Melphalan

CASI PHARMACEUTICALS ANNOUNCES FOURTH QUARTER AND FULL-YEAR 2023 BUSINESS AND FINANCIAL RESULTS

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Thursday, March 28, 2024
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BEIJING, March 28, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the year ended December 31, 2023, and provided an update on key highlights for 2023.

Key Points: 
  • BEIJING, March 28, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the year ended December 31, 2023, and provided an update on key highlights for 2023.
  • CASI reported fourth quarter 2023 revenue of $6.9 million for EVOMELA®, 33% lower than the same period in 2022.
  • 2023 marks a major milestone for CASI and our partner Juventas; Inaticabtagene Autoleucel (CNCT-19 CAR-T cell therapy) was approved by National Medical Products Administration (NMPA) in November 2023.
  • As of December 31, 2023, CASI had cash, cash equivalents and short term investment of $29.1 million compared to $48.6 million as of December 31, 2022.

Avenacy Announces Launch of Melphalan Hydrochloride for Injection in the U.S. Market

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Tuesday, January 16, 2024
Biotechnology, General Health, FDA, Health, Pharmaceutical, Entrepreneurship, Patient, Hospital, Temperature, Anaphylaxis, Food, Multiple myeloma, Chromosome, Human, Melphalan, Safety, Bone marrow, Boxed warning, Bleeding, Aplastic anemia, Infection, Abbreviated New Drug Application, Pharmaceutical industry

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Melphalan Hydrochloride for Injection in the United States as a therapeutic equivalent generic for Alkeran® for Injection (melphalan hydrochloride) approved by the U.S. Food and Drug Administration.

Key Points: 
  • Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Melphalan Hydrochloride for Injection in the United States as a therapeutic equivalent generic for Alkeran® for Injection (melphalan hydrochloride) approved by the U.S. Food and Drug Administration.
  • Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
  • Avenacy’s Melphalan Hydrochloride for Injection is available in a kit containing a 50mg vial of lyophilized active ingredient and a 10mL vial of sterile diluent for admixture.
  • “Melphalan Hydrochloride for Injection will feature our proprietary product packaging and labeling, supporting our commitment to championing reliability, safety, and convenience for our customers.

CASI PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2023 BUSINESS AND FINANCIAL UPDATES

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Tuesday, November 14, 2023
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BEIJING, Nov. 14, 2023 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • BEIJING, Nov. 14, 2023 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the third quarter ended September 30, 2023.
  • He further added, "Our sales revenue for the third quarter of 2023 was $8.8 million, representing a decrease of 13.5% compared to the same period last year and a decrease of 10% from the second quarter of 2023.
  • Revenue was $8.8 million for the three months ended September 30, 2023, compared to $10.2 million for the three months ended September 30, 2022.
  • As of September 30, 2023, CASI had cash, cash equivalents and short-term investments of $34.2 million.

Global Peptide Drug Conjugates Market Expected to Reach $4.21 Billion by 2030, Driven by Rising Cancer Cases - ResearchAndMarkets.com

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Tuesday, October 24, 2023
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The global peptide drug conjugates market is poised for significant growth, with an expected value of USD 4.21 billion by 2030, registering a remarkable Compound Annual Growth Rate (CAGR) of 28.58% during the forecast period.

Key Points: 
  • The global peptide drug conjugates market is poised for significant growth, with an expected value of USD 4.21 billion by 2030, registering a remarkable Compound Annual Growth Rate (CAGR) of 28.58% during the forecast period.
  • Rising Cancer Cases: The market's growth is driven by the global surge in cancer cases and related mortality.
  • The increasing demand for novel treatments like peptide drug conjugates (PDCs) to target uncontrolled cell growth is expected to fuel market growth.
  • For instance, in December 2021, Coherent Biopharma and WuXi STA announced a strategic partnership agreement to develop their current and future therapeutic drugs, including peptide drug conjugates.

