Formulation Development
Eyenovia Announces First Patient Enrolled in Phase 3 VISION-2 Trial of MicroLine for Presbyopia
Eyenovia, Inc. recently announced the first patient has been enrolled in the company’s second Phase 3 clinical trial of MicroLine, its proprietary pilocarpine formulation for…
Zealand Pharma Announces First Subject Dosed in Phase 1 Trial of Amylin Analogue ZP8396 for the Treatment of Obesity
Zealand Pharma A/S recently announced the first patient has been dosed in a Phase 1 clinical trial evaluating the amylin analogue, ZP8396 as a potential…
Processa Pharmaceuticals Announces Next- Generation Capecitabine Inhibits DPD in Phase 1b Interim Analysis
Processa Pharmaceuticals, Inc. recently announced the company’s Next-Generation Capecitabine dosage regimen (a combination of PCS6422 administered with capecitabine) successfully inhibited dihydropyrimidine dehydrogenase (DPD), altering the…
Centogene Expands Partnership With Agios to Generate Novel Insights Into Rare Blood Diseases
Centogene N.V. recently announced it has expanded its partnership with Agios Pharmaceuticals, Inc to provide genetic testing and clinical trial support for Agios’ three global,…
ESCP Models - Hepatitis C Medications (Part 2), Oral Therapeutics
Part 2 of this series fills in the story starting with the first oral HCV therapeutic, Vertex’s Incivek (telaprevir), which predated the first of the Gilead therapeutics by 2.5 years…
Allena Pharmaceuticals Receives Fast Track Designation From FDA for the Development of ALLN-346 for Chronic Treatment of Hyperuricemia in Patients With Gout & Advanced Chronic Kidney Disease
Allena Pharmaceuticals, Inc. recently announced its orally administered, urate-degrading enzyme, ALLN-346, has received Fast Track designation from the US FDA. ALLN-346 is in Phase 2…
Stingthera Announces Clinical Collaboration With Merck to Evaluate SNX281 in Combination With KEYTRUDA in Certain Patients With Advanced Solid Tumors & Lymphoma
Stingthera, Inc. recently announced it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the US and Canada) to evaluate the combination of SNX281, Stingthera’s investigational….
uniQure Announces Latest Positive Recommendation From Data Safety Monitoring Board in Phase 1/2 Clinical Trial of AMT-130 for the Treatment of Huntington’s Disease
uniQure N.V. recently announced the positive recommendation by the independent Data Safety Monitoring Board (DSMB) following a review of safety data from the four patient…
Hyloris Announces Start of Phase 2 Study of Miconazole-Domiphen Bromide Vaginal Cream in Vulvovaginal Candidiasis
Hyloris Pharmaceuticals SA recently announced the first patient has been enrolled in the Phase 2 dose-finding study of Miconazole-Domiphen Bromide (MCZ-DB), a novel dual-mode-of-action vaginal…
Evox Therapeutics Expands Its Exosome Patent Portfolio
Evox Therapeutics Ltd recently announced it has been granted a new European patent, EP3706796, to add to its growing patent portfolio. This patent covers exosomes…
Dunad Therapeutics Enters Strategic Collaboration With Novartis to Develop Next-Generation Oral Targeted Protein Degrader Therapies
Dunad Therapeutics recently announced it has entered a strategic collaboration and license agreement with Novartis to generate orally bioavailable covalent and protein degrading small molecule drugs…..
Strategic Investment in Small Molecule API Development Creates New Flow Chemistry Centre of Excellence at CordenPharma Chenôve
CordenPharma recently announced the completion of a Phase 1 strategic investment to create a Flow Chemistry Centre of Excellence at its CordenPharma Chenôve facility, near…
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…
