News

On January 20, FDA Commissioner Andrew von Eschenback, MD, will step down as commissioner and Frank Torti, MD, will take over as acting commissioner.

MannKind Corporation (Valencia, CA) has purchased an option to license plant-produced recombinant human insulin from SemBioSys Genetics Inc. (Calgary, Canada) for use primarily in MannKind's ultra-rapid acting insulin, Afresa.

The US Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) opened HHS/FDA offices in Costa Rica on January 7. The HHS/FDA presence in the region will allow the countries to work closely together. The office in Costa Rica is the first in a series in Latin America, which will eventually include an HHS/FDA presence in South America and Mexico later in 2009.

The US Food and Drug Administration has issued a new draft guidance document on process validation. This much-awaited revision of the 1987 guidance of the same name has been in the works for at least three years, and is being welcomed by industry experts.

Although no official announcement has been made, former Senate majority leader Tom Daschle is most likely slated to head the Obama administration’s efforts to enact health reform legislation as the new secretary of the Department of Health and Human Services.

AstraZeneca has announced the divestment of the AstraZeneca Biotech Laboratory (ABL) in Södertälje, Sweden, to Recipharm AB of Sweden, a contract development and manufacturing organization.

Merck Serono (Darmstadt, Germany) has begun expansion of the Merck Serono Biotech Center (MSBC), its production site in Corsier-sur-Vevey, Switzerland.

In the Obama administration, an important ally in the House for Tom Daschle, who is expected to be named secretary of the Department of Health and Human Services, will be Rep. Henry Waxman (D-CA), who unseated John Dingell (D-MI), the long-time top Democrat on the House Energy and Commerce Committee, to become the panel’s new chairman.

The FDA has released its guidance on acceptable terms for cooperative manufacturing arrangements for short supply, divided manufacturing, and shared and contract manufacturing for licensed biologics.

WuXi PharmaTech Inc. (Shanghai, China) will discontinue its US biologics manufacturing operations as of December 31, 2008.

Pantec Biosolutions AG (Ruggell, Liechtenstein), a privately owned company developing innovative technologies for transdermal drug delivery, has received CE marking for the company's lead product, P.L.E.A.S.E. (painless laser epidermal system), design which applies micropores into the human skin for the transdermal delivery of large molecular weight drugs.

MorphoSys AG (Munich, Germany) and Galapagos NV (Mechelen, Bengium) have launched a long-term co-development alliance aimed at discovering and developing antibody therapies based on novel modes of action in bone and joint disease, including rheumatoid arthritis, osteoporosis, and osteoarthritis.

Russia has chosen the inactivated polio vaccine (IPV) IMOVAX from Sanofi Pasteur (Paris, France), the vaccines division of Sanofi-Aventis Group, for primary immunization of all infants.

Laureate Pharma, Inc. (Princeton, NJ), has entered into contract manufacturing agreements with Tolerx, Inc. (Cambridge, MA), and Tolera Therapeutics, Inc. (Kalamazoo, MI).

Sartorius Stedim Biotech GmbH (SSB, Goettingen, Germany) has acquired the Swiss-based company, Wave Biotech AG (Tagelswangen, Switzerland).

Todd McLaren has joined Hyde Engineering + Consulting, Inc. as senior vice president of marketing and new business development with overall responsibility for the east coast.

A major problem in personalized medicine has been scale-up.

Isis Innovation (Oxford, UK), the University of Oxford’s technology transfer company, has licensed patents based on the work of Oxford Professor Richard Moxon’s research group and research by Canada’s National Research Council Institute for Biological Science to Novartis Vaccines and Diagnostics.

GlaxoSmithKline Biologicals S.A. (GSK, London, UK) and AFFiRiS GmbH (Vienna, Austria) have announced a collaboration agreement that grants GSK exclusive rights to AFFiRiS’s Alzheimer’s disease vaccine programs that aims at treating Alzheimer’s by targeting the beta-amyloid protein.

The European Medicines Agency (EMEA) has granted license approval to Bayer HealthCare LLC (Bayer, Berkeley, CA) for its new sterile filling facility on its Berkeley, CA, campus.

PDL BioPharma, Inc. (PDL, Redwood City, CA) has appointed John P. McLaughlin to become president and chief executive officer (CEO) following the company’s planned spin-off of its biotechnology assets.

The US Food and Drug Administration (FDA) has approved an efficacy supplemental biologics license application (sBLA) for Eisai Corporation of North America’s (Woodcliff Lake, NJ) ONTAK (denileukin diftitox).

Millipore Corporation (Billerica, MA) and Applikon Biotechnology BV (Schiedam, The Netherlands) have announced an agreement to co-develop and distribute disposable bioreactor systems for biopharmaceutical applications.

Frederic Chereau has been named president and chief executive officer of Pervasis Therapeutics, Inc. (Cambridge, MA).

MedImmune (Gaithersburg, MD) has licensed its proprietary reverse genetics intellectual property to Omninvest, a Hungarian research and manufacturing company, to support the development and construction of new vaccine strains to produce non-live human influenza vaccines.

BAC BV (Naarden, The Netherlands) has announced the expansion of its collaboration with GE Healthcare with the addition of new bioprocess affinity chromatography media to GE Healthcare’s range of custom-designed media.

The US Food and Drug Administration (FDA) has approved New York City-based Lev Pharmaceuticals’ Cinryze [C1 inhibitor (human)] for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), also known as C1 inhibitor deficiency.

The US Food and Drug Administration (FDA) has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE, West Lafayette, IN) a contract to develop the science behind Quality by Design (QbD) and design space specifications