to formulate CytoDyn's PRO 140 bulk drug substance through a fill-and-finish process for clinical-ready vials to advance two National Institutes of Health (NIH)-funded Phase IIb studies...The goal is to validate emerging epigenetic targets for oncology indications and to demonstrate the eligibility of selected target families for drug formalations

The label now carries a boxed warning, advising patients that discontinuing treatment puts them at increased risk of stroke, and the postmarketing experience section was updated to include thrombocytopenia...Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anticoagulation effect and stop the bleeding...NextBio, of Santa Clara, Calif., said it inked a multiyear collaboration with Paris-based Sanofi SA aimed at using NextBio Clinical to incorporate patient

Merck will continue to retain rights to its existing portfolio of sitagliptin-containing products...The first suit pertains to a previously disclosed investigation into discounts and rebates to specialty pharmacies for Myfortic

Celgene Corp., of Summit, N.J., said the European Committee for Medicinal Products for Human Use adopted a positive opinion for Revlimid (lenalidomide) for the treatment of patients with transfusion-dependent anemia due to low or intermediate-1 risk myelodsyplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate...One company, referred to as Royalty Management Co., will focus on managing all development and

Pfizer Inc., of New York, said the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion for Xeljanz (tofacitnib citrate) for the treatment of adults with moderate to severe active rheumatoid arthritis...Pfizer intends to appeal the opinion and seek a re-examination by CHMP

It does not bind to blood coagulation factors or other blood proteins...The acquisition had been expected to be completed on Thursday, making Obagi a wholly owned subsidiary of Valeant

In separate news, another Galapagos unit, Argenta, inked a deal with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to apply its respiratory drug discovery services to an undisclosed target within Boehringer's respiratory disease portfolio...In other news, BioInvent said the first patient has been treated in a Phase II study of BI-505 for smoldering multiple myeloma, or asymptomatic myeloma

for the Brisbane, Australia-based company's Diversity Scanning Array (DSA) and Versatile Assembly on Stable Templates (VAST) technologies in a deal worth up to $240 million in milestones, plus other payments...to conduct a review of merger and acquisition opportunities. (See BioWorld Today, Feb. 1, 2013...It expects to launch the product in Canada, and a number of Central American, South American and Asian countries in 2014 and 2015

BD Rx Inc., of Franklin Lakes, N.J., a wholly owned subsidiary of Becton, Dickinson and Co., reported that the FDA has approved its metoclopramide injection, the second drug to be offered in the recently launched BD Simplist line of prefilled generic injectables...The drug is in Phase III trials as an adjunctive therapy to levodopa...The two companies will collaborate on additional hit-to-lead and lead optimization for two new molecules, with the work taking place at AMRI's laboratories

Net proceeds will be used to complete a Phase II Squalamine eye drop clinical trial for the wet form of age-related macular degeneration, to further the clinical development of the eye drops for the treatment of other neovascular ophthalmic disorders, to fund development of other pipeline molecules, and for general corporate purposes

Inc., of Whitehouse Station, N.J., entered into a nonexclusive deal with Bristol-Myers Squibb Co., of New York, to conduct a Phase II trial of a once-daily oral combination regimen consisting of BMS' NS5A replication complex inhibitor daclatasvir and Merck's NS3/4A protease inhibitor MK-5172 to treat chronic hepatitis C virus infection genotype 1

headquarters in Plainsboro, N.J. The building is part of a $225 million public/private redevelopment project, which used an existing structure and sustainable materials to limit environmental impact

However, there was some promising news to help give the sector a lift going into that meeting...According to Credit Suisse analyst Ravi Mehrotra writing in a research note, "We do not think that we are in a 'biotech bubble,' given that the drivers of the biotech sector's YTD performance are very different from those in '99/'00...Editor's Note: The BioWorld editorial team will be providing comprehensive coverage of BIO 2013 in the daily issues of BioWorld Today.

resulting in an estimated 20 percent increase in EMD Serono's employee base from last July to the end of 2014

Addex said it plans to start a Phase IIa study of dipraglurant in a rare dystonia indication in the first half of this year...OPKO also said it is partnering with Pharmsynthez to develop and market several OPKO products for sale in Russia and certain other Eastern European countries...The assets are to be acquired in exchange for the satisfaction and discharge of $15 million outstanding under the secured notes

The news also adds to the growing fear that biosimilar drug development will prove trickier – and, perhaps costlier – than previously envisioned...Among the other players include Novartis AG, Boehringer Ingelheim, Samsung Biologics and Teva Pharmaceuticals Industries Ltd

In separate news, another Galapagos unit, Argenta, inked a deal with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to apply its respiratory drug discovery services to an undisclosed target within Boehringer's respiratory disease portfolio

Eli Lilly and Co., of Indianapolis, said it acquired two positron emission tomography tracers from Siemens Medical Solutions intended to image tau tangles in the brain, one of two known hallmarks of Alzheimer's disease

The funding will be used to formulate antigens using Immunovaccine's DepoVax adjuvant technology...The company is expected to roll out the drug to pharmacies within 90 days. (See BioWorld Today, Oct. 23, 2012, and March 27, 2013