Formulation Development
Esperion Announces Completion of Phase 3 LDL-C Lowering Development Program
Esperion recently announced completion of the Phase 3 LDL-C Lowering Development Program of bempedoic acid and positive cumulative results. The program consisted of four, pivotal,…
ProQR In-licenses Worldwide Rights to Ophthalmology Drug Candidate From Ionis Pharmaceuticals
ProQR Therapeutics N.V. recently announced the signing of an agreement with Ionis Pharmaceuticals to license QR-1123 (formerly IONIS-RHO-2.5Rx), an RNA medicine for autosomal dominant retinitis…
Athenex Announces FDA Allowance of Investigational New Drug Application
Athenex, Inc. recently announced the FDA has allowed the Investigational New Drug (IND) application for Athenex's oral version of Eribulin currently named Eribulin ORA. This…
TESARO Announces $18-Million Milestone Payments
TESARO, Inc. recently announced the achievement of development milestones that trigger an $18-million payment from Janssen Biotech Inc. The milestones are related to Janssen’s ongoing…
Acer Therapeutics Submits NDA for EDSIVO; Requests Priority Review
Acer Therapeutics Inc. recently announced it has submitted a New Drug Application (NDA) to the US FDA for EDSIVO for the treatment of vascular Ehlers-Danlos…
Verona Pharma Completes Enrollment in Phase 2 Clinical Trial
Verona Pharma plc recently announced it has enrolled the last patient in its Phase 2 clinical trial evaluating the effect of nebulized RPL554 as an add-on to dual therapy using long-acting anti-muscarinic/long-acting beta2-agonists (LAMA/LABA) and triple therapy (LAMA/LABA with an inhaled corticosteroid) in the maintenance treatment of patients with moderate to severe COPD.
Sanofi & Denali Therapeutics to Develop Multiple Molecules; $125 Million Upfront
Sanofi plans to collaborate with Denali Therapeutics Inc. on the development of multiple molecules with the potential to treat a range of neurological and systemic inflammatory diseases.
TRANSDERMAL DELIVERY – Effect of Skin Model on In Vitro Performance of an Adhesive Dermally Applied Microarray – ADAM(TM) – Coated With Zolmitriptan
Hayley Lewis and Mahmoud Ameri, PhD, assessed Strat-M, full-thickness, and dermatomed ex vivo skin on percutaneous delivery of zolmitriptan from innovative drug-coated dermally applied microprojections that target the epidermal/dermal layer for fast and efficient delivery.
Melt Pharmaceuticals Initiates Clinical Development Program
Melt Pharmaceuticals recently announced that following the presentation of clinical data on the MKO Melt (midazolam/ketamine/ondansetron) from a 611-patient IRB approved prospective, controlled, randomized, three…
Athenex Presents Encouraging Clinical Trial Efficacy & Safety Results
Athenex recently announced the presentation of encouraging efficacy and safety data of Oraxol in the treatment of metastatic breast cancer patients who failed previous chemotherapies…
CytomX Therapeutics Presents Clinical Data From Probody Platform
CytomX Therapeutics, Inc. recently presented clinical results from two arms of the PROCLAIM (PRObody CLinical Assessment In Man) module, PROCLAIM-072. PROCLAIM-072 is an ongoing Phase…
Alcami Helps Medicines Development for Global Health Secure FDA Approval
Alcami Corporation recently announced its collaboration with Medicines Development for Global Health (MDGH), a not-for-profit Australian biopharmaceutical company dedicated to the development of affordable medicines and vaccines for neglected diseases prevalent in low and middle-income countries.
Novel Oral Therapies Could Transform the Standard-of-Care for DME & Lead to Preventative Treatment
Verseon, a technology-based pharmaceutical company, is presently developing multiple novel, small-molecule inhibitors of plasma kallikrein for the treatment of DME. Plasma kallikrein is a central mediator in the kallikrein-kinin system (KKS), a well-known pathway addressing an underlying cause of DME.
VistaGen Therapeutics Acquires Worldwide Rights to Develop & Commercialize First-in-Class Intranasally Administered Drug
VistaGen Therapeutics Inc. recently announced it has exercised its option to acquire from Pherin Pharmaceuticals, Inc. the exclusive license for worldwide rights to develop and commercialize PH10, a first-in-class, intranasally administered neuroactive steroid (a pherine), with rapid-onset antidepressant effects for treatment of major depressive disorder (MDD) demonstrated in a Phase 2a study
VBI Vaccines Completes Vaccination in PROTECT Phase 3 Clinical Study
VBI Vaccines Inc. recently announced the last subject has received the last vaccination in the PROTECT Phase 3 study of Sci-B-Vac, the company’s third-generation prophylactic hepatitis B vaccine.
Arcis Biotechnology & Teleflex Sign License Agreement
Arcis Biotechnology recently announced it has signed a technology access agreement with Teleflex Incorporated. Teleflex will harness Arcis’ advanced nucleic acid sample preparation chemistry in the development of a novel technology, which it believes will be disruptive, and is intended to empower clinicians and drive better patient outcomes.
Hovione Increases Production Capacity; One-Site-Shop Expands to Respond to Growing Demands
Hovione recently announced a plan to increase production capacity in oral dosage forms in Portugal to strengthen the integrated offering. New commercial-scale equipment for blending, tableting, and coating will complement existing development small-scale equipment.
Principia Achieves $10 Million in Additional Milestones
Principia Biopharma Inc. recently announced the achievement of $10 million in additional milestones related to successful development activities conducted by Principia as part of the…
EyePoint Pharmaceuticals Receives FDA Approval of YUTIQ
EyePoint Pharmaceuticals, Inc. recently announced the US FDA has approved YUTIQ (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment…
Krystal Biotech Announces Positive Interim Results
Krystal Biotech, Inc. recently announced positive interim results from its ongoing placebo-controlled Phase 1/2 clinical trial of KB103. Two adult Recessive Dystrophic Epidermolysis Bullosa (RDEB),…
