By Anette Breindl Science Editor Emerging diseases are by their nature a disconcerting foe. As with any preventive measure, it's only possible to know for sure if a new infectious agent has gotten in under the radar when patients begin to present with unusual symptoms. Such was the case with HIV; by the time the Morbidity and Mortality Weekly Report described a cluster of five men with the opportunistic infection Pneumocystis carinii pneumonia in 1981, there were likely already thousands of

By Cormac Sheridan Staff Writer Underlining its ambitions in ophthalmology, Shire plc is acquiring SARcode Bioscience Inc. for $160 million up front, plus additional, undisclosed milestones based on the clinical, regulatory and commercial progress of its main asset, lifitegrast, which is undergoing a second pivotal Phase III trial in dry eye disease. The acquisition, which is expected to close in the second quarter, comes hot on the heels of its recent purchase of Premacure AB, of Uppsala

By Mari Serebrov Washington Editor Adamant that pay-for-delay settlements between brand- and generic drugmakers are anticompetitive, the FTC is leaving no stone unturned in its efforts to get the settlements outlawed. Even as the commission was preparing for a Supreme Court hearing Monday on FTC v. Actavis Inc., it was working with lawmakers to get legislation enacted to bar the agreements or make them less attractive. One bill that enjoys bipartisan support, S. 214, would prohibit brand

By Mari Serebrov Washington Editor With sequestration swinging its two-edged blade through the funding for the National Institutes of Health (NIH) and other government research-focused programs, a lot has been said about its impact on the future pipeline of medical researchers. But federal funding isn't the only factor leading to a growing talent drain in the field. Part of the problem is education. And that's where industry can invest in its own future by exposing students as young as junior

By Sharon Kingman Staff Writer LONDON – Study of a family affected by an inherited neurological disease has helped to reveal the identity of an enzyme that could point the way to new therapies for cancer and cardiovascular disease. The existence of the enzyme, which plays a role in maintaining cell survival and DNA repair, has been predicted for at least 30 years and has even been shown to operate in cell cultures. But, until it was linked with the gene defect in the family studied, no one knew

By Nuala Moran Staff Writer LONDON – Mesoblast Ltd. has raised A$170 million (US$174.6 million) in a private placing, bringing total cash reserves for the stem cell specialist to A$332 million and providing funding for a Phase III trial in treating degenerating spinal discs. The shares will be issued at A$6.30, a 2.2 percent discount to the closing price of A$6.44 the day before the private placing was announced on March 6. The new shares represent less than 15 percent of the shares in issue so

By Mari Serebrov Washington Editor Although they hoped it wouldn't come to this, the FDA and National Institutes of Health (NIH) are preparing for the reality of the sequester sword. In the run-up to March 1, the FDA analyzed how the across-the-board cuts would affect its ongoing activities. "A sequestration of the magnitude contemplated, and this late in the budget year, will have public health consequences for an agency that is already making every dollar count," it concluded. That said, the

By Peter Winter Editor Somewhere along the way from the heady days of the dot-com era in 2000 the "magic" of achieving a successful biotech initial public offering (IPO) seems to have been lost. Time was that for biotech companies and the venture capitalists who invested in them, a public stock offering was the first major milestone of business and financial success – a preferred exit strategy for VCs and an opportunity for companies to access future public market capital financings and

By Cormac Sheridan Staff Writer Without revealing much in the way of new data, TopoTarget A/S enjoyed a 45 percent bounce in its share price during early trading Tuesday, as an analysis of the final top-line results from a registration trial of belinostat in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) confirmed the drug exceeded the efficacy level defined by the study's primary endpoint, a minimum objective response rate (ORR) of 20 percent. The threshold had been

By Anette Breindl Science Editor By targeting one specific type of inhibitory brain receptor, researchers have been able to improve neural function and memory in a mouse model of Down syndrome. The findings give additional support to the idea that some neurodevelopmental disorders can be reversed, at least partially, after they are established. The team published their findings in the Feb. 27, 2013, issue of the Journal of Neuroscience. "By targeting this type of receptor, we can normalize not

