EC

Cairn Homes Plc: Total Voting Rights

Retrieved on: 
Monday, July 3, 2023

Each Ordinary Share carries one vote, therefore the total number of voting rights is 671,829,253.

Key Points: 
  • Each Ordinary Share carries one vote, therefore the total number of voting rights is 671,829,253.
  • Cairn Homes plc (“Cairn”) is an Irish homebuilder committed to building high-quality, competitively priced, sustainable new homes and communities in great locations.
  • At Cairn, the homeowner is at the very centre of the design process.
  • A new Cairn home is expertly designed, with a focus on creating shared spaces and environments where communities thrive.

Ecopetrol appointed Germán González Reyes as Vice President of Corporate Affairs and Secretary General in charge of Ecopetrol S.A.

Retrieved on: 
Saturday, July 1, 2023

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Key Points: 
  • BOGOTÁ, Colombia, June 30, 2023 /PRNewswire/ -- Ecopetrol S.A. (BVC: ECOPETROL; NYSE: EC, "Ecopetrol" or the "Company") has appointed Germán González Reyes as acting Vice President of Corporate Affairs and Secretary General, effective from July 5, 2023 and until the appointment of a new Vice President of Corporate Affairs and Secretary General.
  • Germán González Reyes is a lawyer with a specialization in Socioeconomics from Universidad Javeriana and a specialist in International Transportation Law from Universidad Externado de Colombia.
  • He has also served as Vice Minister of Communications for the Republic of Colombia.
  • We do not intend and do not assume any obligation to update these forward-looking statements.

Product Testers Wanted For New Festool KSC 60 Cordless Miter Saw

Retrieved on: 
Thursday, June 29, 2023

LEBANON, Ind., June 29, 2023 /PRNewswire/ -- Festool, a leading manufacturer of innovative, precision-engineered and durable power tool solutions, is launching a nationwide search across the United States for trade professionals and advanced DIYers to test its new KSC 60 Cordless Miter Saw. Festool will select 10 winners who will put the KSC 60 to the test and share their product photos and video reviews with Festool. The company may share the testers' reviews on its social media channels so others can get a deeper sense of how Festool power tools are "built better to build better."

Key Points: 
  • LEBANON, Ind., June 29, 2023 /PRNewswire/ -- Festool, a leading manufacturer of innovative, precision-engineered and durable power tool solutions, is launching a nationwide search across the United States for trade professionals and advanced DIYers to test its new KSC 60 Cordless Miter Saw .
  • Festool will select 10 winners who will put the KSC 60 to the test and share their product photos and video reviews with Festool.
  • Each product tester will receive one KSC 60 Cordless Miter Saw Set that includes a KSC 60 Cordless Miter Saw, 5.0 Ah Energy Set, UG Underframe, Extensions Set and a selection of blades, valued at $2,712.
  • Festool launched the KSC 60 Cordless Miter Saw earlier this year as part of the company's comprehensive and robust cordless lineup.

Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression ≥1%

Retrieved on: 
Thursday, June 29, 2023

Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%.
  • With this EC decision, Opdivo with chemotherapy becomes the first neoadjuvant immunotherapy-based treatment option approved for patients in the European Union (EU) in this setting.
  • The safety profile of Opdivo with chemotherapy was consistent with previously reported studies in NSCLC.
  • “Although we have seen progress in the treatment of earlier-stage non-small cell lung cancer, a significant number of people still face poor outcomes.

Amicus Therapeutics Announces Approval and Launch of New Pompe Disease Therapy in the European Union

Retrieved on: 
Tuesday, June 27, 2023

Pompe disease is an inherited lysosomal disorder caused by deficiency of the enzyme acid α-glucosidase (GAA).

Key Points: 
  • Pompe disease is an inherited lysosomal disorder caused by deficiency of the enzyme acid α-glucosidase (GAA).
  • Amicus plans to immediately launch Pombiliti + Opfolda in Germany and is commencing reimbursement processes with healthcare authorities in other European countries.
  • “Late-onset Pompe disease is a rare, neuromuscular disorder that can have devastating consequences for patients and their families.
  • The European Commission approval for Pombiliti and Opfolda is the realization of the work of so many individuals and teams dedicated to the mission of improving the lives of people living with Pompe disease.

