It's a matter of weeks now until we begin to see: a) to what degree the H1N1 pandemic will again ramp up; b) which manufacturers will have developed vaccines in time to address the need; and c) if those vaccines will work against the dominant strain that develops.

And the first company to cross the finish line . . . is, unofficially, Protein Sciences Corp. of Connecticut, according to company CEO Dan Adams. What follows is the press release from AFP:

A US company that was awarded a 35-million-dollar contract
to develop an influenza vaccine using insect cell technology has produced a
first batch against (A)H1N1 flu, company boss Dan Adams said.

Microsoft's Life Sciences Group has certainly grown, from 5 people when it was established seven years ago to 800 people today. The SharePoint platform, which allows users to customize solutions without having to play programmer is finding increased acceptance. Among new developments:

At the DIA conference in Boston this week, TranSenda International LLC launched the beta of Office Smart Clinical Trials OSCT) Manager, incorporating SharePoint, which allows clinical trial professionals to use Microsoft Office tools, eliminating some of the drudgery of data entry and allowing remote, but secure access. "When conducting clinical trials, life sciences professionals often struggle with toggling in and out of different systems to input their data, and there's an ongoing challenge of knowing which spreadsheet is the 'single version of the truth," said Michael Naimoli US life sciences industry director, in the official press release. Mr. Naimoli comes, not from an IT background but from the industry.

As Robert Webber, CEO of TranSenda International, developer of the software, explains in a recent white paper, the biggest challenges are:

More on some specifics soon.

In the meantime, Microsoft announced winners of the Pharma and Life Sciences Innovation Award. They are :

Discovery and Product Innovation: AstraZeneca and Thermo Fisher Scientific Inc. , for harmonizing disparate processes to record, track and manage a growing number of requests for compound screening. AstraZeneca implemented Thermo Scientific Nautilus Laboratory Information Management Systems (LIMS) to centralize biochemical screenings, map laboratory workflows and dramatically drive efficiency through superior data management. Built on Microsoft’s Visual Studio .NET, Thermo Scientific Nautilus LIMS helped coordinate global requests, automate workflows and standardize screening. Within six months of the deployment, AstraZeneca reportedly realized a 180 percent efficiency gain across its laboratories from the centralized screening process.

Sales and Marketing: Sanofi-Aventis and Brimstone are delivering real-time product information and clinical and patient support materials to communicate with physicians and other stakeholders across multiple channels.

Clinical Development: The Scripps Research Institute and InterKnowlogy for a customized solution based on .NET Framework 3.0, SharePoint and Windows Vista, to display cellular, molecular and atomic levels in 2-D and 3-D, while providing tools for annotations. The result, judges say, was a newfound ability to link multiple kinds of data to an image, making it easier and faster to send information from experiments across the organization. Researchers now spend less time searching for data and more time developing potential treatment solutions.

GlaxoSmithkline, Sanofi-Aventis, and Wyeth feel the pharmaceutical hurt as stocks continue to drop and FDA regulations continue to tighten. Investors are also facing confusion as FDA has begun to share preliminary drug information with the general public.

"The FDA has been under incredible pressure and its creating a bit of a straight-jacket for product development, Jeremy Batstone, an analyst at Charles Stanley said in an interview."

For the full story, click here.

MV

Yesterday's FDA panel rejection of Sanofi's weight loss drug Acomplia could mean trouble ahead for Pfizer and Merck, which are now in Phase III testing of drugs with similar modes of action (targeting endocannabinoid receptors), The Science Daily reported yesterday. 

FDA data showed that Acomplia offered clinically significant weight loss results,  but psychological side effects that included suicidal thoughts.  Derek Lowe wrote about this in On the Pipeline earlier this week.

But Acomplia's rejection has also revived rumors of a potential merger between Sanofi and BMS.

PharmaTimes had the following to say this morning.

"...Sanofi's hopes that rimonabant would be a blockbuster have been dashed somewhat and if any US approval of the drug, which would be called Zimulti there, does take place, it is "unlikely until the next decade at the earliest," said Bear Stearns analyst Alexandra Hauber in a research note.In another note, Paul Diggle of Nomura Code said that "if we assume the drug stays on the market outside the USA with a tougher label or is approved as a secondary product, sales won't be the $3 billion to $5 billion some people expected." He added that Zimulti was the most important product in Sanofi's pipeline, which has "relatively few growth drivers."JP Morgan downgraded the stock from 'overweight' to 'neutral', while reducing their estimates from 78 to 65 euros, noting that Sanofi is also facing the risk of generic competition for its anticoagulant Lovenox (enoxaparin), and the rumours that Total and L'Oreal are expected to dispose of their stakes in the Franco-German drugmaker will exert even more pressure on the company's share price.

Sanofi's current plight has seen speculation grow that the firm may tread down the merger road and try to tie up again with Bristol-Myers Squibb. The company has underperformed its European peers by some 15% over the last year, and it still has a patent dispute over the antithrombotic blockbuster Plavix (clopidogrel) preying on its mind so long-time partner B-MS, with its reasonably healthy pipeline is looking attractive again..."