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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.

On January 15, 2010, Baxter Biosciences (Deerfield, IL) received a warning letter from the US Food and Drug Administration, citing significant deviations from current good manufacturing practices (cGMPs) in the manufacture of Gammagard (human immune globulin) liquid and Gammagard S/D intermediates at its manufacturing facility in Lessines, Belgium.

Repligen Corporation (Waltham, MA) has acquired the assets of BioFlash Partners, LLC (Marlborough, MA), including a technology platform for producing prepacked plug-and-play chromatography columns.

Waters Corporation (Milford, MA) and Daiso Co., Ltd. (Osaka, Japan) have entered into a collaborative agreement to globally market and supply Daisogel bulk packing materials for process chromatography.

Characterizing the higher order structure (HOS) of protein drugs increases manufacturers' understanding of stability and batch-to-batch variability, and may make it possible to link variants or aggregates to safety and efficacy. Yet at the January 24 CMC Strategy Forum in Washington, DC, regulators expressed concern that methods to characterize the three-dimensional structure of proteins are not routinely applied to biotechnology products.

AstraZeneca will cut 500 research and development positions at its US headquarters in Fairfax, DE.

The US Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

German pharmaceutical and chemicals company Merck KGaA will buy US biotech equipment-maker Millipore for $7.2 billion.

Eli Lilly & Company received a warning letter from the US Food and Drug Administration, citing significant deviations from current good manufacturing practices (cGMP) in the manufacture of active pharmaceutical ingredients (APIs) at its facility in Carolina, Puerto Rico.

The US Food and Drug Administration has approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages six weeks through five years, manufactured by Wyeth Pharmaceuticals, Inc. (Collegeville, PA), a wholly owned subsidiary of Pfizer, Inc.

The US Food and Drug Administration has approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia.

Merck & Co. (Whitehouse Station, NJ) has announced restructuring plans that include reducing its companywide workforce by 15% by the end of 2012.

Sanofi Pasteur (Lyon, France) has recalled an additional six lots of its Influenza A (H1N1) 2009 Monovalent Vaccine in prefilled syringes after routine testing found that the antigen content had declined below the specification limit.

Following its recent acquisition of Wyeth, Pfizer has 79 manufacturing plants around the world?43 from Pfizer and 36 from Wyeth-and relationships with about 250 contract manufacturers. It?s a wealth of resources, which altogether make 32,000 SKUs. Now, how to consolidate it all?

Novavax will discontinue negotiations for the previously announced collaboration with Madrid-based ROVI Pharmaceuticals.

The US Food and Drug Administration will collaborate with PATH to advance development of a conjugate vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia.

Vivalis (Nantes, France) has acquired Humalys SAS, a private French biotech research and development company based in Lyon, specialized in the generation of human MAbs.

Workshops Based on the A-MAb Case Study

TenX Biopharma, Inc. (Philadelphia, PA) has signed a licensing agreement to acquire exclusive worldwide rights to develop and commercialize zanolimumab (HuMax-CD4) from Genmab A/S (Copenhagen, Denmark).

GlaxoSmithKline (GSK, London, UK) has begun a series of initiatives, which aim at combating diseases that affect the world?s poorest countries.

Repligen Corporation (Waltham, MA) has extended its longstanding relationship with GE Healthcare Bio-Sciences AB by entering into a five-year supply agreement for recombinant Protein A, a consumable used in the manufacture of monoclonal antibodies (MAbs).

SciClone Pharmaceuticals, Inc. (Foster City, CA) and its partner Sigma-Tau, S.p.A. (Rome, Italy) have received initial topline results in a clinical study evaluating the potential of Zadaxin (thymalfasin) to enhance immune response to the MF59 adjuvanted H1N1 influenza monovalent vaccine, Focetria, from Novartis (Basel, Switzerland).