Risk-shy investors who'd rather bank on approved products make up Capital Royalty L.P.'s second fund, $805 million worth of private equity for betting in increments of between $20 million and $200 million, though the amounts could go higher. "There are very good early stage venture capitalists," such as Avalon Ventures, said Luke Düster, principal with Capital. "But, as the pathway to approval under the FDA becomes longer and more expensive, it requires either a significant amount of long-term

LONDON – Symphogen A/S has taken in a further €41 million (US$54.1 million) as an extension to an earlier €100 million round agreed in 2011, bringing the total raised to $185 million. "For a private biotech, it's a pleasure to have more than €100 million," said Kirsten Drejer, CEO. The extra funding will be used "to extend the runway, not to add more programs," she told BioWorld Today. The spur for raising more money was the validation of Symphogen's antibody mixtures technology in a $632

Less than a year after licensing constipation drug elobixibat from Swedish biotech Albireo AB, Ferring Pharmaceuticals SA initiated enrollment in two Phase III trials of the investigational compound in chronic idiopathic constipation (CIC). The randomized, double-blind studies, Echo 1 and Echo 2, will be conducted at nearly 200 sites worldwide and will enroll approximately 1,700 patients, aiming to demonstrate the efficacy and safety of repeated daily doses of elobixibat against placebo over a

Titan Pharmaceuticals Inc. expressed surprise and disappointment after receiving a complete response letter (CRL) late Tuesday from the FDA for investigational drug Probuphine, a subdermal implant designed for the maintenance treatment of opioid dependence in adults. The reaction may have been warranted, however. At first blush, the CRL appeared to have all the trappings of an ambush. The South San Francisco-based company said the CRL requested additional clinical data demonstrating both the

Much aging research has approached its subject by looking at the molecular processes that drive or slow down aging in individual cells. Sirtuin research is one example, as are investigations into telomeres or the aging marker p16ink4a. (See BioWorld Today, March 25, 2011, and Dec. 27, 2011.) But such studies beg one fundamental question of aging: how tissues do it in concert. Does aging happen at the same time throughout the body because the cells in a living being get their start at the same

Biopharma firms that are working on medical countermeasures (MCMs) to combat radiation exposure are looking to a joint FDA advisory committee meeting Friday to help define a path for development of treatments for use in radiological or nuclear events. Members of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee will discuss whether data from a National Institute of Allergy and Infectious Disease (NIAID)-sponsored study, which showed that the addition to

SAN FRANCISCO – When AiCuris GmbH, of Wuppertal, Germany, analyzed the market for human cytomegalovirus therapies, it found a market with high medical need, neglected by big pharma, featuring a variety of disease manifestations. The market had also fallen under the radar of payers, all resulting in low competition, with the potential for high prices and low marketing and sales costs, according to Helga Rubsamen-Schaeff, AiCuris CEO. In her presentation for a panel featuring the nominees for

Vertex Pharmaceuticals Inc., of Cambridge, Mass., reported total first-quarter 2013 revenues of $328 million, including net product revenues of $206 million from Incivek (telaprevir) and $62 million from Kalydeco (ivacaftor), launched in the U.S. in February 2012. The company's GAAP net loss was $308 million, or $1.43 per share, for the first quarter of 2013. The first-quarter 2013 net product revenues from Incivek were $205.6 million, compared to $356.9 million for the first quarter of 2012

Agenus Inc., of Lexington, Mass., said preliminary data from a Phase II trial showed that newly diagnosed glioblastoma multiforme (GBM) patients treated with Prophage G-100 (heat shock protein-peptide complex-96, HSPPC-96) vaccine plus the standard of care showed a 146 percent increase in progression-free survival (PFS) and a 60 percent increase in overall survival (OS) as compared to the standard of care alone. Results were presented at the 81st American Association of Neurological Surgeons

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