Market News & Trends
Alcami Adds Additional Formulation Development Capabilities
Alcami recently announced the addition of a 3,800 ft² Non-GMP Formulation Development Laboratory (FDL). The dedicated Non-GMP formulation development space, which is co-located within the…
VYNE Reports Positive Preclinical Data for Lead BET Inhibitor in Human Skin Model of Vitiligo
VYNE Therapeutics Inc. recently announced positive preclinical data in an ex vivo skin model of vitiligo. In the preclinical model, pan-bromodomain and extra-terminal (BET) inhibitor…
Targovax ASA & Agenus Announce Collaboration on Mutant KRAS Cancer Vaccine Adjuvanted With QS-21 STIMULON
Agenus and Targovax ASA recently announced they have entered into a clinical collaboration and supply agreement to combine Targovax’s TG mutant KRAS cancer vaccines with Agenus´s clinically validated….
Harpoon Therapeutics Granted Orphan Drug Designation for Small Cell Lung Cancer Treatment
Harpoon Therapeutics, Inc. recently announced the US FDA has granted Orphan Drug Designation for HPN328, a delta like ligand 3- (DLL3) targeting TriTAC, for the…
Evaxion Biotech Completes Recruitment for Phase 1/2a Clinical Trial
Evaxion Biotech A/S has recently now finalized recruitment for Phase 1/2a clinical trial of EVX-02 in adjuvant melanoma patients…..
Cambrex Expands Biopharmaceutical Services Business
Cambrex recently announced it is significantly expanding its existing biopharmaceutical testing services business. The expansion includes 11 additional cGMP….
Evonik Increases Global Supply of Pharma-Grade Plant-Derived Cholesterol for mRNA Vaccines & Gene Therapies
Evonik has boosted its supply of plant-derived cholesterol, one of the most critical components for the manufacture of mRNA vaccines and gene therapies. The large-scale production of….
Exclusive License for Croda to Commercialize SSI’s CAF® Vaccine Adjuvants
Croda International Plc, which uses smart science to improve lives, recently announces it has entered a strategic collaboration with Statens Serum Institut (SSI), the leading…
Fulcrum Therapeutics Announces Phase 3 Clinical Trial
Fulcrum Therapeutics, Inc. recently announced its plans to initiate REACH, a Phase 3 clinical trial of losmapimod in people with facioscapulohumeral muscular dystrophy (FSHD), in…
Aravive Announces Positive Updated Data & New Biomarker Data From Phase 1b Study
Aravive, Inc. recently announced positive new data from the Phase 1b portion of the ongoing Phase 1b/2 trial of batiraxcept in clear cell renal cell…
Skye Bioscience Retains Novotech as CRO for Phase 1 Trial of Glaucoma Drug Candidate
Skye Bioscience, Inc. has recently entered into an agreement with Novotech Health Holdings for its upcoming Phase 1 study in Australia of its SBI-100 drug…
Pii Announces New President & Chief Executive Officer
Pharmaceutics International Inc (Pii) recently announced its Board of Directors has appointed Mr. John Fowler as President and Chief Executive Officer effective March 7, 2022.…
Oculis Strengthens Leading Ophthalmology Pipeline by In-Licensing Neuroprotective Drug Candidate for Glaucoma From Accure Therapeutics
Oculis S.A. and Accure Therapeutics recently announced a licensing agreement granting Oculis exclusive global rights to develop and commercialize ACT-01, a potentially disease-modifying therapy to…
Harpoon Therapeutics Receives FDA Fast Track Designation
Harpoon Therapeutics, Inc. recently announced the US FDA has granted Fast Track designation to HPN217, a BCMA-targeting TriTAC, for the treatment of patients with relapsed,…
Aeterna Zentaris Announces Notice of Allowance for US Patent Covering AEZS-150 for the Potential Treatment of Chronic Hypoparathyroidism
Aeterna Zentaris Inc. recently announced that its licensor, The University of Sheffield, has received a notice of allowance from the USPTO for its patent application No. 16/608,611…..
Enteris BioPharma to Participate in DCAT® Week 2022
Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq:…
Sterling Pharma Solutions Expands Global API Manufacturing Capabilities With Acquisition of Novartis Facility
Sterling Pharma Solutions recently announced it had reached agreement with Novartis to acquire its Ringaskiddy campus (Novartis Ringaskiddy Limited), near Cork, Ireland. Financial details of…
Catalent & TFF Pharmaceuticals Announce New Inhalation Dry Powder Development & Manufacturing Agreement
Catalent and TFF Pharmaceuticals, Inc. recently announced their collaboration agreement focused on the generation, testing, and manufacture of dry powder formulations for a range of…
Editas Medicine Announces Favorable Decision From US PTO in CRISPR Patent Interference
Editas Medicine, Inc. recently announced the USPTO issued another favorable decision to the Broad Institute, Inc. (Broad) involving specific patents for CRISPR/Cas9 editing in human…
CDMOs Need to be Prepared for the Revision of the EU-GMP-Annex 1
Annex 1 of the EU-GMP-Guide Manufacture of Sterile Medicinal Products is considered the most important European regulatory standard for the manufacture of sterile pharmaceutical products. The current revision will have to….
