San Diego, CA (Press Release) – Ligand Pharma­ceu­ticals Incorporated (NASDAQ: LGND) partner CASI Pharma­ceu­ticals, Inc. (Nasdaq: CASI), a U.S. bio­pharma­ceu­tical com­pany focused on devel­op­ing and accelerating the launch of inno­va­tive thera­peutics and pharma­ceu­tical prod­ucts in China, the U.S., and through­out the world, announces the official prod­uct launch of mel­phalan hydro­chlo­ride for injection (EVOMELA) in China which is the first commercial prod­uct launch for CASI. EVOMELA uses Ligand’s Captisol tech­nology in its for­mu­la­tion.

Melphalan hydro­chlo­ride for injection (EVOMELA) received mar­ket approval by the China National Medical Products Admin­istra­tion (NMPA) for use as high-dose con­di­tioning …

Rockville, MD (Press Release) – CASI Pharma­ceu­ticals, Inc. (Nasdaq: CASI), a U.S. bio­pharma­ceu­tical com­pany focused on devel­op­ing and com­mer­cial­iz­ing thera­peutics and pharma­ceu­tical prod­ucts in China, U.S., and through­out the world, announces the prod­uct launch of EVOMELA® (melphalan for injection) in China which is the first commercial prod­uct for the Company.

EVOMELA® received mar­ket approval by the China National Medical Products Admin­istra­tion (NMPA) for use as high-dose con­di­tioning treat­ment prior to hema­to­poietic progenitor (stem) cell trans­plant in patients with multiple myeloma, and as a palliative treat­ment of patients with multiple myeloma for whom oral …

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, …

San Diego, CA (Press Release) – Halozyme Thera­peutics, Inc. (NASDAQ: HALO), a bio­technology com­pany devel­op­ing novel on­col­ogy and drug-delivery ther­a­pies, to­day an­nounced that Janssen-Cilag Inter­na­tional NV (Janssen) has sub­mitted an extension appli­ca­tion to the Euro­pean Medicines Agency (EMA) for the sub­cu­tane­ous de­livery of DAR­ZA­LEX® (dara­tu­mu­mab) for patients with mul­ti­ple myeloma.

"We are pleased that Janssen's filing follows quickly after its filing last week of a Biologics License Appli­ca­tion (BLA) with the U.S. Food and Drug Admin­istra­tion," said Dr. Helen Torley, Pres­i­dent and CEO. "We are par­tic­u­larly ex­cited that, pend­ing ap­­prov­al by the EMA, …

Data sup­porting the appli­ca­tion dem­onstrated that the inves­ti­ga­tional sub­cu­tane­ous for­mu­la­tion im­proved quality of life, reduced admin­istra­tion time, lowered rates of in­fusion-related reac­tions, and was non-inferior com­pared to in­tra­venous admin­istra­tion¹

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son to­day an­nounced the sub­mission of an extension appli­ca­tion to the Euro­pean Medicines Agency (EMA) for sub­cu­tane­ous (under the skin) use of DAR­ZA­LEX® (dara­tu­mu­mab) for the treat­ment of patients with mul­ti­ple myeloma. This sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab is co-formulated with recombinant human hyal­uron­i­dase PH20 (rHuPH20) [Halozyme's ENHANZE® drug de­livery tech­nology]. Dara­tu­mu­mab is cur­rently only approved for in­tra­venous (IV) use.

“This new for­mu­la­tion is an example of our unwavering com­mitment to pur­sue inno­va­tive treat­ment op­tions to sup­port people living with mul­ti­ple myeloma,” …

• Extension of mar­ket­ing authori­za­tion sub­mitted to Euro­pean Medicines Agency for sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab
• Submission based on data from Phase III COLUMBA and Phase II PLEIADES stud­ies

Copenhagen, Denmark (Press Release) – Genmab A/S (CSE:GEN, Nasdaq:GMAB) an­nounced to­day that its licensing part­ner, Janssen Biotech, Inc., has sub­mitted an appli­ca­tion for the extension of the DAR­ZA­LEX® mar­ket­ing authori­za­tion to the Euro­pean Medicines Agency (EMA). This appli­ca­tion seeks ap­­prov­al for the use of the sub­cu­tane­ous (SubQ) for­mu­la­tion of dara­tu­mu­mab in mul­ti­ple myeloma indi­ca­tions where the in­tra­venous for­mu­la­tion of dara­tu­mu­mab is cur­rently approved. In August 2012, Genmab granted Janssen an ex­clu­sive world­wide license to de­vel­op, manu­fac­ture and com­mer­cial­ize dara­tu­mu­mab.

“Janssen has now sub­mitted appli­ca­tions …

Newark, CA (Press Release) – Teneobio, Inc. a clin­i­cal-stage bio­technology com­pany devel­op­ing engi­neered bispecific anti­bodies for the treat­ment of cancer announced today that the first patient has been dosed with TNB-383B in a Phase 1 clin­i­cal study to eval­u­ate the safety and tolerability of its dif­fer­en­ti­ated anti-BCMAxCD3, a bispecific anti­body that redirects T-cells to kill multiple myeloma cells with minimal cytokine release. Earlier this year, Teneobio’s affiliate TeneoOne, Inc. and AbbVie entered a strategic part­ner­ship, giving AbbVie the exclusive right to acquire TeneoOne post-Phase 1 studies and lead the sub­se­quent global devel­op­ment and …