Selected third quarter product approvals.



Actelion Ltd. (SIX:ATLN)

FDA approves Valchlor mechlorethamine to treat stage IA and IB mycosis fungoides, a type of cutaneous T cell lymphoma (CTCL)

Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR)

EC approves Lojuxta lomitapide to treat homozygous familial hypercholesterolemia (hoFH)

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN)

Japan approves Soliris eculizumab to treat atypical hemolytic uremic syndrome (aHUS)

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA)

EC approves Iclusig ponatinib to treat chronic myelogenous leukemia (CML) and Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia (ALL)

Astellas Pharma Inc. (Tokyo:4503)

FDA approves Astagraf XL tacrolimus extended-release capsules to prevent organ rejection in adult kidney transplant recipients

Bavarian Nordic A/S (CSE:BAVA)

EC approves Imvanex smallpox vaccine for active immunization against smallpox disease for the general adult population, including those with weakened immune systems

Bayer AG (Xetra:BAYN)/Amgen Inc. (NASDAQ:AMGN)

EC approves Stivarga regorafenib to treat metastatic colorectal cancer (mCRC) in adults who have

been previously treated with or who are not considered candidates for available therapies. Onyx Pharmaceuticals Inc., now part of Amgen, has U.S. co-promotion rights and is eligible for royalties on worldwide sales

bioMerieux S.A. (Euronext:BIM)

FDA approves Vitek MS for the automated identification of bacteria and yeasts that are known to cause serious illness in humans

Boehringer Ingelheim GmbH/Qiagen N.V. (Xetra:QIA; NASDAQ:QGEN)

FDA approves Boehringer's Gilotrif afatinib as a first-line treatment for metastatic non-small cell

lung cancer (NSCLC) in patients with an EGFR mutation as detected by an FDA-approved test.

FDA concurrently approves Qiagen's companion diagnostic, therascreen EGFR Mutation Kit, to identify patients with EGFR mutation-positive tumors.

Celgene Corp. (NASDAQ:CELG)

FDA approves a label expansion for Abraxane nab-paclitaxel to include first-line treatment of advanced pancreatic cancer in combination with gemcitabine

Celgene Corp. (NASDAQ:CELG)/Johnson & Johnson (NYSE:JNJ)

EC approves Imnovid pomalidomide to treat relapsed and refractory multiple myeloma (MM)

Celltrion Inc. (KOSDAQ:068270)/Hospira Inc. (NYSE:HSP)

EC approves Inflectra/Remsima infliximab, a biosimilar of Remicade infliximab, to treat multiple inflammatory conditions

Curis Inc. (NASDAQ:CRIS)/Genentech Inc./Roche (SIX:ROG; OTCQX:RHHBY)

EC approves Erivedge vismodegib to treat adults with symptomatic metastatic or locally advanced basal cell carcinoma (BCC) for whom surgery or radiotherapy are considered inappropriate

Dendreon Corp. (NASDAQ:DNDN)

EC approves Provenge sipuleucel-T to treat asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (CRPC) when chemotherapy is not yet clinically indicated

Forest Laboratories Inc. (NYSE:FRX)/Laboratoires Pierre Fabre S.A.

FDA approves Fetzima levomilnacipran to treat major depressive disorder (MDD)

Furiex Pharmaceuticals Inc. (NASDAQ:FURX)/Takeda Pharmaceutical Co. Ltd. (Tokyo:4502)

EC approves Incresync alogliptin/pioglitazone as second- or third-line treatment for Type II diabetes in patients who are inadequately controlled on existing therapies or for whom other therapies are contraindicated

Furiex Pharmaceuticals Inc. (NASDAQ:FURX)/Takeda Pharmaceutical Co. Ltd. (Tokyo:4502)

EC approves Vipdomet alogliptin/metformin to treat Type II diabetes in patients who are inadequately controlled on metformin, Actos pioglitazone and metformin or insulin and metformin