SWX:ROG

Genentech’s Subcutaneous Formulation of Tecentriq Demonstrates Positive Phase III Results

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Tuesday, August 2, 2022
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Hospitals, Clinical Trials, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Death, Patient, Time, Health care, Neoplasm, Skin, Human, Tissue, Food, PD-1, Skin cancer, EMA, Â, Etoposide, Melanoma, Treatment of lung cancer, Hoffmann-La Roche, Squamous cell carcinoma, HCC, Immune system, Safety, Bevacizumab, Cancer, American Cancer Society, HIV disease progression rates, BRAF, Halozyme, Carboplatin, PD-L1, Immunotherapy, Liver cancer, NSCLC, FDA, Lung cancer, Blood, RO, Pharmacokinetics, Platinum, Pain, Serum, Survival, Permeability, Paclitaxel, Phase, Mouth, ROG, European Medicines Agency, Glycosaminoglycan, Hepatocellular carcinoma, Bladder cancer, SCLC, Medicine, Pharmaceutical industry, Medical device, Medical imaging, Vaccine, Health insurance, Dentistry, Uranium, Genentech, Atezolizumab

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMscin001 study evaluating a subcutaneous formulation of Tecentriq (atezolizumab) met its co-primary endpoints.

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMscin001 study evaluating a subcutaneous formulation of Tecentriq (atezolizumab) met its co-primary endpoints.
  • The safety profile of the subcutaneous formulation was consistent with that of IV Tecentriq.
  • IMscin001 is a Phase Ib/III, global, multicenter, randomized study evaluating the pharmacokinetics, safety and efficacy of the subcutaneous formulation of Tecentriq, compared with IV Tecentriq, in patients with previously treated locally advanced or metastatic NSCLC for whom prior platinum therapy has failed.
  • The investigational subcutaneous formulation combines Tecentriq with Halozyme Therapeutics Enhanze drug delivery technology.

Genentech to Present Scientific Progress Across Alzheimer’s Disease Pharmaceutical and Diagnostic Portfolio at 2022 AAIC Annual Meeting

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Thursday, July 28, 2022
Stem Cells, Biotechnology, FDA, Health, Pharmaceutical, Neurology, Mental Health, Research, Genetics, Science, Clinical Trials, MRI, Patient, Gantenerumab, Neuron, ADAD, Brain, OLE, APOE, Dementia, Multiple sclerosis, Cerebrospinal fluid, Physician, Immunoglobulin G, Neuroscience, Microglia, Research, Biomarker, Road, Alzheimer's disease, Hoffmann-La Roche, Fortis Healthcare, Risk, Marguerite, Amyloid, Tau, Safety, Crenezumab, Scarlet, PET, Cell damage, Roche, CSF, Machine learning, Biotechnology, Disease, Neurotoxicity, Science, Neurodegeneration, Lists of diseases, Stroke, Autism, Hope, Health, Magnetic resonance imaging, ARIA, II, Tauopathy, Medical imaging, Vaccine, Pharmaceutical industry, Genentech

Today, the companies Alzheimers portfolio spans investigational medicines for different targets, types and stages of the disease.

Key Points: 
  • Today, the companies Alzheimers portfolio spans investigational medicines for different targets, types and stages of the disease.
  • GRADUATION, an open-label study to evaluate the pharmacodynamic effects of once weekly administration in participants with early Alzheimers disease.
  • Unlike most Alzheimers disease prevention studies, it enrolls people up to 25 years before the disease has started in the brain.
  • Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, stroke, Alzheimers disease, Parkinsons disease and autism spectrum disorder.

New Two-Year Data Confirm Genentech’s Vabysmo Improves Vision With Fewer Treatments for People With Wet Age-Related Macular Degeneration

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Thursday, July 14, 2022
Biotechnology, FDA, Other Health, Health, General Health, Pharmaceutical, Optical, Research, Hospitals, Science, Clinical Trials

The two-year data were presented at the 2022 American Society of Retina Specialists Annual Scientific Meeting on July 14.

Key Points: 
  • The two-year data were presented at the 2022 American Society of Retina Specialists Annual Scientific Meeting on July 14.
  • No new safety signals were identified, and Vabysmo continued to be well tolerated, with a favorable benefit-risk profile.
  • In the second year, the dosing schedule for Vabysmo patients could be adjusted based on their response to treatment.
  • Vabysmo (faricimab-svoa) is a prescription medicine given by injection into the eye, used to treat adults with neovascular (wet) agerelated macular degeneration (AMD) and diabetic macular edema (DME).

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

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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.

FDA Grants Priority Review to Genentech’s Mosunetuzumab for People With Relapsed or Refractory Follicular Lymphoma

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Wednesday, July 6, 2022
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The FDA is expected to make a decision on approval of this novel cancer immunotherapy by December 29, 2022.

Key Points: 
  • The FDA is expected to make a decision on approval of this novel cancer immunotherapy by December 29, 2022.
  • New therapeutic options are needed for follicular lymphoma, which often relapses after initial therapy and becomes increasingly difficult to treat each time it returns.
  • The GO29781 study [ NCT02500407 ] is a Phase I/II, multicenter, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of mosunetuzumab in people with relapsed or refractory B-cell non-Hodgkins lymphoma.
  • Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkins lymphoma, accounting for about one in five cases.

