Pharmaceuticals, Biotechnology and Life Sciences
AgeneBio has enrolled its first out of 830 patient in a Phase 3 clinical trial of its investigational medication AGB101, to treat amnestic Mild Cognitive Impairment due to Alzheimer’s Disease (MCI due to AD).
Announcing the approval of Teva’s Sabril generic tablets, FDA Commissioner, Scott Gottlieb said that prioritizing the approval of generic drugs to compete with medicines that face little or no competition is the Agency’s key part of efforts to support access and reduce drug costs to patients.
PledPharma will present its “first in class” drug candidate PledOx phase III program at the Gastrointestinal (GI) Cancers Symposium, taking place in San Francisco today and tomorrow.
Actelion Pharmaceuticals will need to provide more data to evaluate the use of Opsumit in the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension.
Roche will wait until September 2019 for the FDA’s decision, before it can combine Tecentriq with Abraxane and carboplatin for the first-line treatment of lung cancer patients, who don’t have EGFR or ALK genomic tumour aberrations.
Innovent Biologics has started testing on patients its Tyvyt, fully human anti-PD-1 therapeutic monoclonal antibody, with generic name sintilimab injection, in combination with capecitabine and oxaliplatin, patients with advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma (GC or GEJ).
Aquinnah Pharmaceuticals got $750,000 from the Tau Pipeline Enabling Program (T-PEP) to advance its drug development programs in tauopathy diseases.
Geron Corporation has included the first of several key leadership positions in rebuilding its in-house development team to boost a Phase 3 clinical trial of imetelstat in lower risk myelodysplastic syndromes by mid-year 2019.
Neurocrine Biosciences, published a new analysis of Ingrezza (valbenazine) capsules, in the Journal of Affective Disorders, pointing out improvement in tardive dyskinesia (TD) symptoms in patients with primary mood disorders, with no clinically meaningful changes to psychiatric stability.
ADC Therapeutics, oncology drug specialist started the Phase I clinical testing ADCT-601 on patients with selected solid tumors that are locally advanced or metastatic.