Boehringer-Lilly’s diabetes drug fails to receive FDA panel votes

Pharmaceutical Technology | November 14, 2019

The US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted against Boehringer Ingelheim and Eli Lilly’s diabetes drug, empagliflozin. The panel voted 14 to 2, saying that the benefits of 2.5mg dose of the drug do not outweigh its risks as an adjunct to insulin in adults with type 1 diabetes. Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2). In higher doses, the inhibitors were associated with a life-threatening complication, diabetic ketoacidosis (DKA), said Reuters. FDA previously approved 10mg and 20mg empagliflozin (Jardiance) to lower blood sugar levels in patients with type 2 diabetes. The regulator will consider EMDAC’s recommendation while reviewing the drug for type 1 diabetes.

Spotlight

Melva Covington, Senior Director, Head of Field Based Medical Strategy, Sanofi speaking to Ulrich Neumann, eyeforpharma on her hope for the future of the pharma-patient dialogue.

Spotlight

Melva Covington, Senior Director, Head of Field Based Medical Strategy, Sanofi speaking to Ulrich Neumann, eyeforpharma on her hope for the future of the pharma-patient dialogue.

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RESEARCH

Stallergenes Greer and Aptar Pharma Announce Partnership to Develop Novel Connected Device for Allergen Immunotherapy Treatment Delivery

STALLERGENES GREER LTD | October 27, 2021

Stallergenes Greer, a global healthcare company specialising in allergen immunotherapy (AIT), today announced that the company has entered into an exclusive partnership with Aptar Pharma, a global leader in drug delivery systems, services and active material science solutions, for the development of the first of its kind connected device and companion mobile app for patients undergoing Stallergenes Greer’s AIT treatments with sublingual solutions. “This exclusive partnership with Aptar Pharma demonstrates the intensification of Stallergenes Greer’s investments in innovation to provide a large range of precise personalised allergen immunotherapy options adapted to the individual needs and lifestyle of patients. Stallergenes Greer is well advanced on its digital transformation journey and will continue to develop its e-health offering for the benefit of all stakeholders,” stated Dominique Pezziardi, General manager France, Belgium and Luxembourg, Global Head of Pricing and Market Access. Non-adherence to an AIT schedule and premature discontinuation of treatment remain a challenge in AIT management. This innovative, easy-to-use connected device will contribute to improving dose compliance and adherence, thus optimising treatment outcomes. The development work is being undertaken by Aptar Pharma’s Digital Health group, which has capabilities and expertise in device and software development. The product will leverage Aptar Pharma’s Cohero platform, which will be tailored specifically for this use. “We are pleased to combine Aptar Pharma’s Digital Health ecosystem with Stallergenes Greer’s knowledge and leading position in AIT to further improve the treatment journey of patients who suffer from allergiesThe newly developed connected device should be available in France in 2022 and will be progressively rolled-out in Stallergenes Greer’s markets. Sai Shankar, Vice President, Global Digital Healthcare Systems, Aptar Pharma This innovation further illustrates Stallergenes Greer’s commitment to build on precision medicine and personalised healthcare which cater to the needs of both patients and the medical community. ABOUT STALLERGENES GREER LTD Headquartered in London (UK), Stallergenes Greer Ltd is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergy immunotherapy products and services. Stallergenes Greer Ltd is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). ABOUT APTAR PHARMA Aptar Pharma is part of Aptar Group Inc., a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions. Aptar’s innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, personal care, home, food and beverage. Using insights, proprietary design, engineering and science to create dispensing, dosing and protective technologies for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has 13,000 dedicated employees in 20 countries.

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PRACTICE MANAGEMENT

AvKARE bottles mix Viagra generics with antidepressant, triggering recall

AvKARE | December 15, 2020

A conventional drugmaker with a Rolodex loaded with government customers is pulling an energizer and an erectile brokenness medications after the two were bundled together in similar containers. Pulaski, Tennessee-based AvKARE reviewed one parcel of sildenafil 100-mg tablets and one parcel of trazodone 100-mg tablets after the items were stirred up by an outsider bundling provider, the organization said before the end of last week. The jugs had just been delivered to drug stores. AvKARE markets its own private-name conventional medications to a record of government customers, including the branches of Defense, Veterans Affairs and the Health and Human Services. The organization additionally supplies the Indian Health Services, in addition to nongovernment clients around the world. The customer level review influences parts sent to merchants and wholesalers and afterward delivered out from one side of the country to the other, the organization said. The sildenafil part has a March 2022 termination date, while the trazodone parcel lapses in June 2022. AvKARE said it so far hasn't got any result reports from the reviewed parcels. Sildenafil—a nonexclusive rendition of Viagra—can blend inadequately with nitrate-containing drugs for diabetes, hypertension or coronary illness, conceivably bringing pulse down to perilous levels. The upper trazodone hydrochloride, in the interim, can cause sluggishness, dazedness, stoppage and obscured vision, AvKARE cautioned. Those results represent a more serious danger of falls and impeded driving in more seasoned clients who may have bought the organization's erectile brokenness copycat.

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BUSINESS INSIGHTS

Enclara Pharmacia Earns Five Year Contract Extension with VITAS Healthcare

Enclara Pharmacia | February 18, 2022

Enclara Pharmacia the market leader in comprehensive pharmacy benefits management (PBM) services to the hospice community, has announced a five-year contract extension to continue providing comprehensive patient medication management services to VITAS Healthcare, the nation’s leading provider of hospice and palliative care. The contract extension affirms the longstanding collaboration between the two companies based on excellence, innovation and quality care for hospice patients and their families. “The goal of hospice is to provide care and comfort that helps patients maintain the best possible quality of life. Pain and symptom management are central to that work. Our team relies on proper medication management so we value Enclara’s combination of powerful technology and personal service that supports and empowers our team to deliver the best quality care.” Nick Westfall, president and CEO, VITAS Mark Morse, CEO, Enclara, said, “VITAS is an industry leader, and with their scale and commitment to continuous improvement in hospice and palliative care, we are able to better identify and respond to the changing needs of the hospice community. This ultimately positions Enclara to better serve hospices of all shapes and sizes.” Scott Quilty, Chief Commercial Officer, Enclara, noted the VITAS renewal comes as Enclara is completing development of the next generation of its E3 mobile and desktop nurse-facing medication management tools. He said, “I’m grateful to continue this relationship as we prepare to roll out the next generation of our E3 application, E3 ProTM. VITAS’ feedback was essential as we worked to prioritize new features that will empower nurses to efficiently administer clinically appropriate symptom management.” About Enclara Pharmacia Enclara Pharmacia is a national full-service PBM and mail order supplier of medications and clinical services developed specifically for the hospice and palliative care industry. Enclara serves over 400 hospice providers and 97,000 patients nationally, helping to reduce pharmacy costs through a clinically driven model that enables home delivery of pharmaceuticals as well as access to a network of over 65,000 local pharmacies, including an actively managed network subset of over 7,000 retail pharmacies, institutional pharmacies, and Enclara’s own automated fulfillment solutions. About VITAS® Healthcare Established in 1978, VITAS Healthcare is a pioneer and leader in the American hospice movement. Headquartered in Miami, Florida, VITAS operates 49 hospice programs in 14 states and the District of Columbia. VITAS employs 10,618 professionals who care for patients with advanced illness, primarily in the patients’ homes, and also in the company’s 28 inpatient hospice units as well as in hospitals, nursing homes and assisted living communities/residential care facilities for the elderly. At the conclusion of the third quarter of 2021, VITAS reported an average daily census of 18,026.

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