Lancet

HUTCHMED Reports 2023 Full Year Results and Provides Business Updates

Retrieved on: 
수요일, 2월 28, 2024

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:​HCM; HKEX:​13), the innovative, commercial-stage biopharmaceutical company, today reports its financial results for the year ended December 31, 2023 and provides updates on key clinical and commercial developments. HUTCHMED to host results call and webcasts today at 7:30 a.m. EST / 12:30 p.m. GMT / 8:30 p.m. HKT in English, and at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, February 29, 2024.

Key Points: 
  • HUTCHMED is committed to progressively embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders.
  • The 2023 Sustainability Report will be published alongside our 2023 Annual Report in April 2024 and will include further information on HUTCHMED sustainability initiatives and their performance.
  • Net Income attributable to HUTCHMED for 2023 was $100.8 million compared to Net Loss attributable to HUTCHMED of $360.8 million in 2022.
  • The net income attributable to HUTCHMED in 2023 was $0.12 per ordinary share / $0.59 per ADS49, compared to net loss attributable to HUTCHMED of $0.43 per ordinary share / $2.13 per ADS in 2022.

QuidelOrtho Receives Health Canada Approval for Quidel® Triage® PLGF Test for Laboratory Use in Canada

Retrieved on: 
수요일, 3월 6, 2024

QuidelOrtho Corporation (Nasdaq:QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received approval from Health Canada for its Triage PLGF test for laboratory use in Canada.

Key Points: 
  • QuidelOrtho Corporation (Nasdaq:QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received approval from Health Canada for its Triage PLGF test for laboratory use in Canada.
  • The Triage PLGF test is a fluorescence immunoassay to be used with the small footprint Triage MeterPro® Instrument for the quantitative determination of placental growth factor (“PLGF”) in maternal plasma specimens.
  • With the Triage PLGF test, clinicians can be positioned to better detect angiogenic imbalance and assess the risk for these complications.
  • The Triage PLGF test is available to customers in Canada for use with the Triage MeterPro instrument.

Gilead’s Innovative HIV Treatment Research Pipeline Aims to Address Unmet Needs and Advance Public Health

Retrieved on: 
화요일, 3월 5, 2024

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of key data highlighting the breadth of its innovative HIV treatment research pipeline.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of key data highlighting the breadth of its innovative HIV treatment research pipeline.
  • “The latest findings across our HIV pipeline showcase the potential of multiple candidates to help transform HIV management,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences.
  • It is estimated that up to 10% of people with HIV take a complex treatment regimen, defined as 2 or more pills each day.
  • Results showed that all three treatment groups had robust virologic suppression at six months, with consistently low viral loads throughout the study.

Vivacelle Bio and University of Missouri-Kansas City School of Medicine Announce Groundbreaking Results from Phase 2a Clinical Trial of VBI-S for Refractory Hypotension in Severe Septic Shock Patients

Retrieved on: 
목요일, 2월 29, 2024

This landmark study now published in the Lancet's eClinicalMedicine , showcases the potential of VBI-S in transforming the treatment landscape for refractory hypotension in these critically ill patients.

Key Points: 
  • This landmark study now published in the Lancet's eClinicalMedicine , showcases the potential of VBI-S in transforming the treatment landscape for refractory hypotension in these critically ill patients.
  • Patients, after failing standard fluids, received intravenous VBI-S, a revolutionary composition of phospholipid nanoparticles that reversibly absorb nitric oxide.
  • These results fuel our optimism that at last we may have an effective and safe intervention for these very sick patients."
  • This groundbreaking research opens new possibilities for the treatment of septic shock, offering hope and potential survival for millions of patients worldwide.

New Guidance Published in The Lancet Recommends Early Intervention and Use of BIS to Reduce Impact of Arm Lymphedema on Breast Cancer Patients

Retrieved on: 
목요일, 2월 15, 2024

CARLSBAD, Calif., Feb. 15, 2024 /PRNewswire/ -- ImpediMed, a pioneer in the field of medical technology, announced a significant advancement in the fight against breast cancer-related lymphedema, a common but often overlooked condition affecting breast cancer survivors. Leading medical journal eClinicalMedicine, part of The Lancet Discovery Science, recently published new clinical guidance advocating for early detection and prevention strategies, underscoring the validity and efficacy of ImpediMed's innovative approach.

Key Points: 
  • Leading medical journal eClinicalMedicine, part of The Lancet Discovery Science, recently published new clinical guidance advocating for early detection and prevention strategies, underscoring the validity and efficacy of ImpediMed's innovative approach.
  • At the center of these recommendations is bioimpedance spectroscopy (BIS), a cutting-edge technology pioneered by ImpediMed, designed to help detect lymphedema in its early stages before it becomes a significant problem.
  • According to the American Cancer Society 58% of cancer patients diagnosed with breast cancer, melanoma, or pelvic area cancers are at risk for developing limb lymphedema, and over 80% of breast cancer patients are at risk.
  • The Company's SOZO® Digital Health Platform is broadly accepted and recognized for effective and accurate screening of lymphedema.

Ghana’s new vehicle tax aims to tackle pollution – expert unpacks how it’ll work and suggests reforms

Retrieved on: 
목요일, 2월 15, 2024

It’s only the third African country to introduce an explicit carbon tax, after South Africa and Mauritius.

