Novo Nordisk: Once-weekly insulin icodec demonstrates superior reduction in HbA1c

 Novo Nordisk today announced headline results from the ONWARDS 5 phase 3a trial with once-weekly insulin icodec in people with type 2 diabetes.

The ONWARDS 5 trial was a 52-week, open-label efficacy and safety treat-to-target trial investigating once-weekly insulin versus once-daily basal insulin (insulin degludec or insulin glargine U100/U300) in 1,085 insulin-naïve people with type 2 diabetes in a clinical practice setting including fewer trial visits compared to the other ONWARDS phase 3a trials. Once-weekly insulin icodec was used in combination with a dosing guide app to guide titration.

The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with insulin icodec compared with once-daily basal insulin analogues. From an overall baseline HbA1c of 8.9%, once-weekly insulin icodec achieved a superior reduction in estimated HbA1c of –1.68%-points compared with –1.31%-points for the once-daily basal insulins (estimated treatment difference: –0.38%-points).

https://finance.yahoo.com/news/once-weekly-insulin-icodec-demonstrates-120200785.html

Aura Bio Phase 2 Choroidal Melanoma Data Disappoints

 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced that interim Phase 2 data evaluating the safety and efficacy of suprachoroidal (SC) administration using its first VDC product candidate, belzupacap sarotalocan (AU‑011), for the first-line treatment of patients with early-stage choroidal melanoma (indeterminate lesions and small choroidal melanoma (IL/CM)), were presented at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting held September 30-October 3, 2022, in Chicago, IL.

"The Phase 2 interim safety and efficacy data that was presented at AAO is very encouraging for patients with primary choroidal melanoma, as the majority of patients are diagnosed with early-stage disease and have no vision-preserving treatment options. Interim data showed a statistically significant reduction in tumor growth rate and a robust tumor control response with a high rate of visual acuity preservation at the therapeutic regimen," said Dr. Ivana Kim, Director of the Ocular Melanoma Center, Massachusetts Eye and Ear. "Belzupacap sarotalocan offers a favorable safety profile supporting the potential to become the first vision-preserving treatment for early-stage choroidal melanoma, where patients have had to rely on radiotherapy for the last few decades."

"Preliminary analysis of the data from the Phase 2 trial using suprachoroidal administration supports tolerability up to three cycles of therapy and shows a dose-dependent anti-tumor response. The results provide further clinical evidence to support the potential use of belzupacap sarotalocan as a novel targeted therapy in patients with early-stage disease with this targeted route using suprachoroidal administration," said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura Biosciences. "We believe that the data to date provides proof of concept for an additional intraocular route of administration and further supports belzupacap sarotalocan’s target product profile."

https://finance.yahoo.com/news/aura-biosciences-announces-interim-phase-110000174.html

NetScientific Shares Rise After FDA Meeting on HPV Carcinoma Therapy

NetScientific PLC shares rose on Monday after the company said that its portfolio company PDS Biotechnology Corp. has successfully completed an end-of-Phase-2 meeting with the U.S. Food and Drug Administration regarding the combination of its treatment with Merck & Co.'s therapy for papillomavirus carcinoma.

Shares at 1307 GMT were up 0.05 pence, or 13%, at 0.5 pence.

The life-sciences and technology investment company said that PDS has received guidance from FDA on key elements to submit a biologics license application for its PDS0101 asset treatment.

The end-of-Phase-2 meeting was to determine the safety of proceeding to the last phase of the study and identify any additional information necessary to support a marketing application for the uses under investigation.

The combined therapies are targeting the treatment of unresectable, recurrent and metastatic human-papillomavirus-16-positive head-and-neck squamous-cell carcinoma, the company added.

https://www.marketscreener.com/quote/stock/NETSCIENTIFIC-PLC-14285587/news/NetScientific-Shares-Rise-After-FDA-Meeting-on-HPV-Carcinoma-Therapy-41915449/

Walgreens expanding robot network

 

