Formulation Development
VERAXA Biotech & Indivumed Cooperate on the Development of Precision Oncology Antibody
VERAXA Biotech GmbH, Heidelberg, and Indivumed GmbH, Hamburg, recently announced their agreement to jointly discover modulatory and functional antibodies against several targets that are relevant for….
Daré Bioscience Announces FDA Acceptance & Priority Review of NDA for DARE-BV1 for the Treatment of Bacterial Vaginosis
Daré Bioscience, Inc. recently announced the US FDA accepted for filing the company’s New Drug Application (NDA) for DARE-BV1 for the treatment of bacterial vaginosis…..
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)….
ARCA biopharma Announces Submission of PCT Patent Application for the Treatment of COVID-19 Infection & Associated Coagulopathy With rNAPc2
ARCA biopharma, Inc. recently announced it has submitted a Patent Cooperation Treaty (PCT) patent application, following on previously submitted provisional patent applications, for the use…
Catalent to Supply Edenbridge Pharmaceuticals With a Fast-Dissolve Zydis Formulation of Glycopyrrolate Intended as Adjunctive Therapy for Patients With Peptic Ulcer
Catalent recently announced it has signed a commercial supply agreement with Edenbridge Pharmaceuticals, LLC, for a novel formulation of glycopyrrolate using Catalent’s proprietary Zydis orally…
Aravive Announces First Patient Dosed in Phase 1b/2 Clinical Trial of AVB-500 for the Treatment of Pancreatic Adenocarcinoma
Aravive Inc. recently announced it has dosed the first patient in the Phase 1b portion of its Phase 1b/2 trial of AVB-500 in combination with…
Fulcrum Therapeutics Announces Positive Interim Results from Phase 1 Healthy Adult Volunteer Study of FTX-6058 for Sickle Cell Disease
Fulcrum Therapeutics, Inc. recently announced positive interim results from the ongoing single- and multiple-ascending dose (SAD and MAD) Phase 1 trial with FTX-6058 in healthy…
Apollomics Doses First Patient in a Phase 1 Clinical Trial of APL-102
Apollomics Inc. recently announced the successful dosing of the first patient in a Phase 1 clinical study of APL-102 in patients with advanced solid tumors.…
Evonik Acquires JeNaCell to Expand Biomaterials Portfolio for New Medical Device Markets
Evonik has acquired German biotech company JeNaCell. The acquisition expands Evonik’s biomaterials portfolio to provide biotechnologically derived cellulose. The nature-identical material developed by….
DisperSol & Catalent Collaborate to Establish KinetiSol Technology Manufacturing Hub for DisperSol Pharmaceutical Pipeline
DisperSol Technologies and Catalent recently announced a strategic manufacturing collaboration to accelerate the development of multiple DisperSol pharmaceutical products…..
Carrick Therapeutics Announces Collaboration With Roche to Evaluate Novel Samuraciclib Combination to Treat HR+ Breast Cancer
Carrick Therapeutics recently announced a clinical collaboration with Roche to evaluate a novel combination of Carrick’s samuraciclib and Roche’s giredestrant in CDK4/6i resistant HR+, HER2-…
Pacira Announces FDA Approval of Enhanced EXPAREL Manufacturing Process
Pacira BioSciences, Inc. recently announced the US FDA has approved the company’s enhanced manufacturing process for EXPAREL (bupivacaine liposome injectable suspension) which is housed at…
Mustang Bio Receives European Medicines Agency PRIME Designation for MB-107 to Treat X-Linked Severe Combined Immunodeficiency in Newly Diagnosed Infants
Mustang Bio, Inc. recently announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to MB-107, its lentiviral gene therapy for the…
Croda Expands its High Purity Pharmaceutical Excipients Manufacturing Capability
Croda Inc. officially opened its newly expanded pharmaceutical excipients facility with a ribbon cutting celebration. The event, led by Mill Hall Site Director Robert Strouse,…
Biogen Announces Results from Phase 3b NOVA Study Evaluating Every 6-Week Dosing With Natalizumab in Relapsing-Remitting Multiple Sclerosis
Biogen Inc. recently announced results from the 2-year prospective, randomized, interventional, controlled, open-label Phase 3b NOVA study (NCT03689972). NOVA was designed to estimate a potential…
Lumosa Therapeutics Announces Positive Results From LT3001 Phase 2a Clinical Trial in Acute Ischemic Stroke
Lumosa Therapeutics recently announced its Phase 2a clinical trial of LT3001 successfully met its primary safety endpoint. Further, efficacy showed potential for improvements in neurological…
Pace Life Sciences Acquires Drug Delivery Experts, Expanding Capacity & Injectable Drug Product Services
Pace Analytical Life Sciences, LLC, a subsidiary of Pace Analytical Services, LLC, a full-service contract development and manufacturing organization (CDMO), recently announced it has acquired Drug Delivery Experts, LLC (DDE)…..
CatSci & Argonaute RNA Partner to Expedite Oligonucleotide Manufacturing for Gene-Silencing Therapeutics
CatSci Ltd and Argonaute RNA recently announced a chemistry, manufacturing, and control (CMC) development collaboration focused on novel therapeutic oligonucleotides…..
Lantern Pharma & Allarity Therapeutics Enter Into Agreement for Future Clinical Development of Irofulven
Allarity Therapeutics A/S and Lantern Pharma Inc. recently announced they have entered into an exclusive agreement under which Lantern will reacquire global rights to Irofulven (LP-100) and assume full….
Organon & ObsEva Enter Global Development & Commercialization License Agreement
Organon and ObsEva recently announced they have entered into an agreement whereby Organon will license the global development, manufacturing, and commercial rights to ebopiprant….
