Days after the FDA approved the blockbuster Lucentis (ranibizumab injection) in a fourth indication – diabetic retinopathy (DR) in patients with diabetic macular edema (DME) – up-and-comer Pfenex Inc. inked a deal with global giant Hospira Inc. to advance its biosimilar competitor, PF582. Read More
Anthera Pharmaceuticals Inc.'s blisibimod, a peptibody that targets B-cell activating factor (BAFF) for lupus, slid past the interim futility analysis in the phase III trial CHABLIS-SC1, sending shares on an upward ride that ended Tuesday with the stock (NASDAQ:ANTH) closing at $3.25. Read More
DUBLIN – The EU published a new legal text outlining proposals on regulatory cooperation with the U.S. under the Transatlantic Trade and Investment Partnership (TTIP), a comprehensive free trade agreement currently under negotiation. Read More
Researchers have developed a chemically modified form of insulin whose activity depends, to a degree, on blood sugar levels. They hope their "smart" insulin will allow better blood sugar control for diabetes patients. Read More
NEW YORK – "It's probably not an exaggeration to say there's a lot of hype" surrounding the microbiome space, noted Mark Breidenbach, of H.C. Wainwright & Co., who moderated a panel on the subject at the annual BIO CEO & Investor Conference. Read More
HONG KONG, China – As Genor Biopharma Co. Ltd. prepares to move forward with clinical trials for biosimilar Remicade (infliximab, Johnson & Johnson) along a traditional regulatory pathway, regulators in China are still considering an approval pathway specific to biosimilars. Read More
Looking to the tax reform lessons of the past to move forward, the U.S. Senate Finance Committee gazed into the rear view mirror Tuesday at the Reagan years as they picked the brains of former Sens. Bob Packwood (R-Ore.) and Bill Bradley (D-N.J.) for ideas on how to make the U.S. tax code simpler, fairer and more equitable. Read More
strong>Bind Therapeutics Inc., of Cambridge, Mass., closed its previously announced public offering of 3.74 million units at the public offering price of $5.75 per unit, raising $21.5 million. Read More
Amicus Therapeutics Inc., of Cranbury, N.J., said results from preclinical studies of its next-generation Pompe enzyme replacement therapy (ERT) were featured at WorldSymposium 2015 in Orlando, Fla., and that they support clinical development of ATB200 in combination with a chaperone. Read More
Upsher-Smith Laboratories Inc., of Maple Grove, Minn., received an AB (therapeutic equivalent) rating from the FDA for its previously approved Vogelxo (testosterone) gel 1 percent unit-dose tubes and packets. Read More
Amag Pharmaceuticals Inc., of Waltham, Mass., reported that total revenues for the fourth quarter ended Dec. 31, 2014, were 145 percent greater than for the same period in 2013, driven by increased sales of Feraheme (ferumoxytol) Injection and the addition of Makena (hydroxyprogesterone caproate injection) sales following the closing of the acquisition of Lumara Health in November. Read More
Forum Pharmaceuticals Inc., of Watertown, Mass., dosed the first patient in a phase IIa proof-of-mechanism trial to evaluate FRM-0334 in patients with the ultra-orphan rare disease frontotemporal dementia with granulin mutation (FTD-GRN), an early onset and rapidly progressive neurodegenerative brain disorder that can affect behavior, cognition, language and motor skills. Read More
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, reported that the randomized, double-blind, placebo-controlled TOURMALINE-MM1 pivotal phase III trial evaluating the safety and efficacy of ixazomib, the first oral proteasome inhibitor, conducted in patients with relapsed or refractory multiple myeloma (MM) achieved its primary endpoint of improving progression-free survival at the first pre-specified interim analysis. Read More
The FDA finalized guidance this week about developing drugs to treat complicated intra-abdominal infections (cIAI). The guidance, published in Tuesday's Federal Register, discusses the development program and clinical trial designs recommended to support a cIAI indication. Read More
