Clinical News-CliniExpert

Pulmatrix Receives Fast Track Designation for Pulmazole for the Treatment of Asthma-ABPA

LEXINGTON, Mass., Jan. 30, 2020 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PUR1900 ("Pul

Positive Topline Results Demonstrated by Olipudase Alfa, First and Only Investigational Therapy in Late-Stage Development for Acid Sphingomyelinase Deficiency

PARIS, Jan. 30, 2020 /PRNewswire/ -- Olipudase alfa, an investigational recombinant human acid sphingomyelinase, demonstrated positive results in two separate clinical trials evaluating olipudase alfa

Leronlimab Under Evaluation for Potential Treatment of Coronavirus

VANCOUVER, Washington, Jan. 28, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 anta

Fulcrum Therapeutics Receives Orphan Drug Designation for Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD) and Announces Expanded Patent Portfolio

CAMBRIDGE, Mass., Jan. 29, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically de

Incyte Announces that the TRuE-AD2 Pivotal Trial of Ruxolitinib Cream Met its Primary Endpoint in Patients with Atopic Dermatitis

WILMINGTON, Del.--(BUSINESS WIRE)--Jan. 28, 2020 -- Incyte (Nasdaq:INCY) today announced positive topline results from its randomized, vehicle-controlled, pivotal Phase 3 TRuE-AD2 study evaluating the

AstraZeneca to Recover the Global Rights to Brazikumab (MEDI2070) from Allergan

27 January 2020 -- AstraZeneca will recover the global rights to brazikumab (formerly MEDI2070), a monoclonal antibody targeting IL23, from Allergan. Brazikumab is currently in a Phase IIb/III program

BeiGene Announces that the Phase 3 Clinical Trial of its Anti-PD-1 Antibody Tislelizumab in Patients with First-Line Squamous Non-Small Cell Lung Cancer Met the Primary Endpoint of Progression-Free Survival at Interim Analysi

BEIJING, China, and CAMBRIDGE, Mass., Jan. 21, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializin

Rafael Pharmaceuticals Announces the Initiation of a Phase 1b/2 Clinical Trial of CPI-613® (devimistat) in Combination with Gemcitabine and Cisplatin in Patients with Biliary Tract Cancer

Cranbury, NJ, Jan. 21, 2020 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, announced today its col

Genentech’s Risdiplam Meets Primary Endpoint in Pivotal FIREFISH Trial in Infants With Type 1 Spinal Muscular Atrophy

South San Francisco, CA -- January 22, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive topline results from the pivotal Part 2 of the FIREFISH stu

Imfinzi and Tremelimumab Granted Orphan Drug Designation in the US for Liver Cancer

20 January 2020 -- AstraZeneca’s Imfinzi (durvalumab) and tremelimumab, an anti-CTLA4 antibody and potential new medicine, have both been granted Orphan Drug Designation (ODD) in the US for the treatm

Blueprint Medicines Announces Top-line Data for Pralsetinib and Initiates Rolling NDA Submission to FDA for the Treatment of Patients with RET Fusion-Positive Non-Small Cell Lung Cancer

CAMBRIDGE, Mass., Jan. 8, 2020 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherap

CStone Pharmaceuticals and Blueprint Medicines Initiate Phase 1b/2 Clinical Trial of Fisogatinib in Combination with CS1001 for Patients with Hepatocellular Carcinoma

SUZHOU, China and CAMBRIDGE, Mass., Jan. 6, 2020 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company focused on developing and commercializing immuno-o