EU

Certa Therapeutics Announces International Non-Proprietary Name for its First-in-class GPR68 Inhibitor Asengeprast (FT011)

Retrieved on: 
Monday, September 16, 2024

Certa has pioneered drug development targeting GPR68, an important but previously undrugged membrane GPCR receptor, showing it to be a master switch of fibrosis.

Key Points: 
  • Certa has pioneered drug development targeting GPR68, an important but previously undrugged membrane GPCR receptor, showing it to be a master switch of fibrosis.
  • Asengeprast is a novel, first-in-class oral GPR68 antagonist being developed for the treatment of chronic fibrosis in multiple organs.
  • Certa Therapeutics is a clinical-stage biotechnology company focused on improving lives by treating patients with debilitating diseases via novel targeted therapies.
  • The investigational drug products being developed by Certa Therapeutics are undergoing clinical studies to evaluate the safety and effectiveness in humans.

Netradyne Technology Partners with Roos Fleetservice to Enhance Fleet and Driver Safety in Europe

Retrieved on: 
Monday, September 16, 2024

Netradyne , a global provider of artificial intelligence (AI) technology solutions for fleet and driver safety, today announced a strategic partnership with Roos Fleetservice GmbH , a leading provider of fleet management in Germany, to bring Netradyne’s flagship product, Driver•i, to Roos Fleetservice’s European clients.

Key Points: 
  • Netradyne , a global provider of artificial intelligence (AI) technology solutions for fleet and driver safety, today announced a strategic partnership with Roos Fleetservice GmbH , a leading provider of fleet management in Germany, to bring Netradyne’s flagship product, Driver•i, to Roos Fleetservice’s European clients.
  • Roos Fleetservice is part of the Roos Vehicle Logistics GmbH, an established name offering a full suite of fleet management products.
  • “We see immense potential in our partnership with Roos to elevate vehicle safety standards and optimise fleet management across Europe through innovative technology,” said Durgadutt Nedungadi, Sr.
  • Together, we aim to set new standards in vehicle safety and fleet management throughout the EU.”
    View source version on businesswire.com: https://www.businesswire.com/news/home/20240916064567/en/

Curatis: Significantly Increased Sales in Core Business and Projects in Development Pipeline on Track

Retrieved on: 
Monday, September 16, 2024

In the distribution business, the aim is to increase sales by securing additional drugs for distribution in Switzerland and expanding the distribution business geographically to key European markets.

Key Points: 
  • In the distribution business, the aim is to increase sales by securing additional drugs for distribution in Switzerland and expanding the distribution business geographically to key European markets.
  • Curatis is focusing its development activities for C-PTBE-01 on an extremely rare group of aggressive brain tumours (Diffuse Midline Glioma, DMG).
  • In connection with DMG, indirect brain damage regularly occurs due to an accumulation of extracellular fluid in the vicinity of the tumour.
  • C-AM-01 is currently in Phase IIa and the next development step for C-AM-01 is a Phase IIb dose-finding clinical trial.

The best way to regulate AI might be not to specifically regulate AI. This is why

Retrieved on: 
Sunday, September 15, 2024

The new wave of artificial intelligence – so-called AI – is bringing with it promises as well as threats.

Key Points: 
  • The new wave of artificial intelligence – so-called AI – is bringing with it promises as well as threats.
  • By making use of large, underutilised data, it can improve outcomes in services including retailing, health and education.

Most uses of AI are already regulated

  • Separately, the government is consulting about mandatory guardrails for AI in high-risk settings, which would function as a sort of checklist for what developers should consider alongside a voluntary safety standard.
  • Here’s my thinking: most of the potential uses of AI are already covered by existing rules and regulations designed to do things such as protect consumers, protect privacy and outlaw discrimination.

The best approach is to make existing rules work

  • Their job ought to be to show where AI is covered by the existing rules, to evaluate the ways in which AI might fall foul of those rules, and to run test cases that make the applicability of the rules clear.
  • It is an approach that will help build trust in AI, as consumers see they are already protected, as well as providing clarity for businesses.

Some rules will need to be tweaked

  • In some situations, existing regulations will need to be amended or extended to ensure behaviours facilitated by AI are covered.
  • Approval processes for vehicles, machinery and medical equipment are among those that will increasingly need to take account of AI.
  • Where potential harm exists, it will need to be weighed against the potential benefits of the use.

Last mover advantage

South African agriculture needs to crack the Chinese market. How to boost exports

Retrieved on: 
Sunday, September 15, 2024

In 2023 these accounted for 38% of South Africa’s agricultural exports.