Key Points: 
  • It’s only the third African country to introduce an explicit carbon tax, after South Africa and Mauritius.
  • The tax is intended to address harm associated with vehicle emissions.

Why is the government taxing emissions?

  • The proposed vehicle emissions tax under the Emissions Levy Act, 2023 is one of several environmental fiscal reform measures being introduced by the government.
  • Environmental tax reform aims to shift the burden of taxation to environmentally damaging activities, such as pollution.
  • Ghana’s government believes the vehicle emissions tax is a more cost-effective and equitable way to make sure the polluter pays, prevent harm and protect the public.

What has been done so far to reduce air pollution?

  • In 2021, the government introduced a sanitation and pollution levy on petrol and diesel under the Energy Sector Levies Act to raise revenue to improve air quality, among other goals.
  • The levy accrued GHS452 million (US$55 million) in 2022.
  • These measures weren’t well designed from a tax policy point of view as they were not tied to actual vehicular emissions.

How should an emissions tax work and how does the new tax work?

  • Ideally, the tax should be based on the actual carbon dioxide and other pollutant emissions from a vehicle, measured in grams of carbon dioxide per kilometre.
  • Each car owner would pay an annual tax for the amount of CO₂ their car emits above that threshold.
  • The tailpipe emissions test would be done during the annual roadworthiness check by Ghana’s Driver Vehicle and Licensing Authority.

What are the objections to the tax and can they be accommodated?

  • There is also no clear plan for what the tax will be used for after it is collected.
  • Several critics, especially in the manufacturing and transport sector, say there are already too many taxes.
  • But the government is under pressure to raise domestic revenue as part of its International Monetary Fund conditionalities.

How does Ghana’s tax compare with others in Africa?

  • For example South Africa introduced a carbon emissions tax on vehicles in 2010.
  • A 2018 study indicated that South Africa’s CO₂ emissions tax had failed to influence which new cars consumers were buying.
  • Ghana’s proposed emissions tax for vehicles up to 3 litre engine capacity is not unreasonable when benchmarked to South Africa’s.

Can the tax be implemented and will it meet its objectives?

  • The existing sanitation and pollution levy must first be scrapped and replaced with the vehicle emissions tax.
  • The tax bands should conform to emission standards set by the Ghana Standards Authority and the vehicle licensing authority.
  • Having both the sanitation and pollution levy and vehicle emissions tax operating at the same time amounts to double taxation.

What is the tax collection picture in Ghana?

  • Ghana tax collection is currently around 14% of GDP.
  • Its aim is to get to 18% by 2028, comparable with its peers such as Senegal, Namibia, Togo and Rwanda.


Theophilus Acheampong is affiliated with the IMANI Centre for Policy and Education in Accra, Ghana. He has also consulted for the Government of Ghana on environmental fiscal reform in a private capacity.

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
수요일, 2월 14, 2024

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 11/12

      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

Oncolytics Biotech® Initiates Enrollment Expansion of GOBLET Anal Cancer Cohort

Retrieved on: 
수요일, 2월 14, 2024

SAN DIEGO and CALGARY, Alberta, Feb. 14, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the expansion of enrollment for the anal cancer cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq®) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The study was expanded based on positive data from Stage 1 of the study, presented at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) in November 2023 (link to the PR, link to the poster).

Key Points: 
  • "These exciting clinical data, which exceed the Simon two-stage success criteria, provide strong support to expand the evaluation of pelareorep in patients with advanced anal cancer.
  • "We begin the Stage 2 expansion with substantial optimism for patients and the potential of pelareorep, especially considering the initial efficacy signal observed for pelareorep-based therapy in pancreatic cancer.
  • There is currently no established standard therapy for patients with anal carcinoma who have failed first-line treatment.
  • Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study.

Oncolytics Biotech® Initiates Enrollment Expansion of GOBLET Anal Cancer Cohort

Retrieved on: 
수요일, 2월 14, 2024

SAN DIEGO and CALGARY, Alberta, Feb. 14, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the expansion of enrollment for the anal cancer cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq®) in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA). The study was expanded based on positive data from Stage 1 of the study, presented at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) in November 2023 (link to the PR, link to the poster).

Key Points: 
  • "These exciting clinical data, which exceed the Simon two-stage success criteria, provide strong support to expand the evaluation of pelareorep in patients with advanced anal cancer.
  • "We begin the Stage 2 expansion with substantial optimism for patients and the potential of pelareorep, especially considering the initial efficacy signal observed for pelareorep-based therapy in pancreatic cancer.
  • There is currently no established standard therapy for patients with anal carcinoma who have failed first-line treatment.
  • Pembrolizumab for previously treated advanced anal squamous cell carcinoma: results from the non-randomised, multicohort, multicentre, phase 2 KEYNOTE-158 study.

Preterm Births Linked to 'Hormone Disruptor' Chemicals May Cost United States Billions

Retrieved on: 
화요일, 2월 6, 2024

Then, the team looked for associations between these metabolite levels and preterm births.

Key Points: 
  • Then, the team looked for associations between these metabolite levels and preterm births.
  • "Otherwise, investigators are likely going to find the same study results in another few years about the next group of chemicals used as replacements."
  • California, among a few states, has banned some use of phthalates in consumer products, as have European Union member states.
  • Trasande cautions that further research is needed to better understand the specific mechanisms behind the link between phthalate exposure and preterm birth.