Covers composition of mat­ter and method of use for pro­pri­e­tary PDCs™ in com­bi­na­tion with anti-cancer agents

Madison, WI (Press Release) – Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, de­vel­op­ment and com­mer­cial­i­za­tion of targeted treat­ments for cancer, an­nounces that the U.S. Patent and Trademark Office (USPTO) has granted pat­ent num­ber 9,345,718, titled “Phospholipid-Ether Analogs as Cancer-Targeting Drug Vehicles,” re­lated to the com­pany’s phos­pho­lipid-ether analogs for targeting anticancer thera­peutics to tumors and cancer stem cells.

“This seminal pat­ent provides Cellectar with broad pro­tec­tion for Phospholipid Drug Conjugate™ (PDC™) prod­ucts created with our phos­pho­lipid ether tech­nology, as well as the freedom to op­er­ate that is nec­es­sary to …

Outcome of re-examination

London, United Kingdom (Announcement) – On 14 December 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the market­ing authori­sa­tion for the medicinal prod­uct Aplidin, intended for the treat­ment of multiple myeloma. The com­pany that applied for author­i­sa­tion is PharmaMar.

The com­pany requested a re-examination of the initial opinion. After con­sidering the grounds for this request, the CHMP re-examined the opinion, and con­firmed the refusal of the market­ing author­i­sa­tion on 22 March 2018.

What is Aplidin?

Aplidin is a cancer …

Madrid, Spain (Significant Event Notification) – Pursuant to article 228 of the consolidated text of the Spanish Securities Market Act, we hereby inform you of the fol­low­ing SIGNIFICANT EVENT:

“In rela­tion­ to the Significant Fact n. 260272, Pharma Mar informs that the European Medi­cines Agency (EMA) has ad­vanced to Pharma Mar that in the re­exami­nation pro­cedure requested by Pharma Mar in January 2018 in rela­tion­ to the CHMP Opinion issued in December 2017 recom­mend­ing not to grant the market­ing authori­zation for Aplidin in the multiple myeloma indi­ca­tion, the CHMP has …

New York, NY (Press Release) – Phosplatin Thera­peutics LLC, a clin­i­cal stage pharma­ceu­tical com­pany focused on on­col­ogy drug devel­op­ment, an­nounced to­day it has en­rolled the first cohort of patients into its Phase I / II study of PT-112 as a single agent in re­lapsed or re­frac­tory mul­ti­ple myeloma. The Com­pany fur­ther an­nounced having re­ceived FDA Orphan Drug Desig­na­tion for PT-112 in the treat­ment of mul­ti­ple myeloma.

PT-112 is cur­rently under ad­vanced Phase I devel­op­ment in solid tumors. As re­ported at the ASCO 2017 Annual Meeting, PT-112 dis­plays an attractive tol­er­a­bil­ity profile and signals …

• Acquisition Will Add Novel Scientific Platform and Manufacturing Expertise to Celgene’s Research and Operational Capabilities
• JCAR017 is Expected to be a Significant Growth Driver Beyond 2020 with Potential Global Peak Sales of Approximately $3B
• Reaffirming 2020 Financial Targets of $19B-$20B in Total Net Product Sales and Adjusted EPS Greater Than $12.50

Summit, NJ and Seattle, WA (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG) and Juno Thera­peutics, Inc. (NASDAQ:JUNO) today announced the signing of a definitive merger agree­ment in which Celgene has agreed to acquire Juno. Under the terms of the merger agree­ment, Celgene will pay $87 per share in cash, or a total of approx­i­mately $9 billion, net of cash and mar­ketable se­cu­ri­ties acquired and Juno shares already owned by Celgene (approximately 9.7% of outstanding shares). The trans­action was approved by the …

• U.S. FDA grants Priority Review to dara­tu­mu­mab in combi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma in­eli­gible for au­tol­o­gous stem cell trans­plant
• May 21, 2018 PDUFA date

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istration (FDA) has granted Priority Review to the supple­mental Biologics License Application (sBLA) for the use of dara­tu­mu­mab (DARZALEX®) in combi­­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The sBLA was submitted by Genmab’s licensing partner, Janssen Biotech, Inc., in November 2017. Priority Review is an FDA desig­na­tion …

First avail­able IV admin­istra­tion alter­na­tive to VELCADE® (Bortezomib for Injection)

Lake Zurich, IL (Press Release) – Fresenius Kabi announced today the avail­a­bil­ity in the United States of Bortezomib for Injection. Fresenius Kabi Bortezomib for Injection is avail­able as a single dose vial con­taining 3.5 mg of lyophilized powder.

Fresenius Kabi is a global health care com­pany that specializes in medicines and tech­nolo­gies for infusion, transfusion and clin­i­cal nutrition.

“Fresenius Kabi Bortezomib is a cost efficient prod­uct alter­na­tive for our customers and the patients they treat. We are proud to offer an expansive on­col­ogy portfolio …