News

California-based biopharmceutical company Spectrum Pharmaceuticals will develop a biosimilar version of Swiss pharmaceutical giant Roche Holding AG's monoclonal antibody drug rituximab. Spectrum aims to achieve this through a partnership with Viropro Inc (Irvine, CA).

GlaxoSmithKline (GSK) issued a statement on Jan. 2, 2011, to respond to a 60 Minutes segment that aired on Jan 2 that focused on quality-control problems at a former GSK manufacturing facility in Cidra, Puerto Rico. The segment focused on an interview with former GSK employee Cheryl Eckard, who detailed the problems at the facility and which eventually resulted in a $750-million settlement between GSK and federal and state governments that was announced in October 2010.

Merrion Pharmaceuticals, Plc (Dublin, Ireland), a product development company, has signed an oral drug delivery feasibility and option agreement with Rebel Pharmaceuticals, LLC (Thousand Oaks, CA) for two undisclosed compounds. Rebel will evaluate the ability of Merrion?s GIPET technology to enhance the compounds? clinical profiles and provide an improved product.

The US Food and Drug Administration posted on its website the minutes of the latest meetings between the agency and industry, and among stakeholders, regarding the reauthorization of the Prescription Drug User Fee Act V. The meetings were held Nov 17-18.

Baxter International Inc. (Deerfield, IL) and Takeda Pharmaceutical Company Limited (Osaka, Japan) have completed a development, license, and technology transfer agreement. Under the terms of the agreement, Takeda and Baxter will expand on their previously announced collaboration to bring Vero cell culture-based influenza vaccines to the Japanese market. Baxter will license its proprietary Vero cell-based influenza vaccine technology exclusively to Takeda for the Japanese market.

Aushon BioSystems, Inc. (Billerica, MA), a provider of multiplex immunoassay products and services for biomarker discovery, development, and analysis, will partner with LightArray Biotech Company, Ltd. (Shanghai, China) to provide Aushon?s suite of multiplex biomarker products and services to pharmaceutical, biotechnical, and academic research institutions located in mainland China.

GE Healthcare (Uppsala, Sweden) and G-Con Manufacturing LLC (College Station, TX) will develop a modular portable bioprocess manufacturing solution for vaccines and therapeutics. This collaboration combines GE Healthcare?s global presence and expertise in biopharmaceutical manufacturing technology with G-Con?s modular portable cleanroom technology.

China and India will become the world leaders in innovation during the next decade, according to an international survey released by AstraZeneca.

Tolerx, Inc. (Cambridge, MA), a biopharmaceutical company developing novel therapies by modulating T cell activity, and the Cancer Vaccine Acceleration Fund (CVAF, New York, NY)?a nonprofit program of the Cancer Research Institute established in partnership with the Ludwig Institute for Cancer Research?have signed a research agreement to support the development of Tolerx?s drug candidate, TRX518. TRX518 is a monoclonal antibody designed to enhance the immune system by enabling T cells to more effectively attack cancer cells. It is the first anti-glucocorticoid-induced tumor necrosis factor receptor (GITR) drug candidate to enter human clinical trials.

Wassim Nashabeh, PhD, the global head of technical regulatory policy and strategy at Genentech, has joined the Editorial Advisory Board of BioPharm International.

ZRG Partners (Westborough, MA) has released its analysis of overall life sciences hiring trends for Q3 2010 and if you live outside of the Americas, hiring trends are generally up.

Boehringer Ingelheim (Ingelheim, Germany) and MacroGenics (Rockville, MD) have entered into a global alliance to discover, develop, and commercialize antibody-based therapeutics that may span multiple therapeutic areas, including immunology, oncology, respiratory, cardiometabolic, and infectious diseases. These developmental drug candidates will be based on MacroGenics?s dual-affinity re-targeting (DART) platform and will be directed against up to 10 combinations of molecular targets.

