The backlog of new applications is growing again at the Patent and Trademark Office (PTO), thanks in part to sequestration. Using new fees included in the 2011 patent reform to hire and train more examiners, the office had been plowing through the backlog, reducing the pile of nearly 722,000 applications in December 2010 to about 593,000 in February. But since the sequester hit in March, the backlog has grown to more than 600,000. And patent experts expect it to continue growing because of the
By Mari Serebrov | BioWorld Today | Tuesday, May 21, 2013
For more than half a decade, researchers have understood translation to be a key step in gene expression, but it's only recently that drugmakers have begun looking at restoring translational control as a means of treating disease. "People thought of [translation] as the boring half of gene expression," said Steve Worlund, who co-founded and now serves as the president and CEO of Effector Therapeutics Inc., a recent start-up working to develop selective translation regulators. Translation is
By Jennifer Boggs | BioWorld Today | Tuesday, May 21, 2013
Major depression affects more than 15 percent of the population at some point in their lives, and about 7 percent in any given year. Currently approved antidepressants are effective only about half the time – and even then, with a lag time of several weeks after a patient starts taking them. The time lag of antidepressant's effectiveness is something of a mystery. The effects of the newest generation of antidepressants, selective serotonin reuptake inhibitors (SSRIs) seem to be dependent on the
By Anette Breindl | BioWorld Today | Tuesday, May 21, 2013
Shares of Xenoport Inc. (NASDAQ:XNPT) dropped almost to the bottom of their 52-week range early Monday, opening at $5.04 after the company terminated its late stage arbaclofen placarbil (AP, previously XP19986) program in spasticity due to multiple sclerosis (MS) after a pivotal Phase III trial failed to demonstrate statistically significant improvement compared to placebo. The stock lost $1.03 on the day, or 15.3 percent, closing at $5.72. The Santa Clara, Calif.-based company said it would
By Marie Powers | BioWorld Today | Tuesday, May 21, 2013
Abbvie Inc., of Chicago, initiated a Phase III study called SONAR (Study Of Diabetic Nephropathy with Atrasentan) to assess the effects of the investigational compound atrasentan, when added to standard of care, on progression of kidney disease in patients with stage 2 to 4 chronic kidney disease (CKD) and Type II diabetes. SONAR is a multinational, double-blind, placebo-controlled clinical study that is expected to enroll more than 4,000 patients with diabetic nephropathy. The study will
LONDON – Merck Serono is enlarging its venture fund from €40 million to €100 million (US$51 million to $128 million) – increasing its capacity to invest in early stage companies, technologies and products that can be shaped up for the company's internal pipeline. "We started four years ago with €40 million and that was always on the understanding it was not enough for a sustainable long-term fund," said Roel Bulthuis, head of the MS Ventures fund. "What the organization has seen is that the
By Nuala Moran | BioWorld Today | Tuesday, May 21, 2013
Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date I. Modified Agreements APRIL Affymax Inc. (Palo Alto, Calif.) Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) $180 Amended collaboration for Omontys, changing the deal from a profit-sharing arrangement to a milestone and royalty-based compensation structure to Affymax Takeda assumes full responsibility for Omontys and, if it reintroduces the drug to market, Affymax would be eligible to receive royalties and
Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date APRIL Aeterna Zentaris Inc. (Quebec City) Ergomed Clinical Research Ltd. ND Co-development and profit-sharing agreement for AEZS-108 in endometrial cancer Ergomed will receive a single-digit percentage of any net income received by Aeterna Zentaris in that indication, up to a specified maximum amount 4/11/13 Aeterna Zentaris Inc. (Quebec City) Merck KGgA (Darmstadt, Germany) subsidiary ND Deal for manufacturing
Gilead Science Inc.'s oral targeted cancer drug, idelalisib (GS-1101), made a splash last week when the American Society of Clinical Oncology (ASCO) unveiled thousands of abstracts scheduled for presentation at next week's annual meeting in Chicago. In a press conference Wednesday afternoon, Jennifer R. Brown, director of the Chronic Lymphocytic Leukemia Center at the Dana-Farber Cancer Institute, provided Phase I findings suggesting idelalisib, as a single agent, has the potential to stave off
By Marie Powers | BioWorld Insight | Monday, May 20, 2013
Company Company Deal Value Inspiration Biopharmaceuticals Inc. Baxter International Inc. $700M Chiasma Inc. Roche AG $595M Edison Pharmaceuticals Inc. Dainippon Sumitomo Pharma Co. Ltd. $545M Trevena Inc. Forest Laboratories Inc. $460M Abide Therapeutics Inc. Merck & Co. Inc. $430M Moderna Therapeutics Inc. AstraZeneca plc $420M Isis Pharmaceuticals Inc. Roche AG $393M Ambrx Inc. Astellas Pharma Inc. $300M Resolve Therapeutics LLC Takeda Pharmaceutical Co. Ltd. $255M Alchemia Ltd. AstraZeneca
Mirna Therapeutics Inc. announced last week that it has initiated a Phase I trial of MRX34, its microRNA (miRNA) mimic. Andreas Bader, director of research at Mirna, told BioWorld Insight the company believes it's the first miRNA mimic to enter the clinic. Strictly speaking, it's not the first drug in the clinic involving a miRNA. That distinction belongs to Santaris Pharma A/S, which has been in the clinic since 2008 with miravirsen (SPC3649), its inhibitor of miR-122, a liver specific miRNA
By Brian Orelli | BioWorld Insight | Monday, May 20, 2013
"Provided that these experiments are reproducible in the hands of others, the findings offer the potential to accelerate progress toward the development [of these cells] to treat a range of degenerative diseases." – Mary Herbert, professor of reproductive biology at Newcastle University, on the success in cloning human embryonic stem cells from skin cells via somatic cell nuclear transfer "After going over there and seeing how the landscape was changing, it seemed like there was a growing
Amending an oversight in the Jumpstart Our Business Startups (JOBS) Act, the House voted 416-6 to set a deadline for the SEC to implement Regulation A changes. The National Institutes of Health's Office of Biotechnology Activities is proposing a revision to its guidelines for research involving recombinant or synthetic nucleic acid molecules. Under the proposal, as long as an initial human study of certain human gene transfers is approved by a registered institutional biosafety committee (IBC
Financings Acadia Pharmaceuticals Inc. priced a $100 million public offering of 8 million shares of common stock. Ambit Biosciences Corp. completed its IPO for gross proceeds of about $65 million. AxoGen Inc. filed a registration statement on Form S-1 for a proposed $15 million public offering. Discovery Laboratories Inc. closed a $14.25 million public offering of 9.5 million shares at $1.50. Dyax Corp. completed a $30 million registered direct offering to fund R&D activities. Erytech Pharma SA
Last week, researchers from Oregon Health & Science University reported that they had created embryonic stem cells via somatic cell nuclear transfer (SCNT), with a high enough efficiency to bring the creation of patient-specific embryonic stem cell lines into the realm of the possible. Successful medicine, though, takes more than scientific progress. And embryonic stem cells have always been the poster child for that fact. The scientific challenges are formidable in their own right. The hope of
By Anette Breindl | BioWorld Insight | Monday, May 20, 2013
