Phase III
Alkermes, headquartered in Dublin, announced positive topline data from ENLIGHTEN-2, its pivotal Phase III trial of ALKS 3831 (olanzapine/samidorphan) for schizophrenia.
Acacia Pharma Group plc announces that data and analyses from its positive Phase 3 clinical trial of BARHEMSYS™ have been published (Habib et al1) in the online edition of the leading peer-reviewed journal Anesthesiology, the official publication of the American Society of Anesthesiologists.
Vertex Pharmaceuticals announced that two Phase III clinical trials of its triple combination of VX-659, tezacaftor and ivacaftor met their primary endpoint in cystic fibrosis (CF).
Clinical trial authorizations received in all 6 participating countries
Promore Pharma AB, a Swedish biopharmaceutical developer of therapeutic peptides, today announced that the Drug Controller General in India (DCGI) has approved the company’s application to start a clinical Phase III study with PXL01 to prevent post-surgical adhesions after tendon repair surgery.
Vectura was studying VR475, a drug-device combination consisting of budesonide delivered by Vectura’s proprietary nebulizer inhalation system as a treatment for adolescent and adult patients with severe uncontrolled asthma.
The company and the agency discussed the development of SYN-004 (ribaxamase) to prevent antibiotic-mediated Clostridium difficile infection (CDI).
David Johnston, the former chief financial officer of AVEO Oncology, was found guilty of misleading investors about the company’s kidney cancer drug, Tivozanib. Under new leadership, AVEO aims to seek U.S. approval for its kidney cancer drug early next year.
‘Hemophilia: The Musical’ allows teens to share their experiences with the genetic disease.
Denmark-based LEO Pharma and California rare disease drugmaker PellePharm entered into a strategic collaboration worth $760 million to address unmet needs in multiple orphan skin diseases, such as Gorlin Syndrome and High-Frequency Basal Cell Carcinomas (BCCs), two rare forms of skin cancer.
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