When Amgen Inc.'s Blincyto (blinatumomab) gained accelerated approval from the FDA in December to treat patients with relapsed or refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, or B-cell ALL, the compound turned a new chapter in drug development, heralding the arrival of bispecific antibodies. Read More
Going it alone with the oral, once-daily factor Xa inhibitor betrixaban, for which Merck & Co. Inc. handed back rights in 2011, Portola Pharmaceuticals Inc. marches ahead, following a pre-specified futility analysis by the APEX phase III trial's monitoring board. Read More
HYDERABAD, India – If it can overcome some significant hurdles, India could emerge as a major developer of biosimilars in the coming years, said industry players speaking at the largest annual meeting of biotech companies here. Read More
Ohr Pharmaceutical Inc. is raising $25 million to fund dual pivotal phase III studies of its Lucentis-boosting eye drops, OHR-102 (squalamine), in newly diagnosed patients with AMD. Read More
In an effort to standardize the information consumers get about prescription drugs and make it more understandable, the FDA is revising its 2004 draft guidance on how drugmakers should communicate risk information in print ads and promotional labeling. Read More
HONG KONG – A Chinese clinical trial site management organization (SMO) is getting into monoclonal antibodies (MAbs) after acquiring the global development and licensing rights of drug candidates developed by Chinese academic researchers. Read More
HONG KONG – Japanese researchers have for the first time successfully induced human embryonic stem cells to self-organize into a functional three-dimensional structure similar to the cerebellum, providing clues on how to recreate neural structures in the laboratory and potentially leading to new drug discoveries. Read More
BEIJING – Representatives from 100 Chinese pharma and biotech companies recently participated in a technology transfer conference, with "Chinese characteristics": In between name card speed exchanges, the organizers exhorted attendees to improve the quality of domestic drug innovation. Read More
Oncothyreon Inc., of Seattle, priced concurrent but separate underwritten offerings of 13.5 million common shares at $1.50 apiece, for expected proceeds of approximately $20 million, and 1,333 shares of its series B convertible preferred stock at $1,500 apiece, for expected proceeds of about $2 million. Read More
Adimab LLC, of Lebanon, N.H., signed a multitarget discovery and optimization collaboration with Sanofi SA, of Paris, to pursue bispecific molecules against multiple targets. Read More
strong>Dermira Inc., of Menlo Park, Calif., reported positive phase IIb results for DRM04, its topical anticholinergic product, in patients with axillary hyperhidrosis, or excessive underarm sweating. The company conducted an initial phase IIb study (DRM04-HH01) of a topical formulation of an anticholinergic reference agent approved for systemic administration in other indications. Read More
Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, said the European Commission approved a variation to the marketing authorization for Velcade (bortezomib) in the additional indication of previously untreated mantle cell lymphoma in adults who are not suited for blood stem cell transplantation, in combination with Rituxan (rituximab, Biogen Idec Inc./Roche AG), cyclophosphamide, doxorubicin and prednisone. Read More
Researchers from the University of Massachusetts have reported that the innate immune system signaling molecule (STING) plays a role in the autoimmune disease systemic lupus erythematosus (lupus). Innate immune signaling, including STING signaling itself, can be behind several other autoimmune disorders. Read More
