionality as ClikSTAR, enabling a smooth transition to the new pen. Designed for use with the existing Lantus and Apidra cartridges, the AllStar PRO allows patients to transition from the ClikSTAR device while using their existing stock of Lantus or Apidra cartridges. Prescribers will be able to continue to prescribe Lantus and Apidra cartridges. The AllStar PRO is compatible with various needle types, including needles from Becton Dickinson. The AllStar PRO's discrete design is lightweight and slim for ease of use in patients' everyday life. AllStar PRO conceals the dose numbers on the dial extension so that they can only be seen in the dose window. It also features a magnified dose display and audible clicks which provides reassurance when dialling a dose. The AllStar Pro is available in two colours; Silver, which is intended for use with Lantus and Blue, which is intended for use with Apidra. Sanofi medical lead Dr Marie Hartley said Sanofi believes in the AllStar PRO new design and so decided to completely transition from the ClikSTAR to the AllStar PRO. The ClikSTAR pen is no longer available. The AllStar PRO is available through your Sanofi representative or by calling 1800 451 479. We kicked some goals for our members during the 2017 State election last month. Here's the evidence that we had done the groundwork then delivered results when it was going to count - while politicians were being held to account by voters. Individual MPs, candidates and parties spoke up... More Tweet We are a charity and membership organisation providing edu Continue reading >>

Insulin Pen Safety

Insulin Pen Safety

Insulin pens have become a popular way for diabetics to give themselves insulin. Insulin pens are available for multiple insulin types. However, as with any technology, pens can be misused leading to medication errors and inaccurate administration of insulin. Although an insulin pen is easy to use, certain precautions must be taken to assure proper use. Below is a list of safety tips to keep in mind when using an insulin pen: 1. Do not share your insulin pen with anyone: Insulin pens should never be used for more than one person. Using insulin pens on more than one person puts people at risk for infection with blood-borne pathogens such as hepatitis viruses and HIV, which causes AIDS, the agency warns. Infection can occur even if an insulin pen's needle is changed. We are aware of this happening in hospitals, where, for example, a nurse may not realize the risk. Pen needles are changed in between patients but the very same pen is used for multiple patients! This is dangerous because even if the needle is changed, it's still possible for insulin in the pen to become contaminated. Then, when subsequent patients are injected, there's a danger of passing along harmful bacterial or virus. 2. Do not withdraw insulin from an insulin pen cartridge Using insulin pens as "mini" insulin vials, by drawing up insulin into an insulin syringe, can lead to inaccurate dose measurement the next time the insulin pen is used for dose delivery. The reason for this is related to air entering the pen unintentionally, interfering with the proper mechanics of the pen. 3. Do not leave an open needle attached to an insulin pen Leaving an insulin needle attached to an insulin pen can lead to unintentional air entering into the insulin pen. If unintentional air enters into the insulin pen, it can c Continue reading >>

Sanofi Launches Re-usable Insulin Pen Priced Rs 650 - Business Line

Sanofi Launches Re-usable Insulin Pen Priced Rs 650 - Business Line

Sanofi launches re-usable insulin pen priced Rs 650 Volker Korger (right), Director-Diabetes Device Projects Global Medical Device Development, Sanofi Germany; Shailesh Ayyangar, Managing Director-India & Vice-President - South Asia, Group Sanofi; and Shashank Joshi, Consultant Endocrinologist at Lilavati Hospital, at a press conference in Mumbai on Tuesday. Shashi Ashiwal - Business Line The Indian-arm of French company Sanofi has brought out a re-usable insulin delivery pen completely Made-in-India. It took three years to develop the indigenously made device sold under the AllStar brand name, designed on the feed back of people in India, said Shailesh Ayyangar, Sanofi Indias Managing Director and Vice-President. Priced at Rs 650 per pen, the device is pegged at about 20 per cent less than other similar products in the market, he added. A person with diabetes could use the pen-shaped device by fitting it with a cartridge of Sanofis insulin and injecting themselves. There are queries for AllStar from South-East Asian and African markets, he said, and a regulatory pathway is being worked out to sell in these markets. India is estimated to have about 64 million people with diabetes. The product has been designed in-keeping with the specific needs of the local market, he said. The device will be made in Gujarat. For the Rs 2,000-crore Sanofi India, about Rs 400 crore comes from its diabetes portfolio comprising orally consumed drugs and insulin. Outlining the features of the device, Volker Korger, Sanofis Head - Diabetes Device Projects (Frankfurt), said the device was the slimmest, shortest and lightest of pens available in India. The device is the outcome of a multi-country venture, including Germany, the United Kingdom, Taiwan and India, he said. One of the key feature Continue reading >>

