Regulation

Janssen submits NDA to FDA for apalutamide to treat non-metastatic castration-resistant prostate cancer

Janssen Biotech has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC).

Roche’s Perjeta regimen secures FDA priority review in breast cancer

The US Food and Drug Administration (FDA) has granted priority review for Roche’s Perjeta in combination with Herceptin and chemotherapy to treat HER2-positive early breast cancer after surgery.

Merck, Pfizer get EC approval for skin cancer drug Bavencio

Merck and Pfizer have secured the approval of their skin cancer drug Bavencio (avelumab) from the European Commission (EC) as a monotherapy for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults.

Pfizer announces outcome of FDA’s ODAC meeting for SUTENT in patients at high risk of recurrent renal cell carcinoma after surgery

Pfizer announced that the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney).

Ipsen gets EC approval for Xermelo to treat carcinoid syndrome diarrhea

Ipsen announced that the European Commission (EC) has approved Xermelo (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.

FDA grants orphan drug status for Motif Bio’s Staphylococcus Aureus lung treatment

The US Food and Drug Administration (FDA) has granted Motif Bio's investigational drug candidate, iclaprim, orphan drug designation to treat of Staphylococcus aureus lung infections in patients with cystic fibrosis.

CHMP recommends GSK, Innoviva’s single inhaler triple therapy for COPD

GlaxoSmithKline (GSK) and Innoviva announced that a committee of the European Medicines Agency (EMA) has adopted positive opinion for fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) in treating chronic obstructive pulmonary disease (COPD) in adults.

Boehringer Ingelheim receives positive CHMP opinion for adalimumab biosimilar Cyltezo

Boehringer Ingelheim announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorisation Application of Cyltezo (adalimumab biosimilar), to treat multiple chronic inflammatory diseases in adults and children.

FDA approves biosimilar of Avastin to treat five types of cancer

Amgen and Allergan have secured approval from the US Food and Drug Administration (FDA) for Mvasi (bevacizumab-awwb), a biosimilar to Roche's Avastin, to treat five types of cancer.