Walgreens is expanding a robotic network effort when it comes to fulfilling prescriptions in an  effort to ease the labor load of its pharmacy staff. The automated centers can reduce the pharmacist workload by at least 25% and deliver  a cost savings of more than $1 billion each year, according to a Wall Street Journal report.  The drugstore chain has opened eight centers in the past two years and plans to have up to  24 more up and running in three years. Pharmacists will have more time to offer patient services and medical services. "This frees up the capacity of our most skilled professionals," Rina Shah, group vice  president of pharmacy operations and services at Walgreens, told the news outlet.  "We looked at our system and said, 'Why are we filling prescriptions the way we did in 1995?'" https://www.marketscreener.com/quote/stock/WALGREENS-BOOTS-ALLIANCE-19356230/news/Walgreens-expanding-robot-network-to-bolster-pharmacy-operations-41916586/

Rite Aid reports $5M in losses in recent quarter

 Shoplifting cost Rite Aid $5 million in its most recent quarter, with its New York stores taking the hardest hit.

In response the pharmacy chain is testing and deploying new security and theft prevention strategies, according to a Business Insider report.

One approach could include securing "everything," via a lock and key, according to Arnaud Persaud, the company's chief revenue officer.

The company made the announcements during its latest investor call.

"We're looking at literally putting everything behind showcases to ensure the products are there for customers who want to buy it," Persaud said during the call. "We've even had to go to the extent of using off-duty police officers in some of our stores."

https://www.marketscreener.com/quote/stock/RITE-AID-CORPORATION-57476359/news/Rite-Aid-reports-5M-in-losses-in-recent-quarter-41916587/

As NTSB Calls for Passive Alcohol Detection for Drivers, SOBRsafe Offers Solution

  SOBR Safe, Inc. (NASDAQ:SOBR) (SOBRsafe™ or the Company), providers of passive, touch-based alcohol detection technology, today announced that its Safe Driver solutions are in active market use, with broad expansion announced and underway. The National Transportation Safety Board (NTSB) recently highlighted "the need for technology solutions to eliminate impaired driving", and its Chair Jennifer Homendy implored, "We need to implement the technologies we have right here, right now to save lives."​

SOBRsafe's passive alcohol detection in its stationary SOBRcheck™ form is currently helping ensure driver safety for companies like Continental Services and its 1,800 employees across four states. As Continental CEO Matt Hubbard stated, "SOBRsafe provides an innovative solution to proactively manage our existing alcohol policy, while complementing our existing safe operations. SOBRsafe supports our mission to provide a safe environment and community." View an introductory video on SOBRcheck here.

SOBRsafe has now launched its continuous mobile monitoring solution, the fitness-style wearable wristband SOBRsure™. The Company has entered the rideshare industry with partner RubiRides, a service specializing in safe transportation for children. Explained RubiRides Founder and CEO Noreen Butler, "SOBRsafe is revolutionizing preventative alcohol monitoring solutions. SOBRsafe's devices will add yet another layer of confidence to our trips, protecting both drivers and riders and helping ensure that our trips are alcohol-free."

SOBRsafe intends to launch a version of its wearable band for teen drivers in the first quarter of 2023.

"We started SOBRsafe to support recovery and help save lives, and we believe our technology is making a positive contribution now, in real-time," stated SOBRsafe Chairman & CEO Dave Gandini. "Our touch-based technology is hygienic and non-invasive - no breath, blood or urine samples required. With its adoption by employers, agencies and parents, we feel we can bring safer roads to communities across the nation."

https://finance.yahoo.com/news/ntsb-calls-passive-alcohol-detection-120000459.html

Belite 12-Month Interim Results of Phase 1b/2 Study in Adolescent Stargardt Disease Disappoint

 

• LBS-008 (aka Tinlarebant) was safe and well tolerated in adolescent Stargardt Disease (STGD1) subjects at 12-month time point
• The majority of the subjects showed stabilization of BCVA in at least one eye
• A trend for preventing or slowing expansion of autofluorescence continue to be observed
• No atrophic lesion (DDAF) in 12 of 13 subjects at the 12-month treatment period
• 12-month interim data from the ongoing Phase 2 study continue to show stabilization in several parameters, including halting or slowing lesion growth, preservation in retinal thickness, reduction in Ellipsoid Zone (EZ) defect width, and stabilization of visual acuity.

https://www.biospace.com/article/releases/belite-bio-presented-12-month-interim-results-of-lbs-008-phase-1b-2-study-in-adolescent-stargardt-disease-at-aao-annual-meeting-2022/