Formulation Development
Novacap to Expand its Pharmaceutical Offering in US With Major Acquisition
Novacap recently announced it has signed an agreement to acquire Boston-based PCI Synthesis, a leading US pharmaceutical contract development and manufacturing organization (CDMO), further reinforcing Novacap’s capabilities and offering for the pharmaceutical industry.
Epinephrine Nasal Spray in Development for Treatment of Anaphylaxis Shows Promise as Potential Alternative to Intramuscular Injection
INSYS Therapeutics, Inc., a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, announced today that its investigational epinephrine nasal spray showed promise in an early clinical trial as a potential needle-free, non-invasive and easy-to-use alternative to intramuscular injection for the treatment of anaphylaxis.
Zealand Pharma Achieves Milestone in First Phase 3 Trial
Zealand Pharma A/S recently announced that the primary and key secondary objectives of the first multinational Phase 3 clinical trial of dasiglucagon for the treatment…
Paratek Presents New Analysis From Combined Phase 3 Skin Infection Studies
Paratek Pharmaceuticals, Inc. recently presented a new analysis of combined data from the company’s two, pivotal Phase 3 clinical studies of omadacycline in acute bacterial…
Nutriband Signs LOI to Acquire Carmel Biosciences
Nutriband Inc. recently announce it has signed a Letter of Intent to acquire 100% of Carmel Biosciences, a pharmaceutical company that addresses critical needs in…
Nkarta Therapeutics Announces Exclusive License to Natural Killer Cell Technology
Nkarta Therapeutics recently announced it has entered into a worldwide exclusive license agreement for proprietary Natural Killer cell engineering technology jointly owned by the National…
Avalon GloboCare Forms Joint Venture With Jiangsu Unicorn to Establish Provincial Network of Translational Cellular Therapy & Bio-Banking Programs
Avalon GloboCare Corp. recently announced it has formed a joint venture with Jiangsu Unicorn Biological Technology Co. Ltd, which brings extensive medical resources in Jiangsu…
FUJIFILM Cellular Dynamics Licenses University of California – Irvine’s Technologies
FUJIFILM Cellular Dynamics, Inc. (FCDI) recently announced it has entered into an exclusive patent license agreement with the University of California – Irvine (UCI) through its offices at UCI Applied Innovation to license and commercialize UCI’s technologies for derivation of microglia in the commercial research field and also a non-exclusive patent license agreement to commercialize microglia media formulation.
eFFECTOR Initiates Dosing of eFT508 in Phase 2 Expansion of Clinical Trial in Aggressive Form of Non-Hodgkin’s Lymphoma
eFFECTOR Therapeutics, Inc. recently announced that it has dosed the first patient in the Phase 2 expansion portion of its monotherapy trial of eFT508, the company’s oral, small molecule inhibitor of MNK1/2, for the treatment of relapsed, refractory non-germinal center B cell (non-GCB) diffuse large B cell lymphoma (DLBCL).
Axovant Licenses Investigational Gene Therapy for Parkinson’s Disease From Oxford BioMedica; Announces Key Leadership Team Addition
Axovant Sciences recently announced that it has licensed the exclusive worldwide rights to develop and commercialize OXB-102, now AXO-Lenti-PD, from Oxford BioMedica. AXO-Lenti-PD is an investigational gene therapy for Parkinson’s disease that delivers three genes encoding a critical set of enzymes required for dopamine synthesis in the brain.
Immunomodulation Therapies Designed to Suppress Tumors & Fight Infection
Immunomodulation Inc. recently outlined its upcoming plans to advance its investigational product candidate, IMM-010, following consistent positive data from preclinical studies.
RedHill Biopharma Announces New US Patent for its Experimental Ebola Therapy
RedHill Biopharma Ltd. recently announced the United States Patent and Trademark Office (USPTO) has issued a patent covering RedHill’s proprietary experimental therapy for the treatment of Ebola virus disease. The patent is expected to be valid until 2035.
Novel First-In-Class Immunotherapeutic APVO210 Features Unique Mechanism of Action Delivering IL-10
Aptevo Therapeutics Inc. recently announced the publication of preclinical data in Frontiers in Immunology highlighting the activity of APVO210 as a potent and selective immunosuppressive…
Elite Pharmaceuticals Announces Strategic Marketing Alliance With Glenmark Pharmaceuticals
Elite Pharmaceuticals, Inc recently announced the signing of a license, manufacturing, and supply agreement with Glenmark Pharmaceuticals, Inc., USA to market two Elite generic products…
FDA Accepts Larotrectinib NDA & Grants Priority Review
Loxo Oncology, Inc. recently announced the US FDA has accepted the company’s New Drug Application (NDA) and granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion
Amunix Announces Report by Bioverativ on Unprecedented Half-Life Obtained in Patients Treated With Novel, Long-Acting FVIII Utilizing XTEN Technology
Amunix Operating Inc. recently reported that Bioverativ (a Sanofi company) has announced preliminary Phase 1/2a safety and pharmacokinetic clinical data for BIVV001 (rFVIIIFc-VWF-XTEN), a novel and investigational factor VIII therapy for people with hemophilia A that incorporates Amunix’s XTEN technology to improve circulatory half-life.
Bioasis & WuXi Biologics Announce Initial Strategic Development & Manufacturing Collaboration
Bioasis Technologies, Inc.andWuxi Biologics recently announced an initial strategic collaboration for the development and manufacturing of xB3-001, Bioasis’ lead investigational biological candidate to treat brain cancer.
MimiVax Announces Positive Interim Results from Phase II Trial of SurVaxM
MimiVax LLC recently announced positive interim results from a multicenter Phase II study of SurVaxM in patients with newly diagnosed glioblastoma (nGBM).
Nabriva Therapeutics Announces Positive Topline Results From Pivotal Phase 3 Clinical Trial of Oral Lefamulin
Nabriva Therapeutics plc recently announced positive topline results from its Lefamulin Evaluation Against Pneumonia (LEAP 2) clinical trial, the second of two global, pivotal Phase 3 clinical trials of lefamulin. LEAP 2 evaluated the safety and efficacy of 5 days of oral lefamulin compared to 7 days of oral moxifloxacin in adult patients with moderate community-acquired bacterial pneumonia (CABP).
Beta Bionics Receives IDE Approval From the FDA to Begin a Home-Use Clinical Trial Testing the a New Bionic Pancreas System
Beta Bionics, Inc. recently announced it has received FDA approval to begin recruitment for home-use studies testing the insulin-only configuration of its iLet bionic pancreas system in a series of groundbreaking trials in adults and children with type 1 diabetes (T1D).
