Regulation

Amgen’s Repatha approved by FDA for heart attack and stroke prevention

Amgen’s cholesterol drug Repatha (evolocumab) has been approved by the US Food and Drug Administration (FDA) to prevent heart attacks, strokes and coronary revascularizations in adults having cardiovascular disease.

Indivior’s Sublocade secures FDA approval to treat opioid use disorder

Indivior’s Sublocade (buprenorphine extended- release) injection has been approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe opioid use disorder (OUD).

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).