FDA Issues Guidance on Electronic Submissions, Seeks Comments
The US Food and Drug Administration has released a draft guidance document entitled, “Providing Regulatory Submissions in Electronic Format — General Considerations,” and is accepting written or electronic comments on the document until Dec. 22, 2003.
The draft guidance, available at http://www.fda.gov/OHRMS/DOCKETS/98fr/2003D-0465-gdl0001.pdf, discusses general issues common to all types of electronic regulatory submissions for all FDA centers, and updates the previous guidance of the same name issued in January 1999. Changes from the 1999 version include a new section describing the relationship of electronic submissions to the FDA’s 21 CFR part 11 regulation governing electronic signatures, for which the agency issued its final guidance in September [BioInform 09-08-03].
In addition, the draft guidance recommends specific file formats for the submission of electronic data sets. Currently, the FDA accepts and archives datasets in SAS XPORT transport format, according to the document, but also recommends using SGML, XML, and Molfile formats, as well as ASCII in certain circumstances.
Celera to Wind Down Info Business by 2006
Celera Genomics officials said last week that the company expects a “fairly substantial falloff in 2005 and no revenue by the end of 2006” from its data business, which will be fully integrated into sister company Applied Biosystems’ knowledge business by that time.
Celera’s information business is “going away,” said Applera CEO Tony White during the company’s quarterly earnings call on Oct. 22. “Obviously, not going away in the sense that we’re out of the data business, but it’s been integrated into the knowledge business at ABI and these existing contracts — we don’t expect any renewals on those — so we’re winding that down,” he said.
For Celera’s first fiscal quarter of 2004, which ended Sept. 30, 2003, revenues decreased to $17.3 million from $23.6 million in the first quarter of 2003. Online/information business revenues decreased to $15.3 milllion for the quarter, from $20.6 million in the year-ago period.
For the fiscal year, the company expects its revenue to decrease to the range of $55 million to $60 million compared to $88.3 million in fiscal 2003. The primary driver behind this decrease, according to Applera CFO Dennis Winger, “is the anticipated expiration of customer agreements within the online information business that will occur throughout the year.”
Celera reported a net loss of $16.3 million for the quarter, down from a net loss of $19.6 million for the same period last year.
The company reported R&D expenses of $21.8 million, compared to $32.5 million for the year-ago period.
Tripos Posts Q3 Revenue Increase, but Lowers Full-Year Forecast
Tripos last week reported $12.5 million in revenues for the third quarter ending Sept. 30, 2003, a 12 percent increase over the previous year’s third-quarter revenues of $11.1 million.
Despite the quarterly increase, however, the company is lowering its expectations for its fourth-quarter and full-year earnings. “Because economic uncertainty continues to affect our customers’ decision-making, management has determined that it is appropriate to reduce the company's previous revenue forecast,” said Tripos CEO John McAlister in a statement. Tripos is predicting single-digit, rather than double-digit, revenue growth for the year, and does not expect its operating results to be profitable for the year, McAlister said.
Net loss for the third quarter of 2003 was $408,000, down from $778,000 in the year-ago period.
Tripos reported $3.4 million in R&D expenses for the third quarter of 2003, compared to $2.4 million in the same period of 2002, and the company had $4.2 million in cash and cash equivalents as of Sept. 30, 2003.
Optive Research Teams with HP
Optive Research said it has entered an agreement with Hewlett-Packard to optimize its computer-assisted molecular discovery software for use on HP hardware.
Optive will provide support for HP’s 32-bit and 64-bit Linux clusters and HP Tablet PCs and workstations running Optive’s Benchware line of Windows-based software for medicinal chemists.
The companies are also planning a joint program to allow researchers to test HP’s Itanium 2-based Linux clusters running several Optive systems.
BioWisdom and Linguamatics Develop Text-Mining Tools for AstraZeneca
BioWisdom and text-mining software firm Linguamatics said last week that they are co-developing an ontology-based text-mining program for AstraZeneca.
Linguamatics will contribute its natural language processing systems to the collaboration, while BioWisdom will provide its ontologies, the companies said.