Bristol Myers Squibb Receives European Commission Approval of CAMZYOS® (mavacamten), for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (HCM)

Retrieved on: 
Monday, June 26, 2023

Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved CAMZYOS® (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM) in adult patients.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved CAMZYOS® (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM) in adult patients.
  • The EC approval of CAMZYOS is based upon positive efficacy and safety results from two Phase 3 trials, EXPLORER-HCM and VALOR-HCM.
  • “Obstructive HCM is a life-changing disease for many patients who suffer from symptoms that can significantly impact their quality of life.
  • Bristol Myers Squibb thanks the patients and investigators involved in both clinical trials.

ALX Oncology Receives Orphan Drug Designation from the European Commission for Evorpacept for the Treatment of Patients with Gastric Cancer

Retrieved on: 
Monday, June 26, 2023

SOUTH SAN FRANCISCO, Calif., June 26, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that evorpacept, a next-generation CD47 blocker, has received orphan drug designation (“ODD”) from the European Commission (“EC”) for the treatment of patients with gastric cancer.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., June 26, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that evorpacept, a next-generation CD47 blocker, has received orphan drug designation (“ODD”) from the European Commission (“EC”) for the treatment of patients with gastric cancer.
  • This ODD indication includes both gastric cancer and gastroesophageal junction adenocarcinoma (collectively “GC”).
  • The U.S. Food and Drug Administration (“FDA”) also granted ODD to evorpacept for the treatment of patients with GC as previously announced in January 2022.
  • “Receiving orphan drug designation from both the EC and the FDA represents a significant regulatory achievement for ALX Oncology and signifies the growing recognition of evorpacept as a potential new drug to improve clinical outcomes in patients with GC,” said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology.

Government of Canada approves 8 collective agreements representing 138,000 public service employees

Retrieved on: 
Friday, June 23, 2023

Now that these collective agreements have been ratified by members and approved by Treasury Board, they will be signed by both parties in the coming days.

Key Points: 
  • Now that these collective agreements have been ratified by members and approved by Treasury Board, they will be signed by both parties in the coming days.
  • "I am very pleased that we have been able to renew collective agreements for 66% of all represented employees.
  • Public servants across the country work hard to serve Canadians, and we will continue to work toward negotiating agreements that reflect the value of this important work while remaining reasonable for taxpayers."
  • 10 out of 28 collective agreements have now been approved, with 16 additional bargaining units in active negotiations.

LEO Pharma Receives Positive CHMP Opinion for New Adtralza® (tralokinumab) Injection Device

Retrieved on: 
Friday, June 23, 2023

LEO Pharma A/S, has today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion that recommends the approval of Adtralza® (tralokinumab) solution for injection in a new single dose (300 mg) 2 ml pre-filled pen.

Key Points: 
  • LEO Pharma A/S, has today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion that recommends the approval of Adtralza® (tralokinumab) solution for injection in a new single dose (300 mg) 2 ml pre-filled pen.
  • Adtralza, a high-affinity fully human monoclonal antibody,1 has previously been available in a 1 ml pre-filled syringe.
  • For patients who prefer the pre-filled syringe, this administration option will continue to be available in markets where Adtralza is already launched.
  • In the U.S., Adtralza is marketed under the tradename Adbry® and is approved for use in adults with moderate to severe AD.

BioMarin to Present ROCTAVIAN™ (valoctocogene roxaparvovec) Data from Longest and Largest Hemophilia Gene Therapy Clinical Trial Program at the International Society on Thrombosis and Haemostasis (ISTH) 2023 Congress

Retrieved on: 
Thursday, June 22, 2023

SAN RAFAEL, Calif., June 22, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced it will present new data from the ROCTAVIAN™ (valoctocogene roxaparvovec) gene therapy clinical trial program. These data will be shared this week in four oral presentations and two posters at the 31st Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Montreal, Canada.

Key Points: 
  • These data will be shared this week in four oral presentations and two posters at the 31st Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Montreal, Canada.
  • The U.S. Food and Drug Administration (FDA) has set a PDUFA Target Action Date of June 30, 2023, for the Company's Biologics License Application (BLA) for valoctocogene roxaparvovec gene therapy.
  • The European Commission (EC) granted conditional marketing authorization under the brand name ROCTAVIAN on August 24, 2022.
  • "These data presented at ISTH will highlight the clinical impact of ROCTAVIAN for people living with severe hemophilia A more than three years post-infusion."