All The Most Important Pharmaceutical News Stories Of The Week – May 2018 – Week #2
Kymriah® (tisagenlecleucel), first-in-class CAR-T therapy from Novartis, receives second FDA approval to treat appropriate r/r patients with large B-cell lymphoma
May 1, 2018
Novartis has announced that the US Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication – the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Kymriah is not indicated for the treatment of patients with primary central nervous system lymphoma. Kymriah, developed in collaboration with the University of Pennsylvania, became the first chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in August 2017 for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Kymriah is now the only CAR-T cell therapy to receive FDA approval for two distinct indications in non-Hodgkin lymphoma (NHL) and B-cell ALL.
May 2, 2018
Merck KGaA, has announced a development agreement for investigational molecule abituzumab with SFJ Pharmaceuticals Group (SFJ), a US-based company focused on increasing R&D output and productivity through innovative models. In a novel innovation model recently emerging in the biopharma industry, SFJ will finance and also be responsible for Phase II/III development of abituzumab. The agreement reflects Merck’s strategic approach to collaborations, identifying those opportunities that can progress the company’s highly promising clinical stage assets through novel innovation models.
Mavenclad (Cladribine Tablets) Data in Multiple Sclerosis Journal Show an Even Greater Treatment Effect in Patients with Highly Active Multiple Sclerosis
May 2, 2018
Merck KGaA, today announced the Multiple Sclerosis Journal publication of data outlining the effects of MAVENCLAD® (cladribine tablets) treatment on two subgroups of patients with highly active relapsing multiple sclerosis (MS). These results reaffirm the clinical and radiological efficacy previously demonstrated with MAVENCLAD treatment in patients with relapsing MS.
May 2, 2018
Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has announced that it has entered into a definitive agreement under which it will acquire BeneVir Biopharm, Inc. (BeneVir), a privately-held, biopharmaceutical company specializing in the development of oncolytic immunotherapies. BeneVir utilizes a proprietary T-Stealth™ Oncolytic Virus Platform to engineer oncolytic viruses, tailored to infect and destroy cancer cells. Johnson & Johnson Innovation LLC facilitated the transaction.
May 3, 2018
Merck, known as MSD outside the United States and Canada, has announced that the pivotal Phase 3 KEYNOTE-407 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as first line treatment for metastatic squamous non-small cell lung cancer (sNSCLC) met a pre-specified secondary endpoint of overall response rate (ORR) in an early cohort of participants at an interim analysis. Based on these data, Merck has recently submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA).
U.S. FDA Approves Portola Pharmaceuticals’ Andexxa®, First and Only Antidote for the Reversal of Factor Xa Inhibitors
May 03, 2018
Portola Pharmaceuticals, Inc.® has announced that the U.S. Food and Drug Administration (FDA) has approved Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
May 3, 2018
Moderna Therapeutics and Merck, known as MSD outside the United States and Canada, have announced an expansion of their 2016 collaboration to develop and commercialize novel personalized messenger RNA (mRNA) cancer vaccines to now include shared antigen mRNA cancer vaccines including mRNA-5671, Moderna’s mRNA KRAS cancer vaccine.
Alnylam Achieves Alignment with FDA on Accelerated Development Path for Lumasiran, an Investigational RNAi Therapeutic for the Treatment of Primary Hyperoxaluria Type 1 (PH1)
May 3, 2018
Alnylam Pharmaceuticals, Inc., announced today that the Company has reached alignment with the U.S. Food and Drug Administration (FDA) on a pivotal study design for lumasiran, an investigational RNAi therapeutic for the treatment of primary hyperoxaluria type 1 (PH1). The Company and the FDA have aligned on a primary endpoint for the pivotal study based on reduction of urinary oxalate at six months, a biomarker directly linked to the pathophysiology of PH1 and known to be well correlated with disease progression. In addition, Alnylam and the FDA have aligned on a study size of approximately 25 patients with PH1. Based on the discussions with the FDA, the Company is on track to start the Phase 3 study in mid-2018.
New Phase 3 Data Show Esketamine Nasal Spray Demonstrated Rapid Improvements in Depressive Symptoms in Patients with Treatment-Resistant Depression
May 5, 2018
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the results from two Phase 3 clinical studies of the investigational compound esketamine nasal spray in patients with treatment-resistant depression. Data from a study in adults with treatment-resistant depression showed that flexibly dosed esketamine nasal spray plus a newly initiated oral antidepressant demonstrated a statistically significant, clinically meaningful rapid reduction of depressive symptoms as compared to placebo nasal spray plus a newly initiated oral antidepressant.
FDA grants priority review to Roche’s cancer immunotherapy TECENTRIQ (atezolizumab) for initial treatment of people with metastatic NSCLC
May 7, 2018
Roche has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ® (atezolizumab), in combination with Avastin® (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC). The FDA is expected to make a decision on approval by 5 September 2018. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.Top Pharma News of the Week – May 7th last edit: 2018-05-08T19:51:37+00:00 da