BLA

bluebird bio, Inc. (BLUE) Stockholder Alert: Robbins LLP Reminds Investors of bluebird bio, Inc. Class Action

Retrieved on: 
Tuesday, April 2, 2024
Class Action Lawsuit, Professional Services, Legal, Sickle cell disease, Biotechnology, Bluebird, Clinical, DSM-IV codes, Patient, History, News, LLP, Cancer, Commercial, Complaint, BLUE, File, SCD, Bluebird bio, FDA, BLA, Food, Person, Pharmaceutical industry

Robbins LLP reminds investors that a shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired bluebird bio, Inc. (NASDAQ: BLUE) common stock between April 24, 2023 and December 8, 2023.

Key Points: 
  • Robbins LLP reminds investors that a shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired bluebird bio, Inc. (NASDAQ: BLUE) common stock between April 24, 2023 and December 8, 2023.
  • Bluebird is a biotechnology company that researches, develops, and commercializes gene therapies for severe genetic diseases.
  • For more information, submit a form , email attorney Aaron Dumas, Jr., or give us a call at (800) 350-6003.
  • A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation.

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

Retrieved on: 
Tuesday, April 2, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Breast cancer, Goserelin, Patient, Lung, Social media, Immunoglobulin G, National Cancer Institute, Neoplasm, Merck & Co., TNBC, Capecitabine, DXD, BRCA, Clinical Cancer Research, Metabolism, Immunology, Biopharmaceutical, World Health Organization, Cancer, Safety, ADC, BLA, Daiichi Sankyo, Vinorelbine, IHC, Mutation, NSCLC, Disease, Merck, AKT, Death, MD, AstraZeneca, PARP, Oncotarget, PFS, FDA, OS, HER2, Eribulin, Cleavage, Progression-free survival, Triple-negative breast cancer, Female, Emerging, Olaparib, Biology, Sapporo Medical University, Medicine, Pharmaceutical industry

The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.

Key Points: 
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.
  • A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple-negative breast cancer (TNBC) and HR-positive, HER2-negative breast cancer.
  • Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer.

Omeros Corporation Reports Fourth Quarter and Year-End 2023 Financial Results

Retrieved on: 
Monday, April 1, 2024
Mental Health, Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Oncology, PIN, PNH, Patient, Sale, CUD, Graft-versus-host disease, Investment, Clinical trial, Hemolysis, Calcineurin, Emory University, ASH, Risk, L-DOPA, Thumbay Hospital, Behavior informatics, Trial of the century, Myelodysplastic syndrome, Cancer, Safety, Transplant, LID, DRI, BLA, Corporation, Paroxysmal nocturnal hemoglobinuria, Tardive dyskinesia, Parkinson's disease, Publication, DSM-IV codes, Retirement, FDA, PDE7, LDH, Hematology, Mortality, Hematopoietic stem cell transplantation, Bone marrow failure, Abstract, Society, Pharmacology, Pharmaceutical industry

Net loss from continuing operations was $39.3 million for the 2023 fourth quarter compared to $51.7 million for the prior quarter.

Key Points: 
  • Net loss from continuing operations was $39.3 million for the 2023 fourth quarter compared to $51.7 million for the prior quarter.
  • Total operating expenses for the fourth quarter of 2023 were $39.8 million compared to $48.2 million for the third quarter of 2023.
  • Interest expense during the fourth quarter of 2023 was $7.1 million compared to $7.9 million during the prior quarter.
  • During the fourth quarter of 2023, we earned $3.4 million in interest and other income compared to $4.4 million in the third quarter.

Datopotamab Deruxtecan Biologics License Application Accepted in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

Retrieved on: 
Tuesday, April 2, 2024
Oncology, Health, FDA, Clinical Trials, General Health, Pharmaceutical, OS, HER2, IHC, HR, Neutropenia, Congress, DXD, AstraZeneca, NSCLC, Progression-free survival, Patient, Stomatitis, Lung, Doctor of Philosophy, MD, Breast cancer, Anemia, PFS, Fatigue, ADC, Food, BLA, Daiichi Sankyo, PDUFA, Pharmaceutical industry

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.

Key Points: 
  • Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca.
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • “The FDA’s acceptance of the BLA brings us closer to providing patients with previously treated HR positive, HER2 negative breast cancer an alternative option to conventional chemotherapy earlier in the metastatic setting,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.

BLUE INVESTOR NOTICE: Robbins Geller Rudman & Dowd LLP Announces that bluebird bio, Inc. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit

Retrieved on: 
Friday, March 29, 2024
Class Action Lawsuit, Professional Services, Legal, Sickle cell disease, Biotechnology, Bluebird bio, DSM-IV codes, Patient, History, News, Cancer, Complaint, SCD, Bluebird, Food, FDA, BLA

), the bluebird bio class action lawsuit charges bluebird bio and certain of bluebird bio’s top executives with violations of the Securities Exchange Act of 1934.

Key Points: 
  • ), the bluebird bio class action lawsuit charges bluebird bio and certain of bluebird bio’s top executives with violations of the Securities Exchange Act of 1934.
  • A lead plaintiff acts on behalf of all other class members in directing the bluebird bio class action lawsuit.
  • The lead plaintiff can select a law firm of its choice to litigate the bluebird bio class action lawsuit.
  • An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the bluebird bio class action lawsuit.

Atara Biotherapeutics Announces Fourth Quarter and Full Year 2023 Financial Results and Operational Progress

Retrieved on: 
Thursday, March 28, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, The Lancet, Research, Graft-versus-host disease, LD, ASH, International Society, Partnership, Central nervous system, ATRA, Epstein–Barr virus, Patient, Follicular lymphoma, CNS, Biomarker, PTLD, Cancer, Lymphoproliferative disorders, SLE, EBV, NHL, Lymphoma, Mantle cell lymphoma, Investment, ATM, Safety, Pharmacokinetics, Depreciation, File, Workforce, Cell, FDA, BLA, Lupus nephritis, CD19, Food, Autoimmune disease, Pharmaceutical industry

“We are expanding Atara’s proven EBV T-cell platform into allogeneic CAR T therapy for both oncology and autoimmune disease,” said Pascal Touchon, President and Chief Executive Officer of Atara.

Key Points: 
  • “We are expanding Atara’s proven EBV T-cell platform into allogeneic CAR T therapy for both oncology and autoimmune disease,” said Pascal Touchon, President and Chief Executive Officer of Atara.
  • “This includes strong momentum for our lead CAR T program, ATA3219, which is positioned to deliver near-term clinical data for both non-Hodgkin’s lymphoma and lupus nephritis.
  • Subjects will receive lymphodepletion (LD) treatment followed by ATA3219 at a dose of 40, 80, or 160 x 106 CAR+ T cells.
  • Subjects will receive LD treatment followed by ATA3219 at a dose of 40, 80, 240, or 480 x 106 CAR+ T cells.

InnoCare Releases 2023 Results and Business Highlights

Retrieved on: 
Thursday, March 28, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, QD, Tafasitamab, Patient, B-cell lymphoma, NDA, SLE, POC, IND, Clinical trial, Bone marrow, IKZF1, Phase, Therapy, IGA, MCD, Dexamethasone, MCL, Neuromyelitis optica spectrum disorder, IKZF3, AML, NMOSD, Outline of health sciences, DLT, Cancer, Autoimmune disease, Safety, TYK2, HSA, NRDL, BLA, Follicular lymphoma, Food, GC, Development, Multiple sclerosis, PD, CRBN, Public, Gordon Ramsay's Bank Balance, Multiple myeloma, ITP, BCL2, Leukemia, Cmax, Gadolinium, HKEX, SRI, AAD, Proteinuria, DLBCL, Glucocorticoid, IVIG, Loss, European Hematology Association, American Academy, EHA, Lenalidomide, NHL, Non-Hodgkin lymphoma, CCR8, US FDA, BTK, NRS, Pharmaceutical industry

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.
  • In 2023, InnoCare has continued to advance its robust pipeline across various clinical stages, continuously unleashing the power of innovation to meet unmet medical needs.
  • In June 2023, the ITP Phase II result was orally presented at the European Hematology Association (EHA) 2023 Hybrid Congress.
  • InnoCare was approved by the Hong Kong Stock Exchange to remove "B" from the stock code from May 12, 2023.

