Formulation Development
Two New Studies Demonstrate In Vitro Bioactivity Potential of Micronized Dehydrated Human Amnion Chorion Membrane to Prevent Pathological Processes Underlying Osteoarthritis & Tendinopathy
MiMedx Group, Inc. recently announced two peer-reviewed studies investigating the use of micronized dehydrated human amnion chorion membrane (mdHACM) for the treatment of debilitating conditions…
Coherus & Junshi Biosciences Announce FDA Acceptance of BLA Filing for Toripalimab for Treatment of Nasopharyngeal Carcinoma
Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. recently announced the US FDA has accepted for review the Biologics License Application (BLA) for toripalimab in combination with….
Novavax & Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia
Novavax, Inc. and Serum Institute of India Pvt. Ltd. (SII) recently announced that the National Agency of Drug and Food Control of the Republic of…
Gattefossé Expands its Offer With the Launch of Three New Pharmaceutical Excipients
Gattefossé, supplier of specialty ingredients for the health and beauty industries, announces the launch of three new pharmaceutical ingredients: Labrafac™ MC60 and Gelucire® 59/14, for the for oral administration route and Emulfree® Duo….
Moderna Announces First Participant Dosed in Phase 3 Pivotal Registration Study of its mRNA Cytomegalovirus (CMV) Vaccine
Moderna, Inc. recently announced the first participant has been dosed in the Phase 3 pivotal registration study of mRNA-1647, the Company’s cytomegalovirus (CMV) vaccine candidate. This…
Ocugen, Inc. Announces Submission of IND to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate
Ocugen, Inc. recently announced that it has submitted an Investigational New Drug application (IND) with the US FDA to evaluate the COVID-19 vaccine….
Aptinyx Completes Enrollment in Phase 2b Study of NYX-2925 in Painful Diabetic Peripheral Neuropathy
Aptinyx Inc. recently announced the completion of enrollment in the company’s ongoing Phase 2b study of NYX-2925 for the treatment of painful diabetic peripheral neuropathy….
Halberd Files Provisional Patent on Breakthrough Obesity Treatment
Halberd Corporation recently announced the filing of a provisional patent application with the US Patent and Trademark Office covering their extracorporeal removal from the blood…
Evaxion Biotech Announces Clinical Collaboration to Evaluate Lead Product Candidate with KEYTRUDA (pembrolizumab) in Patients With Melanoma
Evaxion Biotech A/S recently announced it has entered into a clinical trial collaboration and supply agreement with subsidiaries of Merck & Co., Inc., Kenilworth, NJ,…
TCR² Therapeutics Announces Clinical Trial Collaboration Agreement With Bristol Myers Squibb
TCR2 Therapeutics Inc. recently announced a clinical trial collaboration agreement with Bristol Myers Squibb to evaluate gavo-cel in combination with Opdivo (nivolumab) and Yervoy (ipilimumab)…
Cybrexa Therapeutics Announces Data Demonstrating Early Signals of Efficacy & Powerful Potential of Antigen-Independent Tumor Targeting
Cybrexa Therapeutics recently announced favorable early Phase 1 data for its lead therapeutic candidate, CBX-12 (alphalex-exatecan). The initial data show robust….
Krystal Biotech Announces Completion of the GEM-3 Pivotal Phase 3 Study Evaluating B-VEC for the Treatment of Dystrophic Epidermolysis Bullosa
Krystal Biotech, Inc. recently announced the last participant has completed the 26-week dosing period and 30-day safety follow up visit in the GEM-3 study, Krystal’s…
Berkeley Lights Announces GSK Acquires Third Beacon Optofluidic System to Expand Antibody Therapeutics Development
Berkeley Lights, Inc. recently announced GlaxoSmithKline (GSK) has purchased an additional Beacon Optofluidic system to expand its antibody therapeutics capacity. The new Beacon system will….
Catalent's Investment in Expanding its State-of-the-Art Gene Therapy Commercial Manufacturing Campus Increases to $360 Million
Catalent recently announced a $230-million expansion project to add three further commercial-scale viral vector manufacturing suites and associated support facilities and services at its gene…
Micropore Appoints New Commercial Director
UK-based Micropore Technologies has recently appointed Denis Smit, Invista’s former Head of New Business Development, to the role of Commercial Director to lead their….
Quris Closes Critical Drug Development Gaps With New Clinical Prediction AI Platform
Quris recently launched the first clinical prediction AI platform to predict which drug candidates will safely work in humans – significantly improving efficacy and cutting drug development….
Phathom Pharmaceuticals Announces Positive Topline Results from PHALCON-EE Pivotal Phase 3 Erosive Esophagitis Trial
Phathom Pharmaceuticals, Inc. recently announced that vonoprazan successfully met its primary endpoints and key secondary superiority endpoints in PHALCON-EE, a pivotal Phase 3 trial evaluating….
Menarini Group & Radius Health Announce Positive Phase 3 Topline Results From the EMERALD Trial Evaluating Elacestrant in Breast Cancer
The Menarini Group and Radius Health, Inc. recently announced positive topline results from the EMERALD study. The study was designed to evaluate elacestrant as a….
Athira Pharma Announces Completion of Enrollment in Phase 2 ACT-AD Trial Evaluating ATH-1017 for Mild-to-Moderate Alzheimer’s Disease
Athira Pharma, Inc. recently announced it has completed enrollment in ACT-AD, a Phase 2 randomized, placebo-controlled study of ATH-1017 in patients with mild-to-moderate Alzheimer’s disease.…
HistoWiz Raises $32-Million Financing to Fully Automate Lab Operations, Launch New AI-Enabled Services & Establish a GLP Histopathology Lab in Miami
HistoWiz, a leading digital histopathology service company, recently announced the closing of a $32-million Series A financing. The company has provided automated histology for over…
