Latest news

Alpalyse Inc. appoints Dr Andrew Munk as chief operating officer
Alphalyse A/S, Denmark, the provider of advanced protein analysis services has appointed Dr Andrew Munk as Chief Operating Officer of Alphalyse Inc. with headquarters in Palo Alto, California. The appointment strengthens the service and support to Alphalyse’s growing customer base throughout the US and Canada.
Dr. Thomas Kofoed, (CEO) Alphalyse commented “We are extremely pleased that Andrew is joining the Alphalyse team. Andrew has the right combination of science and business experience, and will help us bring the best possible support to our customers using our unique ‘Pick ‘n Post’ protein analysis services. Our many customers within protein research and protein drug development throughout the US and Canada will benefit from Andrews scientific expertise and pleasant personality.”
“I am very excited to be joining a clear leader in providing proteomic services to the bio/pharmaceutical industry," said Dr. Munk."I look forward to contributing to Alphalyse’s management team as we continue to grow our business in North America and to deliver innovative services that help clients bring increased efficiencies and speed to their drug discovery efforts.”

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Bavarian Nordic A/S – Major Shareholder Announcement
In pursuance of the Danish Securities Trading Act's section 29, please be informed that Bavarian Nordic A/S has received information that Lønmodtagernes Dyrtidsfond (LD) has increased its holding of shares in Bavarian Nordic A/S, now owning more than 5.4 % of the share capital.
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FDA reschedules Advisory Committee meeting for liraglutide - no change of review timeline anticipated
The US Food and Drug Administration (FDA) has informed Novo Nordisk that the planned Advisory Committee meeting for liraglutide on 2 March 2009 has been rescheduled to 2 or 3 April 2009.
Novo Nordisk submitted the New Drug Application (NDA) to the FDA on 23 May 2008, meaning that an action letter from the agency to the NDA could be expected on 23 March 2009 following a standard 10-month review period. In September, the agency indicated that it would most likely have to extend the date of completing its assessment by a couple of months. The FDA has informed Novo Nordisk that this is still the timeline it is targeting.
FDA advisory committees are panels of independent experts who advise the FDA as they consider regulatory decisions. The advisory committee meetings are open to the public and are common for major pharmaceutical drugs under review.

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MorphoSys and WACKER Intensify Cooperation to Use WACKER Technology for Production of Antibodies
MorphoSys AG and Wacker Chemie AG are intensifying their cooperation in the use of WACKER’s prokaryotic secretion technology. The two companies have signed a new agreement precisely defining areas of use and production limits under which MorphoSys will continue to use the secretion system on a research scale. As a result, MorphoSys will now be able to use the WACKER technology for both the early development phase of therapeutic projects as well as the production of diagnostic and research antibodies. If the agreed quantity limits are exceeded at MorphoSys, WACKER is able to provide a seamless transition to large-scale manufacturing services.
WACKER and MorphoSys entered into a license agreement for the use of the WACKER secretion technology (brand name ESETEC®) for the production of antibodies in 2005. After successful joint process development and subsequent implementation of ESETEC® in MorphoSys’s antibody platform, the license agreement has now been specified in more detail. MorphoSys can use the technology in the research phase for antibody production within its operating segments and also secures rights to produce material for commercial supply within defined quantity limits. Another integral component of the agreement is that MorphoSys can recommend to its partners either WACKER or its biotechnology division Wacker Biotech GmbH for large-scale production.

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Doctors transplant windpipe with stem cells
Doctors have given a woman a new windpipe with tissue grown from her own stem cells, eliminating the need for anti-rejection drugs. "This technique has great promise," said Dr. Eric Genden, who did a similar transplant in 2005 at Mount Sinai Hospital in New York. That operation used both donor and recipient tissue. Only a handful of windpipe, or trachea, transplants have ever been done.
If successful, the procedure could become a new standard of treatment, said Genden, who was not involved in the research.
The results were published online Wednesday in the medical journal, The Lancet.
The transplant was given to Claudia Castillo, a 30-year-old Colombian mother of two living in Barcelona, suffered from tuberculosis for years. After a severe collapse of her left lung in March, Castillo needed regular hospital visits to clear her airways and was unable to take care of her children.
Doctors initially thought the only solution was to remove the entire left lung. But Dr. Paolo Macchiarini, head of thoracic surgery at Barcelona's Hospital Clinic, proposed a windpipe transplant instead.

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Novartis to Combine Heart Pills as Afinitor Cancer Drug Delayed
Novartis AG is betting on a clutch of combination heart pills to replace revenue from its best-selling hypertension drug Diovan, after its most-promising cancer treatment was delayed by three months.
In its first research update since 2006, Novartis said it will combine the newer heart pill Tekturna with Diovan as well as other treatments, and plans to bring them to market before Diovan’s 2012 patent loss. The experimental cancer drug Afinitor may reach the market in the first quarter of 2009, three months later than planned, after U.S. regulators asked for more data, the Basel, Switzerland-based company said in an e-mailed statement today.
Novartis has cut jobs and reined in spending as it prepares for the patent expiration on Diovan, which brought in $1.4 billion in third-quarter sales. The drugmaker has reduced the dependence on prescription medicines by selling its own generic treatments and vaccines, and acquiring a stake in eye-care company Alcon Inc. this year. Tekturna, which was first approved in 2007, had sales of $40 million last quarter.

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Stem cells restore hearing, vision in animals
Stem cells from tiny embryos can be used to restore lost hearing and vision in animals, researchers said on Tuesday in what they believe is a first step toward helping people.
One team repaired hearing in guinea pigs using human bone marrow stem cells, while another grew functioning eyes in tadpoles using frog cells.
While there are no immediate uses for humans, they said their findings help describe some of the most basic biological processes underlying the development of hearing and sight, and may help in the development of the new field of regenerative medicine.
"These discoveries illustrate stem cell research's continuing extraordinary potential to treat a wide range of deadly and disabling diseases that affect millions," said Anand Swaroop, a stem cell researcher at the National Eye Institute, one of the National Institutes of Health.

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Amgen tumor-starving drug gets spotlight
Amgen's head of oncology research said on Tuesday that one of the company's experimental drugs now in mid-stage trials has big potential to better starve tumors of their blood supply when used with standard medicines.
"It's new, we're ahead of the field and it has potential in a number of tumor types," Glenn Begley said at the Reuters Health Summit, calling the AMG 386 drug one of Amgen's most promising oncology products.
"What we're trying to achieve is not incremental," Begley said. "We want to make a difference; we want to have substantial benefit" in further controlling cancer.
Amgen, which aims to become a far bigger player in the oncology field, has tested AMG 386 in combination with drugs that use two related mechanisms to block growth of blood vessels that feed tumors -- including Genentech Inc's Avastin, and Nexavar sold by Bayer AG and Onyx Pharmaceuticals.

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