By Sharon Kingman Staff Writer LONDON – Identification of a protein that orchestrates many of the changes that permit a normal cell to turn into a cancer cell will open up an entirely new field of cancer therapeutics, the researchers who made the discovery predicted. The team, from ICREA in Barcelona, Spain, also established a screening system to identify compounds that will inhibit the protein. Raùl Méndez, group leader at the Institute for Research in Biomedicine in Barcelona, told BioWorld

By Cormac Sheridan Staff Writer DUBLIN, Ireland – Shares in Elan Corp. plc (NYSE:ELN) rose 5 percent to $11.14 Monday in response to an indicative $11 per-share takeover offer from Royalty Pharma. Although Dublin, Ireland-based Elan issued a critical response to the offer, which represents a 4 percent premium to its closing share price Friday, it was not an outright refusal. The investor response suggested there is an appetite in the market for an exit. The company is now in play. With the ink

Sharon Kingman Staff Writer LONDON – While the development of biosimilars – biological medicines designed to be very similar to ones that have already been approved for clinical use – is really still in its infancy, people already are looking to the future and considering what sorts of molecules will come next. Anyone who thought that the son-of-biosimilar might be something that is bigger, better and more important than a biosimilar itself – a kind of molecule that has been dubbed a "biobetter

By Mari Serebrov Washington Editor Provided budget constraints don't derail the FDA's plans, the agency is on track to begin conducting biennial inspections of all drug facilities, both domestic and foreign, in five years, according to FDA Commissioner Margaret Hamburg. That goal is within reach thanks to new and increased user fees included in the FDA Safety and Innovation Act passed last year. Since its implementation in October 2012, the new generic drug user fee has resulted in 2,000 generic

By Anette Breindl Science Editor Memory T cells, because of the sheer speed with which they can respond to an infection, are "the best thing you can have" to protect against a disease, Mark Davis told BioWorld Today. But memory appears to be a misnomer: Davis and his team have shown that every one of more than 20 individuals had memory T cells to viruses they had never been exposed to. Davis said that the findings came as a surprise to his team, which identified the cells in the course of

By Catherine Shaffer Staff Writer A partnership between Roche AG and Chiasma Inc., of New York, promises to take the pain out of therapy for acromegaly, the overproduction of growth hormone. Chiasma's Octreolin is an oral form of octreotide, an analogue of somatostatin that is currently given by injection. Under the agreement, Roche will have a worldwide exclusive license to the drug and will take responsibility for commercialization, with its Genentech Inc. subsidiary in charge of marketing

By Nuala Moran and Cormac Sheridan Staff Writers LONDON – One of the UK's oldest biotech companies looks to be on its way out after reporting the failure of the lead program in Parkinson's disease. Shares in Phytopharm plc fell 80 percent after the announcement Monday that the long-running trial of Cogane showed no difference between the active compound and placebo in the 400-patient Phase II trial. The Godmanchester, UK-based company has begun a strategic review, but Robin Davison, analyst at

By Nuala Moran Staff Writer LONDON – The Innovative Medicines Initiative (IMI) officially launched the European Lead Factory, a €196 million (US$266 million) project in which seven pharma companies will make at least 300,000 compounds available for screening via an open platform. That will allow academic and small company partners access to industry-quality high-throughput screening and speed the translation of new target biology through to drug leads. The cash for the five-year project comes

By Catherine Shaffer Staff Writer Lycera Corp. doubled its sweet 2011 deal with Merck and Co. Inc., of Whitehouse Station, N.J., in a new agreement designed to expand on the companies' prior relationship, which has centered on retinoic acid-related orphan receptor (ROR[gamma]t). Lycera will receive an undisclosed up-front payment and research funding, and could receive more than $300 million in milestone payments based on research, development, regulatory and commercial accomplishments, plus