Market News & Trends
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…
PolyPid Announces Positive Preclinical Data of its Intra-Tumoral OncoPLEX in Brain Cancer
PolyPid Ltd. recently announced positive preclinical data in two key Glioblastoma Multiform (GBM) animal models of its OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes the…
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…
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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)….