By Mari Serebrov Washington Editor 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
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
Generic drugmaker Actavis Inc.'s plan to take over Dublin, Ireland-based Warner Chilcott plc in a stock-for-stock transaction worth about $8.5 billion, thus forming the world's third-largest specialty pharmaceutical firm, would put the combined firm – with about $11 billion in annual revenues – on even more solid footing in the busily consolidating biosimilars realm. "Due to the Irish takeover rules, there's very little we can say at the moment," Paul Bisaro, president and CEO of Actavis, told
By Randy Osborne | BioWorld Today | Tuesday, May 21, 2013
Elcelyx Therapeutics Inc., of San Diego, said it is enrolling patients with Type II diabetes in a Phase IIb trial of NewMet, a delayed-release formulation of generic metformin. Results of the trial's primary endpoint of change in fasting plasma glucose are expected in late summer, and the read-out for long-term glucose lowering and weight benefits is due in the fourth quarter. Intercept Pharmaceuticals Inc., of New York, reported initial results from OBADIAH, an ongoing Phase IIa trial of
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
Asmacure Ltee, of Quebec City, reported findings from four studies of ASM-024, its lead compound for asthma and chronic obstructive pulmonary disease (COPD), at the 2013 American Thoracic Society International Conference in Philadelphia. In a Phase II allergen challenge trial, ASM-024 was shown to reduce methacholine airway responsiveness and improve baseline lung function when delivered as a solution for nebulization formulation in people with mild allergic asthma. A second study evaluating
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 APRIL Actavis Inc. (Parsippany, N.J.) Valeant Pharmaceuticals International Inc. (Aliso Viejo, Calif.) ND Agreement for Actavis to be the exclusive marketer and distributor of an authorized generic of Valeant's Zovirax ointment Terms were not disclosed 4/8/13 Bial SA (S. Mamede do Coronado, Portugal) Ono Pharmaceutical Co. Ltd. (Osaka, Japan) ND Exclusive license agreement for the development 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
Total Value in 2013: $6,192M* Number of Deals in 2013: 97 Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date APRIL Alchemia Ltd. (Brisbane, Australia) AstraZeneca AB (Sodertalje, Sweden; unit of AstraZeneca plc) $240 Deal for Alchemia's Diversity Scanning Array and Versatile Assembly on Stable Templates technologies to discover and develop small molecules for multiple targets in the oncology, respiratory, cardiovascular, metabolism, infection and neuroscience
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
By Mari Serebrov Washington Editor 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