Insulin

Mitsubishi Motors Partners with Healthcare Nonprofit to Reach Underserved Communities in Middle Tennessee

Thursday, August 5, 2021 - 5:07pm

MMNA's CUV Program offers vehicle loans to nonprofit organizations making a difference in their local communities, such as Charis.

Key Points: 
  • MMNA's CUV Program offers vehicle loans to nonprofit organizations making a difference in their local communities, such as Charis.
  • "We are grateful to have been chosen by Mitsubishi Motors to be part of their Community Utility Vehicle Program."
  • "The partnership with Charis Health Center is the latest example of our commitment to safer, healthier communities across the country and at home in Middle Tennessee."
  • For more information on Mitsubishi vehicles, please contact the Mitsubishi Motors News Bureau at 615-257-2698 or visit media.mitsubishicars.com .

Eiger Announces FDA Breakthrough Therapy Designation for Avexitide for Treatment of Congenital Hyperinsulinism

Thursday, August 5, 2021 - 1:00pm

Eiger's application was supported by data from three completed Phase 2 studies in 39 neonates, children and adolescents with congenital hyperinsulinism.

Key Points: 
  • Eiger's application was supported by data from three completed Phase 2 studies in 39 neonates, children and adolescents with congenital hyperinsulinism.
  • "Avexitide represents a promising, targeted approach for the treatment of congenital hyperinsulinism, an urgent, unmet medical need with no approved therapy," said Colleen Craig, MD, Vice President of Metabolic Diseases at Eiger.
  • Avexitide has been granted Breakthrough Therapy Designation by the FDA for the treatment of congenital hyperinsulism, Orphan Drug Designation by the FDA for the treatment of hyperinsulinemic hypoglycemia (which includes congenital hyperinsulinism), Orphan Drug Designation by the EMA for the treatment of congenital hyperinsulinism and Rare Pediatric Disease Designation by the FDA.
  • Avexitide has been granted Breakthrough Therapy Designation by the FDA, as well as Orphan Drug Designation by the FDA for the treatment of hyperinsulinemic hypoglycemia and Orphan Drug Designation by the EMA for the treatment of non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS).

BioVie Announces First Patient Enrolled in Phase 3 Study of NE3107 in Alzheimer’s Disease

Thursday, August 5, 2021 - 1:00pm

The NM101 study ( NCT04669028 ) is a potentially pivotal Phase 3, randomized, double blind, placebo-controlled, US multicenter study of NE3107 in 316 subjects with mild to moderate AD.

Key Points: 
  • The NM101 study ( NCT04669028 ) is a potentially pivotal Phase 3, randomized, double blind, placebo-controlled, US multicenter study of NE3107 in 316 subjects with mild to moderate AD.
  • The mechanistic basis for the study design was recently published in a peer-reviewed article in Neurodegenerative Disease Management ( https://doi.org/10.2217/nmt-2021-0022 ).
  • The Company is conducting a Phase 3 randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate NE3107 in subjects who have mild to moderate Alzheimer's disease (NCT04669028).
  • A Phase 2 study of NE3107 in Parkinsons Disease is planned for later this year, and related compounds have additional potential to treat certain cancers.

Core One Labs’ Virtual Town Hall Reveals Company is Nearing Production of Biosynthesized Psilocybin: Breakthrough In the Psychedelic Space Expected Upon Successful Completion

Thursday, August 5, 2021 - 6:15am

The Company is excited to announce information regarding the status and timing of its breakthrough psilocybin technology that was presented by Dr. Robert E.W.

Key Points: 
  • The Company is excited to announce information regarding the status and timing of its breakthrough psilocybin technology that was presented by Dr. Robert E.W.
  • Hancock, Executive Chairman during its August 4, 2021, Virtual Town Hall.
  • With real opportunity for substantial profitability, Core One is doing everything they can to ensure that their technology is well protected.
  • Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients.

vTv Therapeutics Announces 2021 Second Quarter Financial Results and Provides Corporate Update

Wednesday, August 4, 2021 - 9:30pm

HIGH POINT, N.C., Aug. 04, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the second quarter ended June 30, 2021, and provided an update on the progress of its clinical programs.

