Regulation

Bayer secures approval in EU for Xarelto for patients with coronary or peripheral artery disease

The European Commission (EC) has approved a combination of Xarelto (rivaroxaban) 2.5mg twice daily plus low dose aspirin (acetylsalicylic acid/ASA) once daily for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral arterial disease (PAD) at high risk of ischaemic events.

FDA approves Shire’s hereditary angioedema drug Takhzyro

Shire has secured approval from the US Food and Drug Administration (FDA) for Takhzyro (lanadelumab-flyo) injection as a preventative treatment of hereditary angioedema (HAE) in patients 12 years of age and older.

FDA approves Dompé’s Oxervate to treat neurotrophic keratitis

Dompé has secured approval from the US Food and Drug Administration (FDA) for its Oxervate (cenegermin-bkbj ophthalmic solution) to treat neurotrophic keratitis (NK).

Roche’s lung cancer drug Alecensa secures approval in China

Roche has secured marketing authorization from the China National Drug Administration (CNDA) for its Alecensa (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive and advanced non-small cell lung cancer (NSCLC).

FDA approves Bristol-Myers’ Opdivo to treat metastatic SCLC

The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb's (BMS) Opdivo as the first and only immuno-oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.

Merck, Eisai win FDA approval for Lenvima to treat unresectable HCC

Merck and Eisai have secured approval from the US Food and Drug Administration (FDA) for kinase inhibitor Lenvima (lenvatinib) as the first-line treatment for patients with unresectable hepatocellular carcinoma (HCC).

FDA approves Sun Pharma’s CEQUA for treatment of dry eye disease

Sun Pharmaceutical Industries has secured approval for its dry eye disease treatment CEQUA (cyclosporine ophthalmic solution) 0.09%, from the US Food and Drug Administration (FDA).

Onspira’s bronchiolitis obliterans treatment secures FDA orphan drug status

Onspira Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its investigational product, OSP-101, to treat Bronchiolitis Obliterans (BO).

AHF files review petition with US Supreme Court on Gilead AIDS drug patent case

AIDS Healthcare Foundation (AHF) has filed a petition for writ of certiorari (a petition for review) with the Supreme Court of the US, seeking the Court’s review of the dismissal of a federal lawsuit filed by AHF in January 2016 against Gilead Sciences and other defendants alleging its patent for a key HIV/AIDS drug, tenofovir alafenamide (TAF) is invalid because Gilead manipulated the patent system.