Regulation

FDA accepts to review Sanofi’s multiple myeloma candidate isatuximab

Sanofi said that its biologics license application (BLA) for isatuximab for the treatment of relapsed/refractory multiple myeloma (RRMM) has been accepted for review by the US Food and Drug Administration (FDA).

FDA approves Grifols’ Xembify to treat primary immunodeficiencies

Plasma-derived medicines producer Grifols has secured approval from the US Food and Drug Administration (FDA) for its Xembify, a new 20% subcutaneous immunoglobulin solution, to treat primary immunodeficiencies.

EC approves ViiV Healthcare’s Dovato to treat HIV-1 infection

ViiV Healthcare has secured marketing authorisation from the European Commission (EC) for its Dovato (dolutegravir/lamivudine) to treat HIV-1 infection.

FDA approves new treatment for refractory multiple myeloma

The US Food and Drug Administration granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

Sanofi, Regeneron bag EC approval for skin cancer drug Libtayo

Sanofi and Regeneron Pharmaceuticals have been given conditional approval by the European Commission (EC) for their fully-human monoclonal antibody Libtayo (cemiplimab) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) in adults.

Puma Biotechnology submits sNDA to FDA for Neratinib to treat HER2-positive metastatic breast cancer

Puma Biotechnology has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease).

Sensorion receives EMA agreement on the pediatric investigation plan for Arazasetron in two indications

Sensorion (Paris:ALSEN)(FR0012596468 – ALSEN) a pioneering clinical-stage biopharmaceutical company which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, tinnitus and vertigo, announces today that the European Medicines Agency (EMA) has accepted its Pediatric Investigation Plan (PIP) for both development in the treatment of severe hearing loss (SSNHL) and for prevention of ototoxicity caused by cisplatin (CIO) in the pediatric population.

CHMP recommends EU approval of Roche’s Tecentriq plus Abraxane for metastatic TNBC

Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq (atezolizumab) plus chemotherapy (Abraxane; nab-paclitaxel) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression (≥ 1%) and who have not received prior chemotherapy for metastatic disease.

Pfizer gets FDA nod for Avastin’s biosimilar Zirabev

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Zirabev (bevacizumab-bvzr), an oncology biosimilar to Roche’s Avastin (bevacizumab).