Formulation Development
Ionis & Biogen Announce Topline Phase 1 Study Results
Ionis Pharmaceuticals, Inc. & Biogen, Inc. recently announced topline results from the Phase 1 study of BIIB078 (IONIS-C9Rx), an investigational antisense oligonucleotide (ASO) for people…
European Medicines Agency Commences Review of Novel Gene Therapy Candidate for People With Hemophilia B
CSL Behring recently announced the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for etranacogene dezaparvovec (EtranaDez) under its accelerated assessment procedure.…
RAPT Therapeutics Announces Biomarker Data from Phase 1b Trial
RAPT Therapeutics, Inc. recently announced biomarker data from the company’s randomized placebo-controlled Phase 1b clinical trial of RPT193 in patients with moderate-to-severe atopic dermatitis (AD)…
Prothena Announces FDA Clearance of IND for PRX012, a Subcutaneous Anti-Amyloid Beta Antibody Under Investigation for the Treatment of Alzheimer’s Disease
Prothena Corporation plc recently announced the US FDA has cleared the investigational new drug (IND) application for PRX012, a potential best-in-class anti-amyloid beta (Aβ) antibody…
DFE Pharma, Harro Höfliger & Sterling Announce Unique Partnership to Provide Formulation Services for Respiratory Products
Three leading companies in their respective fields – DFE Pharma (excipients solution provider), Harro Höfliger (equipment supplier), and Sterling (API manufacturer) recently announced a unique partnership….
Provectus Biopharmaceuticals Announces Synthesis of New Halogenated Xanthene Small Molecule
Provectus recently announced it has successfully developed and manufactured a second halogenated xanthene (HX), adding to its lead, clinical-stage, HX small molecule called rose bengal…
WHITE PAPER: Tackling a Changing Climate; Metered Dose Inhalers | Recipharm
Are you prepared for the HFA phasedown? With many industries switching to more environmentally friendly propellants, pMDI developers need to be ready. Recipharm explore alternative…
4D pharma Announces Positive Interim Results From Phase 1/2 Study
4D pharma plc recently announced that in Part B of its signal finding study of MRx0518 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA(R) (pembrolizumab), in…
Rani Therapeutics Announces Initiation of Phase 1 Study for Osteoporosis
Rani Therapeutics Holdings, Inc. recently announced the initiation of a Phase 1 study of RT-102, an oral formulation of the human parathyroid hormone analog PTH(1-34)…
GeoVax Announces Issuance of Cancer Vaccine Patent
GeoVax Labs, Inc. recently announced the U.S. Patent and Trademark Office has issued Patent No. 11278607 to GeoVax, pursuant to the company’s patent application No. 16/068,527 titled….
Viridian Therapeutics Doses First Subject in First-in-Human Clinical Trial Evaluating a Next- Generation IGF-1R Antibody
Viridian Therapeutics, Inc. recently announced it has dosed the first subject in a Phase 1 clinical trial evaluating VRDN-002 for the treatment of thyroid eye…
Jeune Aesthetics Announces Positive Clinical Phase 1 Efficacy Results for Investigational Gene-Based Treatment to Address the Underlying Biology of Aging Skin
Jeune Aesthetics, Inc., a wholly owned subsidiary of Krystal Biotech, Inc., recently announced positive proof-of-concept efficacy data from Cohort 2 of the PEARL-1 study of KB301….
Blue Water Vaccines Announces Publication in Nano Research Supporting Novel S&P Vaccine Platform Versatility
Blue Water Vaccines Inc. recently announced its licensing partner, Cincinnati Children’s Hospital Medical Center, or CCHMC, has published a research paper titled Bioengineered pseudovirus nanoparticles…
Lonza Partners With Oasmia Pharmaceuticals to Manufacture Ovarian Cancer Therapy
Oasmia Pharmaceutical AB and Lonza recently announced the companies have signed a large-scale manufacturing agreement for the main drug intermediate in the supply of….
Vallon Pharmaceuticals Announces Topline Results of its Pivotal SEAL Study for Lead Program
Vallon Pharmaceuticals, Inc. recently announced topline results from its pivotal SEAL study evaluating ADAIR, a proprietary abuse-deterrent formulation of immediate release (IR) dextroamphetamine for the…
Travere Therapeutics Submits NDA for Sparsentan for the Treatment of IgA Nephropathy
Travere Therapeutics, Inc. recently announced it has submitted a New Drug Application (NDA) to the US FDA under Subpart H for accelerated approval of sparsentan…
uniQure Announces Completion of Patient Enrollment in the First Two Cohorts of its Phase 1/2 Clinical Trial
uniQure recently announced the completion of patient enrollment in the first two cohorts of its randomized, double-blinded, Phase 1/2 clinical trial of AMT-130 for the…
Chiesi & Protalix Announce Phase 3 Data From BRIGHT Study in Fabry Disease
Protalix BioTherapeutics, Inc. and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., recently announced final results from the BRIGHT Phase 3 clinical trial evaluating pegunigalsidase alfa….
Nitrase Therapeutics Announces Major Discovery In Parkinson’s Disease
Nitrase Therapeutics, Inc. (formerly Nitrome Biosciences) recently announced an oral presentation at the AD/PD International Conference on Alzheimer’s, Parkinson’s, and related neurological disorders taking place…
physIQ & CellCarta Collaborate to Accelerate a More Precise, Personalized Approach to Vaccine Development
physIQ and CellCarta recently announced a strategic collaboration to undertake a groundbreaking study with the potential to revolutionize vaccine development…..