Medicago Inc. (Quebec City, Canada) a biotechnology company focused on developing vaccines based on proprietary manufacturing technologies and virus-like particles (VLPs), has received clearance from Health Canada to commence a Phase 2 human clinical trial for its H5N1 avian influenza vaccine. Enrolment of volunteers is now underway.

FDA has to address multiple technical and legal issues to bring similar versions of biotech therapies to market.

LigoCyte Pharmaceuticals, Inc. (Bozeman, MN) has announced positive results from a Phase 1?2 challenge study of its norovirus virus-like particle (VLP) vaccine candidate. Baylor College of Medicine?s Robert Atmar, MD, the study's principal investigator, shared data from the trial via an oral presentation at the Infectious Diseases Society of America (IDSA) 2010 Annual Meeting on October 23 in Vancouver, British Columbia.

The US Food and Drug Administration's Puerto Rico district office "may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island," according to Rep. Edolphus Towns (D-NY), chair of the US House of Representatives Committee on Oversight and Government Reform.

Paragon Bioservices, a Baltimore-based CMO focused on the contract research, process development, and manufacturing of biologics, has been awarded a $4.99 million contract to assist the US Army Medical Research Institute for Infectious Diseases (USAMRIID) in its vaccine development efforts.

Laureate Pharma, Inc. (Princeton, NJ) has entered into a development and manufacturing agreement to produce AV-203, AVEO Pharmaceutical?s (Cambridge, MA) monoclonal antibody targeted against ErbB3. Laureate?s services will include process development, protein production, purification, and aseptic filling of AP-203 for AVEO. Laureate expects to supply AVEO with clinical product in the second quarter of 2011. Terms of the manufacturing agreement were not disclosed.

Sanofi-Aventis has told Genzyme to stand aside and let the shareholders decide on whether an acquisition should take place.

ATMI, Inc. has acquired the Belgian biotechnology firm Artelis SA, which offers technologies for cell culture research and manufacturing scale-up.

In a speech on October 6, 2010, FDA Commissioner Margaret Hamburg outlined the FDA's plan for advancing regulatory science. Her address introduced an FDA document, Advancing Regulatory Science for Public Health, which was released concurrent to her talk.

The US Department of Health and Human Services? (HHS) Biomedical Advanced Research and Development Authority (BARDA) is providing three sets of grants totaling $10.4 million to help the World Health Organization (WHO) strengthen developing countries? ability to produce flu vaccines, potentially reducing the global threat from influenza.

Laureate Pharma, Inc. (Princeton, NJ) has secured $20 million in debt and equity financing to grow its business. The new funds will be used to expand existing capacity in protein production and aseptic filling and to expand its service offerings in analytical testing and cell line development.

On September 21, 2010, Gilead Sciences (San Dimas, CA) received a warning letter from the US Food and Drug Administration, citing violations of current good manufacturing practices (cGMP) for its manufacturing and quality processes related to the production of antifungal agent AmBisome at its California facility.

US Health and Human Services Secretary Kathleen Sebelius has predicted that a cell-based seasonal flu vaccine could be on the market by the 2011?2012 flu season, as reported by CIDRAP of the University of Minnesota.

ARTES Biotechnology (Langenfield, Germany) has acquired the Anavax virus-like particle (VLP) technology from Select Vaccines Ltd. (Melbourne, Australia). Anavax is a patent-protected VLP technology that can be applied to develop vaccines for the prevention of several infectious diseases.

IDT Biologika, GmbH (Dessau-Rosslau, Germany), a contract manufacturer of vaccines and biopharmaceuticals, will expand its viral vaccine production capacity with the addition of a new high-speed filling line and additional lyophilization capacity. The company also will add 80 employees to its workforce?an increase of approximately 11%?to meet growth in demand for its biologics production.

SP Scientific (Gardiner, NY) has signed a license agreement to use Praxair's (Danbury, CT) ControLyo nucleation-on-demand technology, which provides pharmaceutical and biotechnology companies with control over the freeze-drying process for drug developmental efforts.