ACT

Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

Retrieved on: 
Wednesday, February 14, 2024

Industry level .................................................................................................. 13

Key Points: 
    • Industry level .................................................................................................. 13

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      1.

    • A reflection paper
      (RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      plan, and it is envisaged that something similar may be needed for other emerging treatment
      modalities (e.g., peptides).

    • Guideline work led by other working parties
      ?

      Revision of the guideline on the requirements for clinical documentation for orally inhaled
      products (CPMP/EWP/4151/00 Rev.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      The planned concept papers (CPs) will formulate problem statements for potential workshops and
      subsequent guidance documents will be informed and enriched by the outcome of discussions of
      workshops to be held in 2024.

    • Guideline work led by other working parties and committees
      ?

      Revision of Guidance on the investigation of medicinal products in the term and preterm
      neonate (EMEA/536810/2008).

    • There is a need for
      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      new guidance in these areas to ensure these novel approaches meet the required evidentiary
      standards and facilitate their evaluation.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      Provide appropriate support to the EU network for generic and hybrid medicines including
      product-specific requirements.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      2.3.

    • ?

      Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
      based biopharmaceutics modelling (PBBM).

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      In order to support adequate evaluation of all methodology MWP will aim to facilitate an
      increase in presence and visibility in relevant committees of methodological expertise from
      across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
      2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
      depot) and melatonin have been prioritised as the next in series for drafting.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      4.2.

    • ?

      Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
      assessment.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      To deliver an improved access to raw data (e.g.

    • ?

      Propose regulatory research priorities for funders in across the activities of Methodology
      Working Party, including in the big data area.

    • ?

      Establish key communication points in national competent authorities and build a resource of
      key messages and communication materials on regulation and methodology.

    • The timing of workshops may need to be arranged according to the

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      specific needs of the guidance ? either before the guidance is finalised to gather views and
      expertise; or once it is finalised for training purposes.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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Rush Enterprises, Inc. Reports Fourth Quarter and Year-End 2023 Results, Announces $0.17 Per Share Dividend

Retrieved on: 
Tuesday, February 13, 2024

Additionally, the Company added a full-service Ford dealership, Rush Truck Centers – Chicago Light- and Medium-Duty, in the fourth quarter of 2023.

Key Points: 
  • Additionally, the Company added a full-service Ford dealership, Rush Truck Centers – Chicago Light- and Medium-Duty, in the fourth quarter of 2023.
  • In the fourth quarter of 2023 we sold 37% more used trucks than we did during the fourth quarter of 2022,” said Rush.
  • The Company’s absorption ratio was 130.8% in the fourth quarter of 2023, compared to 136.5% in the fourth quarter of 2022.
  • Lease and rental revenue increased 5.2% in the fourth quarter of 2023, compared to the fourth quarter of 2022.

UMKC Students Do ‘More in 4’ with New Accelerated Bachelor’s and Master’s Degree Program

Retrieved on: 
Tuesday, February 13, 2024

“As Kansas City's business school, we're thrilled to offer students this opportunity to accelerate their education and jumpstart their careers,” said Brian Klaas, dean of the UMKC Bloch School.

Key Points: 
  • “As Kansas City's business school, we're thrilled to offer students this opportunity to accelerate their education and jumpstart their careers,” said Brian Klaas, dean of the UMKC Bloch School.
  • The new program also aligns with UMKC’s track record as an institution committed to accelerating students’ degree pursuits, launching them more quickly into their desired careers.
  • Program at the UMKC School of Medicine and the 3 + 3 Program at the UMKC School of Law, among others.
  • "UMKC has a long, successful history with accelerated, combined degree programs," said UMKC Chancellor Mauli Agrawal.

The government is well behind on Closing the Gap. This is why we needed a Voice to Parliament

Retrieved on: 
Tuesday, February 13, 2024

Another year, and another Closing the Gap report comes before the parliament and the Australian people.

Key Points: 
  • Another year, and another Closing the Gap report comes before the parliament and the Australian people.
  • The 2024 Closing the Gap report is the first since Australians resoundingly rejected the proposal to enshrine a First Nations Voice to Parliament in the Constitution.
  • With that in mind, it’s unsurprising that in this year’s Closing the Gap report, the government outlines that just four of the 19 targets are on track to be bridged.
  • It’s also committed to building remote training hubs and improving community wifi services for around 20 remote communities.

