Small Molecules

20 Feb 2019 BeiGene Initiates Global Phase 2 Trial of Zanubrutinib in Patients with Relapsed or Refractory Marginal Zone Lymphoma
20 Feb 2019 Reata Announces Positive Phase 2 Data for Bardoxolone Methyl in Patients with Focal Segmental Glomerulosclerosis and in Patients From All Four Cohorts of PHOENIX
20 Feb 2019 AbbVie Announces New Drug Application Accepted for Priority Review by U.S. FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis
20 Feb 2019 Inventiva Announces Results from Phase IIb Clinical Trial with Lanifibranor in Systemic Sclerosis
20 Feb 2019 Vical to Discontinue Clinical Development of VL-2397 as it Considers Near Term Strategic Alternatives
20 Feb 2019 Intercept Announces Positive Topline Results from Pivotal Phase 3 REGENERATE Study of Obeticholic Acid in Patients with Liver Fibrosis Due to NASH
19 Feb 2019 Saniona Tesomet Phase 2a Prader-Willi syndrome trial update
19 Feb 2019 FDA Grants Priority Review to Genentech’s Personalized Medicine Entrectinib
18 Feb 2019 Bayer to obtain full rights to global development and commercialization of oncology compounds Vitrakvi® (larotrectinib) and BAY 2731954 (LOXO-195)
18 Feb 2019 CymaBay Therapeutics Announces Seladelpar Granted Breakthrough Therapy Designation by the FDA for the Treatment of Primary Biliary Cholangitis
18 Feb 2019 Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL747 for Alzheimer’s Disease
15 Feb 2019 Bayer's investigational drug darolutamide plus androgen deprivation therapy (ADT) significantly extends metastasis-free survival compared to placebo plus ADT in non-metastatic castration-resistant prostate cancer
14 Feb 2019 Boehringer Ingelheim and Lilly announce the CAROLINA cardiovascular outcome trial of Tradjenta met its primary endpoint of non-inferiority compared with glimepiride
14 Feb 2019 Lipocine Inc. Announces FDA Clearance of IND to Commence Phase 2 Study of LPCN 1144 in Biopsy Confirmed NASH Subjects
14 Feb 2019 Janssen Announces Preliminary Results from Phase 2 GALAHAD Study in Adults with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Pathway Defects (DRD)
14 Feb 2019 Addex and Indivior to Accelerate Additional GABAB PAM Compounds for Addiction as Indivior Elects to Stop Development of ADX71441
14 Feb 2019 Positive Phase 3 Study for Tezacaftor/Ivacaftor Combination in Children Aged 6-11 Years with Cystic Fibrosis Supports European Medicines Agency Submission
14 Feb 2019 Debiopharm International SA Initiates FUZE, a Clinical Trial Phase II Study Evaluating Debio 1347 in Advanced Solid Tumors Harboring an FGFR fusion
14 Feb 2019 Motif Bio Receives Complete Response Letter from the FDA
14 Feb 2019 Lundbeck and Otsuka report phase III data evaluating brexpiprazole for the treatment of manic episodes associated with bipolar I disorder
14 Feb 2019 Novartis receives FDA approval for Egaten® for the treatment of fascioliasis, a neglected tropical disease
13 Feb 2019 Exelixis to Initiate Phase 1 Clinical Development of XL092, First New Compound to Enter the Clinic from Reinitiated Discovery Efforts
13 Feb 2019 Sojournix Announces Positive Top-Line Phase 1 Data Demonstrating Clinical Proof of Mechanism and Once-Daily (QD) Pharmacokinetics for SJX-653
13 Feb 2019 Summit Doses First Patient in Phase 3 Clinical Trials of Precision Antibiotic Ridinilazole for C. Difficile Infection
12 Feb 2019 IntraBio Investigational New Drug Application Approved by the FDA for the Treatment of Tay-Sachs and Sandhoff Disease

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