Formulation Development
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,…
A Collaborative Effort Paves the Way for a New Approach to Small Batch Manufacturing
In today’s pharmaceutical industry there is a sharp focus on the needs and requirements of the patient. More and more drugs are being developed for specific patient groups. Orphan drugs, for example,….
Pardes Biosciences Initiates First-in-Human Trial for PBI-0451, an Oral Antiviral in Development to Treat & Prevent SARS-CoV-2 Infections
Pardes Biosciences, Inc. recently announced the initiation of a Phase 1 clinical trial, evaluating the company’s lead candidate, PBI-0451 which is being developed as a potential oral….
Fusion Antibodies Partners With Eurofins Discovery to Support Innovative Preclinical Drug Discovery Research
Fusion Antibodies plc recently announced it has entered into a commercial collaboration with Eurofins, a Eurofins Scientific SE (EUFI.PA) group company; a leading provider of products and services to the….
Adhera Therapeutics Signs Exclusive License Agreement With Melior Pharmaceuticals I for New Type 1 Diabetes Drug Candidate
Adhera Therapeutics, Inc. recently announced it has executed an exclusive license agreement with Melior Pharmaceuticals I, Inc. defining the terms and conditions for which Adhera will license MLR-1023….
Poseida Therapeutics Announces FDA Clearance of IND Application for Allogeneic CAR-T Candidate for Relapsed/Refractory Multiple Myeloma
Poseida Therapeutics, Inc. recently announced the US FDA has cleared its Investigational New Drug (IND) application for P-BCMA-ALLO1, the company's first fully allogeneic CAR-T product…
Nuvectis Pharma Raises $15 Million & In-Licenses Exclusive Worldwide Rights to Novel Selective HSF1 Pathway Inhibitor From the CRT Pioneer Fund
Nuvectis Pharma, Inc. recently announced the completion of a $15-million Series A Preferred Stock financing with institutional and private investors. Nuvectis also announced that it…