Delcath Systems, Inc. Announces FDA Approval of HEPZATO KIT™ for the Treatment of Adult Patients with Unresectable Hepatic-Dominant Metastatic Uveal Melanoma

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Tuesday, August 15, 2023
Neutropenia, Exercise, REMS, Genotype, US Foods, Radiation, EAP, Private investment in public equity, Liver disease, HLA, Mitigation, PIPE, DCR, RECIST, Delcath Systems, Uveal melanoma, National Comprehensive Cancer Network, Toxicity, Mum, Aplastic anemia, Vaccine, Lung, NCCN, HDS, PHP, Incidence, Overseas Private Investment Corporation, Bleeding, Dor, Patient, Lymph, Microsoft Access, Anemia, Liver, FDA, Melphalan, Liver failure, Death, Thrombocytopenia, ORR, Food, Medical imaging, Dietary supplement, Pharmaceutical industry

NEW YORK, Aug. 14, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that today the US Food and Drug Administration (FDA) approved HEPZATO KIT (melphalan/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

Key Points: 
  • mUM is a rare and aggressive form of metastatic cancer with a US incidence of approximately 1,000 cases per year.
  • National Comprehensive Cancer Network (NCCN) guidelines recommend liver-directed therapies for mUM patients with liver metastases.
  • HEPZATO KIT is the only liver-directed therapy approved by the FDA for the treatment of mUM and percutaneous hepatic perfusion (PHP), the procedure enabled by HEPZATO KIT, is already included in the NCCN guidelines.
  • "FDA approval of HEPZATO KIT marks the beginning of a new chapter for Delcath and the culmination of the Company's commitment to bring this treatment option to patients suffering from metastatic uveal melanoma," said Gerard Michel, Delcath's Chief Executive Officer.

Cleave Therapeutics Announces Acquisition of Clinical and Preclinical Assets

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Thursday, July 20, 2023
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Cleave Therapeutics, Inc., a clinical-stage biopharmaceutical company, today announced that CASI Pharmaceuticals (NASDAQ: CASI) has acquired the global rights to the company’s clinical asset, CB-5339, and Eikon Therapeutics has acquired rights to the company’s pre-clinical assets.

Key Points: 
  • Cleave Therapeutics, Inc., a clinical-stage biopharmaceutical company, today announced that CASI Pharmaceuticals (NASDAQ: CASI) has acquired the global rights to the company’s clinical asset, CB-5339, and Eikon Therapeutics has acquired rights to the company’s pre-clinical assets.
  • Eikon Therapeutics is a clinical-stage company working to advance breakthrough therapeutics through the purposeful integration of engineering and science.
  • “Both CASI and Eikon have unique capabilities and the expertise to continue advancing Cleave programs for patients with unmet needs in cancer and other indications,” said Amy Burroughs, president and chief executive officer of Cleave Therapeutics.
  • “The robust scientific and clinical insights the Cleave team has generated over the past decade will inform future development across multiple novel targets and disease areas.

BeyondSpring and Leading Cancer Center Present Poster Highlighting Plinabulin’s Ability to Reduce Infectious Neutropenic Fever for Multiple Myeloma Patients Undergoing AHCT

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Wednesday, June 7, 2023
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BeyondSpring and Memorial Sloan Kettering Cancer Center (MSK) presented the data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting .

Key Points: 
  • BeyondSpring and Memorial Sloan Kettering Cancer Center (MSK) presented the data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting .
  • Between January 2022 and February 2023, 15 patients with a median age of 64 received Plinabulin after a high dose of melphalan.
  • The Plinabulin and pegfilgrastim combination appears well tolerated without additional major toxicities post AHCT.
  • “The Plinabulin-pegfilgrastim combination represents a new potential supportive care for MM patients undergoing AHCT.

