Teva Pharmaceutical Industries Ltd., the world's largest generic drugmaker, put an end to speculation about its interest in acquiring Mylan NV on Tuesday, making a $40.1 billion bid for the generics heavyweight, valuing it at $82 per share in a half cash, half stock offer. Read More
WASHINGTON – Alnylam Pharmaceuticals Inc. used the forum of the American Academy of Neurology's (AAN) 67th annual meeting to disclose 12-month data from its ongoing phase II open-label extension (OLE) study of patisiran to treat transthyretin (TTR)-mediated amyloidosis in patients with familial amyloidotic polyneuropathy (FAP). Read More
Dimension Therapeutics Inc.'s $65 million series B financing lets the firm push its adeno-associated virus (AAV) platform and the growing pipeline of gene therapy programs. Read More
SHANGHAI – Any discussion of innovative biologics at the recent Chinabio Forum inevitably brought up biosimilars; it is difficult to have one without the other, probably because local companies of any size or staying power developing biologics take that twin strategy, filling their pipelines with biosimilars, whether me-too or bio-better, along with a smattering of novel candidates. Read More
Inhibiting poly (ADP-ribose) polymerase, or PARP, has proved its mettle against cancers with germline BRCA mutations such as in ovarian cancer, for which Astrazeneca plc's Lynparza (olaparib) gained approval late last year. Read More
LONDON – Taking the EMA's advice on trial design is both voluntary and costly, but a new analysis shows that doing so vastly increases the likelihood of getting marketing approval. Read More
Reflecting its "current thinking," the FDA released final guidance Tuesday on efficacy endpoints for clinical trials of non-small-cell lung cancer (NSCLC) drugs. Read More
BOGOTA, Colombia – A visit by Agustin Laje to Beijing earlier this month has helped cement ties between Cuba and China, particularly in terms of exploring biotech opportunities. Read More
Horizon Pharma plc, of Dublin, closed an underwritten public offering of about 17.7 million shares priced at $28.25 each. Including a full exercise by the underwriters of their option to purchase up to 2.3 million additional ordinary shares, Horizon raised about $475.2 million in net proceeds. Read More
Genvec Inc., of Gaithersburg, Md., said it entered a collaboration agreement with the Laboratory of Malaria Immunology and Vaccinology (LMIV) of the National Institute of Allergy and Infectious Diseases. Read More
Blend Therapeutics Inc., of Watertown, Mass., presented preclinical data showing that BTP-114, a personalized cisplatin prodrug, improved and sustained tumor growth inhibition in models, as compared to the conventional platinum cytotoxic drug. Read More
Delcath Systems Inc., of New York, disclosed approval of amendments to its clinical trial authorizations filed with the UK's Medicines and Healthcare Products Regulatory Agency and Germany's Federal Institute for Drugs and Medical Devices for the expansion of the company's global phase II Melphalan/HDS program for the treatment of patients with unresectable hepatocellular carcinoma to include a cohort of patients with intrahepatic cholangiocarcinoma. Read More
Pfizer Inc., of New York, said Xalkori (crizotinib) has been designated a breakthrough therapy by the FDA to potentially treat patients with ROS1-positive non-small-cell lung cancer (NSCLC), which occurs in about 1 percent of NSCLC cases. Read More
Pfizer Inc., of New York, said its phase III study of inotuzumab ozogamicin met its first primary endpoint of demonstrating a higher complete hematologic remission rate in adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL) compared to that achieved with standard-of-care chemotherapy. Read More