Key Points: 
  • HIGH POINT, N.C., Aug. 04, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the second quarter ended June 30, 2021, and provided an update on the progress of its clinical programs.
  • vTv expects to report topline results from this mechanistic study in late third quarter or early fourth quarter of 2021.
  • Cash Position:The Companys cash position as of June 30, 2021, was $10.8 million compared to $8.4 million as of March 31, 2021.
  • Net Loss Before Non-Controlling Interest:Net loss before non-controlling interest was$0.8 million for the second quarter of 2021 compared to net loss of$5.9 million for the first quarter of 2021.

Tandem Diabetes Care Announces Second Quarter 2021 Financial Results and Updated Full Year 2021 Sales Guidance

Wednesday, August 4, 2021 - 9:05pm

Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today reported its financial results for the quarter ended June 30, 2021 and updated its sales guidance for the year ending December 31, 2021.

Key Points: 
  • Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today reported its financial results for the quarter ended June 30, 2021 and updated its sales guidance for the year ending December 31, 2021.
  • Gross margin increased to 54 percent in the second quarter of 2021 from 50 percent in the same period of 2020.
  • For the second quarter of 2021, operating expenses totaled $87.0 million, compared to $66.4 million for the same period of 2020.
  • Operating margin for the second quarter of 2021 was 3 percent of sales compared to negative 11 percent for the same period of 2020.

NRx Pharmaceuticals Partners with MannKind Corporation to Develop ZYESAMI™ (aviptadil) Inhaler for Respiratory Conditions

Wednesday, August 4, 2021 - 11:48am

The stable, sterile liquid formulation of ZYESAMI developed by NRx is suitable for emergency use and stockpiling purposes.

Key Points: 
  • The stable, sterile liquid formulation of ZYESAMI developed by NRx is suitable for emergency use and stockpiling purposes.
  • NRx Pharmaceuticals (Nasdaq:NRXP) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients.
  • MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases.
  • This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S.

CerpassRx Announces Integrated Partnership with Virta Health

Tuesday, August 3, 2021 - 1:00pm

DALLAS, Aug. 3, 2021 /PRNewswire/ --Today, CerpassRx, a Texas-based pharmacy benefit management company, announced the launch of its integrated partnership with diabetes reversal leader Virta Health .

Key Points: 
  • DALLAS, Aug. 3, 2021 /PRNewswire/ --Today, CerpassRx, a Texas-based pharmacy benefit management company, announced the launch of its integrated partnership with diabetes reversal leader Virta Health .
  • Through this partnership, Virta will be available to members and eligible dependents who have pharmacy benefits through CerpassRx and are between the ages of 18 and 79.
  • "CerpassRx has long been a leader in connecting its members with innovative healthcare solutions like Virta," said Trent Myers, VP of Commercial at Virta.
  • Through this dynamic partnership, CerpassRx and Virta Health will be able to transform member's lives by reversing type 2 diabetes, while also lowering healthcare costs and placing all program fees 100% at risk.

SynDevRx Announces Research Collaboration with Maine Medical Center Research Institute to Study the Effects of SDX-7320 In Obesity-Accelerated Multiple Myeloma Models

Tuesday, August 3, 2021 - 12:00pm

The collaboration will study the role of MetAP2 in obesity-accelerated growth and metastatic potential of multiple myeloma a form of cancer that develops in bone marrow.

Key Points: 
  • The collaboration will study the role of MetAP2 in obesity-accelerated growth and metastatic potential of multiple myeloma a form of cancer that develops in bone marrow.
  • "We're excited to test this drug, SDX-7320, in these models of cancers accelerated by obesity," lead investigator Michaela Reagan, PhD, said.
  • "Obesity changes the composition of the blood and bone marrow, making it more conducive for multiple myeloma cells to develop or proliferate.
  • "Maine Medical Center, and Dr. Reagan in particular, have some of the best models for illustrating the effects obesity has on the microenvironment of multiple myeloma," noted SynDevRx Sr. Director of Translational Research, Dr. Peter Cornelius, PhD.

Viatris Inc. and Biocon Biologics Receive Historic Approval for First Interchangeable Biosimilar Semglee® (insulin glargine-yfgn injection) for the Treatment of Diabetes

Thursday, July 29, 2021 - 4:29am

The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus.

Key Points: 
  • The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus.
  • Semglee is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes.
  • Biocon Biologics, Executive Chairperson, Kiran Mazumdar-Shaw said: "We are extremely proud to be the first to obtain approval of an interchangeable Biosimilar product in the U.S.
  • This will allow pharmacy level substitution and thereby provide convenient and affordable access to Semglee, a quality Biosimilar Insulin Glargine."