Market News & Trends
Sterling Pharma Solutions Expands Global API Manufacturing Capabilities With Acquisition of Novartis Facility
Sterling Pharma Solutions recently announced it had reached agreement with Novartis to acquire its Ringaskiddy campus (Novartis Ringaskiddy Limited), near Cork, Ireland. Financial details of…
Catalent & TFF Pharmaceuticals Announce New Inhalation Dry Powder Development & Manufacturing Agreement
Catalent and TFF Pharmaceuticals, Inc. recently announced their collaboration agreement focused on the generation, testing, and manufacture of dry powder formulations for a range of…
Editas Medicine Announces Favorable Decision From US PTO in CRISPR Patent Interference
Editas Medicine, Inc. recently announced the USPTO issued another favorable decision to the Broad Institute, Inc. (Broad) involving specific patents for CRISPR/Cas9 editing in human…
CDMOs Need to be Prepared for the Revision of the EU-GMP-Annex 1
Annex 1 of the EU-GMP-Guide Manufacture of Sterile Medicinal Products is considered the most important European regulatory standard for the manufacture of sterile pharmaceutical products. The current revision will have to….
After 25 Years, There is a CEO Transition at Hovione!
Hovione recently announced the Board of Directors and the shareholders have approved the appointment of Dr. Jean-Luc Herbeaux as Hovione’s Chief Executive Officer, effective….
Santhera Signs Gene Therapy Agreement With SEAL Therapeutics
Santhera recently entered into an agreement with SEAL Therapeutics, a spin-off company from the Biozentrum of the University of Basel, which will further develop a….
Durable & Deepening Clinical Responses Observed in Post-Treatment Period of Evelo Bioscience’s Phase 2 Clinical Trial
Evelo Biosciences, Inc. recently announced data from the post-treatment follow-up (Part B) of its Phase 2 trial of EDP1815 in mild and moderate psoriasis, which…
Genevant Sciences & Arbutus Biopharma File Patent Infringement Lawsuit Against Moderna
Genevant Sciences and Arbutus Biopharma Corporation recently filed a lawsuit in the US District Court for the District of Delaware against Moderna, Inc. and an…
Vallon Pharmaceuticals Announces Issuance of US Patent Covering ADAIR for the Treatment of Cognitive Impairment Associated With COVID-19
Vallon Pharmaceuticals, Inc. recently announced the United States Patent and Trademark Office (USPTO) has issued patent No. 11,253,490 covering the use of its proprietary investigational…
TFF Pharmaceuticals Announces Inhaled Niclosamide Significantly Inhibits Viral Replication of the Omicron Variant of SARS-CoV-2
TFF Pharmaceuticals, Inc. recently announced that results from its recently completed in vitro neutralization and viral replication assays indicate that the company’s inhaled niclosamide product candidate completely….
Vaxart’s S-Only COVID-19 Vaccine Candidate Produces Strong-Cross Reactive Mucosal & Systemic Immune Responses in Non-Human Primates
A new study published on BioRxiv.org demonstrates that Vaxart’s S-only COVID-19 clinical vaccine candidate, now being studied by Vaxart in Phase 2 trials, generated antibodies…
BioDelivery Sciences International Announces ELYXYB is Now Available in the US for the Acute Treatment of Migraine
BioDelivery Sciences International, Inc. recently announced the US commercial launch and availability of ELYXYB (celecoxib oral solution), the first and only FDA-approved ready-to-use oral solution…
HiberCell Initiates its Phase 1a/b Clinical Trial in Patients With Advanced Solid Tumors
HiberCell has recently initiated a Phase 1a/b clinical trial of HC-7366, a first-in-class selective, orally bioavailable modulator of General Control Nonderepressible 2 (GNC2) for the…
Cyclerion Therapeutics & Ariana Pharma Announce Artificial Intelligence-Driven Precision Medicine Collaboration
Cyclerion Therapeutics, Inc. and Ariana Pharma recently announced an artificial intelligence-driven, precision medicine collaboration. This collaboration is expected to identify biomarkers of response to refine…
Recce Pharmaceuticals Announces Final Subjects Dosed in Third Cohort of Phase 1 Clinical Trial
Recce Pharmaceuticals Ltd recently reported the final three subjects of cohort three at 500mg have been intravenously dosed in the Phase 1 intravenous (IV) clinical…
Rani Therapeutics Unveils High-Capacity RaniPill Device for Oral Delivery of Biologics
Rani Therapeutics Holdings, Inc. recently announced the development of a high-capacity oral biologics device known as the RaniPill HC (High Capacity), capable of delivering up to….
BrainsWay Announces Results Demonstrating Efficacy of Deep TMS in Treating Anxiety Symptoms Comorbid to Depression
BrainsWay Ltd. recently announced the publication of results in the Journal of Clinical Medicine further defining the efficacy of the company’s proprietary Deep TMS treatment…
Moderna Initiates Phase 3 Portion of Pivotal Trial for mRNA Respiratory Syncytial Virus Vaccine Candidate
Moderna, Inc. recently announced the Data and Safety Monitoring Board (DSMB) for the RSV program has endorsed the start of the Phase 3 portion of…
Supernus Receives Notice Assigning Early October 2022 PDUFA for SPN-830 Apomorphine Infusion Device NDA
Supernus Pharmaceuticals, Inc. recently announced it received notice from the US FDA that the company’s New Drug Application (NDA) resubmission for its apomorphine infusion device…
Poseida Therapeutics Appoints New President, Gene Therapy
Poseida Therapeutics, Inc. recently announced Brent Warner has joined the company as President, Gene Therapy, effective February 21, 2022. “Brent brings deep pharmaceutical expertise and…
