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Agios announces publication of Tibsovo phase III data in The Lancet Oncology demonstrating significant improvement in progression-free survival in previously treated IDH1-mutant cholangiocarcinoma patients.

Written by | 20 May 2020

Agios Pharmaceuticals, Inc. announced that The Lancet Oncology has published data from its global Phase III ClarIDHy study of Tibsovo (ivosidenib) in previously treated cholangiocarcinoma patients with an… read more.

Results of GERAS-US Study shows societal cost burden for early stages of Alzheimer’s disease.- Eli Lilly

Written by | 20 May 2020

Eli Lilly and Company announced baseline results from the GERAS-US Study examining the societal costs associated with mild cognitive impairment (MCI), mild dementia (MILD), and caring for someone… read more.

Adamis Pharmaceuticals resubmits NDA for Zimhi for the treatment of opioid overdose..

Written by | 19 May 2020

Adamis Pharmaceuticals Corporation announced the resubmission of the Company’s New Drug Application (“NDA”) to the FDA for its Zimhi (naloxone HCI Injection, USP) 5mg/0.5mL product candidate for the… read more.

Phase III clinical study of JTA 004 commences to reduce osteoarthritis pain in the knee.- Bone Therapeutics

Written by | 18 May 2020

Bone Therapeutics announces it has commenced treating the first patients for the pivotal JTA 004 phase III clinical study in Hong Kong SAR. Several clinical trial sites in… read more.

Phase III clinical study of JTA 004 commences to reduce osteoarthritis pain in the knee.- Bone Therapeutics

Written by | 18 May 2020

Bone Therapeutics announces it has commenced treating the first patients for the pivotal JTA 004 phase III clinical study in Hong Kong SAR. Several clinical trial sites in… read more.

FDA provide complete response letter for Ayvakit in fourth-line gastrointestinal stromal tumor.- Blueprint Medicines

Written by | 16 May 2020

Blueprint Medicines announced that the FDA has issued a complete response letter (CRL) for the new drug application of Ayvakit (avapritinib) for the treatment of adults with unresectable… read more.

PTI 125 did not meet its primary endpoint in a phase IIb study for Alzheimer’s disease.- Cassava Sciences

Written by | 16 May 2020

Cassava Sciences, Inc. reported top-line results from a Phase IIb study of PTI 125, its lead investigational drug, in patients with Alzheimer’s disease. This study did not meet… read more.

Phase III SEER-1 trial of RGN 259 shows efficacy in neurotrophic keratopathy.- ReGenTree + RegeneRx Biopharma

Written by | 16 May 2020

ReGenTree, a U.S. joint venture company owned by GtreeBNT Co. and RegeneRx Biopharmaceuticals, announced the results of a randomized, double masked, placebo-controlled Phase III clinical trial (SEER-1) using… read more.

FDA approves Opdivo + Yervoy for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L.- BMS

Written by | 16 May 2020

Bristol Myers Squibb announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the FDA for the first-line treatment of… read more.

FDA grants priority review of sutimlimab, potential first approved treatment of hemolysis for cold agglutinin disease.- Sanofi

Written by | 15 May 2020

The FDA has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). Sutimlimab,… read more.

FDA grants priority review of sutimlimab, potential first approved treatment of hemolysis for cold agglutinin disease.- Sanofi

Written by | 15 May 2020

The FDA has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). Sutimlimab,… read more.

Pfizer announces positive top-line results from phase III Lot Consistency Study of 20-Valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age

Written by | 15 May 2020

Pfizer Inc. announced top-line results from a second Phase 111 study (NCT03828617), which described the safety and evaluated the consistency of immune responses elicited across three different lots… read more.

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