Market News & Trends
BioNTech Receives FDA Fast Track Designation for its FixVac Candidate BNT111 in Advanced Melanoma
BioNTech SE recently announced the US FDA granted Fast Track Designation for BNT111, an investigational cancer immunotherapy for the potential treatment of advanced melanoma. BNT111…
Sterling Pharma Solutions Announces $13.5-Million Investment at Dudley, UK, to Increase Process Development & Manufacturing Capacity
Sterling Pharma Solutions recently announced the next phase of a multi-year investment strategy at its site in Dudley, UK. The $13.5-million plan will see the…
Verrica Pharmaceuticals Announces FDA Acceptance of its IND Application for Potential First-in-Class Oncolytic Peptide-Based Immunotherapy for the Treatment of Basal Cell Carcinoma
Verrica Pharmaceuticals Inc. recently announced the US FDA has accepted its Investigational New Drug Application (IND) for LTX-315, a potential first-in-class oncolytic peptide, for the…
Molecular Templates Announces Fast Track Designation Granted by FDA for MT-6402
Molecular Templates, Inc. recently announced the US FSA has granted Fast Track Designation for MT-6402 for the treatment of patients with advanced non-small cell lung…
First Subject Dosed in Biosplice Therapeutics Phase 1b Clinical Trial in Oncology
Biosplice Therapeutics, Inc. recently announced the dosing of the first subject in a Phase 1b, open-label, multi-center, dose-escalation, dose expansion clinical trial of cirtuvivint in…
OWP Pharmaceuticals Announces IND Authorization for the First-Ever Oral Liquid Formulation of Atomoxetine Hydrochloride for the Treatment of ADHD
OWP Pharmaceuticals, Inc. recently announced it has received IND authorization from the FDA for the first-ever oral suspension of atomoxetine hydrochloride. Offering an important delivery…
Nemera to Build State-of-the-Art Manufacturing Facility in Poland to Serve More Customers & Patients
Based in Szczecin, this facility extends Nemera’s manufacturing capabilities and will bring more drug delivery device solutions to patients. Following the dynamic growth of the…
BD Launches BD UltraSafe Plus™ 2.25-mL Passive Needle Guard Enabling Patient Ease of Use & Safety
BD (Becton, Dickinson and Company) recently announced the launch of the BD UltraSafe Plus 2.250-mL Passive Needle Guard for use by pharmaceutical companies in drug-device…
Denali Therapeutics Announces Strategic Partner Takeda Exercises Option to Co-Develop & Co-Commercialize Brain-Penetrant Progranulin Replacement Therapy
Denali Therapeutics Inc. recently announced its strategic partner Takeda Pharmaceutical Company Limited has exercised an option, pursuant to an existing collaboration agreement between the two…
Alzheimer’s Disease Preventative Nasal Vaccine to be Tested at Boston's Brigham & Women’s Hospital
Boston's Brigham and Women’s Hospital recently announced it would test a nasal vaccine for Alzheimer’s disease. The move, the hospital said in a press release, represents the culmination of…
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Molex Expands European Manufacturing Footprint & Capabilities With State-of-the-Art Campus in Poland
Molex recently announced a major expansion of its global manufacturing footprint with the opening of a new campus in Katowice, Poland. The facility’s initial 23,000-square-meter manufacturing space will….
Kala Pharmaceuticals Completes Sale of EYSUVIS & INVELTYS to Alcon Inc
Kala Pharmaceuticals, Inc. recently announced it has completed the sale of its commercial portfolio and related intellectual property assets to Alcon Inc., a transaction that was….
Insightful Science Acquires Protein Metrics to Expand its R&D Solution to Include Proteomics
Insightful Science recently announced it has completed the transaction to acquire Protein Metrics, Inc. to expand the company’s R&D value chain to widen the biopharmaceutical protein analysis arena….
Acer Therapeutics & Relief Therapeutics Announce NDA Submission for ACER-001 for Treatment of Urea Cycle Disorders
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)….