Berlin, CT (Press Release) – Breckenridge Pharma­ceu­tical, Inc. an­nounced to­day that the U.S. Food and Drug Admin­istra­tion has ap­prov­ed Breckenridge's Abbreviated New Drug Appli­ca­tion for Poma­lido­mide Capsules (generic for Pomalyst®).

Breckenridge has part­nered with Natco Pharma Limited for the de­vel­op­ment and manu­fac­ture of this prod­uct. According to in­dus­try sales data, Pomalyst had annual sales of $957 mil­lion during the twelve months ending Sep­tem­ber 2020. Celgene, Breckenridge and Natco have set­tled the U.S. district court lit­i­ga­tion with respect to this prod­uct.

About Breckenridge

Breckenridge Pharma­ceu­tical, Inc., a sub­sid­i­ary of Towa Pharma­ceu­tical (Osaka, Japan), part­ners …

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 …

• Median pro­gres­sion-free sur­vival and over­all re­sponse rate doubled among patients re­ceiv­ing EPd com­pared to poma­lido­mide and low-dose dexa­meth­a­sone alone
• Second Empliciti-based com­bi­na­tion approved in Europe for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the Euro­pean Com­mis­sion (EC) has approved Empliciti (elo­tuzu­mab) plus poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. This ap­prov­al is based on data from the ELOQUENT-3 trial in which EPd doubled both median pro­gres­sion-free sur­vival (PFS) and …

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) to­day an­nounced that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the Euro­pean Medicines Agency has adopted a pos­i­tive opinion on a Type-II variation appli­ca­tion for Empliciti (elo­tuzu­mab) plus poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. The CHMP recom­men­da­tion will now be reviewed by the Euro­pean Com­mis­sion, …