‘What’s next?’ is the wrong question to ask

  • This question has become a staple of pundits and commentators trying to look smart following a referendum process during which they fundamentally failed on the civics, the politics and the journalism of Indigenous issues.
  • Before we ask about what comes next though, we must ask what has come already, and whether efforts at closing the gap over the past three years, since the agreement was overhauled by the Morrison government, have worked.
  • The Agreement requires government decision-makers to accept that they do not know what is best for Aboriginal and Torres Strait Islander people.

Closing the Gap in 2024

  • The one thing to understand about the gap in outcomes between Indigenous and non-Indigenous peoples is that it is not something that ever needed be this way.
  • As the Productivity Commission found, “it is a direct result of the ways in which governments have used their power over many decades”.
  • There is also the National Skills Agreement, which includes a dedicated stream of funding for closing the gap to support community-controlled registered training organisations.
  • Also, next time you run into one of the many MPs and shadow ministers who campaigned against a Voice to Parliament, ask them what their plan is to close the gap and empower Indigenous peoples and communities.


James Blackwell is a Member of the Uluru Dialogue at UNSW.

Plug Delivers Several Portable Liquid Hydrogen Refuelers to Customers

Retrieved on: 
Monday, February 12, 2024

LATHAM, N.Y., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Plug Power Inc. (NASDAQ: PLUG), a global leader in comprehensive hydrogen solutions for the green hydrogen economy, delivered several first-of-its-kind liquid hydrogen portable refuelers to transit agencies and trucking fleet customers.

Key Points: 
  • LATHAM, N.Y., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Plug Power Inc. (NASDAQ: PLUG), a global leader in comprehensive hydrogen solutions for the green hydrogen economy, delivered several first-of-its-kind liquid hydrogen portable refuelers to transit agencies and trucking fleet customers.
  • The product was designed to reduce infrastructure costs and deployment time for medium-duty and heavy-duty hydrogen-powered commercial vehicles.
  • “Our portable refueler product is a prime example of Plug’s cutting-edge innovation driving cost-effective adoption of hydrogen in hard-to-abate sectors like transportation,” said Andy Marsh, Plug CEO.
  • To learn more about being a Plug portable refueler customer, visit https://www.plugpower.com/learn-more-about-plugs-portable-refueler/ .

HILDA data show women’s job prospects improving relative to men’s, and the COVID changes might have helped

Retrieved on: 
Sunday, February 11, 2024

The latest HILDA survey shows Australia’s gender gap in employment continuing to close, with progress beginning on the earnings gap.

Key Points: 
  • The latest HILDA survey shows Australia’s gender gap in employment continuing to close, with progress beginning on the earnings gap.
  • Remarkably, the progress has continued notwithstanding the disruptions caused by COVID; there are indications they may even have helped.

Employment lifting

  • For men of that age, the proportion in paid employment has changed little during those two decades, fluctuating between 80% and 84%, allowing the gap in employment between men and women to narrow eight percentage points.
  • Most of the gain has taken place since 2009 when one in ten women of that age were in paid employment, a figure that has since climbed to one in four, not too far off the one in three men of that age employed.
  • While men remain well ahead in full-time employment, that gap is narrowing too.
  • If the gender gap in employment is to be eliminated, it is clear couples with children will need to share the load more equally.

Wages lifting

  • In 2001, women employed full-time earned on average 79% of what men earned.
  • Average female earnings have climbed from 66% of male earnings in 2001 to 75% in 2021.

How COVID might have helped

  • HILDA shows the proportion of employees working from home in 2020 and 2021 has increased substantially.
  • The proportion working any hours at home climbed from 25.1% in 2019 to 37.3% in 2021.
  • There are health risks from working from home while unwell and also career risks from working at home.
  • “Out of sight” can mean “out of mind” when it comes to promotions.

Some small steps on sharing the caring

  • The improvement accelerated slightly in 2020 and 2021, via both an increase in the hours worked on domestic chores by men and a slight decrease for women.
  • In 2021, mothers of dependent children were still spending 75% more time on unpaid housework and child care than their male partners.


Roger Wilkins receives funding from the Australian Research Council.

