2Q approvals

Selected second quarter clinical and regulatory approvals.



Algeta ASA (OSE:ALGETA)/Bayer AG (Xetra:BAYN)

FDA approves Xofigo radium-223 dichloride to treat castration-resistant prostate cancer (CRPC) in patients with symptomatic bone metastases

Astellas Pharma Inc. (Tokyo:4503)

The Netherlands approves Vesomni solifenacin/tamsulosin (EC905) to treat moderate to severe storage symptoms and voiding symptoms associated with benign prostatic hyperplasia (BPH)

Astellas Pharma Inc. (Tokyo:4503)

FDA approves a label expansion for Tarceva erlotinib to include first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) and EGFR-activating mutations

Avanir Pharmaceuticals Inc. (NASDAQ:AVNR)

EC approves Nuedexta dextromethorphan/quinidine to treat pseudobulbar affect (PBA)

Baxter International Inc. (NYSE:BAX)

EC approves HyQvia as replacement therapy for adults with primary immunodeficiencies. The product is a subcutaneous formulation of IV Gammagard and recombinant human PH20 hyaluronidase enzyme (rHuPH20)

Baxter International Inc. (NYSE:BAX)

FDA approves Rixubis recombinant Factor IX (rFIX) to treat hemophilia B in patients 16 years of age or older

Bayer AG (Xetra:BAYN)

EC approves 2.5 mg twice-daily Xarelto rivaroxaban to prevent atherothrombotic events in combination with standard antiplatelet therapy after acute coronary syndrome (ACS) in adults with elevated cardiac biomarkers

BioAlliance Pharma S.A. (Euronext:BIO)

FDA approves Sitavig acyclovir Lauriad to treat recurrent orofacial herpes

bioMerieux S.A. (Euronext:BIM)/GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

FDA approves companion diagnostic THxID BRAF test to detect BRAF V600E and V600K mutations. The product was approved with GSK's Mekinist trametinib and Tafinlar dabrafenib to treat metastatic or unresectable melanoma

Bristol-Myers Squibb Co. (NYSE:BMY)/Ono Pharmaceutical Co. Ltd. (Tokyo:4528; Osaka:4528)

Japan approves subcutaneous Orencia abatacept to treat rheumatoid arthritis (RA)

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519)/Roche (SIX:ROG; OTCQX:RHHBY)

Japan approves Perjeta pertuzumab to treat HER2-positive inoperable or recurrent breast cancer


FDA approves Kcentra 4-factor prothrombin complex concentrate for the urgent reversal of anticoagulation with vitamin K antagonist therapy, including warfarin, in adults with acute major bleeding

Gilead Sciences Inc. (NASDAQ:GILD)

EC approves Stribild elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate to treat HIV-1 infection in treatment-naïve adults or adults without mutations associated with resistance to the antiviral agents in the product

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)

FDA approves Tafinlar dabrafenib to treat metastatic or unresectable melanoma with a BRAF V600E mutation