Formulation Development
Evonetix Delivers First Chip-Synthesized DNA to the University of Cambridge
Evonetix recently announced DNA synthesized using its unique semiconductor chip technology was delivered to the Department of Chemical Engineering and Biotechnology at the University of Cambridge. This milestone marks the start of the next stage of development of the….
Alvotech Enters Commercialization Agreement With Polifarma for Proposed Biosimilar to Eylea
Alvotech recently announced it has entered an exclusive agreement with Polifarma Ilac San. ve tic. A.S. for the commercialization in Turkey of AVT06, a proposed…
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…
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….
ON-DEMAND WEBINAR – Solve Common Design Challenges in Inhalation Devices With Porous Polymers
The effectiveness of inhalation devices relies on their ability to deliver the pharmaceutical directly to the targeted part of the body with precision and calculated dosing. Since these devices….
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…
WHITEPAPER - How to Mitigate Risk for Biologics During Fill/Finish Manufacturing
Aseptic processing with the highest degree of sterility assurance, filling accuracy, and quality is critical for high-value, small-batch therapies. This white paper explores the specialized…
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…