Key Points: 
  • In 2023 these accounted for 38% of South Africa’s agricultural exports.
  • The EU is another important market for South Africa’s agricultural sector, accounting for a 19% share in 2023.
  • Asia and the Middle East accounted for a quarter of South Africa’s agricultural exports in 2023.
  • South Africa’s agricultural exports to China accounted for a mere 0.4% of Chinese imports in 2023.
  • Three government departments must lead the conversation – Trade, Industry and Competition; Agriculture; and International Relations and Cooperation.

What’s holding South Africa back

  • South Africa has strong political ties with China, bilaterally and through the umbrella group known as Brics and the Forum for China-Africa Cooperation.
  • What South Africa doesn’t have is preferential market access to China’s food markets.

What China buys

  • South Africa is among the top ten global agricultural exporters in most fruits, and a significant producer of wine.
  • South Africa’s current major exports to China are wool, citrus, nuts, sugar, wine, maize, soybeans, beef and grapes.
  • The producers of all these products could benefit from wider access to China.

What’s to be done

Joint statement by High Representative/Vice-President Borrell and Vice-President Šuica on the International Democracy Day

Retrieved on: 
Saturday, September 14, 2024

The European Union remains steadfast in its commitment to strengthen and defend democracy, both within and beyond our borders.

Key Points: 
  • The European Union remains steadfast in its commitment to strengthen and defend democracy, both within and beyond our borders.
  • Nearly half of the world's population across more than 70 countries will have had the opportunity to elect their representatives.
  • This year, millions across the world are reaffirming their commitment to democracy, whether as candidates or voters, often in challenging circumstances.
  • Upholding democracy is key to preserve and promote the dignity of every citizen, as well as fostering social justice, inclusive development, and peace.

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Combination With Transarterial Chemoembolization Significantly Improved Progression-Free Survival Compared to TACE Alone in Patients With Unresectable, Non-Metastatic Hepatocellular Carcinoma

Retrieved on: 
Saturday, September 14, 2024

Median PFS was 14.6 months (95% CI, 12.6-16.7) for the KEYTRUDA plus LENVIMA-based regimen versus 10.0 months (95% CI, 8.1-12.2) for TACE alone.

Key Points: 
  • Median PFS was 14.6 months (95% CI, 12.6-16.7) for the KEYTRUDA plus LENVIMA-based regimen versus 10.0 months (95% CI, 8.1-12.2) for TACE alone.
  • The safety profile of the KEYTRUDA plus LENVIMA-based regimen was consistent with that observed in previously reported studies evaluating the combination.
  • Serious adverse events were observed in 33.3% of patients receiving KEYTRUDA plus LENVIMA in combination with TACE versus 12.4% of patients receiving TACE alone.
  • After completing two years of combination therapy, LENVIMA may have been administered as a single agent until protocol-specified discontinuation criteria were met.

Avacta Reports Updated Phase 1 Clinical Data of AVA6000 at the European Society for Medical Oncology (ESMO) Congress Demonstrating Multiple Ongoing, Durable Responses in Solid Tumors

Retrieved on: 
Saturday, September 14, 2024

Upon the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

Key Points: 
  • Upon the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.
  • Professor Chris Twelves, Lead Investigator and Professor of Medicine, University of Leeds, commented:
    "The AVA6000 data presented at ESMO continue to demonstrate encouraging efficacy with several ongoing, durable responses.
  • The observed efficacy aligns with a highly favorable safety profile including a lack of the significant cardiac toxicity that is often seen with doxorubicin treatment.
  • I am looking forward to working with the Company, colleagues and patients on the continued development of AVA6000."

Orphan designation: Heterologous swine glyco-humanised polyclonal antibody against T lymphocytes Treatment of peripheral T-cell lymphoma, 25/07/2024 Positive

Retrieved on: 
Saturday, September 14, 2024

Overview This medicine was designated as an orphan medicine for the treatment of peripheral T cell lymphoma in the European Union on 25 July 2024.

Key Points: 
  • Overview This medicine was designated as an orphan medicine for the treatment of peripheral T cell lymphoma in the European Union on 25 July 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: camrelizumab Treatment of hepatocellular carcinoma, 25/07/2024 Positive

Retrieved on: 
Saturday, September 14, 2024

Overview This medicine was designated as an orphan medicine for the treatment of hepatocellular carcinoma in the European Union on 25 July 2024.

Key Points: 
  • Overview This medicine was designated as an orphan medicine for the treatment of hepatocellular carcinoma in the European Union on 25 July 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: