News

Roche (Basel, Switzerland) will acquire 100% of Innovatis, AG (Bielefeld, Germany).

Covance Inc. (Princeton, NJ) has completed an additional 8,000-sq. ft. to its biotechnology services facility in Harrogate, UK.

SAFC Biosciences (Lenexa, KS) has completed the conversion of its dry powder cell culture media continuous milling production site in Lenexa, KS to animal component free (ACF) status. This is the first of several similar conversions planned by SAFC Biosciences to support growing customer requirements for ACF manufacturing.

The US Food and Drug Administration has released a new draft guidance on somatic cell therapies that are designed to advance the treatment of heart disease through the regeneration of cardiac tissues.

ImClone Systems, Inc. (Branchburg, NJ), and Bristol-Myers Squibb (BMS, New York, NY) voluntarily recalled 13 lots of their cancer drug Erbitux (cetuximab) after a report from a doctor?s office about a leaking cap on a vial of the biologic.

Pall Corporation (East Hills, NY) has acquired an exclusive license to manufacture, market, and sell Single Pass TFF (SPTFF), an SPF Innovations, LLC (Watertown, MA) technology for biopharmaceutical applications.

When the final version of the Quality by Design (QbD) case study is made public this summer, it will be an aspirational document, says Ken Seamon, PhD, one of the project?s facilitators. "If the regulatory authorities read our final document and said 'yes, this is all fine,' we will have failed," he said.

Intercell AG (Vienna, Switzerland) has received the US Food and Drug Administration?s approval for Ixiaro, a vaccine for the prevention of Japanese Encephalitis (JE).

Novozymes Biopharma UK Ltd. (Nottingham, UK) has signed a license agreement with GE Healthcare Life Sciences (Chalfont St. Giles, UK), which enables Novozymes Biopharma to produce and deliver native, animal-free Protein A using GE Healthcare technology.

Nobilon, the human vaccine business of Schering-Plough Corporation (Kenilworth, NJ), have entered into an agreement with the World Health Organization (WHO, Geneva, Switzerland) to provide access to pandemic influenza vaccine manufacturing technology to developing countries.

Sanofi Pasteur (Lyon, France), the vaccines division of the Sanofi-Aventis Group, has received marketing authorization from the European Commission for the first intradermal (ID) influenza vaccine using BD Soluvia microinjection system developed by BD (Franklin Lakes, NJ).

Biopharmaceutical companies have been seeing the importance of sustainability and green efforts. Two companies in particular have embraced sustainability and green manufacturing.

Genzyme Corporation (Cambridge, MA) has received a complete response letter from the US Food and Drug Administration regarding its application to market Lumizyme (alglucosidase alfa). In its letter, the agency outlines the remaining items that must addressed before the application can be approved. To gain approval, Genzyme must also resolve issues identified in a warning letter that the company received simultaneous to the complete response letter.

GE Healthcare (Chalfont St Giles, UK) has entered into a marketing collaboration with Tecan (Mannedorf, Switzerland) to provide customers with access to both companies' expertise in laboratory automation and process development. The agreement will enable process developers to implement specifically designed protocols and accessories for GE Healthcare's PreDictor 96-well plates on Tecan Freedom EVO workstations. The automation collaboration is designed to reduce hands-on time required for screening process conditions.

ImClone Systems, a subsidiary of Eli Lilly and Company (Indianapolis, Indiana), and Bristol-Myers Squibb (BMS, New York, NY), have received a complete response letter from the US Food and Drug Administration for the first-line squamous cell carcinoma of the head and neck supplemental Biologics License Application (sBLA) for Erbitux (cetuximab).

Novavax (Rockville, MD) has achieved favorable preclinical results for a new pandemic influenza virus-like particle (VLP) vaccine candidate that provided protection against several H5N1 virus strains.

Implicit Bioscience Ltd (Brisbane, Australia) has acquired the clinical-stage monoclonal antibody IC14 from Eli Lilly and Company (Indianapolis, Indiana). Implicit has paid an undisclosed consideration combining cash and stock to Lilly. Lilly will also receive a royalty on future IC14 sales.

Waters Corporation (Milford, MA) and LabVantage Solutions, Inc. (Bridgewater, NJ) have formed a partnership to integrate laboratory software for improved efficiency and effectiveness. Collaborating with existing common customers, Waters and LabVantage have already integrated LabVantage's Sapphire Laboratory Information Management Suite (LIMS) with Waters NuGenesis Scientific Data Management System (SDMS) and Empower 2 chromatography data software (CDS) solutions.

In the Food and Drug Administration?s draft revision of the 1987 Process Validation Guidance, the lack of clarity about how the revised guideline applies to legacy products and the potential burden of new requirements for ongoing process monitoring are common concerns raised in many of the comments submitted by industry to the agency. To date, more than 45 companies or organizations have submitted comments on the draft revision, issued in November 2008.

In addition to providing tax breaks and investing billions to jump start the economy, last month?s economic stimulus package supports healthcare for the unemployed and takes steps to modernize the nation?s troubled healthcare system.

Oxford Expression Technologies (OET, Oxford, UK) and Eden Biodesign (Liverpool, UK) have signed a co-marketing agreement.

Apotex, Inc. (Toronto, Canada) and Intas Biopharmaceuticals Limited (IBPL, Ahmendabad, India) have extended their business agreement to develop a biosimilar version of pegfilgrastim, a protein that is used to treat neutropenia (a side effect of cancer chemotherapy).

Even the best biotech companies lack a crystal ball. In 2003, Genentech had a shortage of manufacturing capacity. So they started an internal campaign, called "Every Gram Counts," to produce as much as possible.

The US Food and Drug Administration issued its first approval on February 6 for a biological product produced by genetically engineered animals.

Richter-Helm BioLogics GmbH & Co. KG (Hamburg, Germany) and Athera Biotechnologies AB (Stockholm, Sweden) have signed an agreement for the development and manufacturing of Annexin A5, Athera?s novel product for prevention of plaque rupture and athero-thrombosis.

With counterfeit and adulterated medicines posing an increasing risk to patients in the United States and worldwide, the US Pharmacopeial (USP, Rockville, MD) Convention announced on February 4, new standards for two widely used drug products that have been involved in episodes of adulteration resulting in patient deaths.

Following a discussion with the US Food and Drug Administration, ImClone Systems, acquired last fall by Eli Lilly and Company (New York, NY), and Bristol-Myers Squibb (New York, NY) have withdrawn the supplemental Biologics License Application for the use of Erubitux (cetuximab) in advanced non-small cell lung cancer.

The US Food and Drug Administration has launched a voluntary pilot program that will help promote the safety of drugs and active drug ingredients produced outside the United States.