AMGEN PRESENTS NEW SCIENTIFIC AND CLINICAL RESEARCH ACROSS ITS DIVERSE ONCOLOGY PORTFOLIO AND PIPELINE AT ASCO 2023

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Thursday, June 1, 2023
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THOUSAND OAKS, Calif., June 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new scientific and clinical research across its diverse oncology portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from June 2-6 in Chicago. More than 25 abstracts from Amgen-sponsored and collaborative studies, including three oral presentations and two poster discussions, will feature data in hard-to-treat tumor types, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and small cell lung cancer (SCLC).

Key Points: 
  • Additional Analyses from DeLLphi-300 Highlight Safety and Clinical Efficacy of Tarlatamab, an Investigational First-in-Class BiTE® Immunotherapy, in Patients with SCLC With Treated and Stable Brain Metastases
    THOUSAND OAKS, Calif., June 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new scientific and clinical research across its diverse oncology portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from June 2-6 in Chicago.
  • More than 25 abstracts from Amgen-sponsored and collaborative studies, including three oral presentations and two poster discussions, will feature data in hard-to-treat tumor types, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and small cell lung cancer (SCLC).
  • "Our presentations at ASCO will illustrate how we're advancing novel approaches to address the toughest thoracic and colorectal cancers with limited treatment options," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
  • "We're focused on expanding the reach and impact of our transformative, first-in-class medicines to help more people living with cancer."

Accuray CyberKnife® and TomoTherapy® Platforms Featured in More Than 55 Abstracts Presented at ESTRO 2023, Reinforcing Systems' Versatility, Efficiency and Effectiveness

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Wednesday, May 17, 2023
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SUNNYVALE, Calif., May 17, 2023 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that new data presented at the European Society for Radiotherapy and Oncology (ESTRO) meeting reinforces the benefits of the company's CyberKnife® and TomoTherapy® platforms, including the latest generation Radixact® System. More than 55 abstracts highlighting Accuray technologies were presented at the 2023 ESTRO annual congress held in Vienna, Austria, from May 12 to May 16, 2023, building on existing clinical evidence and supporting the systems' use to deliver (ultra) hypofractionated radiation treatments for the precise and personalized treatment of a wide range of cancers.

Key Points: 
  • During the meeting, Accuray hosted a symposium titled " Advances in Hypofractionation for Breast and Prostate Cancer " featuring clinical experts who discussed the most recent – and promising – clinical studies.
  • "The information sharing that takes place at meetings such as ESTRO is focused on the same critical goal – improving patient care.
  • Delivering ablative doses to target spinal metastases, ensuring good local control and low rates of toxicity while protecting critical organs5.
  • It is not CE marked and availability is subject to regulatory clearance or approval in some markets.

Jasper Therapeutics Announces Positive Clinical Data from a Phase I/II Trial of Briquilimab as a Conditioning Treatment in Sickle Cell Disease and Beta Thalassemia

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Tuesday, January 3, 2023
Bone marrow, Genetic distance, Melphalan, NHLBI, SCD, Busulfan, Therapy, Nominal interest rate, Sickle cell disease, Phenotype, Toxicity, Alemtuzumab, Cellular, Patient, Thalassemia, Beta thalassemia, Physician, Safety, B cell, Transplant, Cell, Dentistry

The addition of briquilimab is being studied as a potential way to achieve a higher percentage of healthy donor stem cell engraftment (donor chimerism) without increased toxicity.

Key Points: 
  • The addition of briquilimab is being studied as a potential way to achieve a higher percentage of healthy donor stem cell engraftment (donor chimerism) without increased toxicity.
  • The Phase 1/2 clinical study is led by Dr. John F. Tisdale, Director of the Cellular and Molecular Therapeutics Laboratory, NHLBI.
  • Briquilimab has the potential to improve disease-free survival in combination with low-dose irradiation as part of a transplant conditioning regimen.
  • All three sickle cell study participants treated with briquilimab have successfully engrafted with no briquilimab-related severe adverse events observed.