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Keep up with the regulator's latest rulings on novel drugs and expanded indications, as the second half of 2023 promises some major milestone FDA approvals.
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Panbela Announces Issuance of New Patent in China for Claims of a Novel Process for the Production of SBP-101Patent developed in collaboration with Syngene International Ltd.
9/26/2023
Panbela today announced an Issue Notification for the Chinese patent 201980010826.7 titled “METHODS FOR PRODUCING (6S,15S)-3,8,13,18- TETRAAZAICOSANE-6,15-DIOL”.
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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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Biosimilar Monoclonal Antibodies Market Size, Share, Growth, Report By 2032
9/25/2023
According to Vision Research Report, the global biosimilar monoclonal antibodies market size was valued at USD 8.76 billion in 2022 and it is projected to hit around USD 65.42 billion by 2032, growing at a CAGR of 22.27% from 2023 to 2032.
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Ligand’s Partner Jazz Pharmaceuticals Receives European Commission Approval for Enrylaze® (a recombinant Erwinia asparaginase or crisantaspase) for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
9/22/2023
Ligand’s Partner Jazz Pharmaceuticals Receives European Commission Approval for Enrylaze ® (a recombinant Erwinia asparaginase or crisantaspase) for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma.
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Accent Therapeutics Bolsters Leadership Team with Key Executive Hires
9/21/2023
Accent Therapeutics today announced the appointments of Jason Sager, M.D. as Chief Medical Officer, Steven Mennen, Ph.D., as Vice President of Pre-Clinical Development and Stuart Ince, Ph.D. as Vice President of Program Leadership.
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Ligand’s Partner Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI® Demonstrating Long-Term Kidney Function Preservation in IgAN; Narrowly Missing eGFR Total Slope Endpoint versus Active Control
9/21/2023
Ligand Pharmaceuticals Incorporated announced that its partner Travere Therapeutics, Inc. released topline, two-year confirmatory secondary endpoint results from its pivotal, head-to-head Phase 3 PROTECT Study of FILSPARI® in IgA nephropathy versus irbesartan.
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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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The consent agreement struck between the FTC and Amgen and Horizon Therapeutics could have significant implications for ongoing and future M&A challenges, experts told BioSpace.
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Future Fields Announces New Paradigm in CDMO Services Optimized for Small-to-Medium-Sized Biopharma Companies
9/20/2023
Future Fields, a pioneering biotechnology company that has built the world’s first synthetic biology system to use fruit flies for recombinant protein production, announced the launch of its contract development and manufacturing organization service.
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Amgen Launches Partners of Choice Network of Eight Leading Oncology Academic Centers
9/20/2023
Amgen announced the launch of Amgen Partners of Choice, a new network that brings together Amgen's oncology research and development experts and world-class clinical leaders at eight research centers across the globe.
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ReCode Therapeutics Announces Closing of Extension to Series B Financing
9/19/2023
ReCode Therapeutics today announced the closing of an extension to its Series B financing.
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Avanzanite Bioscience Further Strengthens Leadership Team With Country Manager of Germany
9/19/2023
Avanzanite Bioscience B.V., a specialty commercial-stage pharmaceutical company with a corporate mission of boosting orphan drug access and unlocking their full potential in European markets, announced the appointment of Marc-Andre Goldschmidt as Country Manager of Germany.
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Oxford BioTherapeutics to Participate in Panel Discussion at Boehringer Ingelheim’s Upcoming Transforming Science Day: Europe
9/19/2023
Oxford BioTherapeutics announces that its Chief Executive Officer, Christian Rohlff, will participate in the panel discussion titled “It takes a village: A holistic approach to external innovation” at Boehringer Ingelheim’s upcoming Transforming Science Day: Europe.
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Xencor Appoints Barbara J. Klencke, M.D., to Board of Directors
9/19/2023
Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, today announced the appointment of Barbara J. Klencke, M.D., to its board of directors.
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Ligand Spins Out and Merges Pelican Subsidiary with Primordial Genetics to Form Primrose Bio
9/18/2023
Ligand Pharmaceuticals Incorporated announced that it has entered into a merger agreement, pursuant to which its subsidiary, Pelican Technology Holdings, Inc., has become a wholly owned subsidiary of Primrose Bio, Inc. Primrose Bio is a stand-alone private company focused on synthetic biology.
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KayoThera, Inc. Nominates First-in-Class, Oral Inhibitor of the Retinoid Pathway in Genetically Defined Oncology Indications as a Development Candidate
9/18/2023
KayoThera, Inc. (“KayoThera”), an early-stage therapeutics company developing first-in-class, oral, small molecule inhibitors of the retinoid pathway, today announces that it has selected KAYO-1609 as its first drug development candidate.
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In the largest biotech Series C financing so far this year, Generate:Biomedicines raised $273 million, while Neumora and RayzeBio announced IPO pricing valued at more than $560 million combined.
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The Swiss pharma’s shareholders on Friday approved spinning off the generics and biosimilars division, with plans to launch at least five additional biologic drugs.
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The two biotech companies announced initial public offering pricing Thursday, respectively, with shares beginning trading Friday and valued at more than $560 million cumulatively.