With a Phase III study on its lead investigational product, CPX-351 (cytarabine:daunorubicin) liposome Injection, currently enrolling patients, Princeton, N.J.-based Celator Pharmaceuticals Inc. said it raised $32.5 million to support the trial. The private placement of common stock and warrants to purchase common stock represents a final closing, which generated a total of $39.3 million, including $6.8 million from prior closings, The financing, the company expects, will fully fund the Phase

The slow pace of progress is wearing on the SEC's Advisory Committee on Small and Emerging Companies as it waits for the commission to move on recommendations it's suggested to help small companies get the capital they need to grow and create jobs. Meeting for the fourth time to sort through possible relief routes for small companies struggling to stay afloat in an inhospitable public market, the committee acknowledged that "it takes a while to move the beast." The SEC is considering the

Almirall SA, of Barcelona, Spain, and Forest Laboratories Inc., of New York, reported positive topline results from AUGMENT COPD, the second six-month pivotal Phase III trial evaluating the efficacy and safety of investigational fixed-dose combinations of aclidinium bromide (LAMA) and formoterol fumarate (LABA), delivered in the Pressair (Genuairn outside the U.S.) inhaler. The 400/12 mcg combination of aclidinium/formoterol demonstrated statistically significant improvements in change from

Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted a breakthrough therapy designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD. Janssen Biotech Inc. and the Danish company Genmab A/S entered an agreement, which granted Janssen an exclusive

Actavis Inc., of Parsippany, N.J., and Valeant Pharmaceuticals International Inc., of Montreal, said Actavis Specialty Brands has acquired worldwide rights to Valeant's metronidazole 1.3 percent vaginal gel antibiotic, a topical antibiotic for the treatment of bacterial vaginosis. Under terms of the agreement, Actavis Specialty Brands is acquiring the product for about $55 million, which includes up-front and certain milestone payments, and minimal royalties for the first three years of

One of the most basic ways to classify neurons is by the transmitter they use to communicate. And that transmitter was long thought to be "immutable," Davide Dulcis told BioWorld Today. One dogma of neuroscience has long been that "no matter what you do to a neuron, once it's GABAergic, dopaminergic or what have you, it's not going to change for the rest of its life." Over the past few years, however, it has become clear that neurons can and do change the transmitters they use to communicate

The FDA put some lift under the wings of Raptor Pharmaceutical Corp., approving the orphan drug Procysbi (RP103, cysteamine bitartrate delayed-release) on its PDUFA date in the initial indication of nephropathic cystinosis (NC). The metabolic disorder primarily affects children, causing systemic toxic cystine accumulation and leading to progressive and irreversible tissue damage and multiple organ failure. The drug was approved for adults and children 6 and older, who account for 90 percent of

Addex Therapeutics SA, of Geneva, disclosed positive preclinical data for its GABAB receptor-positive allosteric modulator in a rodent model of chronic alcohol dependence. The Addex alcoholism candidate, ADX71441, demonstrated robust and dose-dependent suppression of alcohol intake in animals lasting 24 hours. ADX71441 is an oral small molecule, with potential for once-daily dosing. Ascletis Inc., of Hangzhou, China, licensed the development, manufacturing and commercialization rights to

SAN FRANCISO – One-third of all biotechnology deals in 2012 were for oncology assets, according to Deloitte Recap LLC, a higher percentage than any other therapeutic area. Cancer is a very appealing indication for biotech product development because of shorter development timelines, faster approvals and premium pricing. However, the bar is rising for clinical performance, and there are signs the honeymoon is over for the $100,000-per-year cancer therapy. A panel of experts at Deloitte's

Oxford BioTherapeutics (OBT) Ltd. entered a target validation deal with Boehringer Ingelheim GmbH that will offer near-term revenues, with the added prospect of long-term development milestones and product royalties. The shape of the deal is markedly different from the headline-grabbing pact involving five antibody and antibody-drug conjugate (ADC) programs it entered last year with Menarini Group, of Florence, Italy. (See BioWorld Today, Oct. 30, 2012.) That deal is focused on what for OBT

The possibility of an initial public offering (IPO) – noted in December, when Regado Biosciences Inc. collected $51 million in a Series E financing intended to help fund Phase III trials – moved closer to reality, as the firm filed a registration statement to trade on Wall Street. Regado, of Basking Ridge, N.J., did not specify in the paperwork the number of shares nor the proposed price range in the IPO, and a spokesperson said the firm's quiet period prevents further comment. The IPO could

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said prescribing information for Pradaxa (dabigatran etexilate), an oral anticoagulant for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation was updated. 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. The label also now includes data from

Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., reported updated median overall survival data from an ongoing Phase II trial of oral sapacitabine in older patients with intermediate-2 or high-risk myelodysplastic syndromes after treatment failure of front-line hypomethylating agents. Median overall survival to date for all 63 patients treated is about nine months, while median overall survival for each of the three randomization schedules is about 10 months for arm G, 10 months for

Shares of AVEO Oncology Inc. plummeted to historic lows Tuesday with the realization that the company may have to conduct a second Phase III trial before the FDA considers approving tivozanib to treat advanced renal cell carcinoma (RCC). In its heaviest trading since going public in March 2010, shares of the Cambridge, Mass.-based biotech (NASDAQ:AVEO) dropped to an all-time low, closing Tuesday at $5.11, down $2.33, or 31.3 percent. Prior to Tuesday's fall, which saw more than 10 million

The following data were reported from European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Berlin: Pfizer Inc., of New York, presented results from a Phase III study investigating immunogenicity, tolerability and safety of Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults 18 to 49. The study met all primary and secondary objectives and provided the clinical foundation for the company's regulatory submission in the

Merck & Co. Inc., of Whitehouse Station, N.J., and Pfizer Inc., of New York, have entered a worldwide (except Japan) collaborative agreement for the development and commercialization of Pfizer's ertugliflozin (PF-04971729), an investigational oral sodium glucose co-transporter (SGLT2) inhibitor being evaluated for the treatment of Type II diabetes. Ertugliflozin is Phase III-ready, with trials expected to begin later in 2013. Under terms of the agreement, Merck, through a subsidiary, and Pfizer

BioLineRx Ltd., of Jerusalem, said the first patient was enrolled in a Phase I/II trial of BL-8020, an orally available, interferon-free treatment for hepatitis C virus (HCV). The open-label trial will evaluate efficacy, safety and tolerability at two sites in France, enrolling up to 32 HCV-infected patients of any genotype who previously failed or relapsed following standard-of-care treatment. The primary endpoint is to evaluate the effect of the 16-week combination therapy, comprised of