Arrive Partners With AllMart Marketplace to Launch Its Smart Mailbox Solution in Antigua

Retrieved on: 
Thursday, February 8, 2024

INDIANAPOLIS, IN, Feb. 08, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – Arrive Technology Inc. ("Arrive"), a technology company focused on facilitating the last inch of the last-mile for autonomous delivery, announced today that it has signed an agreement with AllMart Marketplace (“AllMart”) to initially deploy up to 25 Arrive smart mailboxes to facilitate secure deliveries on the island nation of Antigua. This announcement comes on the heels of Arrive’s previously announced agreement and plan of merger with Bruush Oral Care Inc. (Nasdaq: BRSH) (“Brüush”).

Key Points: 
  • “We look forward to our partnership with Arrive leading to further improvements, such as drone delivery, in the future.”
    AllMart consumers will initially share use of the Arrive smart mailboxes.
  • Customers will receive unique personal identification numbers, so only they can access the mailbox to retrieve their orders, with Arrive’s proprietary technology ensuring accurate deliveries.
  • Arrive CEO Dan O’Toole said the deployment of Arrive mailboxes in Antigua results from Arrive’s recent acquisition of Airbox Technologies Inc. ("Airbox") and its patent portfolio.
  • AllMart is a subsidiary of ACT Antigua, which sells a wide array of consumer goods including food, alcohol, medicine, tools and home décor.

Aduro Clean Technologies Featured on Viewpoint with Dennis Quaid

Retrieved on: 
Thursday, February 8, 2024

This special segment will highlight the innovative solutions and sustainable advancements Aduro is making in the chemicals and energy sectors.

Key Points: 
  • This special segment will highlight the innovative solutions and sustainable advancements Aduro is making in the chemicals and energy sectors.
  • The feature on Viewpoint with Dennis Quaid offers Aduro a highly recognised platform to showcase its patented Hydrochemolytic™ Technology (HCT) to a global audience.
  • "Our participation in the Viewpoint with Dennis Quaid series represents a significant opportunity to demonstrate the transformative potential of our Hydrochemolytic™ Technology on a prestigious and widely recognized platform," said Ofer Vicus, CEO of Aduro.
  • The Viewpoint with Dennis Quaid series is known for its insightful exploration of innovative technologies and breakthroughs that are shaping our world.

TEAMSTERS CALL ON LAWMAKERS TO PASS TEMP BILL

Retrieved on: 
Wednesday, February 7, 2024

ALBANY, N.Y., Feb. 7, 2024 /PRNewswire/ -- Yesterday, the Teamsters were joined by their allies at the New York Committee for Occupational Safety and Health, La Colmena, the National Employment Law Project, the Retail Wholesale Department Store Union (RWDSU), and WE ACT for Environmental Justice in calling on the New York Senate and General Assembly to pass the Temperature Extreme Mitigation (TEMP) Act (S1604/A8935).

Key Points: 
  • "By enacting the TEMP Act, we ensure that protections are consistently put into effect, safeguarding the well-being of our workforce both in the present and for generations to come."
  • "Our workers and communities face dire consequences without immediate action," said Jeffrey Brylski, President of Teamsters Joint Council 46.
  • Founded in 1903, the International Brotherhood of Teamsters represents 1.3 million hardworking people in the U.S., Canada, and Puerto Rico.
  • Follow us on Twitter @Teamsters and "like" us on Facebook at Facebook.com/teamsters .

Shaping the Future of Sustainable Freight: ACT Shipper-Carrier Connect Debuts in Las Vegas Alongside ACT Expo 2024

Retrieved on: 
Wednesday, February 7, 2024

Santa Monica, Calif., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Today, organizers of the Advanced Clean Transportation (ACT) Expo , recognized as the largest event in advanced commercial vehicle technology, announced the inaugural ACT Shipper-Carrier Connect – scheduled for May 22-23, 2024, at the Las Vegas Convention Center, co-located with ACT Expo.

Key Points: 
  • Santa Monica, Calif., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Today, organizers of the Advanced Clean Transportation (ACT) Expo , recognized as the largest event in advanced commercial vehicle technology, announced the inaugural ACT Shipper-Carrier Connect – scheduled for May 22-23, 2024, at the Las Vegas Convention Center, co-located with ACT Expo.
  • ACT Shipper-Carrier Connect will serve as a collaborative forum, bringing together shippers, carriers, and logistics providers to collectively shape the future of sustainable freight, identifying practical opportunities to achieve shared economic and environmental sustainability goals.
  • ACT Shipper-Carrier Connect will convene the key stakeholders from the North American road freight value chain.
  • This discussion is set against the backdrop of ACT Expo, where improved clean vehicle availability and improved total cost of ownership for some advanced technology vehicles will be on display.