Formulation Development
ViGeneron Signs Global Development & Commercialization Agreement With Biogen
ViGeneron GmbH recently announced a global collaboration and licensing agreement with Biogen Inc. to develop and commercialize gene therapy products based on adeno-associated virus (AAV) vectors to treat….
University of Calgary Joins the Phase 2 Trial of LSALT Peptide for the Treatment of Complications in Hospitalized COVID-19 Patients
Arch Biopartners Inc. RECENTLY announced the University of Calgary Cumming School of Medicine has joined the Phase 2 trial of its lead drug LSALT peptide (Metablok), targeting the prevention….
Rhythm Pharmaceuticals Announces Sale of Priority Review Voucher for $100 Million
Rhythm Pharmaceuticals, Inc. recently announced it has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $100 million.…
Ocuphire Pharma Initiates LYNX-1 Phase 3 Study Investigating Nyxol in Night Vision Disturbances
Ocuphire Pharma, Inc. recently announced the initiation of patient recruitment and screening in late December for its LYNX-1 Phase 3 registration study evaluating the safety…
PHASTAR Announces Investment by Charterhouse Capital Partners
PHASTAR recently announced an investment made by Charterhouse Capital Partners LLP that will support PHASTAR’s growth in biometrics and geographic expansion. Charterhouse is making its…
Akston Biosciences & LakePharma Announce Strategic Partnership to Manufacture Second-Generation COVID-19 Vaccine
Akston Biosciences and LakePharma recently announced they have established a strategic partnership in which LakePharma will manufacture commercial quantities of Akston’s adjuvated COVID-19 vaccine candidate (AKS-452),…
Oncorus to Build GMP Viral Immunotherapy Clinical Manufacturing Facility
Oncorus, Inc. recently announced it has signed a 15-year lease to build a state-of-the-art, 88,000-square-foot Good Manufacturing Practice (GMP) viral immunotherapy clinical manufacturing facility in…
Inozyme Pharma Announces Authorization to Proceed in US & UK With Phase 1/2 Clinical Trial
Inozyme Pharma, Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application and that the United Kingdom Medicines and Healthcare…
EyePoint Pharmaceuticals Announces $15.7-Million Equity Investment
EyePoint Pharmaceuticals, Inc. recently announced Ocumension Therapeutics has made a $15.7-million equity investment in EyePoint. Under the terms of the agreement, Ocumension has purchased approximately…
Ajinomoto Bio-Pharma Services & Revance Therapeutics Announce Manufacturing Agreement
Ajinomoto Bio-Pharma Services and Revance Therapeutics, Inc. recently announced a strategic commercial manufacturing agreement for the supply of DaxibotulinumtoxinA for….
Vectura Earns $11-Million Milestone as Hikma Receives US FDA Approval for Generic Advair DiskusR
Vectura Group plc recently announced its partner Hikma Pharmaceuticals has launched its generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder)….
Aurinia & Lonza Announce Exclusive Agreement for Dedicated Voclosporin Manufacturing Capacity
Aurinia Pharmaceuticals Inc. and Lonza recently announced they have expanded their exclusive manufacturing relationship. The parties entered into a collaborative agreement to build….
Gattefossé Continues International Development & Builds Production Site in Texas
Gattefossé is investing 30 million euros in its industrial operations and announced the construction of a brand new manufacturing plant in Lufkin, TX. This asset will produce lipid-based….
Passage Bio Teams With Catalent to Start cGMP Manufacturing for Lead Gene Therapy Products
Passage Bio, Inc. and Catalent recently announced that manufacturing operations have commenced to support adeno-associated virus (AAV) production for Passage Bio’s lead….
Syneos Health & ConcertAI Announce Strategic Collaboration to Accelerate the Use of Real World Evidence & AI to Advance Oncology Research
Syneos Health and ConcertAI recently announced a strategic collaboration to accelerate and streamline the implementation of novel oncology clinical trial research and study designs…..
Theratechnologies Announces New Findings for its Lead Investigational Compound for the Treatment of Several Additional Cancers
Theratechnologies Inc. recently announced new preclinical in vivo findings regarding the efficacy and tolerability of its novel investigational proprietary peptide-drug conjugate (PDC), TH1902, for the….
Daré Bioscience Announces Positive Topline Results From Phase 3 Trial
Daré Bioscience, Inc. recently announced positive topline results from the DARE-BVFREE Phase 3 randomized, double-blinded, placebo-controlled clinical trial evaluating DARE-BV1 in 307 women diagnosed with…
Kronos Bio Announces FDA Clearance of IND for Oral CDK9 Inhibitor
Kronos Bio, Inc. recently announced US FDA clearance of the company’s Investigational New Drug (IND) application for KB-0742, a highly selective, orally bioavailable inhibitor of…
Ionis Announces Initiation of the Global Phase 3 BALANCE Study
Ionis Pharmaceuticals, Inc. recently announced the initiation of the Phase 3 BALANCE study for AKCEA-APOCIII-LRx in adult patients with familial chylomicronemia syndrome (FCS). FCS is…
Catalent to Invest $10 Million to Expand High Potency Containment Capabilities for Micronization
Catalent recently announced it is investing $10 million in isolator capabilities at its sites in Malvern, PA, and Dartford, UK, to expand its micronization capabilities…
