Emicizumab

New Data Reinforce the Benefit of Early Preventative Treatment With Genentech’s Hemlibra (emicizumab-kxwh) for Babies With Severe hemophilia A

Retrieved on: 
Saturday, December 9, 2023
Research, Infectious Diseases, Baby, Maternity, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Consumer, Health, Science, Safety, Haemophilia, Pediatrics, Pathology, ASH, University, Risk, World Federation of Hemophilia, HAVEN, Roche, World government, Death, ROG, Pharmacokinetics, Caregiver, Trauma, Phase, Intraparenchymal hemorrhage, Biomarker, Parent, Society, Vein, Life, Intracranial hemorrhage, Pharmaceutical industry, Birth control, Emicizumab, Genentech

Results showed that Hemlibra achieved meaningful bleed control in babies up to 12 months of age and was well tolerated.

Key Points: 
  • Results showed that Hemlibra achieved meaningful bleed control in babies up to 12 months of age and was well tolerated.
  • However, for many babies with hemophilia A, prophylaxis is not started until after the first year of life because of the high treatment burden.
  • Hemlibra, which is already approved and being used to treat babies with hemophilia A, provides a flexible treatment option that can be administered subcutaneously from birth at different dosing frequencies.
  • It is approved for the routine prophylaxis of people with hemophilia A in more than 115 countries worldwide.

Adicet Announces Appointment of Katie Peng to the Board of Directors

Retrieved on: 
Tuesday, July 11, 2023
Biotechnology, Pharmaceutical, Health, Oncology, SMA, Indiana University, University, Senior, Spinal muscular atrophy, ACET, Berkeley, Marketing, Bio, Amgen, Roche, Kelley School of Business, Allergan, Cancer, Multimedia, Medicine, Research, Multiple sclerosis, CAR, Emicizumab, Therapy, Neurology, Pharmaceutical industry, Genentech

Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today announced the appointment of Katie Peng to its Board of Directors.

Key Points: 
  • Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today announced the appointment of Katie Peng to its Board of Directors.
  • View the full release here: https://www.businesswire.com/news/home/20230711946213/en/
    “We are delighted to welcome Katie to our Board of Directors,” said Chen Schor, President and Chief Executive Officer of Adicet Bio.
  • Before joining Roche, Ms. Peng held several commercial roles at Amgen Inc. and began her career as a research scientist at Allergan plc.
  • She also serves as a board member for California Life Sciences.

CHOP's Hemostasis and Thrombosis Center Celebrates 50th Anniversary

Retrieved on: 
Wednesday, June 7, 2023
Ruth M. Rothstein CORE Center, Bleeding, Vein, CHOP, HIV, Hematology, Mother, Disability, Emicizumab, Hockey, Therapy, Novel, Not, Haemophilia, IX, Philadelphia, Coagulopathy, DSM-IV codes, Bleeding diathesis, Child, HTC, CDC, Pain, Social, Disorder, AIDS, MD, Patient, Nursing, Division, Maternal and Child Health Bureau, Thrombosis, Diagnosis, Hospital, World Blood Donor Day, Caregiver, FDA, Hemostasis, Football, National Intrepid Center of Excellence, Disease, Children's Hospital of Philadelphia, Birth control, Pharmaceutical industry

PHILADELPHIA, June 7, 2023 /PRNewswire/ -- The Hemostasis and Thrombosis Center (HTC) at Children's Hospital of Philadelphia (CHOP) is proudly celebrating 50 years of providing comprehensive care to children and adolescents with hemophilia and other inherited bleeding or clotting disorders. The Center was founded in 1973 and was one of the first HTCs established in the country and is considered a Center of Excellence for the diagnosis, treatment and prevention of bleeding and clotting disorders, serving as a national resource for other institutions.

Key Points: 
  • PHILADELPHIA, June 7, 2023 /PRNewswire/ -- The Hemostasis and Thrombosis Center (HTC) at Children's Hospital of Philadelphia (CHOP) is proudly celebrating 50 years of providing comprehensive care to children and adolescents with hemophilia and other inherited bleeding or clotting disorders.
  • "What started at CHOP as caring for 48 patients a year with hemophilia has grown into providing care for over 1,000 children with all types of bleeding and clotting disorders at our Center," says Leslie Raffini, MD, Director of the Hemostasis and Thrombosis Center at Children's Hospital of Philadelphia.
  • Hemophilia is an X-linked inherited bleeding disorder that is caused by a clotting factor deficiency that can cause frequent, painful joint bleeds and disability.
  • During this time, donated blood was the only treatment available for hemophilia patients, which led to many of them becoming infected with HIV.

Octapharma to put the perspectives of patients and clinicians under the spotlight at the 16th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD)

Retrieved on: 
Wednesday, January 18, 2023
Haemophilia, Congress, Octapharma, Emicizumab, VIII, Patient, Faculty, Factor VIII, Medical device, Pharmaceutical industry

Treatment decisions need to consider the perspectives of both the patient and the clinician to find the ideal approach for each patient.

