Formulation Development
EXECUTIVE INTERVIEW - HERMES PHARMA: Reducing Risk, Speeding Development - A CDMO Model Including GCP-Sponsorship to Better Meet the Needs of Pharma Companies
Dr. Martin Koeberle, Head of Analytical Development & Stability Testing, and Dr. Bernice Wild, Head of Stability Testing and Senior QA Manager GCP, at HERMES PHARMA, discuss the challenges of developing innovative oral medicines, as well as how these new service offerings are helping meet a critical need among companies looking to bring portfolio-enhancing formulations to market.
PRIMARY CONTAINER CLOSURE SYSTEMS - In From the Cold: Realizing the Benefits of Primary Packaging Innovation for Lyophilized Drug Products
Neal Higgins discusses the benefits and challenges associated with lyophilization before reviewing some of the current macro influences, West’s design philosophy and QBD blueprint, and data to demonstrate the efficacy of the 4040 elastomer platform.
PLACENTA-ON-A-CHIP - The Future of Drug Discovery In Women’s Health
Hagar Labouta, PhD, presents how researchers continue to increase the complexity of their placenta-on-a-chip models and, as their research progresses, they are confident this technology will aid the development of novel therapies to treat a wide range of maternal and fetal conditions.
Evonik Strengthens Portfolio of Nanoparticle Technologies & Services for Parenteral Drug Delivery
Evonik is strengthening its platform of parenteral drug delivery solutions with three new standard PLA-PEG di-block copolymers and a new nanoparticle formulation service using….
Investigational Treatment for Fragile X Syndrome Receives Rare Pediatric Disease Designation From FDA
Shionogi & Co., Ltd. recently announced the US FDA has granted Tetra Therapeutics Inc. Rare Pediatric Disease Designation for zatolmilast (BPN14770), an investigational treatment being…
Omega Therapeutics Announces Promising Preliminary Clinical Data for OTX-2002 From Ongoing MYCHELANGELO I Trial
Omega Therapeutics, Inc. recently announced encouraging preliminary safety, tolerability, pharmacokinetic, and translational data from the initial two dose level cohorts (n=8) from Part 1 of its ongoing Phase 1/2 MYCHELANGELO I study evaluating….
Phathom Pharmaceuticals Announces Vonoprazan NDA Submission for Non-Erosive GERD
Phathom Pharmaceuticals, Inc. recently announced the submission of an NDA to the FDA for vonoprazan as a daily treatment for Non-Erosive gastroesophageal reflux disease (GERD)…
bYoRNA & Dyadic Announce a Collaboration Targeting the Production of Abundant, Low-Cost mRNA From C1-Cells
bYoRNA SAS and Dyadic International, Inc. recently announced they entered into a development and commercialization agreement to work on disruptive bioproduction technologies that will help…
SOHM Announces Acquisition of ABBIE, a World-Class Gene-Editing Platform That Can Deliver Genetic Payloads Using Non-Viral Vectors
With this acquisition, SOHM is well-positioned as a competitive player in the $5.3 billion gene-editing market in 2023. The gene-editing market is expected to grow….
MilliporeSigma to Become First Provider to Offer Fully Integrated mRNA Services
MilliporeSigma is the first CTDMO to offer integrated services for all critical stages of mRNA development, manufacturing, and commercialization, including products and….
AcuraStem Enters Into License Agreement With Takeda to Advance PIKFYVE Therapeutics
AcuraStem recently announced it has entered into a license agreement with Takeda to develop and commercialize AcuraStem’s PIKFYVE targeted therapeutics including AS-202, an innovative antisense oligonucleotide…
Coya Therapeutics Licenses Exclusive Worldwide Rights to Exosome Engineering Technology From Carnegie Mellon University
Coya Therapeutics, Inc. recently announced licensing of the exclusive, worldwide rights of a proprietary Exosome Engineering Technology from CMU with potential applications across multiple indications, including…
Clene Reports Significant Long-Term Survival Improvement From CNM-Au8 Treatment in HEALEY ALS Platform Trial Compared to PRO-ACT Historical Controls
Clene Inc. recently announced long-term follow-up data for patients treated with CNM-Au8 30 mg for up to 133 weeks in the HEALEY ALS Platform Trial.…
Biora Therapeutics Announces Submission of IND Application for BT-600 Program Featuring NaviCap Ingestible Drug Delivery Device
Biora Therapeutics, Inc. recently announced submission of an Investigational New Drug (IND) application with the US FDA that supports the next phase of development of…
Replay Announces Partnership Between Syena & JURA Bio to Advance T Cell Receptor NK Therapies in Cancer
Replay recently announced a research collaboration between JURA Bio and Syena to develop T cell receptor (TCR) based therapies. “JURA Bio’s highly differentiated TCR discovery…
Bora Collaborates With Sunway Biotech to Launch Global Nutraceuticals Offering
Bora Health, a global design, development and distribution partner of pharmaceuticals and health foods and part of the Bora group, recently announced its merged with Sunway Biotech, a leading ingredients manufacturer and….
Revolo Biotherapeutics Announces Completion of Phase 1 Multiple Ascending Dose Clinical Trial of Immune-Resetting Drug Candidate
Revolo Biotherapeutics recently announced the completion of a Phase 1 multiple ascending dose (MAD) clinical trial evaluating the safety and tolerability of the company’s immune-resetting…
Oxford Biomedica & Institut Mérieux Enter Exclusive Negotiations With Respect to Proposed Acquisition by Oxford Biomedica of ABL Europe From Institut Mérieux as Part of Pure-Play CDMO Transformation
Oxford Biomedica plc and Institut Mérieux SA recently announced they have entered into exclusive negotiations with respect to the proposed acquisition by Oxford Biomedica of…
Vir Biotechnology Announces First Participant Dosed in New Phase 1 Trial Evaluating Investigational T Cell Vaccine for the Prevention of HIV
Vir Biotechnology, Inc. recently announced the first participant has been dosed in a Phase 1 trial evaluating the safety, reactogenicity, and immunogenicity of VIR-1388, an investigational novel T cell vaccine for….
LIXTE Biotechnology Announces a Supported Collaborative Trial to Study LIXTE’s First-in-Class PP2A Inhibitor, Plus GSK’s Immunotherapy in Clear-Cell Ovarian Cancer
The Phase 1b Clinical Trial Focuses on Assessing the Safety and Efficacy of the Two-Drug Combination in a Cancer Associated with Longer Survival to Immunotherapy When Genetically Deficient in PP2A….
