Regulation

Pharming submits supplemental BLA to FDA for Ruconest for prophylaxis of hereditary angioedema attacks

Pharming Group has submitted a supplemental biologics license application (BLA) to the US Food and Drug Administration (FDA) for Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema (HAE).

European Commission approves Tremfya to treat moderate to severe plaque psoriasis

Janssen-Cilag International announced that the European Commission (EC) has approved Tremfya (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

FDA approves ViiV Healthcare’s two-drug regimen to treat HIV-1 infection

Specialist HIV firm ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its two-drug regimen (2DR) Juluca to treat certain adults with human immunodeficiency virus type 1 (HIV-1).

UK regulator accuses Concordia of overcharging NHS for thyroid drug

The UK Competition and Markets Authority (CMA) has accused Canadian pharma company Concordia International of abusing its dominant position by increasing the price of a thyroid drug by about 6,000%.

Samsung Bioepis’ trastuzumab biosimilar gets EC approval for breast cancer

The European Commission (EC) has approved Samsung Bioepis' Ontruzant, a biosimilar version of Genentech’s Herceptin (trastuzumab), for the treatment of breast cancer in early and metastatic stages and also for metastatic gastric cancer.

Roche’s Hemlibra secures FDA approval for hemophilia A with inhibitors

Roche’s Hemlibra (emicizumab-kxwh) has been approved by the US Food and Drug Administration (FDA) for routine prophylaxis to prevent or reduce frequency of bleeding episodes in patients with hemophilia A who have factor VIII inhibitors.

Sprycel approval expanded to include treatment of children with Ph+ CML in chronic phase

The US Food and Drug Administration (FDA) has expanded the indication for Bristol-Myers Squibb’s Sprycel (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).

Merck gets FDA approval for Prevymis to prevent CMV infection and disease in adult allogeneic stem cell transplant patients

Merck has announced that the US Food and Drug Administration (FDA) has approved Prevymis (letermovir) once-daily tablets for oral use and injection for intravenous infusion.

Roche secures FDA approvals for cancer drugs Zelboraf and Alecensa

Roche has secured approvals from the US Food and Drug Administration (FDA) for its blood cancer drug Zelboraf (vemurafenib) and lung cancer drug Alecensa (alectinib).