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Aerami Therapeutics Announces Orphan Drug Designation for Imatinib for the Treatment of Pulmonary Arterial Hypertension August 31, 2021
Aerami Therapeutics, Inc. recently announced the US FDA has granted the company orphan drug designation for imatinib for treatment of...AC Immune Announces First Positive Cognitive Results for a Tau-Targeting Monoclonal Antibody in Alzheimer’s Disease August 31, 2021
AC Immune SA recently announced Genentech, a member of the Roche Group, has informed the company that Lauriet, a placebo-controlled...SPECIAL FEATURE - Injection Devices: Designing Simplicity, Safety & Adherence Into One Delivery System August 26, 2021
Contributor Cindy Dubin, in this annual report, speaks with industry innovators and takes a deep dive into the myriad injectables that are currently in development or recently introduced to the market.
GENE THERAPY - Solving the Puzzle: Aligning the Pieces of Gene Therapy & Creating Success for Patients August 26, 2021
Sue Washer, MBA, reviews the various elements that must come together in developing safe, effective, and commercially viable viral-based gene therapies.
NASAL SPRAY BIOEQUIVALENCE - Between-Batch Bioequivalence (BBE): An Alternative Statistical Method to Assess In Vitro Bioequivalence of Nasal Product August 26, 2021
Jonathan Bodin, Stéphanie Liandrat, Gabriel Kocevar, and Céline Petitcolas explain how one way to prove equivalence, without long and expensive clinical trials, is to conduct in vitro bioequivalence evaluation between the Innovator (Reference product) and the proposed generic (Test product).
DIGITAL CUSTOM PLATFORM - PCI Pharma’s Digital Transformation: Reaching New Levels of Customer Experience August 26, 2021
Wayne Hull and Rebecca Coutts, PhD, explain how incorporating digital transformation as core to their company’s business strategy was a decision based on increasing evidence that investment in digital solutions provides real and measurable returns.
Vifor Pharma & Cara Therapeutics Announce US FDA Approval of Injection for Treating Moderate-to-Severe Pruritus in Hemodialysis Patients August 23, 2021
Cara Therapeutics and Vifor Pharma recently announced the US FDA has approved KORSUVA (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with….
ProPhase Labs Acquires Whole Genome Sequencing Company August 17, 2021
ProPhase Labs, Inc. recently announced the acquisition of Nebula Genomics, a privately-owned personal genomics company. The company’s recently formed subsidiary,...atai Launches Revixia Life Sciences to Develop Salvinorin A for a Variety of Mental Health Conditions August 17, 2021
atai Life Sciences recently announced the launch of Revixia Life Sciences, a wholly owned subsidiary developing Salvinorin A (SalA) to...Acer Therapeutics & Relief Therapeutics Announce NDA Submission for ACER-001 for Treatment of Urea Cycle Disorders August 10, 2021
Acer Therapeutics Inc. Relief Therapeutics recently announced the submission of a New Drug Application (NDA) to the US FDA for ACER-001 (sodium phenylbutyrate) for the treatment of Urea Cycle Disorders (UCDs)….
Biogen Announces Results from Phase 3b NOVA Study Evaluating Every 6-Week Dosing With Natalizumab in Relapsing-Remitting Multiple Sclerosis August 4, 2021
Biogen Inc. recently announced results from the 2-year prospective, randomized, interventional, controlled, open-label Phase 3b NOVA study (NCT03689972). NOVA was...Dyadic Announces Technology Transfer & Licensing Agreement With South Africa’s Rubic Consortium July 28, 2021
Dyadic International, Inc. recently announced it signed a COVID-19 vaccine technology transfer and licensing agreement with the Rubic Consortium, a...2021 Respiratory Drug Development eBook – The Three Cs Driving Respiratory Drug Delivery June 29, 2021
In this third annual Drug Development & Delivery Respiratory eBook, several companies discuss what they are currently working on to propel the respiratory sector.
Crinetics Pharmaceuticals Announces Dosing of First Patient in Phase 3 PATHFNDR-1 Study June 29, 2021
Crinetics Pharmaceuticals, Inc. recently announced the randomization of the first acromegaly patient in its Phase 3 clinical trial of paltusotine, PATHFNDR-1. This trial will be one of two planned Phase 3 studies assessing….
Fulcrum Therapeutics Announces Results from ReDUX4 Trial With Losmapimod in Facioscapulohumeral Muscular Dystrophy Demonstrating Slowed Disease Progression & Improved Function June 29, 2021
Fulcrum Therapeutics, Inc. recently announced results from the company’s Phase 2b trial, ReDUX4, in people with facioscapulohumeral muscular dystrophy (FSHD). Results being presented with….
Kura Oncology Doses First Patient in Phase 1b Expansion Cohorts With Menin Inhibitor KO-539 June 29, 2021
Kura Oncology, Inc. recently announced the first patient has been dosed in the Phase 1b portion of KOMET-001, a Phase...Corbus Pharmaceuticals Announces Topline Results from DETERMINE Phase 3 Study of Lenabasum for Treatment of Dermatomyositis June 29, 2021
Corbus Pharmaceuticals Holdings, Inc. recently announced topline results from the Phase 3 DETERMINE study of lenabasum in adults with the...CHMP Recommends Approval of RINVOQ (upadacitinib) for the Treatment of Atopic Dermatitis June 29, 2021
AbbVie recently announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion...WEARABLE PLATFORM - Next-Generation Wearable Drug Delivery: Prefilled Devices Provide a Truly Patient-Centric Solution June 2, 2021
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 June 2, 2021
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.