Key Points: 
  • Treatment decisions need to consider the perspectives of both the patient and the clinician to find the ideal approach for each patient.
  • The interactive Octapharma symposium at the 16th Annual Congress of EAHAD in Manchester, UK, will present the perspectives of three clinicians and three patients on key treatment decisions encountered during the lives of people with haemophilia A.
  • The three patients and their families will share their experiences, the challenges they have faced, and decisions that they have taken.
  • "We appreciate the importance of bringing together the perspectives of both clinicians and people with haemophilia A in order to provide individualised care and improve the lives of patients."

Interim Data From Phase III Study Presented at ASH 2022 Show Hemlibra (emicizumab-kxwh) Achieved Meaningful Bleed Control in Infants From Birth

Retrieved on: 
Sunday, December 11, 2022
Research, Parenting, Baby, Maternity, Biotechnology, General Health, Pharmaceutical, Consumer, Health, Science, Other Science, Intracranial hemorrhage, Phase, Arm, Leg, Lung, Ixa, Factor, Female, Thrombotic microangiopathy, Haemophilia, Inherited disorders of trafficking, Life, Protein, Skin, APCC, Society, TMA, ABR, Patient, Blood, RO, HAVEN, Parent, Bleeding, AE, Woman, World government, Quality of life, ROG, Caregiver, Clinical trial, VIII, Safety, Brain, Hoffmann-La Roche, Pharmacokinetics, World Federation of Hemophilia, Trauma, AES, ASH, Factor X, Risk, Birth control, Pharmaceutical industry, Emicizumab, Genentech

The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from December 10-13, 2022.

Key Points: 
  • The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from December 10-13, 2022.
  • Hemlibra provides a flexible treatment option that can be administered subcutaneously from birth at different dosing frequencies.
  • HAVEN 7 is a Phase III, multi-center, open-label study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of Hemlibra in infants with severe hemophilia A without factor VIII inhibitors.
  • Genentech also presented data from the European Haemophilia Safety Surveillance (EUHASS) database and the prospective observational ATHN 7 study at ASH 2022.

NovalGen announces one oral and two poster presentations at the American Society of Hematology Annual Meeting

Retrieved on: 
Thursday, November 3, 2022
Experiment, AST, Company, Chemistry, Risk, Fatigue, Therapy, Phase, FIX, 2021 Essex County Council election, Society, GLOBE, Monoclonal antibody, Safety, Thrombocytopenia, Incidence, ALT, AES, ATD, IND, Microangiopathy, Poster, CRS, Toxicity, Mantle cell lymphoma, Half-life, TCE, APC, HLE, Chronic lymphocytic leukemia, Factor X, CEO, CR, Emicizumab, Nausea, CMC, FX, MCL, Haemophilia, Headache, Hematology, Technology, Drug discovery, Treatment, Patient, ROR1, CLL, Vaccine, Medical device, Pharmaceutical industry

LONDON, Nov. 03, 2022 (GLOBE NEWSWIRE) -- NovalGen Ltd (“NovalGen”), a biopharmaceutical company developing breakthrough cancer therapies, alongside an auto-regulation platform, today announces the online publication of three abstracts submitted to the American Society of Hematology Annual meeting, to be held December 10-13, 2022.

Key Points: 
  • Adverse events (AEs) were largely limited to week 1 of cycle 1 and all were reversible.
  • The most common AEs were Grade 1 or 2 nausea (70%), headaches (60%), and fatigue (50%) and thrombocytopenia (30%).
  • Consequently, emicizumab is associated with a high incidence of thromboembolic events and thrombotic microangiopathies, particularly when combined with activated prothrombin complex concentrates.
  • This study heralds a new class of therapeutics for haemophilia A with a self-regulating off switch designed to enhance safety without compromising efficacy.

Genentech to Present Data at ASH 2022 Showcasing Strength of Hematology Portfolio and Expanding Into New Areas to Address More Patient Needs

Retrieved on: 
Thursday, November 3, 2022
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Other Health, ROG, Society, DLBCL, Cyclophosphamide, European Medicines Agency, FDA, Population, Adult, European Commission, B-cell lymphoma, Interim, Hematology, Rituximab, Hoffmann-La Roche, Acquisition, Disease, Spark Therapeutics, Phase, 2021 Essex County Council election, Food, Multiple myeloma, ASH, Degenerative disease, VIII, Lymphoma, Prednisone, RO, Muscle, Intracranial hemorrhage, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PNH, NHL, Polatuzumab vedotin, Joint, Haemophilia, MM, Industry, Safety, Royal commission, Doxorubicin, Therapy, Quality of life (healthcare), Emicizumab, Risk, Lymphatic system, News, AAV, Follicular lymphoma, Pharmaceutical industry, Medical device, Patient, EU, Genentech

The data we are presenting reinforce our ongoing commitment to redefining treatment paradigms, improving on existing standards of care and addressing a diversity of patient and healthcare system needs.

