FDA Clears First Rapid Test for Bacterial Contamination in Pooled Platelets

FDA NEWS RELEASE, Nov. 13, 2009 
 
The U.S. Food and Drug Administration today cleared for marketing the Platelet PGD Test System, the first rapid test for the detection of bacterial contamination in pooled platelets derived from whole blood.

Platelets are used to prevent or treat bleeding in individuals with dangerously low platelet counts, including those undergoing chemotherapy for cancer, following major trauma, during or after surgery, and in individuals who do not produce adequate numbers of platelets. Platelets have the potential to be contaminated with bacteria and it is important to detect and interdict such contamination before transfusion.  Patients who are transfused with contaminated platelets are at risk of developing serious and potentially life-threatening infections.

The Platelet PGD Test System consists of a single-use test strip that, in fewer than 60 minutes, produces a signal that indicates the presence of bacteria.  The test is intended for use mainly by hospital transfusion services as a quality control test for the detection of bacteria after platelets derived from whole blood have been pooled, just prior to a patient  blood transfusion.

“Bacterial contamination of platelets is the leading infectious cause of patient fatalities associated with platelet transfusions,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.  “A rapid test for pooled platelets is an important step in improving safety for patients who are transfused with platelets.”

Clinical studies showed that the Platelet PGD Test System improved the sensitivity for detecting bacterial levels by 100 to 1000-fold over existing methods used to test pooled platelets prior to transfusion.

The Platelet PGD Test System is manufactured by Verax Biomedical, in Worcester, Mass. 

(Verax's homepage)

SantoSolve AS raises USD 5.5 million   

Tuesday, October 20 2009 

Norwegian pharmaceutical/biotech company SantoSolve AS has raised USD 5.5 million in a private placement with Scandinavian VCs Teknoinvest, InnovationsKapital and Investinor.

(SantoSolve's homepage)

For more about Investinor's investment in SantoSolve click here (Norwegian only).

Affitech Appoints Dr Robert Burns as CEO and Dr Alexander Duncan as SVP Research & Development

Experienced biopharmaceutical executives form new leadership team of antibody medicines company 
 

Copenhagen, Denmark, 1 September 2009 

Affitech A/S, the antibody medicines company, today announced that it has appointed two experienced biotech executives to head its management team.  Dr Robert Burns, previously CEO of Celldex Therapeutics Inc., has today assumed overall responsibility for Affitech as its new Chief Executive Officer.  Dr Alexander Duncan, previously SVP Biopharmaceuticals for Astra Zeneca – Medimmune, also joins Affitech today as Senior Vice President of Research and Development.   Dr Robert Burns takes over the Affitech CEO role from Dr Achim Kaufhold who, having successfully completed the recent combination of Affitech and Pharmexa, is leaving the Company.

(Affitech's homepage)

For the whole press release click here.

GLO AB CLOSES SEK 82M SERIES B INVESTMENT ROUND

Lund, Oslo & Stockholm  – ( September 2, 2009) -- Lund (Sweden) based nanowire semiconductor LED developer GLO AB today announced the closing of an SEK 82 million Series B investment round (approximately USD 11.6 million).

Dr. Bo Pedersen, GLO’s chief executive officer, said, “We are delighted to welcome as new investors both Hafslund Venture AS, a wholly owned subsidiary of Hafslund ASA, and Agder Energi Venture AS, a unit of Agder Energi AS.”  Both Hafslund and Agder are major power generation companies in the Nordic region, and both have substantial, successful investment track-records with a renewable energy focus.  Hafslund Venture, for example, made its first investment in Renewable Energy Corporation in 1998, and is today the second largest shareholder in a company that has become one of the leading PV Solar companies in the world.

Current investors joining in the round in GLO include funds advised by venture capital firms Provider Venture Partners of Stockholm, Teknoinvest and Nano Future Invest of Oslo, joined by LU Innovation together with LUAB, the investment arm of Lund University (Sweden), as major owners, along with the founders and employees of GLO. 

For the whole press release click here.