Dexamethasone

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

Retrieved on: 
Wednesday, March 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

Retrieved on: 
Saturday, April 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

Retrieved on: 
Monday, March 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

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.

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

Retrieved on: 
Monday, March 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)

Retrieved on: 
Wednesday, March 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.

U.S. FDA Oncologic Drugs Advisory Committee recommends CARVYKTI® (ciltacabtagene autoleucel) for the earlier treatment of patients with relapsed or refractory multiple myeloma

Retrieved on: 
Friday, March 15, 2024
Dexamethasone, Type, Health, Survival, Multiple myeloma, Disease, Bortezomib, Oncology, Patient, Committee, EMA, Lenalidomide, European Medicines Agency, Daratumumab, DPD, Society, Johnson & Johnson, ODAC, Safety, ASCO, Food, Hematology, FDA, CHMP, Immunomodulatory imide drug, PVD, Annual general meeting, PDUFA, Pharmaceutical industry

RARITAN, N.J., March 15, 2024  /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommends 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 (PI) and an immunomodulatory agent (IMiD) and who are refractory to lenalidomide. The committee reviewed survival and safety data from the Phase 3 CARTITUDE-4 study and voted unanimously in favor of CARVYKTI® (11 to 0) finding the risk-benefit assessment of CARVYKTI® for the proposed indication as favorable. A supplemental Biologics License Application (sBLA) supported by the CARTITUDE-4 study is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) date of April 5, 2024. 

Key Points: 
  • "We are pleased with the advisory committee's support for CARVYKTI in earlier lines of treatment based on the CARTITUDE-4 data," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • "As a physician and researcher committed to advancing patient care, the potential of CARVYKTI in earlier lines of therapy represents an important therapeutic option for patients with multiple myeloma."
  • The ODAC is convened upon request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of oncologic diseases.
  • The committee provides non-binding recommendations based on its evaluation; however, final decisions on approval of the drug are made by the FDA.

Mustang Bio Reports Full-Year 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Monday, March 11, 2024
Fast Track, ICT, ICV, Research, WM, Indolent lymphoma, XSCID, NHL, ASH, FDA, Birmingham School of Law, City, Cancer, DSM-IV codes, Mustang, Sale, Nature, Tocilizumab, GBM, Standard of care, Safety, Dexamethasone, Society, University, Mayo Clinic, Clinical professor, Translation, University of Washington, Foreign investment, Tumor microenvironment, Associate, CRS, Patient, Clinical trial, Disease, Survival, CFIUS, Cytokine release syndrome, Follicular lymphoma, Pharmaceutical industry

WORCESTER, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.

Key Points: 
  • WORCESTER, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.
  • Research and development expenses were $40.5 million for the year ended December 31, 2023, compared to $62.5 million for 2022.
  • 2023 and Recent Corporate Highlights:
    In July 2023, Mustang announced that it amended its previously announced asset purchase agreement with uBriGene (Boston) Biosciences Inc. (“uBriGene”) and closed the transaction.
  • In October 2023, Mustang completed a registered direct offering priced at-the-market for approximately $4.4 million in gross proceeds.

C4 Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, February 22, 2024
BRAF, PD, Research, International Myeloma Foundation, Sale, Lung cancer, Workforce, Poster, Melanoma, P-value, Clinical trial, ATM, BCMA, Therapy, CCCC, Roche, Completeness, CRC, AACR, Conference, Colorectal cancer, Merck, NHL, Research and development, Cancer, Dexamethasone, Administration, Patient, Finance, Biogen, Pharmaceutical industry

WATERTOWN, Mass., Feb. 22, 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 year ended December 31, 2023, as well as recent business updates.

Key Points: 
  • As of February 2024, three escalation cohorts are complete and dose escalation continues with a fourth dose level currently enrolling.
  • In December 2023, C4T and Merck entered into a license and research collaboration to discover and develop degrader antibody conjugates.
  • Net loss per share for the year ended December 31, 2023 was $2.67, compared to $2.62 for the year ended December 31, 2022.
  • Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of December 31, 2023 were $281.7 million, compared to $337.1 million as of December 31, 2022.

New Real-World Data Further Support the Use of Veklury® (Remdesivir) for People Hospitalized With COVID-19

Retrieved on: 
Tuesday, March 5, 2024
Health, Infectious Diseases, Hospitals, COVID-19, Clinical Trials, Pharmaceutical, Biotechnology, Omicron, PCC, Dexamethasone, Senior, Patient, Mortality, Immunodeficiency, Gilead Sciences, CROI, MD, Risk, Pharmaceutical industry

One study showed Veklury® (remdesivir) was associated with a reduced risk of certain long-COVID symptoms in people who were hospitalized for COVID-19.

Key Points: 
  • One study showed Veklury® (remdesivir) was associated with a reduced risk of certain long-COVID symptoms in people who were hospitalized for COVID-19.
  • “As we enter the fourth year of COVID-19, Veklury remains the antiviral standard of care for people hospitalized for COVID-19.
  • Results from this analysis build on existing evidence that support the importance of treating COVID-19 early in the disease course with an antiviral.
  • Patients on invasive mechanical ventilation/ECMO at baseline had a 19% (p=0.0182) reduced risk for mortality at Day 28.