Formulation Development
EXECUTIVE INTERVIEW - Alcami: Unlocking the Potential of Transformative Medicine for 40 Years
Mike Babics, Vice President, Parenteral Services at Alcami, discusses the company’s recent expansions in formulation and analytical development, manufacturing, release testing, and biostorage of clinical and commercial drug products for both solid dosage and parenteral products.
Ryvu Therapeutics & BioNTech Enter Global Collaboration to Develop & Commercialize Immuno-Modulatory Small Molecule Candidates
The companies enter a multi-target research collaboration to develop multiple small molecule programs targeting immune modulation in cancer and potentially other disease areas based on targets selected by BioNTech….
First Wave BioPharma Files INDA for Enhanced Microgranule Delivery Formulation of Adrulipase
Upon IND clearance, Phase 2 clinical trial investigating adrulipase as a treatment for exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis is expected to initiate in early 2023 with topline clinical data anticipated in the first half of 2023….
Aridis Announces a Key Milestone of Closing of Patient Enrollment in the Phase 2a Study of AR-501 in Cystic Fibrosis Patients
Aridis Pharmaceuticals, Inc. recently announced the closing of patient enrollment in the multiple ascending dose (MAD) and dose-ranging cohorts in the Phase 2a clinical trial of…
BioXcel Therapeutics Announces First Patients Dosed in SERENITY III Phase 3 Trial for Acute Treatment of Agitation in Adults With Bipolar I or II Disorder or Schizophrenia
BioXcel Therapeutics, Inc., a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, recently announced the first 13 patients have…
Avectas, CCRM & OmniaBio Expand Their Collaboration to Accelerate the Manufacture of Edited iPSCs Using SOLUPORE Technology
Avectas and CCRM, with its subsidiary OmniaBio Inc., have recently announced an expansion of their collaboration, to enable the development of gene-edited induced pluripotent stem….
Immutep Enters Second Clinical Trial Collaboration Agreement With Merck KGaA & Pfizer for New Combination Study of its First-in-Class LAG-3 Candidate, Eftilagimod Alpha & Avelumab to Treat Urothelial Cancer
New collaboration builds on encouraging clinical data previously reported from INSIGHT-004 in multiple solid tumor indications from the combination of eftilagimod alpha (efti) and avelumab (BAVENCIO)….
Context Therapeutics Nominates CTIM-76 Bispecific Antibody Candidate to Develop Treatment for Claudin 6-Positive Solid Tumors
Context Therapeutics Inc. recently announced the selection of CTIM-76, a T cell-engaging bispecific antibody, as its lead clinical development candidate to target Claudin 6 (CLDN6)…
INmune Bio Focused on Novel Clinical Trial Designs to Advance Next Generation of Alzheimer’s Disease Treatments
INmune Bio, Inc. recently participated in the 15th CTAD Conference in San Francisco November 29 to December 2. “This year’s CTAD is showcasing a potential…
WHITEPAPER - Maintaining Sustainable Business Practices During the Energy & Supply Crisis
As we come to the end of another year, our global economy faces many significant challenges. Recently, a colleague asked me, “As a biopharma executive, which of today’s major issues are the ones that keep you up at night?”
Incannex Engages Eurofins to Manufacture Novel Addiction Treatments CannQuit-N and CannQuit-O
Incannex Healthcare Limited recently announced it has engaged multinational contract development and manufacturing organisation (CDMO) Eurofins Scientific to manufacture Incannex’s two distinct medicated….
Enlivex Receives Allocetra IND Clearance From the US FDA for Treatment of Patients With Advanced Solid Malignancies
Enlivex Therapeutics Ltd. recently announced the US FDA has cleared an Investigational New Drug (IND) application to study Allocetra in patients with advanced solid malignancies.…
uniQure Announces FDA Approval of First Gene Therapy for Adults With Hemophilia B
Historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy, and generates elevated and sustained factor IX levels….
XOMA Acquires Royalty & Milestone License to Ebopiprant, a Preterm Labor Asset, Being Developed by Organon
XOMA assumes the rights to ebopiprant from ObsEva, including the Organon License, Patent Estate, and Merck KGaA, Darmstadt, Germany, license, for a $15 million outlay….
IntelGenx Receives FDA PDUFA Date for RIZAFILM
IntelGenx Corp., a leader in pharmaceutical films, recently announced the US FDA has accepted for review its Class 2 response to the 2020 Complete Response…
Palisade Bio is Granted Fast Track Designation From US FDA for LB1148 for Accelerated Return of Bowel Function following GI Surgery
Palisade Bio, Inc. recently announced the US FDA has granted Fast Track designation to LB1148 for the acceleration of time to return of bowel function…
RxCelerate Acquires Methuselah Health & Launches ProQuant World-Beating Proteomics Service
Next-generation proteomics technology made available to the biotech and pharmaceutical industry through the acquisition of Methuselah Health by leading R&D services provider, RxCelerate….
Evaxion Announces Promising Results From Phase 1/2a Clinical Trial of Personalized DNA Cancer Immunotherapy
Evaxion Biotech A/S recently announced promising clinical data from the Phase 1/2a first-in-human study of its DNA-based cancer immunotherapy, EVX-02….
Attralus & Ossianix Announce Option & License Agreement Using the TXP1 Brain Shuttle for Targeted Delivery of a Pan-Amyloid Removal Therapeutic for Neurodegenerative Disorders
Attralus, Inc. and Ossianix recently announced they have entered into a definitive agreement using Ossianix’ brain shuttle technology to enhance the targeted delivery of novel….
VYNE Therapeutics Announces First Subjects Dosed in Phase 1a/b Clinical Trial Evaluating Pan-BET Inhibitor for the Treatment of Vitiligo
VYNE Therapeutics Inc. recently announced the first subjects have been dosed in a Phase 1a/b clinical trial evaluating VYN201 for the treatment of vitiligo. VYN201…
