Company

Product

Description

Indication

Status

Date


Celltrion Inc., of Incheon, South Korea, and Teva Pharmaceutical Industries Ltd., of Jerusalem

Herzuma (trastuzumab-pkrb)

HER2/neu receptor antagonist biosimilar to Herceptin (trastuzumab)

Adjuvant and metastatic breast cancer

FDA approved for HER2 overexpressing node positive or node negative breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, and as part of a treatment regimen with docetaxel and carboplatin; it also was approved for use in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic disease

12/17/18

Discgenics Inc., of Salt Lake City

IDCT

Allogeneic injectable disc cell therapy

Degenerative disc disease

Japan's PMDA approved a clinical trial notification application; 38-patient study expected to begin enrolling patients in Japan in first half of 2019

12/11/18

Genmab A/S, of Copenhagen

Darzalex (daratumu-mab)

Monoclonal antibody

Multiple myeloma

Submitted sNDA to Japan's MHLW to treat newly diagnosed MM ineligible for autologous stem cell transplant, in combination with bortezomib (Velcade, Takeda Oncology Co.), melphalan and prednisone

12/14/18

Hisamitsu Pharmaceutical Co. Ltd., of Tosu City, Japan, and subsidiary Noven Pharmaceuticals Inc., of Miami

HP-3070 (asenapine)

Systemic transdermal formulation

Schizophrenia

Submitted an NDA with the FDA

12/17/18

Mayne Pharma Group Ltd., of Adelaide, Australia

Tolsura (Suba-itraconazole 65-mg capsules)

Antifungal

Blastomycosis, histoplasmosis and aspergillosis

Approved by FDA for use in patients intolerant or refractory to amphotericin B

12/12/18

Mesoblast Ltd., of Melbourne, Australia

Remestem-cel-L

Donor-derived mesenchymal stem cell therapy

Graft-vs.-host disease

Gained FDA agreement on proposed chemistry and manufacturing for commercialization; will support BLA in early 2019 seeking approval to treat children with steroid-refractory acute GVHD

12/13/18

Takeda Pharmaceutical Co. Ltd., of Osaka, Japan

Adcetris (brentuximab vedotin)

CD30-modulating ADC

Hodgkin lymphoma

EMA's CHMP issued positive opinion to extend marketing authorization, in combination with adriamycin/vinblastine/dacarbazine, in previously untreated CD30+ stage IV Hodgkin lymphoma

12/14/18

Zai Lab Ltd., of Shanghai

Zejula (niraparib)

PARP 1/2 inhibitor

Ovarian cancer

China's NMPA accepted NDA as a category 1 drug for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal ovarian cancer who are in complete or partial response to platinum-based chemotherapy

12/12/18


Notes

The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found.

For more information about individual companies and/or products, see Cortellis.

 

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