Formulation Development
Bayer to Advance Two First-of-its-Kind Cell & Gene Therapies for Parkinson’s Disease
Bayer AG recently announced that BlueRock Therapeutics (BlueRock) successfully administered the first dose of its pluripotent stem cell-derived dopaminergic neurons, named DA01, to a….
Akoya & AstraZeneca to Collaborate on Spatial Biology Approach to Profiling Tumor-Immune Biology
Akoya Biosciences, Inc. recently announced a collaboration with AstraZeneca to advance new multiplex immunofluorescence (mIF) workflows and spatial biomarker signatures….
Harpoon Therapeutics Presents Updated Interim Clinical Data for the PSMA-Targeting TriTAC HPN424
Harpoon Therapeutics, Inc. recently presented interim data from the ongoing dose-escalation portion of a Phase 1/2a trial for HPN424 in patients with metastatic castration-resistant prostate…
iTeos Therapeutics Announces New Phase 1/2a Data Indicating Antitumor Activity of its Adenosine A2A Receptor Antagonist
iTeos Therapeutics, Inc. recently announced new clinical data from its ongoing Phase 1/2a clinical trial of inupadenant (EOS-850), a next-generation adenosine receptor (A2AR) antagonist, at…
IN8bio Completes Treatment of First Cohort in Phase 1 Clinical Trial With Gamma Delta T-Cell Therapy in Patients with Newly Diagnosed Glioblastoma Multiforme
IN8bio, Inc. recently announced an update from the ongoing Phase 1 clinical trial of INB-200, its DeltEx drug resistant immunotherapy (DRI), MGMT-gene modified gamma delta…
Cullinan Oncology Announces Phase 1/2a Interim Data for Cullinan Pearl’s CLN-081 in NSCLC EGFR Exon 20 Patients
Cullinan Oncology, Inc. recently announced additional details pertaining to Cullinan Pearl’s ongoing Phase 1/2a trial of CLN-081 in Non-Small Cell Lung Cancer (NSCLC) patients whose…
Addex Starts Phase 2 Clinical Study of ADX71149 for Epilepsy
Addex Therapeutics recently announced the first patients have been enrolled into a Phase 2 clinical study evaluating JNJ-40411813 (ADX71149) in patients with epilepsy. JNJ-40411813 (ADX71149)…
Mirati Therapeutics & Zai Lab Enter Development & Commercialization Collaboration
Mirati Therapeutics, Inc. and Zai Lab Limited recently announced the companies have entered into a collaboration and license agreement for adagrasib, a small-molecule….
Immutep Enters Into New Collaboration With Merck KGaA
Immutep Limited recently announced a new collaboration and supply agreement with Merck KGaA , Darmstadt, Germany, for a Phase 1/2a clinical trial in patients with….
Corbus Pharmaceuticals Licenses Two Integrin Targeting mAbs Further Expanding Pipeline Into Cancer & Fibrotic Diseases
Corbus Pharmaceuticals Holdings, Inc. recently announced licensing deals for two new monoclonal antibodies (mAbs), CRB-601 and CRB-602, that target integrins to inhibit activation of….
Aptamer Group Collaborates With World-Leading Pharmaceutical Company to Evaluate Optimer Technology
Aptamer Group recently announced that it has signed an agreement with the multinational pharmaceutical and biopharmaceutical company Takeda Pharmaceutical Company Limited…..
Hovione & iBET Announce Strategic Collaboration
Hovione was a founding member of iBET in 1989 and has just re-joined the membership of the Instituto de Biologia Experimental e Tecnológica. In order…
PDS Biotechnology Establishes Partnership With Head & Neck Cancer Alliance
PDS Biotechnology Corporation and the Head and Neck Cancer Alliance (HNCA) recently announced a partnership that seeks to raise awareness of new and developing treatment…
Santhera & ReveraGen Announce Positive & Statistically Highly Significant Topline Results
Santhera Pharmaceuticals and ReveraGen BioPharma, Inc. recently announced positive key results from the VISION-DMD study, demonstrating robust efficacy across multiple efficacy endpoints and favorable safety…
Verrica Pharmaceuticals Announces Extension of FDA Review Period of its NDA for VP-102 for the Treatment of Molluscum Contagiosum
Verrica Pharmaceuticals Inc. recently announced the US FDA has extended the review period for the New Drug Application (NDA) for VP-102 for the treatment of…
uniQure Announces Positive Recommendation to Advance Phase 1/2 Clinical Trial of AMT-130 for the Treatment of Huntington’s Disease
uniQure N.V. recently announced the independent Data Safety Monitoring Board (DSMB) overseeing the Phase 1/2 clinical trial of AMT-130 for the treatment of Huntington’s disease…
Ocugen On Track to Submit EUA Application to US FDA for its COVID-19 Vaccine Candidate
Ocugen, Inc. recently confirmed its plan to submit its Emergency Use Authorization (EUA) application for COVAXIN to the US FDA in June. “Since we have…
WEARABLE PLATFORM - Next-Generation Wearable Drug Delivery: Prefilled Devices Provide a Truly Patient-Centric Solution
Mindy Katz says with increasingly positive expectations for the wearable device market to provide an intuitive and user-friendly drug delivery experience, her company continues to optimize its wearable platform solution, investigating new technologies and processes to improve the offerings for patients and providers.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Meeting Demand for Biologics & Specialty Drugs
Contributor Cindy Dubin highlights the formulation development and manufacturing offerings from some of the leading CDMOs to address a myriad of challenges – from complex compounds to poor solubility to dual-release profiles.
FORMULATION FORUM - Nanosuspension Dosage Forms: Product Development & Scale Up
In this month’s column on formulation development challenges, Jim Huang, PhD, discusses nanosuspensions prepared via the top-down process, ie, the wet milling process.
