[{"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avexis Receives EC Approval and Activates \u201cDay One\u201d Access Program for Zolgensma\u00ae, the only Gene Therapy for Spinal Muscular Atrophy","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Cell and Gene therapy","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Novartis Pharmaceuticals Corporation"},{"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Data Show Early Treatment with Mayzent\u00ae Show Benefits in Cognitive Performance in Patients with Secondary Progressive 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Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Announces U.S. Court of Appeals for the Federal Circuit (CAFC) Upholds Validity of GILENYA\u00ae (Fingolimod) Dosage Regimen Patent","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Novartis Pharmaceuticals Corporation"},{"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Peer-reviewed Safety and Tolerability Data Further Strengthens Kesimpta\u2019s (Ofatumumab) Favorable Benefit-risk Profile in Patients With Relapsing Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Approved","date":"March 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Details:
GILENYA (fingolimod) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.
Lead Product(s):
Fingolimod Hydrochloride
Therapeutic Area: Neurology
Product Name: Gilenya
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
September 21, 2022
Details:
New data from study showed that after four years nearly 8 out of 10 of people with RMS, treated continuously with Kesimpta® (ofatumumab) had no evidence of disease activity compared with 5 out of 10 of those who switched to Kesimpta at later date after teriflunomide treatment.
Lead Product(s):
Ofatumumab
Therapeutic Area: Neurology
Product Name: Kesimpta
Highest Development Status: Approved
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Genmab
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 27, 2022
Details:
Gilenya® (fingolimod), an oral, once-daily at 0.5mg and 0.25mg versus once-daily subcutaneous injections of glatiramer acetate 20mg in reducing disease activity over 12 months in patients with relapsing remitting multiple sclerosis (RRMS).
Lead Product(s):
Fingolimod Hydrochloride
Therapeutic Area: Neurology
Product Name: Gilenya
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 21, 2022
Details:
Phase 3 ASCLEPIOS I/II trials and the ALITHIOS open-label extension demonstrated the efficacy and safety of continuous Kesimpta® (ofatumumab) treatment and in those switched from teriflunomide, with no new safety risks identified over the treatment period.
Lead Product(s):
Ofatumumab
Therapeutic Area: Neurology
Product Name: Kesimpta
Highest Development Status: Approved
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 05, 2022
Details:
Analysis demonstrated positive effects of OCREVUS on cognition, with 70% of patients having improved cognition, as measured with SDMT. Clinically meaningful improvement was observed in 34% of patients treated with OCREVUS and worsening in 30% of patients treated with OCREVUS.
Lead Product(s):
Ocrelizumab
Therapeutic Area: Neurology
Product Name: Ocrevus
Highest Development Status: Approved
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 04, 2022
Details:
OCREVUS (ocrelizumab), a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage.
Lead Product(s):
Ocrelizumab
Therapeutic Area: Neurology
Product Name: Ocrevus
Highest Development Status: Approved
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Genentech
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 25, 2022
Details:
The overall fatal outcome (0.8%) and hospitalization rates (9.4%) due to COVID-19 in Kesimpta, a targeted, precisely dosed and delivered B-cell therapy-treated patients were lower than the rates reported in the overall MS population.
Lead Product(s):
Ofatumumab
Therapeutic Area: Neurology
Product Name: Kesimpta
Highest Development Status: Approved
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 18, 2022
Details:
Multiple Sclerosis Journal has published data from the ALITHIOS open-label extension study which provide a robust picture of continuous safety data for Kesimpta, showing it was well tolerated in ~2000 patients with up to 3.5 years exposure with no new safety risks identified.
Lead Product(s):
Ofatumumab
Therapeutic Area: Neurology
Product Name: Kesimpta
Highest Development Status: Approved
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 02, 2022
Details:
PIVLAZ (clazosentan sodium), a selective endothelin A receptor antagonist received Japanese PMDA approval on the basis of statistically significant result from the Japanese Phase 3 program for the prevention of cerebral vasospasm after subarachnoid hemorrhage treatment.
Lead Product(s):
Clazosentan Sodium
Therapeutic Area: Neurology
Product Name: Pivlaz
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
January 20, 2022
Details:
HEC Pharma filed the ANDA to get generic version of Novartis' Gilenya® (fingolimod), in response to that Novartis filed litigation against ANDA filers for US Patent No. 9,187,405 and extend the validity of Gilenya till 2027.
Lead Product(s):
Fingolimod Hydrochloride
Therapeutic Area: Neurology
Product Name: Gilenya
Highest Development Status: Approved
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
January 04, 2022
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