Genentech Provides Update on Alzheimer’s Prevention Initiative Study Evaluating Crenezumab in Autosomal Dominant Alzheimer’s Disease

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Thursday, June 16, 2022
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), together with Banner Alzheimers Institute, today announced results from the Alzheimers Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) Colombia Trial.

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), together with Banner Alzheimers Institute, today announced results from the Alzheimers Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) Colombia Trial.
  • The study evaluated the potential of crenezumab, an investigational medicine, to slow or prevent Alzheimers disease in cognitively unimpaired people who carry a specific genetic mutation which causes early-onset Alzheimers disease.
  • Within its Alzheimers pipeline, Genentech is also evaluating the potential of gantenerumab in autosomal dominant Alzheimers disease, as well as for the prevention of sporadic Alzheimers and treatment of early Alzheimers in late stage clinical trials.
  • The Alzheimers Prevention Initiative (API) is an international collaborative formed in 2009 to launch a new era of Alzheimers prevention research.

Genentech Announces Positive Data from Broad Blood Cancer Portfolio at European Hematology Association Annual Meeting

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Friday, June 10, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MM, Chronic lymphocytic leukemia, Congress, Hoffmann-La Roche, RO, NHL, Lymphatic system, ROG, Venetoclax, European Hematology Association, Polatuzumab vedotin, Prednisone, Patient, Phase, EHA, DLBCL, Cyclophosphamide, CLL, PFS, Doxorubicin, Pharmaceutical industry, Genentech

With these new long-term data and other studies of fixed-duration therapies in our portfolio, we are working to lessen the treatment burdens associated with long-term cancer care.

Key Points: 
  • With these new long-term data and other studies of fixed-duration therapies in our portfolio, we are working to lessen the treatment burdens associated with long-term cancer care.
  • These data were recently presented at the American Society of Clinical Oncology 2022 Annual Meeting and have been submitted for approval to the European Medicines Agency (EMA).
  • In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis.
  • The patients doctor will do blood tests to check their blood counts during treatment with Venclexta and may pause dosing.

FDA Approves Genentech’s Evrysdi (risdiplam) for Use in Babies Under Two Months With Spinal Muscular Atrophy (SMA)

Retrieved on: 
Tuesday, May 31, 2022
Biotechnology, Baby, Maternity, FDA, Other Health, Health, General Health, Pharmaceutical, Research, Consumer, Science, Clinical Trials

Because of its efficacy in multiple settings, Evrysdi is now available for people with SMA from pre-symptomatic newborns to older adults.

Key Points: 
  • Because of its efficacy in multiple settings, Evrysdi is now available for people with SMA from pre-symptomatic newborns to older adults.
  • Evrysdi is a prescription medicine used to treat spinal muscular atrophy (SMA) in children and adults.
  • It is not known if Evrysdi passes into breast milk and may harm your baby
    You should receive Evrysdi from the pharmacy as a liquid.
  • If Evrysdi gets in your eyes, rinse your eyes with water
    The most common side effects of Evrysdi include:

New Pivotal Data Demonstrate Clinical Benefit of Genentech’s Glofitamab, a Potential First-in-Class Bispecific Antibody for People With Aggressive Lymphoma

Retrieved on: 
Thursday, May 26, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology

Cytokine release syndrome (CRS) was the most common adverse event occurring in 63.0% of patients.

Key Points: 
  • Cytokine release syndrome (CRS) was the most common adverse event occurring in 63.0% of patients.
  • CRS events were predictable, generally low grade (mainly Grade 1 [47.4%] or 2 [11.7%]), occurred at initial doses, and only one patient discontinued glofitamab due to CRS.
  • Glofitamab is being investigated in several clinical trials and explored in earlier lines of lymphoma treatment.
  • Glofitamab is an investigational CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells.

Data at the 2022 ASCO Annual Meeting Highlight Genentech’s Continued Commitment to Innovation in Oncology and Personalized Healthcare

Retrieved on: 
Tuesday, May 24, 2022
Biotechnology, Pharmaceutical, Health, Oncology, Bone, Hyperuricemia, Death, Risk, ROS1, Pain, Nausea, Blood, Entrectinib, Dizziness, TRK, Liver disease, Disease, Severe cognitive impairment, Confusion, Liver, Symptoms of COVID-19, Memory, Patient, Fusion, QT, Adult, Health care, Hallucination, Uric acid, NSCLC, FDA, CNS, Heart, Electrolyte, Oral medicine, Heart failure, Genentech, Fertility, Vomiting, Attention, Mutation, Movement, Hepatotoxicity, Cancer, Central nervous system, Sleep, Birth control, Vaccine, Pharmaceutical industry, Dentistry, Atezolizumab

Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

Key Points: 
  • Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.
  • A healthcare provider may temporarily stop treatment, decrease the dose, or permanently stop Rozlytrek if a patient develops liver problems with Rozlytrek.
  • Healthcare providers may stop Rozlytrek and refer to an eye specialist if a patient develops severe vision problems during treatment with Rozlytrek.
  • Patients should tell their healthcare provider right away if they have any loss of vision or any change in vision, including: