In a decision that could erode the underpinnings of numerous diagnostic and biologic patent claims, the Supreme Court ruled Thursday that naturally occurring, isolated DNA is not patent eligible. However, the court's unanimous decision in The Association for Molecular Pathology v. Myriad Genetics Inc. upheld the patent eligibility of complementary DNA (cDNA), which is synthetically created. In striking down Myriad's isolated DNA claims to the BRCA1 and BRCA2 genes, the court said the Salt Lake
By Mari Serebrov | BioWorld Today | Friday, June 14, 2013
Apceth GmbH, of Munich, Germany, received approval to conduct a clinical cancer trial with its genetically modified adult mesenchymal stem cells. The multicenter, open-label trial will recruit patients suffering from advanced adenocarcinomas of the gastrointestinal tract. The therapy is based on mesenchymal stem cells harvested from the patient's own (autologous) bone marrow, which are processed, genetically modified and re-infused into the patient. Celgene Corp., of Summit, N.J., said oral
Astrazeneca plc, of London, the University of Manchester and Cancer Research Technology, the commercial arm of Cancer Research UK, inked two agreements to seek new cancer drugs. In the first agreement, scientists at the Cancer Research UK Paterson Institute for Cancer Research at the University of Manchester will develop potential drugs targeting a key protein involved in DNA damage response, with Astrazeneca providing the preliminary compounds. Astrazeneca will have first rights to the
Takeda California Inc., of San Diego, a subsidiary of Takeda Pharmaceutical Co. Ltd., partnered with Sea Lane Biotechnologies, of Mountain View, Calif., giving Takeda access to Sea Lane's Concirt human antibody libraries for its drug discovery program in exchange for an up-front payment and milestone option fees for projects initiated under the collaboration. Sea Lane also is eligible for downstream milestone option payments. The two-year agreement has a pre-negotiation option to extend. "We
By Catherine Shaffer | BioWorld Today | Friday, June 14, 2013
Predicting protein folding has made strides in recent years, mainly through unconventional approaches. Computer games like foldit have been able to apply crowdsourcing to proteins, and solve structures that had evaded traditional computing power. (See BioWorld Today, Aug. 13, 2010.) But George Rose, who is at Johns Hopkins University, said he thinks that the problem can, and perhaps should, be solved in a more fundamental way. Current methods for predicting a protein's shape when folded from
By Anette Breindl | BioWorld Today | Friday, June 14, 2013
Esperion Therapeutics Inc., of Plymouth, Mich., filed terms for its initial public offering, planning to raise $63 million by offering 4.5 million shares at a price range of $13 to $15. The company would list under the symbol "ESPR." Cytomedix Inc., of Gaithersburg, Md., amended its previous financing with Lincoln Park Capital, and said in paperwork filed with the SEC that it has registered and may sell up to about 10.3 million shares to Lincoln.
Amarantus Bioscience Holdings Inc., of Sunnyvale, Calif., said it signed a laboratory services agreement with BD Biosciences, a segment of BD (Becton, Dickinson and Co.), of Franklin Lakes, N.J, under which BD's Custom Technology Team will perform sample analysis on Amarantus' LymPro Test for Alzheimer's disease. Financial terms were not disclosed. Amgen Inc., of Thousand Oaks, Calif., said the FDA expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant
SAN DIEGO – At a Calbio session, Cambell Alliance, the business consulting segment of Inventiv Health Inc., presented its survey of business development professionals. In addition to the forward-looking examination of dealmaking expectations, a panel gave their experiences in the ever-changing business development. Most survey respondents – both primarily out-licensers and primarily in-licensers – expect the number of deals for early stage assets to increase. For Phase III assets, 59 percent
By Brian Orelli | BioWorld Today | Friday, June 14, 2013
For Celgene Corp., entering Japan proved a relatively brisk venture, said Jerome Zeldis, the company's chief medical officer, but China – where Celgene also has established itself, and is launching Revlimid (lenalidomide) this week – represents something more of a challenge for biotech and pharma firms. "I don't think any other company has ever walked into Japan, established a footprint and gotten to approval faster than we did," Zeldis said, noting that the Summit, N.J.-based firm gained
By Randy Osborne | BioWorld Today | Friday, June 14, 2013
Abbvie Inc., of Chicago, reported results from the CONCERTO trial testing different predefined doses of methotrexate in combination with anti-TNF-alpha drug Humira (adalimumab) in moderate to severe rheumatoid arthritis. CONCERTO showed that, at week 26, a statistically significant increasing trend was observed in the proportion of patients achieving low disease activity with an increasing dose of methotrexate when used with open-label Humira. Results were presented at the European League
Although Amgen Inc.'s top-line data from TRINOVA-1, the first of three Phase III trials evaluating trebananib, also known as AMG 386, proved positive in ovarian cancer with regard to progression-free survival (PFS), whether this will be enough for approval remains in question. The company reported that a statistically significant difference was observed in PFS, with a 34 percent knock-down in the risk of disease progression or death (hazard ratio = 0.66, 95 percent confidence interval, 0.57, 0
By Randy Osborne | BioWorld Today | Thursday, June 13, 2013
Aphios Corp., of Woburn, Mass., said it entered joint research collaboration and commercialization agreements with Vivacell Biotechnology Espana SL, of Cordoba, Spain, to develop therapeutics for multiple sclerosis and other neurodegenerative diseases of the central nervous system. Researchers collaborating with Vivacell recently discovered a class of nonpsychotropic cannabinoids that appear to have multiple activities on key molecular targets involved in neuroinflammatory and neurodegenerative
The FDA etched a distinct line between orphan drug designation and exclusivity in a final rule released Wednesday, making it clear that getting the designation doesn't guarantee seven years of market exclusivity. A hypothesis of superiority is enough to get the designation when another drug has already been approved for the same orphan indication, but evidence of clinical superiority is needed for exclusivity, according to the rule, which amends the regulations issued in 1992 to implement the
By Mari Serebrov | BioWorld Today | Thursday, June 13, 2013
Ablynx NV, of Ghent, Belgium, will make an oral and poster presentation for arthritis candidate, ALX-0061, at the Annual European Congress of Rheumatology in Madrid, Spain, showing a strong efficacy and safety profile for the drug in a Phase II study. Pooled data at 24 weeks of treatment demonstrated that ALX-0061 led to an improvement of 84 percent in ACR20 and 58 percent DAS28 remission. At all doses, the drug was well tolerated with no clinically relevant neutropenia, no clinically
Bristol-Myers Squibb Co., of New York, reported year two data from the AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve rheumatoid arthritis Subjects With Background Methotrexate) trial of 646 patients comparing the safety and efficacy of the subcutaneous formulation of abatacept (Orencia) vs. adalimumab (Humira, Abbvie Inc.), each on a background of methotrexate (MTX), in biologic naïve patients with moderate to severe rheumatoid arthritis (RA). Results from the second year of
TAIPEI, Taiwan – Diminutive drug discovery firm PRISM Pharma Co. Ltd., of Yokohama, Japan, has closed a Series C round of funding of approximately ¥1.4 billion (US$15 million) with the funds earmarked for upcoming clinical trials for the company's investigative oncology drug PRI-724 in non-oncology related conditions, initially fibrosis. PRI-724 is the first drug candidate developed from the company's Protein Secondary Structure Mimetic (PRISM) library, a database of compounds compiled and
By Dave Silver | BioWorld Today | Thursday, June 13, 2013
Researchers from the University of California at Berkeley have developed a method that allows them to better target gene therapy viral vectors via directed evolution. For now, they have used their method to make a vector that can more easily reach the back of the eye. But in theory, their method, which consists of multiple rounds of mutagenesis for directed evolution, could be used as a general method to develop viruses for tissues that have been challenging to reach with gene therapy. The
By Anette Breindl | BioWorld Today | Thursday, June 13, 2013
Atlanta's Emory University launched a new initiative to help bridge the ever-widening gap between the laboratory discoveries that trumpet the possibility of breakthrough medical treatments and the proof-of-concept data that are needed to entice significant industry investment – known as the dreaded "Valley of Death" in the landscape of drug discovery. Emory, which in 2009 established the Emory Institute for Drug Development (EIDD), now has set up DRIVE (Drug Innovation Venture at Emory LLC), an
By Jennifer Boggs | BioWorld Today | Thursday, June 13, 2013
In a decision that could erode the underpinnings of numerous diagnostic and biologic patent claims, the Supreme Court ruled Thursday that naturally occurring, isolated DNA is not patent eligible. However, the court's unanimous decision in The Association for Molecular Pathology v. Myriad Genetics Inc. upheld the patent eligibility of complementary DNA (cDNA), which is synthetically created. In striking down Myriad's isolated DNA claims to the BRCA1 and BRCA2 genes, the court said the Salt Lake