North Chicago, IL (Press Release) – AbbVie (NYSE: ABBV), a research-based global bio­pharma­ceu­tical com­pany, today announced the U.S. Food and Drug Admin­istra­tion (FDA) has placed a partial clin­i­cal hold on all clin­i­cal trials eval­u­ating veneto­clax (VENCLEXTA®/​VENCLYXTO®) for the inves­ti­ga­tional treat­ment of multiple myeloma. The partial clin­i­cal hold follows a review of data from the ongoing Phase 3 BELLINI trial (M14-031), a study in re­lapsed / refractory multiple myeloma, in which a higher proportion of deaths was observed in the veneto­clax arm compared to the control arm of the trial. As a result of …

• PDUFA Action Date Extended by Three Months to July 6, 2019
• FDA Has Requested Additional Existing Information for Review

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for selinexor. The NDA, which is cur­rently under Priority Review by the FDA, is seeking accelerated approval for selinexor in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of patients with re­lapsed refractory multiple myeloma who have received at least three prior ther­a­pies …

Suzhou, China (Press Release) – CStone Pharma­ceu­ticals (Suzhou) Co., Ltd. ("CStone", stock code: 2616.HK) announced that the National Medical Products Admin­istra­tion (NMPA) recently approved com­pany's histone deacetylase 6 (HDAC6) selective inhibitor CS3003 for Phase I clin­i­cal trial in China. This is a multi-center, Phase I dose escalation study synchronously conducted in China and Australia in patients with ad­vanced solid tumors and re­lapsed or refractory multiple myeloma.

Dr. Frank Jiang, Chairman and CEO, commented: "CS3003 is the ninth drug can­di­date of CStone with Investigational New Drug approval obtained in China. At present, there …

Application sup­ported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot pro­gram

Raritan, NJ (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking approval of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

The sBLA, based upon data from the Phase 3 MAIA (MMY3008) clin­i­cal study, is being reviewed by the FDA under the Real-Time Oncology Review (RTOR) pilot pro­gram, which for …

Henderson, NV and San Diego, CA (Press Release) – Secura Bio, Inc. (www.securabio.com), an integrated, commercial-stage bio­pharma­ceu­tical com­pany dedicated to the world­wide com­mer­cial­iza­tion of sig­nif­i­cant on­col­ogy ther­a­pies, today announced that it has acquired the global rights to Farydak® (panobinostat) from Novartis.

Farydak® (panobinostat) is a prescription oral medication used in com­bi­na­tion with pro­te­a­some inhibitors and corticosteroids to treat patients with re­lapsed or refractory multiple myeloma who had received prior treat­ments. Farydak is a member of the histone deacetylase (HDAC) inhibitor family with a very potent and unique mode of action slowing the growth …

Doxorubicin Hydrochloride Cytori – First Intended for European Market

San Diego, CA (Press Release) – Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that it officially filed a formal new drug appli­ca­tion pre-submission request to the European Medicine Agency (EMA) for Doxorubicin Hydrochloride Cytori. This sub­mission is the precursor to filing an Article 58 Application for a Marketing Authorization Application (MAA) via EMA’s centralized approval pro­ce­dure. In June 2017, the EMA Committee for Medicinal Products for Human Use (CHMP) con­firmed that Doxorubicin Hydrochloride Cytori was eli­gible for sub­mission of a MAA via the centralized pro­ce­dure.

In addi­tion, in late 2018, the EMA CHMP …

Stamford, CT (Press Release) – Imbrium Therapeutics L.P., a clin­i­cal-stage bio­pharma­ceu­tical com­pany and operating sub­sid­i­ary of Purdue Pharma L.P., in conjunction with Mundipharma EDO GmbH, today announced that they have enrolled the first patient in the expansion stage of a Phase 1/2 clin­i­cal trial of tino­sta­mus­tine, an inves­ti­ga­tional treat­ment, in patients with re­lapsed refractory (R/R) hema­to­logic malig­nan­cies in the U.S. and Europe.

Following a dose escalation trial to estab­lish­ tolerability, this expansion phase seeks to in­ves­ti­gate the over­all response rate, duration of response and safety of five cohorts of patients with R/R cancers, …