Montreal, QC (Press Release) – ExCellThera Inc., an ad­vanced clin­i­cal stage bio­technology com­pany delivering molecules and bio­engineer­ing solu­tions to expand stem and immune cells for thera­peutic use, announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has granted regenerative medicine ad­vanced ther­apy (RMAT) desig­na­tion to its lead tech­nology, ECT-001, in the treat­ment of hema­to­logic malig­nan­cies. The RMAT desig­na­tion is based on strong data from Phase I/II clin­i­cal trials using ECT-001 to expand stem and immune cells for the treat­ment of blood cancers.

RMAT desig­na­tion is granted by the FDA under the 21st …

New York, NY (Press Release) – ChemioCare USA Inc. (“ChemioCare” or the “Company”), a plat­form com­pany focused on pro­pri­e­tary trans­dermal delivery, announced today the Company is initiating devel­op­ment of a trans­dermal for­mu­la­tion of lena­lido­mide, which is cur­rently marketed in an oral form. ChemioCare believes that by applying its permeation en­hanced trans­dermal tech­nology (PETT), it can poten­tially target and deliver the optimal con­tin­uous lena­lido­mide AUC (drug level area under the curve) that may lead to reduced drug toxicity and im­prove­ment in the over­all safety profile of the drug. These im­prove­ments can be ex­pec­ted to …

Rockville, MD (Press Release) – CASI Pharma­ceu­ticals, Inc. (Nasdaq: CASI), a U.S. pharma­ceu­tical com­pany with a plat­form to develop and accelerate the launch of inno­va­tive thera­peutics and pharma­ceu­tical prod­ucts in China, the U.S., and through­out the world, announces the signing of a license agree­ment for exclusive world­wide rights to the inves­ti­ga­tional anti-CD38 mono­clonal anti­body (Mab) TSK011010 pro­gram from Black Belt Therapeutics Limited.

Under the terms of the agree­ment, CASI has obtained global rights to TSK011010 for an up­front pay­ment of 5 million euros and an equity investment of 2 million euros, as well …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stockholm: ONCO) to­day an­nounced that the US pat­ent and trademark office has issued a notice that they in­tend to grant addi­tional pat­ents to Oncopeptides AB in the US. Oncopeptides has pre­vi­ously re­ceived the corresponding pat­ent pro­tec­tion both in Japan and Europe.

These pat­ents (application numbers 14/438473 and 15/225323) pro­tect, inter alia, the freeze-dried for­mu­la­tion. The pat­ent pro­tec­tion extends to 2033. The freeze-dried preparation with melflufen is in­tended to be mar­keted at a future ap­­prov­al.

"We have now approved for­mu­la­tion pat­ents in all major key mar­kets …

• Supplemental new drug appli­ca­tion (sNDA) submitted in Japan for dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone as treat­ment for patients newly diag­nosed with multiple myeloma who are not can­di­dates for high-dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant
• Submission based on data from Phase III MAIA study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharma­ceu­tical K.K. has submitted a supple­mental new drug appli­ca­tion (sNDA) to the Ministry of Health, Labor and Welfare (MHLW) in Japan, for the use of dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) as treat­ment for patients newly diag­nosed with multiple myeloma who are not can­di­dates for high-dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant (ASCT). The MHLW will grant a priority review of the appli­ca­tion, based on the …

PRIME (PRIority MEdicines) desig­na­tion based on clin­i­cal study re­­sults eval­u­ating safety and ef­fi­cacy of novel CAR-T ther­apy in the treat­ment of patients with ad­vanced re­lapsed or re­frac­tory mul­ti­ple myeloma

Beerse, Belgium (Press Release) - The Janssen Pharma­ceu­tical Com­panies of John­son & John­son to­day an­nounced that the Euro­pean Medicines Agency (EMA) has granted a PRIME (PRIority MEdicines) desig­na­tion for the com­pany’s inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA) chi­meric an­ti­gen re­cep­tor T-cell (CAR-T) ther­apy, JNJ-68284528 (JNJ-4528). PRIME offers en­hanced inter­action and early dialogue to optimise devel­op­ment plans and speed up evaluation of cutting-edge, scientific ad­vances that target a high unmet med­i­cal need.¹

“The PRIME desig­na­tion of this novel BCMA CAR-T ther­apy highlights the value of regu­la­tory inno­va­tion in the Euro­pean Union,” said Sjaak Bot, …

Successful manu­fac­tur­ing and re­lease of GMP vials of UCARTCS1

New York, NY (Press Release) – Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on gene-edited CAR T-cells (UCART), an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the Com­pany’s Inves­ti­ga­tional New Drug (IND) appli­ca­tion to ini­ti­ate a Phase 1 clin­i­cal trial for UCARTCS1, in patients with mul­ti­ple myeloma (MM). The IND for UCARTCS1 was filed on De­cem­ber 28, 2018 and approved by the FDA within a month, on Jan­u­ary 25, 2019. Cellectis is the sponsor of the UCARTCS1 clin­i­cal study (MUNDI-01) and …