Sanofi - Diabetes And Cardiovascular Diseases - Sanofi

Sanofi - Diabetes And Cardiovascular Diseases - Sanofi

Life is a health journey, and the global trends toward longer life expectancies and increasingly more sedentary lifestyles have made diabetes and cardiovascular disease worldwide public health concerns. The effects of diabetes and cardiovascular disease are severe, particularly because many people live with both. Research has, however, helped turn these diseases into chronic conditions that can be treated, and many people now live longer, more active and more fulfilling lives. Diabetes is caused by either a lack of insulin in the body (type 1) or the inability of the body to use the insulin it produces (type 2). At Sanofi, we have been developing insulin treatments for diabetes for close to a century. We offer a comprehensive portfolio of diabetes medicines, including insulins, to lower blood sugar levels and today, more than 50% of people on once-daily basal insulin treatments are supported by Sanofi. Cardiovascular disease is a group of disorders of the heart and blood vessels. Building on Sanofis legacy of more than 50 years of fighting cardiovascular disease, we deliver innovative therapeutic solutions for cardiovascular conditions to people at high risk for cardiac events (such as a heart attack) and who need additional treatment options beyond currently available medications. People living with diabetes and cardiovascular disease still face many challenges. They see their doctors only few times a year; miss support in between; and need to adapt their nutrition, exercise and medication. Diabetes and cardiovascular disease are also a burden for healthcare systems worldwide, due to the increasing number of cases and associated healthcare costs. Even as therapeutic solutions become more effective, we recognize that the management of these diseases is a 24/7 job. As a Continue reading >>

New Sanofi Insulin Savings Program Aims To Lower Out-of-pocket Costs For People Living With Diabetes - Apr 5, 2018

New Sanofi Insulin Savings Program Aims To Lower Out-of-pocket Costs For People Living With Diabetes - Apr 5, 2018

New Sanofi insulin savings program aims to lower out-of-pocket costs for people living with diabetes - The new Insulins VALyou Savings Program improves affordability for eligible people prescribed Lantus (insulin glargine 100 Units/mL) and Admelog (insulin lispro injection) - Admelog, the first follow-on mealtime insulin, is now available in the U.S. BRIDGEWATER, N.J., April 5, 2018 / PRNewswire / --Sanofi's new Insulins VALyou Savings Program will seek to help lower out-of-pocket costs for people living with diabetes who otherwise would pay full retail price for Lantus or Admelog. This includes certain uninsured patients who don't qualify for traditional patient assistance programs, in addition to some commercially insured patients with a high deductible that has not been reached on their plan. Under this new program, the total out-of-pocket cost a person will pay for Lantus or Admelog will be $99 for a 10 mL vial or $149 for a box of five 3 mL pens and is available at all U.S pharmacies. For some people, the program could offer significant savings compared to the out-of-pocket cost of other long-acting or fast-acting insulins. "We understand that many people living with diabetes struggle to afford critically needed medications, especially those facing high out-of-pocket costs when paying for their insulin," said Michelle Carnahan, North America Diabetes and Cardiovascular Head, Sanofi. "This program helps support those we can today, while we continue to innovate to help even more people tomorrow. It is our goal to do our part to find ways that help people living with diabetes gain access to insulins they need to help manage their disease, at a clear and consistent price, regardless of their pharmacy choice." In addition to this program, Sanofi will continue offering Continue reading >>

New Sanofi Insulin Savings Program Aims To Lower Out-of-pocket Costs For People Living With Diabetes

New Sanofi Insulin Savings Program Aims To Lower Out-of-pocket Costs For People Living With Diabetes

New Sanofi insulin savings program aims to lower out-of-pocket costs for people living with diabetes - The new Insulins VALyou Savings Program improves affordability for eligible people prescribed Lantus (insulin glargine 100 Units/mL) and Admelog (insulin lispro injection) - Admelog, the first follow-on mealtime insulin, is now available in the U.S. BRIDGEWATER, N.J., April 5, 2018 /PRNewswire/ --Sanofi's new Insulins VALyou Savings Program will seek to help lower out-of-pocket costs for people living with diabetes who otherwise would pay full retail price for Lantus or Admelog. This includes certain uninsured patients who don't qualify for traditional patient assistance programs, in addition to some commercially insured patients with a high deductible that has not been reached on their plan. Under this new program, the total out-of-pocket cost a person will pay for Lantus or Admelog will be $99 for a 10 mL vial or $149 for a box of five 3 mL pens and is available at all U.S pharmacies. For some people, the program could offer significant savings compared to the out-of-pocket cost of other long-acting or fast-acting insulins. "We understand that many people living with diabetes struggle to afford critically needed medications, especially those facing high out-of-pocket costs when paying for their insulin," said Michelle Carnahan, North America Diabetes and Cardiovascular Head, Sanofi. "This program helps support those we can today, while we continue to innovate to help even more people tomorrow. It is our goal to do our part to find ways that help people living with diabetes gain access to insulins they need to help manage their disease, at a clear and consistent price, regardless of their pharmacy choice." In addition to this program, Sanofi will continue offering th Continue reading >>

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