Part Two

Velatura Announces Revolutionary Pilot Project with DocuSign to Streamline Patient Consent, Improve Efficiency

Retrieved on: 
Monday, March 11, 2024

Secure and timely sharing of patient information between patients and providers is crucial for delivering coordinated care across diagnoses, treatments and healthcare settings.

Key Points: 
  • Secure and timely sharing of patient information between patients and providers is crucial for delivering coordinated care across diagnoses, treatments and healthcare settings.
  • “By joining forces with Velatura, we’re not only streamlining patient consent – we’re revolutionizing it,” said Robert Chatwani, President & General Manager of Growth at DocuSign.
  • Together, we are leveraging technology to streamline workflows and fundamentally reshape healthcare for the better.”
    The pilot project will begin rolling out to select Velatura network provider facilities this spring.
  • Velatura and DocuSign will be hosting a webinar titled, “Beyond Paperwork: Optimizing Patient Consent for Improved Healthcare Coordination,” with a panel discussion on March 19 at 1 p.m. ET/10 a.m. PT.

Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis

Retrieved on: 
Monday, March 11, 2024

The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.

Key Points: 
  • The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.
  • Overall rates of treatment-emergent adverse events (TEAEs) were 69.8% for continued amlitelimab treatment, 71.9% for the amlitelimab withdrawal-arm and 66.7% for placebo.
  • TEAEs more commonly observed included headache (11.6% amlitelimab continuation, 3.9% amlitelimab withdrawal, 6.7% placebo), upper respiratory tract infection (9.3% amlitelimab continuation, 5.5% amlitelimab withdrawal, 20% placebo).
  • Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Constellation Forecasts Strong Earnings Growth in 2024 and Beyond as Demand and Support for Clean Energy Builds

Retrieved on: 
Tuesday, February 27, 2024

“State and federal policies, bipartisan political support, public opinion surveys and increased customer demand for reliable and clean energy all point to strong and growing support for nuclear energy to power our economy for decades to come.

Key Points: 
  • “State and federal policies, bipartisan political support, public opinion surveys and increased customer demand for reliable and clean energy all point to strong and growing support for nuclear energy to power our economy for decades to come.
  • The PTC provides revenue visibility and also preserves Constellation’s ability to capture upside from tightening power market conditions.
  • The nation’s top technology firms have set goals to power this growth with clean and dependable energy.
  • Growing recognition of nuclear energy as a reliable clean energy resource creates opportunities for Constellation to forge new customer relationships and capture additional value from our 180 million MWh of annual clean energy output.

Netsmart Supports Whole-Person Care Provisions in 42 CFR Part 2 Final Rule

Retrieved on: 
Tuesday, February 20, 2024

Strengthens penalties by applying the same requirements of the HIPAA Breach Notification Rule to breaches of records under Part 2.

Key Points: 
  • Strengthens penalties by applying the same requirements of the HIPAA Breach Notification Rule to breaches of records under Part 2.
  • As a founding member of The Partnership to Amend 42 CFR Part 2 , Scalia stated the long-awaited Final Rule is another step forward for coordinated, whole-person care for individuals nationwide.
  • These major changes to 42 CFR Part 2 will take effect on February 16, 2026.
  • To learn more about these regulation changes, read the 42 CFR Part 2 Final Rule Fact Sheet and register for the upcoming Netsmart webinar on Thursday, March 28 at 1 p.m.

Tenet Energy Receives Invitation from U.S. Department of Energy to Submit Part II Application for Electric Vehicle Title 17 Loan

Retrieved on: 
Thursday, February 15, 2024

Tenet Energy Inc. (“Tenet”), a climate financial technology platform to accelerate America’s sustainable energy transition, starting with electric vehicles, announced today that the U.S. Department of Energy (“DOE”) has invited the Company to submit the Part II loan application under the DOE Title 17 program for Tenet’s EV Auto Lending project.

Key Points: 
  • Tenet Energy Inc. (“Tenet”), a climate financial technology platform to accelerate America’s sustainable energy transition, starting with electric vehicles, announced today that the U.S. Department of Energy (“DOE”) has invited the Company to submit the Part II loan application under the DOE Title 17 program for Tenet’s EV Auto Lending project.
  • “This progress lets us be closer to unlocking a path of accessibility and affordability for electric vehicles nationwide.
  • Tenet will continue to work on advancing the DOE Title 17 process during 2024 and will provide further updates as appropriate.
  • The foregoing matters are wholly dependent on the results of DOE review and evaluation of a Part II application, and DOE's determination whether to proceed.