Key Points: 
  • The data we are presenting reinforce our ongoing commitment to redefining treatment paradigms, improving on existing standards of care and addressing a diversity of patient and healthcare system needs.
  • The data at this years meeting exemplify Genentechs commitment to investing in its current portfolio to further improve patient outcomes.
  • Further information on the key abstracts featuring Genentech medicines that will be presented at ASH can be found in the table below.
  • Follow Genentech on Twitter via @Genentech and LinkedIn and keep up to date with ASH Annual Meeting news and updates by using the hashtag #ASH22.

New Data From Phase III HAVEN 6 Study Reinforce Favorable Safety and Efficacy Profile of Genentech’s Hemlibra (emicizumab-kxwh) in People With Moderate or Mild Hemophilia A

Retrieved on: 
Monday, July 11, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, People, Safety, International Society on Thrombosis and Haemostasis, Thrombosis, Socioeconomics, ABR, Factor, Brain, CHESS, HAVEN, APCC, TMA, European Medicines Agency, Cost, Man, Bleeding, Joint, Hoffmann-La Roche, Lung, Arm, Blood, Leg, Woman, Pharmacokinetics, Risk, Factor X, International Society, Haemophilia, Skin, AE, Gaps, Thrombotic microangiopathy, Phase, Patient, VIII, 1991 World Sportscar Championship, ROG, Protein, Ixa, RO, Factor VIII, Pharmaceutical industry, Birth control, Emicizumab, ISTH, EU, Genentech

The data presented at ISTH this year underscore Genentechs commitment to addressing gaps in care for hemophilia A, thereby ensuring that broader populations can potentially benefit from Hemlibra.

Key Points: 
  • The data presented at ISTH this year underscore Genentechs commitment to addressing gaps in care for hemophilia A, thereby ensuring that broader populations can potentially benefit from Hemlibra.
  • In addition to HAVEN 6, data from the CHESS II (Cost of Haemophilia across Europe: a Socioeconomic Survey-II) and CHESS PAEDs studies will also be presented at ISTH 2022.
  • These data show most adults with moderate or mild hemophilia A and more than half of children with moderate hemophilia A may not receive preventative treatments.
  • HAVEN 6 is a Phase III, multicenter, open-label, single-arm study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of Hemlibra in people with moderate or mild hamophilia A without factor VIII inhibitors.

Interim Data From Phase III HAVEN 6 Study Demonstrate Favorable Safety and Efficacy Profile of Genentech’s Hemlibra (emicizumab-kxwh) in People With Moderate or Mild Hemophilia A

Retrieved on: 
Monday, December 13, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Hoffmann-La Roche, Phase, Headache, Poster, Blood, AE, Thrombotic microangiopathy, Protein, 1991 World Sportscar Championship, Ixa, Factor, TMA, AES, Population, Brain, TES, APCC, Woman, Thrombus, Pharmacokinetics, Lung, Head, ABR, TE, RO, Safety, Man, Patient, Leg, Exposition, Haemophilia, Ageing, Arm, VIII, Factor VIII, Bleeding, ASH, HAVEN, Skin, Society, ROG, Factor X, Pharmaceutical industry, Birth control, Genentech, Emicizumab, EU

We remain committed to working together with the hemophilia community as we further explore the efficacy and safety of Hemlibra in broader populations.

Key Points: 
  • We remain committed to working together with the hemophilia community as we further explore the efficacy and safety of Hemlibra in broader populations.
  • HAVEN 6 is a Phase III study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of Hemlibra in people with moderate or mild hemophilia A without factor VIII inhibitors.
  • This interim analysis was conducted after 50 participants with moderate hemophilia A completed at least 24 weeks in the study or withdrew.
  • These data further confirm the favorable safety profile of Hemlibra, consistent with results from previous HAVEN and STASEY studies.

Denali Therapeutics Appoints Katie Peng as Chief Commercial Officer

Retrieved on: 
Monday, September 27, 2021
MPS, Spinal muscular atrophy, Emicizumab, Neurodegeneration, SMA, Kelley School of Business, Security (finance), Hunter syndrome, NASDAQ, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, MPS II, Traffic barrier, Biomarker, Degenerative disease, Senior, Marketing, GLOBE, Industry, Medicine, University, Allergan, Roche, Neurology, Ophthalmology, General manager, SAN, Leadership, Risk, Berkeley, COVID-19, MBA, Research, Amgen, Forward-looking statement, Indiana University, BBB, Time, Multiple sclerosis, SEC, Pharmaceutical industry, Management

We are excited about Katie joining Denali to build and lead our commercial organization.

Key Points: 
  • We are excited about Katie joining Denali to build and lead our commercial organization.
  • I am thrilled to join Denalis leadership team and build the commercial organization, said Ms. Peng.
  • Prior to Genentech, Ms. Peng held several commercial roles at Amgen and began her career as a research scientist at Allergan.
  • The forward-looking statements in this press release are based on information available to Denali as of the date hereof.