Formulation Development
Stemline Therapeutics Receives Approval for First & Only Treatment Specifically Indicated for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer
The Menarini Group recently announced the US FDA has approved ORSERDU for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced…
Anti-Bb Antibody Receives US FDA Clearance to Start Clinical Trial in Naïve aHUS Patients
NovelMed recently announced the US FDA cleared the company’s investigational drug NM8074 to initiate an efficacy trial in patients with aHUS in coming months. NovelMed…
BioAegis Therapeutics Announces FDA Clearance of IND for its Inflammation Regulator Protein for the Treatment of ARDS
BioAegis Therapeutics, Inc. recently announced the US FDA has approved its Investigational New Drug (IND) application for recombinant plasma gelsolin to proceed for the….
INmune Bio, Inc. Announces Pre-Clinical Data That Support a Pioneering Approach to Treating Duchenne Muscular Dystrophy
INmune Bio, Inc. in collaboration with Professor Armando Villalta, PhD, of University California, Irvine School of Medicine, has shown targeting soluble TNF (sTNF) using a…
Ocuphire Announces Topline Results From Phase 2 Trial of Oral APX3330 in Diabetic Retinopathy & Plans for End-of-Phase 2 Meeting With FDA
Ocuphire Pharma, Inc. recently announced topline efficacy and safety results from its ZETA-1 Phase 2 trial evaluating oral APX3330 for the treatment of diabetic….
AC Immune’s Anti-Amyloid Beta Vaccine for Alzheimer’s Shows Positive Initial Interim Safety & Immunogenicity in Phase 1b/2 Trial
AC Immune SA recently announced the first interim safety, tolerability, and immunogenicity findings from the Phase 1b/2 ABATE trial of its anti-amyloid-beta (Abeta) vaccine ACI-24.060…
Inhibikase Therapeutics Announces FDA has Lifted the Full Clinical Hold on IkT-148009 in Parkinson’s Disease
Inhibikase Therapeutics, Inc. recently announced the US FDA has lifted the full Clinical Hold on IkT-148009 in Parkinson’s disease (PD). “We are grateful for the…
Eloxx Pharmaceuticals Announces First Patients Enrolled in Phase 2 Clinical Study Evaluating Treatment for Alport Syndrome
Eloxx Pharmaceuticals, Inc. recently announced the first patients have now been enrolled in its Phase 2 study of ELX-02 for the treatment of Alport syndrome…
Hyloris Announces Commercial Partnership for Maxigesic IV in 9 European Countries
Hyloris Pharmaceuticals SA recently announced its partner AFT Pharmaceuticals has signed an exclusive licensing and distribution agreement with Salus Pharmaceuticals for Maxigesic IV, a novel,…
Alvotech & Bioventure Announce Approval of AVT02 (Adalimumab) as Simlandi in Saudi Arabia
AVT02 as Simlandi is the first biosimilar approved under the strategic partnership between Alvotech and Bioventure….
Experic Expands Analytical Laboratory Capabilities & Facilities
Experic recently announced the expansion of its analytical laboratory and services. The new laboratory is located in the same office park as Experic’s headquarters in…
SOTIO Doses First Patient in AURELIO-05 Phase 2 Trial of Nanrilkefusp Alfa in Combination With Cetuximab
SOTIO Biotech recently announced the first patient was dosed in its Phase 2 AURELIO-05 combination trial of nanrilkefusp alfa (previously known as SOT101), an IL-15 superagonist, and….
Evaxion Receives FDA Fast-Track Designation for Personalized Cancer Immunotherapy
Evaxion Biotech A/S recently announced the US FDA has granted fast track designation for the company’s personalized cancer therapy, EVX-01, in combination….
Strata Oncology Announces Addition of Gilead as Strata PATH Trial Collaborator
Strata Oncology, Inc. recently announced Gilead Sciences, Inc. has agreed to collaborate on the Strata Precision Indications for Approved THerapies (Strata PATH) trial by providing…
(e-Book) Lyophilization Trends in Pharma & Biopharma Drug Development
This 30-page eBook is exactly what you have been looking for. Find out what is driving the lyophilization market and how working with a CDMO will save time and money and help you comply with increasing regulatory requirements.
BriaCell Announces Positive End of Phase 2 Meeting With the FDA for Bria-IMT Combination in Advanced Metastatic Breast Cancer
BriaCell Therapeutics Corp. is pleased to announce that it has received agreement and positive feedback from its End of Phase 2 meeting with the FDA…
Avidity Biosciences Granted FDA Fast Track Designation for the Treatment of Facioscapulohumeral Muscular Dystrophy
Avidity Biosciences, Inc. recently announced the US FDA has granted Fast Track designation to AOC 1020 for the treatment of facioscapulohumeral muscular dystrophy (FSHD). FSHD…
Teon Therapeutics Announces Clinical Trial Collaboration With Merck to Evaluate Novel Oral Immune Response Modifier in Combination with KEYTRUDA
Teon Therapeutics (Teon) recently announced it has entered into the clinical trial collaboration agreement with Merck for the combination arm of Teon’s ongoing, two-armed, open-label, dose….
Ingenza Collaborates With Amplifica to Advance Novel Alopecia Treatments
Industrial biotech specialist Ingenza recently announce it is collaborating with clinical-stage biopharmaceutical company Amplifica Holdings Group, Inc. to develop an innovative treatment to address androgenic…
Needle-Free Patch Technology for mRNA Vaccines Aims to End Need for Frozen Storage & Improve Access
CEPI, the Coalition for Epidemic Preparedness Innovations, and Vaxxas have recently signed a partnership agreement to advance the development of Vaxxas’ needle-free vaccine-patch delivery technology in a project….
