Hong Kong (Company Announcement) – This announcement is made by Genscript Biotech Corpo­ra­tion (the “Company”, together with its sub­sid­i­aries, the “Group”) with respect to a second report recently issued by Flaming Research (“Flaming”) (the “Second Report”) which con­tains alle­ga­tions against the Company, and is published by the Company pursuant to Rule 13.09 of the Rules Governing the Listing of Securities (the “Listing Rules”) on The Stock Exchange of Hong Kong Limited (the “Stock Exchange”) and the Inside Information Provisions (as defined in the Listing Rules) under Part XIVA of the Securities and Futures …

Madison, WI (Press Release) – Cellectar Biosciences (Nasdaq: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of drugs for the treat­ment of cancer, to­day up­dates interim over­all sur­vival (OS) data from the com­pany’s on­go­ing Phase 1b clin­i­cal trial eval­u­ating CLR 131 for the treat­ment of re­lapsed/refractory (R/R) mul­ti­ple myeloma (MM).

The results to date show that OS is cur­rently at 19.4 months. Cellectar con­tinues to monitor these patients and in­tends to up­date OS results as data be­come avail­able. All 15 patients from the Phase 1b, single-dose cohorts were …

• Approval of a More Convenient Once-Weekly Kd70 Regimen Based on Data From Phase 3 Head-to-Head A.R.R.O.W. Study
• Application Granted Priority Review Desig­na­tion
• Application Reviewed and Approved Under FDA's Real-Time Oncology Review and Assessment Aid Pilot Programs

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the supple­mental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLIS® (car­filz­o­mib) to in­clude a once-weekly dosing option in com­bi­na­tion with dexa­meth­a­sone (once-weekly Kd70) for patients with re­lapsed or refractory multiple myeloma. The approval is based on data from the Phase 3 A.R.R.O.W. trial, which dem­onstrated that KYPROLIS admin­istered once-weekly at 70 mg/m² with dexa­meth­a­sone achieved superior pro­gres­sion-free survival (PFS) and over­all …

Silver Spring, MD (Press Release) – Today the U.S. Food and Drug Admin­istra­tion permitted mar­ket­ing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow.

“At the FDA, we’re continuing to maximize oppor­tuni­ties for inno­va­tion that can im­prove patient out­comes,” said FDA Com­mis­sioner Scott Gottlieb, M.D. “Today’s approval is an im­por­tant step for­ward for patients suffering from ALL and multiple myeloma. Determining whether …

Madison, WI (Press Release) – Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of drugs for the treat­ment of cancer, an­nounces to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has ini­ti­ated direct talks with the com­pany con­cern­ing a possible exemption for CLR 131 from the Import Alert placed on the Centre for Probe Develop­ment and Com­mer­cial­i­za­tion (CPDC), the sole supplier of Cellectar’s drug CLR 131.

As an­nounced on August 10, 2018, Cellectar was in­formed by CPDC of the Import Alert on August 7, 2018, …

The Agreement Will Support the Development of a Potential New Treatment Option for Multiple Myeloma

Austin, TX (Press Release) – Molecular Templates, Inc. (Nasdaq:MTEM) today announced an agree­ment with Takeda Pharma­ceu­tical Company Limited (Takeda) for the joint devel­op­ment of CD38-targeted engi­neered toxin bodies (ETBs) for the treat­ment of patients with diseases such as multiple myeloma. The lead devel­op­ment can­di­date is a CD38-targeted ETB that resulted from a pre­vi­ous discovery col­lab­o­ration be­tween the two com­pa­nies.

The parties devel­oped pre­clin­i­cal stage ETBs targeting CD38 under the prior discovery col­lab­o­ration. Takeda and Molecular Templates will further develop the ETBs for the treat­ment of multiple myeloma under this new license, devel­op­ment and …

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the Euro­pean Medicines Agency (EMA) has val­i­dated the Com­pany’s type II variation appli­ca­tion for Empliciti (elo­tuzu­mab) in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with 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. Validation of the appli­ca­tion con­firms the sub­mission is com­plete and begins the EMA’s centralized review process.

“Given the need for new treat­ment …