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Monday, May 10, 2021 8:15:06 PM
Recent Partner Highlights:
Janssen achieved several important successes related to the subcutaneous formulation of DARZALEX® (daratumumab) using ENHANZE® technology during the first quarter and since including:Janssen Pharmaceutical K.K. announced approval fromJapan's Ministry of Health, Labour and Welfare (MHLW) in March for the subcutaneous formulation of DARZALEX® (known as DALACURO® in Japan) for the treatment of multiple myeloma. Accordingly, Halozyme recognized $5 million in milestone revenues.The Janssen Pharmaceutical Companies of Johnson & Johnson announced Health Canada approved DARZALEX® SC (daratumumab injection), a subcutaneous (SC) formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd, also known as DCyBorD) in April for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. There were previously no approved therapies for the disease.Janssen Biotech, Inc. received U.S. Food and Drug Administration accelerated approval in January for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. There were previously no approved therapies for the disease.In March, Horizon completed dosing for its first trial exploring a subcutaneous (SC) formulation of TEPEZZA®(teprotumumab-trbw) using ENHANZE® technology. The trial is a small, single-dose Phase 1 pharmacokinetic trial which includes evaluating the use of ENHANZE® drug-delivery technology for a SC formulation, which could potentially shorten drug administration time, reducing healthcare practitioner time and offering additional flexibility and convenience for patients.Bristol Myers Squibb (BMS) has advanced plans to initiate a Phase 3 study of nivolumab with ENHANZE® technology for patients with advanced or metastatic clear cell renal cell carcinoma during the second quarter of 2021. Accordingly, Halozyme recognized $25 million in milestone revenues.During the first quarter, argenx reached two important achievements related to its development of efgartigimod using ENHANZE® including:In February 2021, argenx announced a "go" decision for its late-stage ADHERE trial evaluating subcutaneous (SC) efgartigimod using ENHANZE® technology in chronic inflammatory demyelinating polyneuropathy (CIDP). argenx plans to continue enrollment to include approximately 130 patients to support potential registration of SC efgartigimod for the treatment of CIDP.In January 2021, argenx initiated a Phase 3 study of ARGX-113 using ENHANZE® technology in pemphigus vulgaris and pemphigus foliaceus, rare autoimmune diseases that cause painful blisters on the skin and mucous membranes.
Recent CDMO News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 11:50:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 11:48:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/15/2024 08:40:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/12/2024 08:30:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:02:39 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:02:27 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:01:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:01:05 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:00:54 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2024 09:00:45 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/11/2024 12:23:26 AM
- Avid Bioservices Reports Financial Results for Fourth Quarter and Fiscal Year Ended April 30, 2024 • GlobeNewswire Inc. • 07/02/2024 08:05:04 PM
- Avid Bioservices to Report Financial Results for Quarter and Fiscal Year Ended April 30, 2024, After Market Close on July 2, 2024 • GlobeNewswire Inc. • 07/01/2024 11:00:21 AM
- Avid Bioservices Earns Committed Badge from EcoVadis for Sustainability Performance • GlobeNewswire Inc. • 05/23/2024 12:05:46 PM
- Avid Bioservices to Participate at Upcoming Investor Conferences • GlobeNewswire Inc. • 05/07/2024 08:05:11 PM
- Avid Bioservices Reports Financial Results for Third Quarter Ended January 31, 2024 • GlobeNewswire Inc. • 04/24/2024 09:25:33 PM
- Avid Bioservices Announces Receipt of Deficiency Notice from Nasdaq Regarding Late Form 10-Q • GlobeNewswire Inc. • 03/20/2024 11:00:10 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 11:30:11 AM
- Avid Bioservices Announces Pricing of Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/07/2024 04:58:48 AM
- Avid Bioservices Announces Proposed Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/06/2024 09:32:07 PM
- Avid Bioservices Announces Certain Preliminary Financial Results for Third Quarter Ended January 31, 2024 • GlobeNewswire Inc. • 03/06/2024 09:31:28 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 09:30:18 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/26/2024 09:57:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/13/2024 12:34:35 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:39:18 AM
Alliance Creative Group (ACGX) Releases Q2 2024 Financial and Disclosure Report with an increase of over $130,000 in Net Income from Q2 2023 to Q2 2024 • ACGX • Aug 14, 2024 8:30 AM
Avant Technologies Unveils AI-Powered Healthcare Infrastructure to Deliver Intelligent Healthcare Solutions • AVAI • Aug 14, 2024 8:00 AM
SANUWAVE Announces Record Quarterly Revenues: Q2 FY2024 Financial Results • SNWV • Aug 13, 2024 7:11 AM
Kona Gold Beverages, Inc. Nears Completion of Reverse Merger with New Candidate • KGKG • Aug 12, 2024 10:00 AM
Maybacks Global Entertainment and DigiTrax Entertainment Sign Agreement to Broadcast "Karaoke Cloud" on iDreamCTV • AHRO • Aug 12, 2024 8:45 AM
HealthLynked Partners with RxSpark to Enhance Medication Access and Management for Patients • HLYK • Aug 12, 2024 8:00 AM