Biogen Received European Commission Approval for SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia

Retrieved on: 
Monday, February 12, 2024

“Friedreich’s ataxia patients treated with SKYCLARYS in the clinical trial experienced important and clinically meaningful improvements for their daily lives.

Key Points: 
  • “Friedreich’s ataxia patients treated with SKYCLARYS in the clinical trial experienced important and clinically meaningful improvements for their daily lives.
  • At the end of the 48-week study, patients who received SKYCLARYS had significantly improved modified Friedreich Ataxia Rating Scale (mFARS) scores relative to placebo.
  • Biogen is committed to working closely with all stakeholders to ensure that eligible European patients can have access to this treatment.
  • SKYCLARYS is also approved for use in the United States, and Biogen is engaging with regulatory authorities in other regions.

FREYR Battery Provides Operations and Financial Update

Retrieved on: 
Wednesday, February 7, 2024

FREYR Battery (NYSE: FREY) (“FREYR” or the “Company”), a developer of clean, next-generation battery cell production capacity, has provided an update this morning on the Company’s operational progress at the Customer Qualification Plant (“CQP”) in Mo i Rana, Norway; and a financial update on FREYR’s cash position at year-end 2023.

Key Points: 
  • FREYR Battery (NYSE: FREY) (“FREYR” or the “Company”), a developer of clean, next-generation battery cell production capacity, has provided an update this morning on the Company’s operational progress at the Customer Qualification Plant (“CQP”) in Mo i Rana, Norway; and a financial update on FREYR’s cash position at year-end 2023.
  • Automatic production of active cathodes and anodes is the next major milestone in documenting the viability of the SemiSolid platform at GWh scale.
  • “FREYR continues to believe that contributing to the development of a U.S. battery value chain by scaling 24M’s U.S.-based technology platform is a potential source of long-term competitive differentiation,” commented Oscar Brown, FREYR’s Chief Financial Officer.
  • As previously announced, FREYR will report full financial results for the quarter and year ended December 31, 2023, on February 29, 2024.

SparingVision Reaches Final Dose Escalation Step in PRODYGY Trial with SPVN06 for retinitis pigmentosa

Retrieved on: 
Wednesday, January 24, 2024

The trial has now progressed to the final dose cohort of the dose-escalation phase (Part 1).

Key Points: 
  • The trial has now progressed to the final dose cohort of the dose-escalation phase (Part 1).
  • SPVN06 is a breakthrough gene therapy approach aimed at stopping or slowing disease progression in patients affected by rod-cone dystrophy, (RCD), regardless of their genetic background.
  • SparingVision is initially focusing on mid-stage RP, one of the leading inherited causes of blindness globally.
  • This progress of the PRODYGY trial to the third cohort at the highest dose of SPVN06 follows an earlier positive recommendation from the DSMB to dose the second cohort at the medium dose in August 2023.

Locus Biosciences Announces $23.9 Million in Funding from BARDA to Support First Phase 2 Trial of CRISPR-engineered Bacteriophage Therapy

Retrieved on: 
Tuesday, January 23, 2024

RESEARCH TRIANGLE PARK, N.C., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Locus Biosciences, Inc. (“Locus”), a clinical-stage biotechnology company developing a new class of precision engineered bacteriophage treatments for a diverse set of bacterial diseases, today announced the release of $23.9 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to continue the development of Locus’ CRISPR-enhanced bacteriophage therapy, LBP-EC01, for treating urinary tract infections (UTIs) caused by drug-resistant Escherichia coli (E. coli) based on positive results from a Phase 2a clinical trial.

Key Points: 
  • Approximately 80% of these are caused by E. coli, often including difficult-to-treat strains that are resistant to commonly used antibiotics.
  • The funding will be used to advance LBP-EC01 into the blinded, placebo-controlled, Part 2 of the ELIMINATE Phase 2 trial.
  • In 2020, Locus and BARDA announced an agreement to co-fund development of LBP-EC01.
  • The award announced today brings the amount released under the contract to $48.9 million.