Dexamethasone

C4 Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights

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水曜日, 5月 8, 2024
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WATERTOWN, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today reported financial results for the first quarter ended March 31, 2024, as well as recent business highlights.

Key Points: 
  • Revenue: Total revenue for the first quarter of 2024 was $3.0 million, compared to $3.8 million for the first quarter of 2023.
  • General and Administrative (G&A) Expense: G&A expense, net of a one-time $0.5 million restructuring charge, was $10.3 million for the first quarter of 2024.
  • Net Loss and Net Loss per Share: Net loss for the first quarter of 2024 was $28.4 million, compared to $34.8 million for the first quarter of 2023.
  • Net loss per share for the first quarter of 2024 was $0.41 compared to $0.71 for the first quarter of 2023.

Oculis Reports Q1 2024 Financial Results and Provides Company Updates

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水曜日, 5月 8, 2024
Dexamethasone, Pain, State, Inflammation, Investment, Refractive surgery, Safety, NDA, OCS, Research, Cataract, DED, AON, Development, IND, Retina, ASCRS, Research and development, Patient, Society, Pharming, CHF, Genotype, DME, Bank statement, Clinical trial, Annual general meeting, Ophthalmology, Pharmaceutical industry

The two ongoing Phase 3 52-week trials, DIAMOND-1 and DIAMOND-2, started as planned in December 2023 and February 2024, respectively.

Key Points: 
  • The two ongoing Phase 3 52-week trials, DIAMOND-1 and DIAMOND-2, started as planned in December 2023 and February 2024, respectively.
  • Concurrently, the Company listed on the Nasdaq Iceland Main Market in addition to Nasdaq Global Market in the U.S.
    Snehal Shah, Pharm.
  • The Company also aims to complete an IND submission for OCS-05 in the U.S. in 2024.
  • The Company’s management uses these measures to better analyze its financial results and better estimate its financial outlook.

Starton Therapeutics Announces Enrollment Completion for STAR-LLD Phase 1b Clinical Trial in Multiple Myeloma

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木曜日, 4月 25, 2024
Dexamethasone, FDA, Multiple myeloma, Safety, Pharmacokinetics, Bortezomib, Neutropenia, Science, CLL, Patient, Fatigue, Rash, Malignancy, Clinical trial, Therapy, Lenalidomide, Pharmaceutical industry

PARAMUS, N.J., April 25, 2024 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary dermal technologies, announced today the successful completion of enrollment for its STAR-LLD Phase 1b clinical trial in multiple myeloma.

Key Points: 
  • PARAMUS, N.J., April 25, 2024 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary dermal technologies, announced today the successful completion of enrollment for its STAR-LLD Phase 1b clinical trial in multiple myeloma.
  • “This milestone marks a significant step forward in our commitment to bringing more advanced therapies to patients.
  • We extend our gratitude to the participants, investigators, and clinical teams whose dedication and collaboration have made this achievement possible significantly ahead of our original timelines,” stated Pedro Lichtinger, Chairman and CEO of Starton Therapeutics.
  • Together, we are not just advancing science; we are transforming lives.”
    Starton previously disclosed preliminary trial findings regarding the safety and efficacy of STAR-LLD for multiple myeloma.

Opna Bio Presents Promising Preclinical Data in Multiple Myeloma with OPN-6602 and in Malignant Mesothelioma with OPN-9840 Showing Significant Tumor Growth Inhibition at the American Association of Cancer Research Annual Meeting

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水曜日, 4月 10, 2024
Research, Venture Capital, Clinical Trials, Professional Services, Biotechnology, Health, Pharmaceutical, Science, Oncology, CREB-binding protein, NF2, Dexamethasone, FDA, MYC, TGI, Cancer, Bone marrow, Abdomen, Multiple myeloma, Mouse, MYB, Mesothelioma, EP300, Streets of Rage, Doctor of Philosophy, IND, Glomus tumor, TEAD, FMRP, Therapy, BRAF, CBP, Thomas Jefferson University, Patient, Neurofibromatosis, Hippopotamus, Neoplasm, Standard of care, AACR, E1A, IRF4

Data were shared at the American Association of Cancer Research (AACR) Annual Meeting, taking place April 5-10, 2024 in San Diego.

Key Points: 
  • Data were shared at the American Association of Cancer Research (AACR) Annual Meeting, taking place April 5-10, 2024 in San Diego.
  • Multiple myeloma is an aggressive blood cancer derived from malignant plasma cells in the bone marrow.
  • "We are excited to begin our Phase 1 study of OPN-6602 in patients with multiple myeloma this summer.
  • Malignant mesothelioma is a rare and aggressive cancer that primarily affects the lining of the lungs or abdomen.

Oncopeptides and Vector Pharma FZCO Announce Collaboration to Provide Pepaxti to Patients in the Middle East and North Africa 

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水曜日, 3月 27, 2024
Vector, Dexamethasone, Disease, Bone marrow, Partnership, Patient, Multiple myeloma, Cancer, WODA, Health professional, PDC, Medicine, Pharmaceutical industry

Under the terms of this exclusive agreement, Vector will distribute Pepaxti to patients in the MENA region for the treatment of patients with multiple myeloma.

