Formulation Development
ProQR Announces Axiomer RNA Editing Licensing & Research Collaboration With Lilly
ProQR Therapeutics N.V. recently announced a global licensing and research collaboration with Eli Lilly and Company (Lilly) focused on the discovery, development, and….
Longeveron Partners With Kinesiometrics to Create & Implement Cutting-Edge Smart Phone App to Measure Physical Responses to Cell Therapy
Longeveron Inc. has entered into an agreement with Kinesiometrics Inc., to provide a cutting-edge, digital data-driven solution for objective real-time measurement of functional capacity and quality….
AzurRx BioPharma Announces Acquisition of First Wave Bio & its Proprietary Niclosamide Formulations Targeting Multi-Billion Dollar Inflammatory Bowel Disease Indications
AzurRx BioPharma, Inc. recently announced it has entered a definitive agreement to acquire First Wave Bio, Inc. in a stock and cash transaction valued at….
Denali Therapeutics Announces Initiation of Phase 1b Study of EIF2B Activator DNL343 in ALS
Denali Therapeutics Inc. recently announced that dosing recently commenced in a Phase 1b study of DNL343, its brain-penetrant small molecule activator of EIF2B, in participants diagnosed…
Kinnate Biopharma Inc. Presents Preclinical Data on its Lead FGFR Inhibitor Candidate
Kinnate Biopharma Inc. recently announced results from preclinical studies evaluating its lead Fibroblast Growth Factor Receptor (FGFR) inhibitor candidate, KIN-3248. These findings were presented during…
Pii Invests in Expansion of Sterile Fill-Finish Capacity & Capabilities
Pii has strategically invested in expansion of our sterile fill-finish capacity and capabilities, with production lines capable of supporting large commercial scale batch sizes. Specifically,…
Evelo Biosciences Announces Issuance of US Patent for Pharmaceutical Compositions of Single Strains of Naturally Occurring Bacteria as Medicines
Evelo Biosciences, Inc. recently announced the US Patent and Trademark Office has issued a new composition of matter patent (No. 11,090,341) for medicines comprising pharmaceutical…
Decibel Therapeutics Receives Orphan Drug & Rare Pediatric Disease Designations for DB-OTO for the Treatment of Otoferlin-Related Congenital Hearing Loss
Decibel Therapeutics recently announced the US FDA has granted both Orphan Drug Designation and Rare Pediatric Disease Designation for the company’s lead gene therapy product…
ABITEC Corporation & Larodan AB Announce Brand Refresh After Successful Integration of the Two Companies
ABITEC Corporation, an ABF Ingredients company, recently announced in July 2020 the acquisition of Swedish manufacturer and international marketer of state of the art, high-purity research grade lipids, Larodan AB….
MacroGenics Announces Final Overall Survival Results From SOPHIA Study of MARGENZA in Patients with HER2-Positive Metastatic Breast Cancer
MacroGenics, Inc. recently announced the final overall survival (OS) results of the SOPHIA Phase 3 study in adult patients with metastatic HER2-positive breast cancer…..
Nature Medicine Publishes Positive Phase 3 Anakinra Study Results in Patients With COVID-19 Pneumonia
Swedish Orphan Biovitrum AB (Sobi) and the Hellenic Institute for the Study of Sepsis recently announced that Nature Medicine has published positive results from the investigator-sponsored Phase 3….
Impel NeuroPharma Announces US FDA Approval of TRUDHESA Nasal Spray for the Acute Treatment of Migraine
Impel NeuroPharma, Inc. recently announced the US FDA approved TRUDHESA (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura….
Newron Initiates First Potentially Pivotal Study With Evenamide in Patients With Schizophrenia
Newron Pharmaceuticals S.p.A. recently announced the initiation of Study 008A, the first potentially pivotal study with evenamide in patients with schizophrenia. Study 008A, a 4-week,…
AIM ImmunoTech Submits Pre-IND Application to the FDA for Phase 2 Clinical Study of Ampligen as a Potential Infusion Therapy for Post-COVID-19 Cognitive Dysfunction
AIM ImmunoTech Inc. recently announced it has submitted a Pre-Investigational New Drug application (Pre-IND) to the US FDA for a Phase 2 clinical study of…
Soleno Therapeutics Announces Positive Data Showing Continued Significant Improvements in Symptoms of PWS Following 1 Year Treatment With DCCR
Soleno Therapeutics, Inc. recently announced top-line results from the company’s ongoing open-label extension study, C602, evaluating investigational, once-daily DCCR (Diazoxide Choline) Extended-Release tablets for patients…
Celsion Reports T-cell & B-cell Response From In Vivo Studies With its PLACCINE DNA Vaccine Platform
Celsion Corporation recently announced results from preclinical in vivo studies showing production of antibodies and cytotoxic T-cell response specific to the spike antigen of SARS-CoV-2…
TCR² Therapeutics Receives FDA Orphan Drug Designation for Gavo-cel for the Treatment of Cholangiocarcinoma
TCR2 Therapeutics Inc. recently announced the US FDA has granted the company Orphan Drug Designation (ODD) to gavo-cel for the treatment of cholangiocarcinoma. New clinical…
Adamis Pharmaceuticals Doses First Patients in Phase 2/3 Clinical Trial for Tempol in the Treatment of COVID-19
Adamis Pharmaceuticals Corporation recently announced the initiation of patient dosing in the Phase 2/3 clinical trial for Tempol, an oral antiviral product candidate, in adult patients…
Genezen Appoints New CEO as GMP Expansion Begins
Genezen Inc., a cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has appointed Ray Kaczmarek as CEO. Mr. Kaczmarek has over 28 years…
Sterling Pharma Solutions Awarded Gold Medal by EcoVadis, Recognizing Achievements in Sustainability
Sterling Pharma Solutions recently announced it has been awarded a gold medal by EcoVadis, in recognition of the company’s sustainability management system through its policies,…
