Market News & Trends
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…
Sensirion Expands its Flow Sensor Portfolio for Ventilators
Sensirion, the sensor expert for medical ventilation and the world’s leading manufacturer of flow sensors, is expanding its product portfolio for the MD&M West 2021…
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.…
Metrics Contract Services Expands With New Suites & Equipment
Metrics Contract Services (Metrics), a full-service global contract development and manufacturing organization (CDMO), has recently expanded its novel oral solid dose commercial facility in Greenville, NC, adding 3,760….
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….
Pharmaceutics International, Inc. to Platform West Pharmaceutical Services, Inc.’s Daikyo Crystal Zenith Container-Closure Components for Aseptic Fill-Finish
Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization (CDMO) will include Daikyo Crystal Zenith (CZ) container-closure components, offered by West Pharmaceutical Services, Inc…..
Syneos Health & Aetion Partner to Offer RWE Solutions to Advance Drug Development & Commercialization
Syneos Health and Aetion recently announced a partnership to provide regulatory-grade data and analytics-driven solutions to advance drug development and improve patient outcomes….
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…
BIMI International Medical Inc. Enters Into A MOU to Acquire Chongqing Zhuoda Pharmaceutical
BIMI International Medical Inc. recently announced the signing of a Memorandum of Understanding (MOU) on July 30, 2021 to acquire Chongqing Zhuoda Pharmaceutical Co, Ltd.…
