Hyderabad, India (Press Release) – Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has launched a generic version of poma­lido­mide 1 mg, 2 mg, and 4 mg capsules in India. Pomalidomide is sold by Celgene Inc., in the USA, under the brand name POMALYST®.

Pomalidomide is a thalido­mide analogue indicated, in com­bi­na­tion with dexa­meth­a­sone, for patients with multiple myeloma (a type of blood cancer) who have received at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some inhibitor and have dem­onstrated disease pro­gres­sion on or within 60 days of completion of the last …

First-in-class CD38-directed mono­clonal anti­body now approved for use in com­bi­na­tion with two standard of care regi­mens

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV (“Janssen”) today announced that the European Com­mis­sion (EC) has granted approval to DARZALEX®▼ (dara­tu­mu­mab) for use in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib (VELCADE®) and dexa­meth­a­sone, for the treat­ment of adult patients with multiple myeloma (MM) who have received at least one prior ther­apy.

The EC’s de­ci­sion was based on data from the Phase 3 POLLUX (MMY3003) study, presented in the plenary session at ASCO 2016 and published in the New England Journal of Medicine, in August 2016¹; and Phase 3 CASTOR (MMY3004) study, presented …

DARZALEX® com­bi­na­tion ther­apy sig­nif­i­cantly im­proved pro­gres­sion-free survival (PFS) com­pared to standard of care regi­mens alone

Toronto, ON (Press Release) – Janssen Inc. announced today that Health Canada has approved DARZALEX® (dara­tu­mu­mab), in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of patients with multiple myeloma who have received at least one prior ther­apy.¹ Due to the high unmet medical need for multiple myeloma patients, DARZALEX® was granted a Priority Review by Health Canada for this sub­mission.

Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow un­con­trol­lably in the bone marrow.^2,3 The dis­ease can be very complex to treat as …

Lund, Sweden (Press Release) – Active Biotech AB (Nasdaq Stockholm:ACTI) an­nounces to­day that Active Biotech has been granted Orphan Drug Desig­na­tion by the U.S. Food and Drug Admin­istra­tion (FDA) for its inves­ti­ga­tional novel agent tasquinimod, for the treat­ment of mul­ti­ple myeloma.

The FDA Orphan Drug Desig­na­tion pro­gram provides orphan status to drugs and bio­log­ics which are defined as those in­tended for the safe and ef­fec­tive treat­ment, diagnoses or prevention of rare dis­eases or disorders that effect fewer than 200,000 people in the U.S. This desig­na­tion provides for a seven year mar­ket­ing exclusivity …

• Xgeva is Currently Indicated for the Prevention of Skeletal-Related Events Known as Bone Complications in Patients With Solid Tumors
• Applications Include Data From the Largest Inter­na­tional Trial Conducted in Multiple Myeloma

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) and an appli­ca­tion for a variation to the market­ing authori­za­tion to the European Medicines Agency (EMA) for XGEVA® (denosumab). The sub­missions to regu­la­tory author­i­ties seek to expand the cur­rently approved XGEVA indi­ca­tion for the prevention of skeletal-related events (SREs) in solid tumors to in­clude patients with multiple myeloma. The appli­ca­tions in­clude new data from the pivotal …

• Recruitment Resumes Across All Selinexor Trials in Hematological Malignancies
• Timelines for Ongoing and Planned Studies Expected to Remain Materially Unchanged

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) Division of Hematology Products has lifted the partial clin­i­cal hold placed on the clin­i­cal trials for selinexor (KPT-330), enabling patient enroll­ment and dosing of new patients in the Company’s clin­i­cal trials of selinexor in hema­to­logical malig­nan­cies. The partial clin­i­cal hold was not the result of any patient death or any change in the safety profile of selinexor. Enrollment may now resume …

• All cur­rently enrolled patients with stable disease or better can con­tinue receiving selinexor
• Company has amended investigator’s brochure and informed consent documents as requested by FDA
• Company ex­pec­ts timelines for both ongoing and planned studies to remain ma­teri­ally unchanged

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­ti­cal com­pany, today announced that it has received written notice from the U.S. Food and Drug Admin­istra­tion (FDA) that its clin­i­cal trials for selinexor (KPT-330) have been placed on partial clin­i­cal hold. While the partial clin­i­cal hold remains in effect, patients with stable disease or better may remain on selinexor ther­apy. No new patients may be enrolled until the partial clin­i­cal hold is lifted.

The FDA has indicated that the partial …