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A first-of-its-kind vaccine to prevent breast cancer has shown favorable results in animal models, according to a study by researchers at Cleveland Clinic?s Lerner Research Institute (Cleveland, OH).

The US Food and Drug Administration has approved Prolia (denosumab), manufactured by Amgen Inc. (Thousand Oaks, CA), for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Thomson Reuters' Mark Gordon looks at how real partnership opportunities are developing in a virtual pharma world.

Xcellerex, Inc. has begun construction of a state-of-the-art current good manufacturing practices-compliant FlexFactory biomanufacturing facility at its headquarters in Marlborough, MA.

The pharmaceutical and medical device industries can learn from Toyota's recalls to avoid their own "runaway" quality problems.

Now is not an easy time to lead a pharmaceutical company. The patent cliff is fast approaching, pipeline challenges remain, capital markets are tight, and the blockbuster model is fast on its way out. Meanwhile, regulations on sales and marketing continue to tighten.

Althea Technologies, Inc. (San Diego, CA), a provider of services for biopharmaceutical development and manufacturing will acquire the assets and IP portfolio of Altus Pharmaceuticals (Cambridge, MA).

Archivel Farma's (Badalona, Spain) treatment for tuberculosis (TB) will shortly start Phase 2 clinical trials.

DSM Biologics (Parsippany, NJ), a business unit of DSM Pharmaceutical products, has reached an agreement for the acquisition of the assets and associated business of the Rhobust technology from Upfront Chromatography A/S (Copenhagen, Denmark) for pharmaceutical and other applications.

Crucell N.V. (Leiden, the Netherlands) has been awarded $110 million from UNICEF to supply its pediatric vaccine Quinvaxem to the developing world.

G. Steven Burrill released his 24th annual report on the state of the biotech industry at the BIO International Convention held in Chicago this month. Biotech 2010 -Life Sciences: Adapting for Success provides insight into biotech' s changing environment and how the industry will need to adapt to it.

Delaware-based, iBio, Inc. has been awarded a grant of rights to use its proprietary technology, the iBioLaunch platform, in support of a $5.3 million government-funded project for the development of a single vaccine to protect against both anthrax and plague.

Ernst & Young has released its annual report on the state of the biotech industry, Beyond Borders: Global Biotechnology Report 2010, and overall, things are looking good for the industry.

Waters Corporation (Milford, MA) and Ireland's National Institute for Bioprocessing Research and Training (NIBRT, Dublin, Ireland) have formed a collaboration that will create the world?s first database for glycan analysis by UltraPerformance liquid chromatography (UPLC).

The biopharmaceutical company Genzyme Corporation (Cambridge, MA), is expected to be fined $175 million by the US FDA as part of the agency?s enforcement action to ensure that products manufactured at Genzyme?s Allston, MA, plant are made in compliance with GMP regulations.

Dutch biopharmaceutical company Crucell N.V. (Leiden, the Netherlands) and GlaxoSmithKline Biologicals (GSK, London, UK) will collaborate on developing a second-generation malaria vaccine candidate.

Sinovac Biotech, Ltd. (Beijing, China), a vaccine manufacturer, has signed an exclusive license, supply, and distribution agreements with Parenteral Biotech Ltd., a subsidiary of Parenteral Drugs (India), Ltd., an India-based pharmaceutical company.

Millions of infants and young children in the world?s poorest countries will receive potentially life-saving vaccines that help protect against pneumococcal disease, including pneumonia?the world's biggest childhood killer, through agreements made through the GAVI Alliance with GlaxoSmithKline (London, UK) and Pfizer Inc. (New York, NY).

The biopharmaceutical company Genzyme Corporation (Cambridge, MA), which suffered from a series of manufacturing problems including viral contamination at its Allston Landing plant in June 2009, has announced that it will phase out its fill-finish operations from the plant gradually.

A critical GMP requirement for drug manufacturers is to validate analytical test methods to ensure that they are suitable for their intended uses. There are published guidelines available that the industry can follow for validation but there are none for qualification, which is a key step in the validation process.

Ranbaxy Laboratories Limited (Gugaon, India) will develop an undisclosed biosimilar therapeutic produced in the Pfenex platform, a Pseudomonas-based recombinant protein expression technology developed by Pfenex Inc. (San Diego, CA).

The US Food and Drug Administration has notified Genzyme Corporation (Cambridge, MA) that it intends to take enforcement action to ensure that products manufactured at its Allston, MA, plant are made in compliance with good manufacturing practice regulations.

After months of increasingly rancorous debate, the House finally approved legislation March 21 that makes significant changes in the nation?s healthcare system.

The US Food and Drug Administration is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine, manufactured by GlaxoSmithKline (GSK) for rotavirus immunization in the US, while the agency learns more about components of an extraneous virus detected in the vaccine.

On February 12, Genzyme (Cambridge, MA) notified Cerezyme users of an impurity found in a vial manufactured at its Waterford, Ireland plant.

The Texas Plant-Expressed Vaccine Consortium launched Project GreenVax, a biotherapeutic manufacturing initiative that is designed to show proof-of-concept for a technology that could reduce the time to produce vaccines for infectious disease.

Sanquin Blood Supply Foundation (Amsterdam, the Netherlands), the Netherlands Cancer Institute (Amsterdam, the Netherlands), and the Netherlands Vaccine Institute (Bilthoven, the Netherlands), have launched the AmpVacs project, which aims to develop a broadly protective synthetic influenza A vaccine component.

The US Food and Drug Administration has issued final guidance to help manufacturers who are developing cell-based viral vaccines to address emerging and pandemic threats.

Humacyte, Inc. (Research Triangle Park, NC) and Xcellerex, Inc. (Marlborough, MA) have entered into an initial strategic collaboration for Xcellerex to develop a manufacturing process that will enable the production of Humacyte?s lead regenerative medicine product using Xcellerex?s XDR single-use bioreactor system in its FlexFactory.

The US Food and Drug Administration and the European Medicines Agency (EMA) have agreed to a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions.