News

Artelis SA (Brussels, Belgium) and Selexis SA (Geneva, Switzerland) have announced  manufacturing yields of more than 31 grams per liter in a CHO-based monoclonal antibody production process, in multiple harvests from a perfusion-like process.

Novavax, Inc. (Rockville, MD) has announced favorable results from the second stage of the Phase 1/2a human clinical trial of its pandemic influenza virus-like particle (VLP) vaccine candidate.

The North Carolina Biotechnology Center has announced the five sponsoring companies chosen for the first year of its Industrial Fellowship Program.

Robert Leisk has joined Biokinetics as a senior vice president responsible for international biopharmaceutical business development for projects emanating from North America.

Cytos Biotechnology AG (Schlieren, Switzerland) has entered into an exclusive global research, option, and license agreement with Pfizer Vaccines LLC (Pfizer, New York, NY) to research, develop, manufacture, and commercialize novel vaccines for a defined number of human diseases.

Scott Neilson has been appointed to the position of Chief Operating Officer of AAIPharma.

Pall Corporation (East Hills, NY) has purchased GeneSystems (Bruz, France), a privately held biotechnology company that has developed a molecular diagnostics platform.

Chemists are reporting a major advance toward developing a safer, fully-synthetic version of heparin, the widely used blood thinner currently produced from pig intestines.

The American biotech giant Genentech, Inc. has rejected an offer by the Swiss drug-maker Roche to acquire the 44% of Genentech it does not already own, but said it would be willing to consider a higher bid.

Bridge Laboratories (Gaithersburg, MD), a preclinical contract research organization, will build its second preclinical facility in China.

The US Departments of Health and Human Services (HHS) and Homeland Security (DHS) have released guidance on allocating and targeting pandemic influenza vaccine.

The US Food and Drug Administration is launching a two-year fellowship program aimed at attracting scientists, engineers, and health professionals to the agency.

Cobra Biomanufacturing Plc (Keele, UK), a manufacturer of biopharmaceuticals, has extended its manufacturing agreement and intends to form a joint venture with ViroMed Co. Ltd. (Seoul, Korea), a specialist in the development of DNA and protein-based therapeutics.

Gail Sofer, a member of BioPharm International’s Editorial Advisory Board, has retired from her position as director of regulatory compliance at GE Healthcare.

Pfizer (New York, NY) has announced plans to close its manufacturing plant located at Little Island, Ireland, after a failed attempt to find a buyer for the facility.

Denny Kraichely, PhD, principal research scientist and group leader of pharmaceutical development and marketed product support at Centocor R&D, Inc. (Radnor, PA), a Johnson & Johnson Company, has joined the Editorial Advisory Board of BioPharm International.

Roche (Basel, Switzerland) will acquire Arius Research Inc. (Toronto, Canada) in an all-cash transaction for approximately $190 million.

GeoVax Labs, Inc. (Atlanta, GA) and Vivalis (Nantes, France) have signed a letter of intent (LOI) for joint collaboration and commercial license using Vivalis’s EBx technology to manufacture the MVA component of GeoVax’s HIV-1 vaccine.

Eric S. Langer, president and managing partner at BioPlan Associates, Inc. (Rockville, MD) has joined the Editorial Advisory Board of BioPharm International.

Florida Biologix (Alachua, FL), a biopharmaceutical development and contract manufacturing organization, has entered into a current good manufacturing practices (cGMP) manufacturing agreement with the National Taiwan University Hospital (Taipei, Taiwan).

The US Food and Drug Administration has approved this year’s seasonal influenza vaccines that include new strains of the virus likely to cause the flu in the US during the 2008–2009 season.

Since the principles of Quality by Design (QbD) for pharmaceutical manufacturing first emerged a few years ago, many companies have been struggling to understand the key concept of design space?what it is exactly, and how to establish it.

Biotechnology firm ImClone has responded to the offer that it received from Bristol-Myers Squibb for a buyout, saying it would review the deal but its initial view is that the bid is much too low.

Bristol-Myers Squibb has proposed to acquire its cancer drug partner ImClone Systems in an all-cash deal worth around $4.5 billion.

The FDA has ordered Amgen and Johnson & Johnson to make safety-related changes to the labeling of their erythropoeisis-stimulating agents (ESAs), Aransesp and Procrit.

Genentech, Inc., (South San Francisco, CA) has formed a special committee of its Board of Directors to assess the proposal from the Swiss drug-maker Roche (Basel, Switzerland) to take over the remaining shares of the American biotech giant.

Enough Republicans sided with Democrats last month to approve legislation canceling a scheduled 10.6% cut in Medicare fees for physicians. In doing so, the legislators tacked on dozens of provisions pleasing to beneficiaries and providers alike.

Genentech (South San Francisco, CA) has informed healthcare professionals that an increased number of complaints have been received regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent.