[{"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves GSK\u2019s BENLYSTA As the First Medicine for Adult Patients with Active Lupus Nephritis in the US","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"GSK"},{"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GSK Receives European Approval for Expanded Use of Benlysta to Treat Adult Patients with Active Lupus Nephritis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"GSK"},{"company":"EirGen Pharma","sponsor":"Horizon Therapeutics","pharmaFlowCategory":"D","amount":"$65.0 million","upfrontCash":"$65.0 million","newsHeadline":"Horizon Therapeutics plc Announces Purchase of Manufacturing Facility to Support Growth of On-Market Rare Disease and Pipeline Biologics","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"EirGen Pharma"},{"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lupus Research Alliance Applauds U.S. FDA Approval of AstraZeneca's anifrolumab-fnia (Saphnelo\u2122) for Systemic Lupus Erythematosus (SLE)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"August 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"AstraZeneca"},{"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"SAPHNELO (anifrolumab) Approved in the US for Moderate to Severe Systemic Lupus Erythematosus","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"August 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"AstraZeneca"},{"company":"Stallergenes Greer","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Stallergenes Greer Receives Market Approval in Austria for Its Sublingual Allergen Immunotherapy Tablet for Household Mite Allergy","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Stallergenes Greer"},{"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saphnelo Recommended for Approval in The EU by CHMP for The Treatment of Patients with Systemic Lupus Erythematosus","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"AstraZeneca"},{"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"China\u2019s National Medical Products Administration Approves Benlysta (belimumab) for Adult Patients with Active Lupus Nephritis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"GSK"},{"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saphnelo Approved in The EU for The Treatment of Moderate to Severe Systemic Lupus Erythematosus","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"AstraZeneca"},{"company":"AstraZeneca","sponsor":"Alexion Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ultomiris Recommended for Approval in the EU by CHMP for the Treatment of Adults with Generalised Myasthenia Gravis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"AstraZeneca"},{"company":"Arecor","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Arecor Granted European Patents Protecting Proprietary Formulations of High Concentration Humira\u00ae Biosimilar","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Biosimilar","date":"August 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Arecor"},{"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ultomiris Approved in Japan for the Treatment of Adults With Generalised Myasthenia Gravis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"AstraZeneca"},{"company":"Hikma Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Hikma Launches Ryaltris\u2122 Seasonal Allergic Rhinitis Nasal Spray in The US","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Hikma Pharmaceuticals"}]
Details:
The efficacy and safety of RYALTRIS (olopatadine hydrochloride) was established in a robust clinical studies program in over 4,000 patients with SAR. Twice-daily RYALTRIS™ provided statistically significant improvement in both nasal and ocular symptoms vs placebo.
Lead Product(s):
Olopatadine Hydrochloride,Mometasone Furoate
Therapeutic Area: Immunology
Product Name: Ryaltris
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
August 30, 2022
Details:
Ultomiris (ravulizumab), the first and only long-acting C5 complement inhibitor, offers immediate, complete and sustained complement inhibition. Ultomiris is approved in the US and Japan for the treatment of certain adults with gMG.
Lead Product(s):
Ravulizumab
Therapeutic Area: Immunology
Product Name: Ultomiris
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
August 25, 2022
Details:
Humira approved as 50 mg/mL adalimumab product comprising citrate as formulation ingredient. An product was subsequently launched by AbbVie with high adalimumab concentration in absence of citrate, providing greater patient convenience due to the lower injection volumes.
Lead Product(s):
Adalimumab
Therapeutic Area: Immunology
Product Name: Undisclosed
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
August 09, 2022
Details:
Ultomiris (ravulizumab), the first and only long-acting C5 complement inhibitor, offers immediate, complete and sustained complement inhibition. Ultomiris is administered intravenously every eight weeks in adult patients, following a loading dose.
Lead Product(s):
Ravulizumab
Therapeutic Area: Immunology
Product Name: Ultomiris
Highest Development Status: Approved
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Alexion Pharmaceuticals
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
July 25, 2022
Details:
The approval by the European Commission was based on results from the Saphnelo clinical development programme, including the TULIP Phase III trials and the MUSE Phase II trial.
Lead Product(s):
Anifrolumab-fnia
Therapeutic Area: Immunology
Product Name: Saphnelo
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
February 16, 2022
Details:
Benlysta (belimumab), a B-lymphocyte stimulator (BLyS) specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. Belimumab does not bind to B cells directly or directly deplete B cell populations.
Lead Product(s):
Belimumab
Therapeutic Area: Immunology
Product Name: Benlysta
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
February 10, 2022
Details:
Approval is based on the positive response from Saphnelo (Anifrolumab) in TULIP Phase III trials and the MUSE Phase II trial for treatment of adult patients with active autoantibody-positive systemic lupus erythematosus, despite receiving standard therapy.
Lead Product(s):
Anifrolumab
Therapeutic Area: Immunology
Product Name: Saphnelo
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
December 20, 2021
Details:
The STAGR320 phase III clinical trial, which included 1,600 patients from 231 participating investigative sites in 13 countries, assessed the treatment of HDM-induced allergic rhinitis in adult and adolescent patients.
Lead Product(s):
House Dust Mite Allergen Extracts
Therapeutic Area: Immunology
Product Name: Actair
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 09, 2021
Details:
In these trials, more patients treated with SAPHNELO experienced a reduction in overall disease activity across organ systems, including skin and joints, & achieved sustained reduction in oral corticosteroid use compared to placebo, with both groups receiving standard therapy.
Lead Product(s):
Anifrolumab
Therapeutic Area: Immunology
Product Name: Saphnelo
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
August 02, 2021
Details:
The adverse reactions that occurred more frequently in patients who received Saphnelo in the three clinical trials included nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster and cough.
Lead Product(s):
Anifrolumab-fnia
Therapeutic Area: Immunology
Product Name: Saphnelo
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
August 02, 2021
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