[{"company":"Pacira BioSciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pacira Announces Publication of Phase 4 Study of EXPAREL in Cesarean Section Procedures in Anesthesia & Analgesia","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Pacira BioSciences"},{"company":"Novartis Pharmaceuticals Corporation","sponsor":"Amgen Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis' Phase IV Study Showed Superior Tolerability and Efficacy of Aimovig\u00ae Compared to Topiramate in Migraine Prevention","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Novartis Pharmaceuticals Corporation"},{"company":"Ipsen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Analyses of Pivotal Phase III Trial Data Highlight Long Duration of Response for Dysport\u00ae in Five Therapeutic Indications","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Ipsen"},{"company":"Merck & Co. Inc.","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data Presented at ACTRIMS Forum 2021 Indicate MAVENCLAD\u00ae-treated RMS Patients Mount Protective Antibody Response to Common Vaccines","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Merck & Co. Inc."},{"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis To Present Broad Range of Portfolio Data At ECTRIMS, Reinforcing Long-Standing Commitment to People Living with Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Novartis Pharmaceuticals Corporation"},{"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kesimpta\u00ae (ofatumumab) Data at ECTRIMS Highlights Preservation of Ig G Levels and Safety Experience Over Extended Exposure (~3.5 Years) in People Living with Relapsing Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Novartis Pharmaceuticals Corporation"},{"company":"Eli Lilly","sponsor":"Biohaven Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Emgality\u00ae Versus Nurtec\u00ae ODT Head-to-Head Migraine Preventive Treatment Study Now Enrolling Patients","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Eli Lilly"},{"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Update on the Phase 4 Confirmatory Study of ADUHELM\u00ae","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Biogen"},{"company":"Biogen","sponsor":"Eisai","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Update on the Phase 4 ENVISION Confirmatory Study of ADUHELM\u00ae","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"January 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Biogen"},{"company":"Merck Group","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New MAVENCLAD\u00ae Data at ACTRIMS Forum 2022 Show Favourable Efficacy Outcomes Versus Other Oral DMTs and Lower Occurrence of Further Relapses or Disability Progression","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Merck Group"},{"company":"Baudax Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Baudax Bio Initiates Phase IV Clinical Trial Evaluating ANJESO\u00ae in Pediatric Patients Following Surgery","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Baudax Bio"},{"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biogen Submits Final Protocol for ADUHELM\u00ae (aducanumab-avwa) Phase 4 ENVISION Trial to FDA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Biogen"}]
Details:
The confirmatory ENVISION trial is a requirement based on FDA’s accelerated approval of ADUHELM® (aducanumab-avwa), a monoclonal antibody directed against amyloid beta, 100 mg/mL injection for intravenous use in early Alzheimer’s disease.
Lead Product(s):
Aducanumab
Therapeutic Area: Neurology
Product Name: Aduhelm
Highest Development Status: Phase IV
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 30, 2022
Details:
Anjeso (meloxicam) injection, a preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory, and antipyretic activities, which are believed to be related to the inhibition of COX-2 and subsequent reduction in prostaglandin biosynthesis.
Lead Product(s):
Meloxicam
Therapeutic Area: Neurology
Product Name: Anjeso
Highest Development Status: Phase IV
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 08, 2022
Details:
New real-world data show MAVENCLAD® (cladribine tablets) had lower annualised relapse rates and longer time to first relapse and time to switch than fingolimod, dimethyl fumarate and teriflunomide in relapsing multiple sclerosis patients.
Lead Product(s):
Cladribine
Therapeutic Area: Neurology
Product Name: Mavenclad
Highest Development Status: Phase IV
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 24, 2022
Details:
ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
Lead Product(s):
Aducanumab
Therapeutic Area: Neurology
Product Name: Aduhelm
Highest Development Status: Phase IV
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Eisai
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
January 27, 2022
Details:
The accelerated approval of ADUHELM in the United States has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit.
Lead Product(s):
Aducanumab
Therapeutic Area: Neurology
Product Name: Aduhelm
Highest Development Status: Phase IV
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
December 16, 2021
Details:
The study is evaluating once-monthly Emgality® (galcanezumab-gnlm) injection compared to Nurtec® ODT (rimegepant), a tablet patients take every other day, on patient-centric measures, including reductions in monthly migraine headache days and quality of life improvement.
Lead Product(s):
Galcanezumab
Therapeutic Area: Neurology
Product Name: Emgality
Highest Development Status: Phase IV
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Biohaven Pharmaceuticals
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
November 18, 2021
Details:
Kesimpta is a targeted B-cell therapy that delivers superior efficacy with a similar safety and tolerability profile compared with teriflunomide, a first-line treatment in multiple sclerosis (MS).
Lead Product(s):
Ofatumumab,Tetanus Toxoid Vaccine,13-valent Pneumococcal Conjugate Vaccine
Therapeutic Area: Neurology
Product Name: Kesimpta
Highest Development Status: Phase IV
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
October 14, 2021
Details:
Ofatumumab is an anti-CD20 IgG1κ human monoclonal antibody used for treatment for chronic lymphocytic leukemia and relapsing forms of multiple sclerosis (MS).
Lead Product(s):
Ofatumumab
Therapeutic Area: Neurology
Product Name: Kesimpta
Highest Development Status: Phase IV
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
October 07, 2021
Details:
MAGNIFY-MS retrospective analysis demonstrates patients develop protective antibody levels for at least six months following seasonal influenza and varicella zoster vaccines, irrespective of vaccine timing relative to MAVENCLAD dosing.
Lead Product(s):
Cladribine
Therapeutic Area: Neurology
Product Name: Mavenclad
Highest Development Status: Phase IV
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 25, 2021
Details:
Analyses of pivotal study data of Dysport® reveal a large proportion of study patients did not require retreatment for at least 12 weeks (and at least 16 weeks for pediatric upper limb spasticity).
Lead Product(s):
Botulinum toxin type A
Therapeutic Area: Neurology
Product Name: Dysport
Highest Development Status: Phase IV
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
January 15, 2021
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