Regulation

FDA approves Roche’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma

Roche announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) plus Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The safety profile observed in the Tecentriq combination was consistent with the known safety profiles of the individual medicines.

Novartis gets EC nod for Cosentyx drug in paediatric psoriasis

Novartis has secured approval from the European Commission (EC) for its Cosentyx (secukinumab) to treat moderate-to-severe plaque psoriasis in children and adolescents aged between six and 18 years.

TAGRISSO granted FDA breakthrough therapy status in EGFR-mutated lung cancer

AstraZeneca’s TAGRISSO (osimertinib) has been granted Breakthrough Therapy Designation (BTD) in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent.

Takeda gets FDA breakthrough therapy status for pevonedistat to treat higher-risk HR-MDS

Takeda Pharmaceutical has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational drug pevonedistat to treat patients with higher-risk myelodysplastic syndromes (HR-MDS).

FDA grants breakthrough therapy designation to Merck’s MK-6482 in VHL disease-associated RCC

Merck announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate in Merck’s oncology pipeline, for the treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required.

Celltrion secures EC approval for Remsima SC for five more indications

Celltrion Healthcare has secured approval from the European Commission (EC) for the subcutaneous (SC) formulation of autoimmune disease drug Remsima (infliximab, CT-P13) for the treatment of five more indications.

Janssen gets CHMP positive opinion for expanded use of IMBRUVICA, rituximab combo in CLL

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for IMBRUVICA (ibrutinib) to include the combination with rituximab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

Jazz Pharmaceuticals gets US FDA approval of Xywav for cataplexy associated with narcolepsy

Jazz Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution on July 21, 2020 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

Aurinia announces FDA acceptance of NDA filing and priority review for voclosporin to treat lupus nephritis

Aurinia Pharmaceuticals, a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for voclosporin, as a potential treatment for lupus nephritis (LN), a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus (SLE).