• 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

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, …

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 …

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 …

As you may remember from my pre­vi­ous column, I started treat­ment with Darzalex, Revlimid, and dexa­meth­a­sone in early Octo­ber.

By now, I have re­ceived six weekly Darzalex (dara­tu­mu­mab) in­fusions, and quite a bit has hap­pened as I adjust to being on a new regi­men.

After the first in­fusion, I had a mild cough that turned into quite a deep, hacking cough. I could hardly sleep for a week. It didn’t appear to be a "productive" cough, so I took Benadryl (di­phen­hy­dra­mine) and cough med­i­cines and sat upright a lot at …

Swiss researchers have published results of a small clin­i­cal trial testing whether nelfinavir, a drug originally used to treat AIDS, can overcome resistance to Revlimid in re­lapsed multiple myeloma patients.

The trial was motivated by pre­vi­ous research showing that nelfinavir can overcome resistance to Velcade, for a period of time, in many re­lapsed myeloma patients.

Unfortunately, the results of the more recent nelfinavir trial are not as en­cour­ag­ing as the pre­vi­ous research involving nelfinavir and Velcade. Less than a third of the patients in the more recent trial responded to the three-drug …

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

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% …

The European Com­mis­sion has approved two of Celgene’s IMiD®-based com­bi­na­tion regi­mens:

• REVLIMID in combi­nation with bor­tez­o­mib and dexa­meth­a­sone (RVd) in adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant
• IMNOVID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (PVd), in adult patients with multiple myeloma, who have received at least one prior treat­ment regi­men in­­clud­ing REVLIMID.

Boudry, Switzerland (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that the European Com­mis­sion (EC) has approved two new triplet regi­mens based on Celgene’s pro­pri­e­tary IMiD treat­ments, REVLIMID (lena­lido­mide) and IMNOVID (poma­lido­mide).

REVLIMID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (RVd), is now indicated for the treat­ment of adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant. In addi­tion, IMNOVID, in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (PVd), is now indicated for the treat­ment of adult patients with multiple myeloma who have received at …