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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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Bouncing back from a previous rejection, ImmunityBio on Monday secured the FDA’s green light for its IL-15 superagonist Anktiva for non-muscle invasive bladder cancer.
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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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ImmunityBio Announces FDA Approval of ANKTIVA®, First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
4/23/2024
ImmunityBio, Inc., an immunotherapy company, announced that the U.S. Food and Drug Administration has approved ANKTIVA plus Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
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The FDA will close out April with five target action dates around indications that include pediatric seizures and a neurological cancer in children.
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NIAID-Sponsored Study Shows N-803 Combined with Neutralizing Antibodies Could Lead to Sustained HIV Viral Control After Discontinuation of Antiretroviral Therapy
3/6/2024
ImmunityBio (NASDAQ: IBRX) today announced the recent publication of preclinical data in the online issue of Science, First Release indicating that combination therapy with N-803, an IL-15 superagonist, and broadly neutralizing antibodies may potentially enable the immune system to manage human immunodeficiency virus (HIV) without the need for antiretroviral treatment.
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N-803 Combined with Natural Killer Cells Showed Potential to Reduce HIV Viral Load in HIV Positive Subjects; Part of HIV Cure Study
3/5/2024
ImmunityBio (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced data from a Phase 1 pilot study showed N-803 combined with natural killer cells could have the potential to reduce viral load in people living with HIV.
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ImmunityBio Announces Full Accrual of First Two Phases of Cancer Vaccine Trial in Participants with Lynch Syndrome and Initiation of Randomized Controlled Phase of the Trial
2/21/2024
ImmunityBio today announced that enrollment and initial follow-up has been completed for the safety portions of a clinical trial that is studying ImmunityBio’s investigational cancer vaccine of a tri-valent combination of antigens delivered by a second-generation Adenovirus vector.
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ImmunityBio Quality-of-Life Study in BCG-Unresponsive Bladder Cancer Trial Indicates Improved Physical Function in the 71% Complete Responders Suggesting a Favorable Risk-Benefit Ratio for N-803 Plus BCG
2/5/2024
ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that findings from Patient-Reported Outcomes (PROs) of participants in the phase 2/3 QUILT 3.032 study of N-803 plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) were published by the peer-reviewed journal Urology Practice.
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LadRx Issues 2024 Update to Shareholders
1/9/2024
LadRx Corporation issued the below letter to shareholders providing a corporate update and anticipated milestones for 2024 regarding arimoclomol and LADR-7.
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Trading cash for single-digit royalties on products, the deal provides ImmunityBio with the cash it’ll need to potentially commercialize its bladder cancer drug, if approved. The PDUFA date is April 23, 2024.
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ImmunityBio Announces $320 Million Investment by Oberland Capital, with $210 Million Funded at Closing, Bringing Total Financing in 2023 to $850 Million
1/2/2024
ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company (“ImmunityBio” or the “Company”), today announced an up to $320 million royalty financing and equity investment in the Company by Oberland Capital, with $210 million of gross proceeds received at closing on December 29, 2023.
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As Its Domestic Market Grows, South Africa Moves Toward Greater Local Biopharmaceutical Production
12/13/2023
Partnerships with companies based in the U.S. and elsewhere are one factor driving growth in the industry, but obstacles remain. -
ImmunityBio to Participate in 35th Annual Piper Sandler Healthcare Conference
11/16/2023
ImmunityBio, Inc. ( NASDAQ: IBRX ), a clinical-stage immunotherapy company, announced today that the company will be participating in the 35th Annual Piper Sandler Healthcare Conference, which is taking place in New York City, November 28-30, 2023.
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First Data for ImmunityBio’s Memory Cytokine-Enriched NK Cells in Small Cell Lung Cancer at SITC Meeting Show Promising Anti-tumor Activity
11/7/2023
ImmunityBio, Inc., a clinical-stage immunotherapy company, announced new data showing that the company’s Memory Cytokine-Enriched Natural Killer cells may provide benefit to patients with small cell lung cancer and patients with other types of neuroendocrine tumors.
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FDA Accepts ImmunityBio’s BLA Resubmission as Complete and Sets New PDUFA Date
10/26/2023
ImmunityBio, Inc. announced that the U.S. Food and Drug Administration has accepted for review ImmunityBio’s resubmission of its Biologics License Application for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease, and considered it as a complete response to the FDA’s May 9, 2023 complete response letter.
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ImmunityBio Announces Biological License Application Resubmission for N-803 in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Carcinoma-In-Situ
10/23/2023
ImmunityBio, Inc. (NASDAQ: IBRX) today announced it has completed the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for N-803 (Anktiva®), a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease.
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Bluejay Therapeutics expands management team and hired Christopher Holterhoff as senior Vice President, head of business development
9/21/2023
Bluejay Therapeutics, Inc. today announced the appointment of Christopher Holterhoff as Senior Vice President, Head of Business Development.
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ImmunityBio Announces $470 Million Equity and Debt Financing From Founder, Dr. Patrick Soon-Shiong and Nant Entities
9/11/2023
ImmunityBio, Inc. announced that it has executed financing transactions resulting in approximately $200 million of proceeds to the Company through a financing including an exchange into equity of current debt and a new convertible debt instrument from Nant Capital, LLC, an entity affiliated with Dr. Patrick Soon-Shiong, the Company’s Founder, Executive Chairman and Global Chief Scientific and Medical Officer.
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ImmunityBio Names Enrique Diloné as Chief Technology Officer
8/3/2023
ImmunityBio, Inc. ( NASDAQ: IBRX ), a clinical-stage immunotherapy company, today announced that it has named Enrique Diloné, Ph.D., to the newly created role of Chief Technology Officer.