News

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.

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.

The FDA is launching a pilot program to allow manufacturers to electronically file drug establishment registration and drug listing information, such as ingredients, labeling, and manufacturing information.

French biopharmaceutical company Trophos SA (Marseille, France) has appointed Damian Marron as chief executive officer.

Intas Biopharmaceuticals Limited (IBPL, Ahmedabad, India) has acquired the US-based biotechnology corporation, Biologics Process Development Incorporated (BPD Inc., Poway, CA).

Roche (Nutley, NJ) has introduced a flexible purchase program that will allow US businesses to maintain access to their own stockpile of Tamiflu for use in a pandemic situation, with limited upfront investment and more adaptability to deal with unknown factors inherent in pandemic planning.

The United States and the Socialist Republic of Vietnam have signed a memorandum of understanding (MOU) to enhance the safety of food, feed, drugs, and medical devices traded between the two nations.

Sanofi Pasteur (Lyon, France), the vaccines division of the Sanofi-Aventis Group, has announced the inauguration of a high-tech vaccine production facility in France to respond to soaring demand worldwide.

The nation's bioscience industry continues to grow as states and regions vie to attract high-wage jobs, according to a study released on June 18, 2008, by Battelle (Columbus, OH) and the Biotechnology Industry Organization (BIO, Washington, DC).

Boehringer Ingelheim GmbH (Ingelheim, Germany) will acquire Actimis Pharmaceuticals, Inc. (San Diego, CA), through a structured buyout in which Boehringer Ingelheim will acquire shares of Actimis depending on the achievement of several successive milestones with Actimis’s leading asthma compound AP768.

Peregrine Pharmaceuticals, Inc. (Tustin, CA), has entered into a five-year contract worth up to $44.4 million to test and develop bavituximab and an equivalent fully human antibody as potential broad-spectrum treatments for viral hemorrhagic fever infections.

PacificGMP (San Diego, CA) and Pacific Biopharma Group (San Diego, CA) have signed a merger agreement to develop a cGMP (current good manufacturing practices) biologics contract manufacturing organization (CMO) in Taizhou, China.

BN ImmunoTherapeutics, Inc. (Mountain View, CA), has initiated Phase 1/2 clinical studies with its therapeutic vaccine candidate against prostate cancer.