Key Points: 
  • Under the terms of this exclusive agreement, Vector will distribute Pepaxti to patients in the MENA region for the treatment of patients with multiple myeloma.
  • The two parties have agreed on a revenue split on all Pepaxti sales in the region, with Vector carrying all costs through their existing structure in the region.
  • “I am excited to announce this regional agreement with Oncopeptides,” says Vector Pharma FZCO Managing Partner Patrick Jordan.
  • “We are happy for our partnership with Vector and look forward to working together as we enter this promising region together.

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

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土曜日, 4月 6, 2024
Guillain–Barré syndrome, Bone marrow, Medical College of Wisconsin, Encephalopathy, Survival, Immunotherapy, BCMA, Patient, Hypotension, Mortality, B-cell maturation antigen, Edema, Periodic breathing, Associate professor, Dexamethasone, Certification, Neutropenia, Dizziness, Risk, Headache, Chills, Myelodysplastic syndrome, Coagulopathy, DPD, Johnson & Johnson, Immune system, Effect, Fatigue, Thrombocytopenia, Food, Disease, Drive, Appetite, Lymphocytopenia, JNJ, Constipation, Multiple myeloma, Acute myeloid leukemia, CRS, Death, Hypersensitivity, Cytopenia, Cytokine release syndrome, ASCO, Use, Hematology, FDA, PVD, Annual general meeting, T cell, DSM-IV codes, Incidence, Tachycardia, Bortezomib, Diarrhea, Viral, Hope, United, Cough, Daratumumab, Nausea, Society, Division, Physician, Pharmaceutical industry

HORSHAM, Pa., April 5, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

Key Points: 
  • "This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • CARVYKTI® is a cell therapy that works by harnessing a patient's immune system, or T cells, to fight the disease.
  • Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients.
  • Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI® production.

Oculis Reports Q4 and Full Year 2023 Financial Results and Update on Company Progress

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月曜日, 3月 18, 2024
Research, TNF, AON, Dexamethasone, Congress, International, International Financial Reporting Standards, Telecanthus, Inflammation, DME, Patient, SNP, NDA, American Academy, G&A, POC, Business analyst, IND, Abstract, DED, Bank statement, Genotype, Investment, Retina, Diabetic retinopathy, OCS, Safety, CHF, Pain, Stage 2, Pharmaceutical industry

Riad Sherif M.D., Chief Executive Officer of Oculis: “2023 was a remarkable milestone-rich year for Oculis.

Key Points: 
  • Riad Sherif M.D., Chief Executive Officer of Oculis: “2023 was a remarkable milestone-rich year for Oculis.
  • These non-IFRS financial measures exclude the impact of items that the Company’s management believes affect comparability or underlying business trends.
  • The Company’s management uses these measures to better analyze its financial results and better estimate its financial outlook.
  • The resulting non-cash foreign exchange impact of such reclassification amounted to CHF 5.0 million or $5.7 million for the year ended December 31, 2023.

InnoCare Releases 2023 Results and Business Highlights

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木曜日, 3月 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.

Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension

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月曜日, 3月 25, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, FDA, AOE, Otitis externa, Patient, Dexamethasone, Ciprofloxacin, Abbreviated New Drug Application, Pseudomonas aeruginosa, Medication, Infection, Staphylococcus aureus, Amneal Pharmaceuticals, Food

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension.
  • “This approval represents the addition of another complex, high value medicine,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics.
  • “It reflects the ongoing shift of our leading affordable medicines portfolio towards complex products and the continued successful diversification of our business.”
    The most common adverse reactions reported with ciprofloxacin and dexamethasone otic suspension were ear pain (2.3%), ear discomfort (3%), and ear pruritus (1.5%).
  • For full prescribing information, see package insert located here .

Onco360 Selected as the Preferred National Specialty Pharmacy Partner for XPOVIO® (selinexor)

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水曜日, 3月 13, 2024
Oncology, Health, Clinical Trials, Research, Pharmaceutical, Science, Diagnosis, B-cell lymphoma, Dexamethasone, Selinexor, Partnership, Bortezomib, Patient, Carfilzomib, National Cancer Institute, Multiple myeloma, B cell, Lenalidomide, Daratumumab, Therapy, Bone marrow, Food, FDA, DLBCL, Follicular lymphoma, Pharmaceutical industry

Onco360®, the nation’s largest independent Oncology Pharmacy, is now the national specialty pharmacy network partner for Karyopharm’s product XPOVIO® (selinexor), a first-in-class, XPO-1 inhibitor.

Key Points: 
  • Onco360®, the nation’s largest independent Oncology Pharmacy, is now the national specialty pharmacy network partner for Karyopharm’s product XPOVIO® (selinexor), a first-in-class, XPO-1 inhibitor.
  • “Onco360 is excited to expand our partnership with the team at Karyopharm and become the preferred national specialty pharmacy partner for XPOVIO,” said Benito Fernandez, Chief Commercial Officer.
  • Multiple myeloma is an incurable hematological malignancy involving plasma cells.
  • Only 50 percent of patients diagnosed with multiple myeloma survive past five years following initial diagnosis.