Articles tagged with: Immunomodulatory Agents

Press Releases»

[ by | Nov 12, 2020 7:00 am | Comments Off ]

Applications sup­ported by pos­i­tive re­sults from the Phase 3 APOLLO study, which dem­onstrated longer pro­gres­sion-free sur­vival in patients re­ceiv­ing the sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab1

Janssen Submits Applications In U.S. And EU Seeking Approval of Darzalex Faspro (Daratumumab And Hyaluronidase-fihj) / Darzalex (Daratumumab) Subcutaneous (SC) Formulation In Combination With Pomalidomide And Dexamethasone For Patients With Relapsed Or Refractory Multiple Myeloma RARITAN, N.J., Nov. 12, 2020 /PRNewswire/ -- The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day the sub­mission of regu­la­tory appli­ca­tions to the U.S. Food and Drug Admin­istra­tion (FDA) and Euro­pean Medicines Agency (EMA) seek­ing ap­prov­al of the dara­tu­mu­mab sub­cu­tane­ous (SC) for­mu­la­tion, known as DAR­ZA­LEX FASPRO™ (dara­tu­mu­mab and hyal­uron­i­dase-fihj) in the U.S. and as DAR­ZA­LEX® SC in the Euro­pean Union (EU). The appli­ca­tions seek ap­prov­al of the com­bi­na­tion of DAR­ZA­LEX FASPRO™ / DAR­ZA­LEX® SC in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (D-Pd) for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple …

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[ by | Sep 17, 2020 6:59 am | Comments Off ]
  • Dr. Reddy’s li­censed to sell vol­ume-limited amounts of ge­ner­ic lena­lido­mide in the U.S. be­gin­ning on a con­fi­den­tial date after the March 2022 date pre­vi­ously granted to Natco
  • Dr. Reddy’s also li­censed to sell ge­ner­ic lena­lido­mide in the U.S. without vol­ume lim­i­ta­tion be­gin­ning on Jan­u­ary 31, 2026
  • The earliest li­censed entry of any ge­ner­ic lena­lido­mide in the U.S. con­tinues to be March 2022, based on set­tle­ments reached

Bristol Myers Squibb Announces Settlement Of U.S. Patent Litigation For Revlimid (Lenalidomide) With Dr. Reddy’s New York, NY (Press Release) – Bristol Myers Squibb (NYSE:BMY) to­day an­nounced that its wholly owned sub­sid­i­ary, Celgene, and Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, DRL) have set­tled their lit­i­ga­tion re­lated to pat­ents for REVLIMID® (lena­lido­mide).

As part of the set­tle­ment, the parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin DRL from mar­ket­ing ge­ner­ic lena­lido­mide be­fore the expiration of the pat­ents-in-suit, except as provided for in the set­tle­ment, …

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[ by | Jul 31, 2020 3:38 pm | Comments Off ]
  • Phase 3 APOLLO ran­dom­ized study eval­u­ating sub­cu­tane­ous dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone versus poma­lido­mide and dexa­meth­a­sone alone in re­lapsed or re­frac­tory mul­ti­ple myeloma met the pri­mary end­point of im­prov­ing pro­gres­sion-free sur­vival
  • Janssen in­tends to discuss the data with health author­i­ties for po­ten­tial regu­la­tory sub­missions

Genmab Announces European Myeloma Network And Janssen Achieve Positive Topline Results From Phase 3 APOLLO Study Of Daratumumab In Combination With Pomalidomide And Dexamethasone In Relapsed Or Refractory Multiple Myeloma Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day that the Euro­pean Myeloma Network (EMN) in col­lab­o­ration with Janssen Re­search & De­vel­op­ment, LLC (Janssen) re­ported pos­i­tive re­­sults from the Phase 3 APOLLO (MMY3013) study of the sub­cu­tane­ous (SC) for­mu­la­tion of dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (Pd) versus Pd alone as treat­ment for patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have pre­vi­ously been treated with lena­lido­mide (an immuno­modu­la­tory drug) and a pro­te­a­some in­hib­i­tor (PI). The study met the pri­mary …

