FDA approval of Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME) gives the longstanding eye treatment breathing room in an increasingly crowded ophthalmologic market.
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.
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.
In a deal that could reshape the landscape for the emerging biosimilars drug class, New York-based Pfizer Inc. agreed to acquire Hospira Inc. for $90 per share in cash, or a deal valued at approximately $17 billion.
Onconova Therapeutics Inc. delivered two pieces of information to the Street after Monday's market close, and neither sat particularly well with investors. The Newtown, Pa.-based biotech said it firmed up plans to conduct a phase III trial with the intravenous (I.V.) formulation of rigosertib in patients with higher-risk myelodysplastic syndrome (HR-MDS) who failed treatment with hypomethylating agents (HMAs).
A pair of papers in the February 2015 issue of Health Affairs shone a harsh spotlight on seemingly disparate, but ultimately related topics: falling revenues from approved drugs and the challenges facing uptake of biosimilars.
Can life get any better for Biogen Idec Inc.? Growth in the company's multiple sclerosis (MS) franchise, led by Tecfidera (dimethyl fumarate), and keen interest in an early stage Alzheimer's disease (AD) candidate propelled the big biotech's shares (NASDAQ:BIIB) Friday to a 52-week high of $397.
The FDA expanded the approved use of Imbruvica (ibrutinib), more than two months ahead of its PDUFA date of April 17, as the first therapy indicated to treat patients with Waldenström's macroglobulinemia (WM), a rare type of B-cell lymphoma. The approval represents the fourth indication for Imbruvica, developed jointly by Pharmacyclics Inc. and Johnson & Johnson (J&J) unit Janssen Biotech Inc.
The $49.5 million initial public offering (IPO) by drug-device maker Zosano Pharma Corp. was modest by comparison to 2014 blockbusters by the likes of Juno Therapeutics Inc. and Kite Pharma Inc.
