Market News & Trends
Syneos Health to be Acquired for Approximately $7.1 Billion
Syneos Health, Inc. recently announced it has entered into a definitive agreement to be acquired by a consortium of private investment firm affiliates composed of Elliott Investment Management, Patient Square Capital….
Minerva Neurosciences Announces Update on its NDA for the Treatment of Negative Symptoms in Schizophrenia
Minerva Neurosciences, Inc. recently announced that on May 8, 2023, it received confirmation from the US FDA that its New Drug Application (NDA) for roluperidone…
Salipro Biotech & DyNAbind Announce Milestone Achievement in Collaboration to Enable DEL for Membrane Proteins
The two biotech companies report that they have successfully screened and identified several small molecule compounds that bind to a challenging membrane protein drug target….
Adaptive Biotechnologies Announces FDA Acceptance of Genentech’s INDA for the First Neoantigen-Directed T-Cell Therapy Product in Oncology
Adaptive Biotechnologies Corporation recently announced the US FDA has accepted an investigational new drug (IND) application submitted by its collaborator, Genentech, a member of the…
Longeveron Announces New Long-Term Survival Data From ELPIS I Trial of Lomecel-B for Hypoplastic Left Heart Syndrome
Longeveron Inc. recently announced new long-term follow-up data from the its ELPIS I trial of Lomecel-B for patients with hypoplastic left heart syndrome (HLHS). The…
Vetter Expands Production Capacities & Services at its Austrian Site
Vetter continues to drive the expansion of capacities and services for the provision of clinical trial materials. With the implementation of additional equipment for aseptic production and the expansion of storage….
FDA Approves the Manufacture of New Microbiome-Based Therapeutic at Recipharm Site
Recipharm recently announced its subsidiary, GenIbet Biopharmaceuticals, has been approved by the US FDA as a manufacturing site of VOWST, a breakthrough orally administered fecal…
Veranova Appoints New Chief Executive Officer
[caption id="attachment_138250" align="alignleft" width="174"] Mike Riley[/caption] Veranova recently the appointment of Mike Riley as the company’s Chief Executive Officer. In this capacity, Mr. Riley will…
Eisai Enters Joint Development Agreement With Blissbio for Antibody Drug Conjugate With Option Rights for Strategic Collaboration
Eisai Co., Ltd. recently announced it has entered into a joint development agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd., for BB-1701, an antibody-drug conjugate (ADC) with option rights for a….
Omnix Medical Announces Excellent Topline Data From Phase 1 Clinical Trial of Novel Anti-Infective
Omnix Medical recently announced positive top-line results from the Phase 1 clinical trial of its lead compound OMN6, an anti-infective with a completely novel mechanism…
CureVac Announces Dosing of First Participant in Combined Phase 1/2 Study of Multivalent, Modified Influenza Vaccine Candidates Developed in Collaboration With GSK
CureVac N.V., a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), recently announced the first participant was…
Enlivex Announces Issuance of European Patent Covering the Use of Allocetra to Prevent Cytokine Release Syndrome Resulting From CAR T-Cell Therapy
Enlivex Therapeutics Ltd. recently announced the issuance of a European patent, No. 3865189, titled Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment. The patent provides added intellectual….
Arranta Bio Signs Contract With MIT to Develop Rapid Manufacturing of mRNA Therapeutics
Arranta Bio, part of Recipharm’s biologics business, has recently signed a contract with MIT to develop a continuous manufacturing technology for mRNA therapeutics. The contract is part….
Hovione & H&T Presspart Extend Partnership to Advance High-Efficiency Device Technology for Dry Powder Inhalation Formulation Delivery
Hovione and H&T Presspart have entered in a strategic partnership to advance the development of Presspart’s Sunriser Capsule-based Dry Powder Inhaler platform. The demand for….
Zevra Therapeutics Announces FDA Acceptance of IND Application for KP1077 in Narcolepsy
Zevra Therapeutics, Inc. recently announced the acceptance of an Investigational New Drug (IND) application by the US FDA to begin a Phase 1 clinical trial…
Eterna Therapeutics Acquires Allogeneic Immuno-Oncology Platform From Exacis Biotherapeutics
Acquisition includes Exacis’ entire pipeline of engineered cell therapy programs for hematologic and solid tumors….
Tenaya Therapeutics Receives FDA Fast Track Designation for TN-201
Tenaya Therapeutics, Inc. recently announced the US FDA has granted Fast Track designation for its gene therapy product candidate, TN-201, being developed for the treatment…
Eloxx Pharmaceuticals Announces FDA Clearance to Begin Single Ascending Dose Study of ZKN-013
Eloxx Pharmaceuticals, Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application to initiate a single ascending dose (SAD) clinical…
Ovid Therapeutics Announces Collaboration With Graviton Bioscience, Proven Developers of Selective ROCK2 Inhibitors
Ovid Therapeutics Inc. and Graviton Bioscience Corporation recently announced a collaboration agreement to innovate novel medicines they believe will significantly change….
Aldevron Announces Expansion of mRNA Production Capability
Aldevron recently announced it will expand its mRNA production capabilities to include lipid nanoparticle (LNP) encapsulation and aseptic fill-finish capabilities enabling mRNA cGMP manufacturing services from…