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[ by | Apr 30, 2020 7:00 am | Comments Off ]
Starton Therapeutics Files PCT And US Patent Application For Continuous Delivery Of Lenalidomide And Class Of Immunomodulatory Agents

New York, NY (Press Release) – Starton Thera­peutics Inc. (“Starton” or the “Com­pany”), a bio­technol­ogy com­pany focused on trans­forming standard of care thera­peutics, to­day an­nounced that it has filed PCT (“Patent Cooperation Treaty”) and US Non-Provisional pat­ent appli­ca­tions entitled “Continuous Delivery of Lena­lido­mide and Other Immuno­modu­la­tory Agents” on April 21, 2020 (PCT Appli­ca­tion No. PCT/US20/29159 and U.S. Appli­ca­tion No. 16/854,810).

The PCT appli­ca­tion, filed with the PCT re­ceiv­ing office at the U.S. Patent & Trademark Office, allows Starton to file pat­ent appli­ca­tions to seek pro­tec­tion for the methods disclosed therein in most major …

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[ by | Dec 27, 2019 9:00 am | Comments Off ]
Starton Successfully Completes Proof Of Concept Study For Transdermal Lenalidomide

New York, NY (Press Release) – Starton Thera­peutics Inc. (“Starton” or the “Company”), a bio­technol­ogy com­pany focused on trans­forming standard of care thera­peutics, to­day an­nounced the com­ple­tion of a proof of concept study of multiple myeloma with lena­lido­mide using a model which emulates trans­dermal de­livery. The results of the study dem­onstrate that a con­tin­uous sub­cu­tane­ous (SC) de­livery of lena­lido­mide is superior in terms of efficacy and equivalent in tolerability when com­pared to a standard once daily pulsatile dosing of Revlimid® (Celgene Corpo­ra­tion) in mice. The pos­i­tive out­come provides a clear path for de­vel­op­ment …

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[ by | Jul 10, 2019 7:00 am | Comments Off ]

POMALYST®, in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone, provides a new medication option for patients living with multiple myeloma

Health Canada Approves Pomalyst-Based Triplet Combination For Patients With Multiple Myeloma Toronto, ON (Press Release) – Celgene Inc. announced today that Health Canada has approved a POMALYST® (poma­lido­mide)-based triplet com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone. This is a new treat­ment option for patients with multiple myeloma (MM) who have received at least one prior treat­ment regi­men that in­cluded REVLIMID® (lena­lido­mide).

POMALYST® is an oral medication taken daily and is indicated, in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of adult patients with MM who have received at least one prior treat­ment regi­men that in­cluded lena­lido­mide.1,2

"The treat­ment landscape for multiple myeloma has sig­nif­i­cantly changed …

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[ by | Jul 8, 2019 3:24 pm | Comments Off ]

Topline data from the ran­dom­ized Phase II GRIFFIN study in trans­plant eli­gible, newly diag­nosed patients with multiple myeloma treated with dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone met the study’s pri­mary end­point with a higher per­cent­age of stringent com­plete response in the dara­tu­mu­mab arm as com­pared with patients who received lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone alone

Genmab Announces Positive Topline Results In The Phase II GRIFFIN Study Of Transplant Eligible, Newly Diagnosed Patients With Multiple Myeloma Treated With Daratumumab In Combination With Lenalidomide, Bortezomib, And Dexamethasone Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that topline data from the Phase II GRIFFIN (MMY2004) study of newly diag­nosed patients with multiple myeloma eli­gible for high-dose chemo­ther­apy and au­tol­o­gous stem cell trans­plan­ta­tion (ASCT), who were treated with dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone (VRd), met its pri­mary end­point, demonstrating a higher per­cent­age of stringent com­plete responses (sCR) than patients who received VRd alone. Specifically, the topline data showed that 42.4% of patients treated with dara­tu­mu­mab in com­bi­na­tion with VRd achieved a sCR, com­pared to 32.0% …

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