OmniAb Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Wednesday, March 20, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Research, Multiple myeloma, Lung cancer, Partner, NMPA, Growth, NSCLC, CIDP, Partnership, Telephone, GSK, Patient, TED, NASDAQ Biotechnology Index, Epitope, Artificial intelligence, Sale, Myasthenia gravis, Neonatal Fc receptor, Fluorouracil, Graves' ophthalmopathy, Investment, Teclistamab, NBI, National Medical Products Administration, Johnson & Johnson, Drug development, Safety, Chicken, Machine learning, Gastrointestinal cancer, Immunoglobulin G, BLA, Chronic inflammatory demyelinating polyneuropathy, Pharmaceutical industry

OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.

Key Points: 
  • OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and 12 months ended December 31, 2023, and provided operating and partner program updates.
  • OmniAb launched two new technologies during 2023 including OmniDeep™ and, during the fourth quarter, OmnidAb™.
  • Fourth quarter 2023 and recent partner highlights include the following:
    Immunovant reported positive initial results for batoclimab in Graves’ disease (GD).
  • OmniAb was added to the Nasdaq Biotechnology Index (NBI) in the fourth quarter.

AffyImmune Therapeutics Appoints Matt Britz as Chief Executive Officer and Pete Gelinas as SVP of CMC

Retrieved on: 
Tuesday, March 19, 2024
Research, Genetics, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, CALD, Control, Thyroid cancer, Growth, Bluebird bio, MAA, Drug discovery, Business, MIT, Britz, Patient, SVP, Marketing Authorisation Application, Merck, MSAT, Business development, Acquisition, CMC, Betibeglogene autotemcel, Technology transfer, Senior, MBA, CMCF, Therapy, Takeda, Equinox Group, Dana–Farber Cancer Institute, Multimedia, Chemical engineering, DFCI, Partnership, Biology, BLA, Pharmaceutical industry

AffyImmune Therapeutics, Inc ., a clinical-stage biopharmaceutical company committed to developing novel, first-in-class, affinity-tuned CAR T cell therapies, announced today the appointment of Matt Britz to Chief Executive Officer and Pete Gelinas as Senior Vice President of Chemistry, Manufacturing, and Controls.

Key Points: 
  • AffyImmune Therapeutics, Inc ., a clinical-stage biopharmaceutical company committed to developing novel, first-in-class, affinity-tuned CAR T cell therapies, announced today the appointment of Matt Britz to Chief Executive Officer and Pete Gelinas as Senior Vice President of Chemistry, Manufacturing, and Controls.
  • Matt is well-suited to lead AffyImmune as CEO as the Company accelerates clinical development of AIC100 in thyroid cancer, and in other indications with high unmet medical need.
  • Matt Britz joined AffyImmune in June 2021 as Senior Vice President (SVP), Business Development and was promoted to Chief Operating Officer in January 2022.
  • Pete Gelinas brings over 15 years of extensive experience in Manufacturing and CMC Product Development to AffyImmune.

BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy

Retrieved on: 
Thursday, March 14, 2024
Cardiology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Civil service commission, Glucose, Survival, ALT, DSM-IV codes, Associate, Blas, Medicine, Patient, Esophageal cancer, Committee, Sodium, Alkaline phosphatase, University, Cancer, EMA, BGNE, Quality of life, Tislelizumab, Lung cancer, Section, European Medicines Agency, Lymphocyte, ITT, European Commission, Anemia, Division, ESCC, Fatigue, University of Southern California, BLA, Food, Pharmaceutical industry

TEVIMBRA will be available in the U.S. in the second half of 2024.

Key Points: 
  • TEVIMBRA will be available in the U.S. in the second half of 2024.
  • The FDA is also reviewing Biologics License Applications (BLAs) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
  • BeiGene has launched more than 17 potentially registration-enabling trials with TEVIMBRA, of which 11 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts.
  • More than 900,000 patients have been prescribed TEVIMBRA globally to date.