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Fourth Annual Optimizing Biologics Formulation Development
January 9, 2012—January 10, 2012
San Diego, CA, USA
CHI PepTalk 2012
January 9, 2012—January 13, 2012
San Diego, CA, USA
European Pre-Filled Syringes
January 18, 2012—January 19, 2012
London, United Kingdom
Latin America: Regulatory Compliance Requirements for Life Science Products
(Focus: Brazil, Mexico, Argentina)
January 19, 2012—January 20, 2012
San Francisco, CA, USA
Enhancing Drug Bioavailability & Solubility
January 25, 2012—January 26, 2012
Boston, MA, USA

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FDA Announces Public Meeting to Discuss Biosimilar User Fees
On Dec. 6, 2011, FDA announced that a public meeting will be held on Dec. 16, 2011 to discuss recommendations for a user fee program for biosimilar biological products for fiscal years 2013–2017. 
Biogen Idec, Samsung Form Biosimilars Joint Venture
Samsung and Biogen Idec agreed to invest $300 million to establish a joint venture to develop, manufacture, and market biosimilars. The deal is Samsung’s latest effort to strengthen its position in biosimilars. 
AstraZeneca and MRC form Landmark Collaboration
In an initiative that could signal a new era in private–public partnerships, AstraZeneca will make 22 compounds available for free to medical researchers next year for projects funded by the United Kingdom’s Medical Research Council. 
UK Adopts Multimillion-Pound Life-Sciences Strategy
The United Kingdom’s life-sciences industry this week welcomed a new, multimillion-pound strategy that aims to both support the industry and encourage innovation in the unsettled economic climate. 
PhRMA Foundation Funds Comparative-Effectiveness Research
Last week, the PhRMA Foundation awarded Johns Hopkins University and the University of Washington each a $250,000 grant to establish a three-year graduate certificate program. The program is formally known as the PhRMA Foundation Center of Excellence for a Comparative-Effectiveness Research Educational Program. The funds are the foundation’s first grants to educational institutions. 
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Anion-exchange media offers high dynamic binding capacity
Bio-Rad’s Nuvia Q ultrahigh-capacity anion-exchange media has a dynamic binding capacity of about 170 mg/mL. The high dynamic binding capacity enables customers to process large volumes in a short time. The media also requires smaller columns for given steps, and thus less hardware, than other anion-exchange media do. The product’s good flow properties and fast mass-transfer kinetics enable users to run processes at rates of 150 to 600 cm/h without losing the high dynamic binding capacity and while maintaining low backpressure.
The Nuvia Q media is intended for intermediate or polishing steps and has strong selectivity for typical feedstream contaminants, such as host-cell protein and DNA. The media withstands alkaline reagents, such as sodium hydroxide, and can thus be reused many cycles after being subjected to clean-in-place protocols.
The media is also designed to provide high recovery, which, together with its long life cycle, helps to reduce users’ costs. The Nuvia Q media requires less elution volume from the column for users to collect product. This characteristic eliminates the need to concentrate the product for the following purification step. |
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Agilent Technologies has agreed to acquire BioSystem Development, a provider of products and services used in protein purification and characterization.
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Aveo Pharmaceuticals and Boehringer Ingelheim have entered into an agreement for large-scale process development and clinical manufacturing of ficlatuzumab, Aveo’s HGF inhibitory antibody that is currently in Phase II clinical development for treating nonsmall cell lung cancer. Boehringer Ingelheim will produce ficlatuzumab for clinical trials at its biopharmaceutical site in Fremont, California. Aveo retains all rights to the development and commercialization of ficlatuzumab. Financial terms of the agreement were not disclosed.
Bristol-Myers Squibb (BMS) has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals, part of Johnson & Johnson’s Janssen, to evaluate the use of daclatasvir (BMS-790052), BMS’s investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals’ investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus.
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Eisai’s research subsidiary, H3 Biomedicine, has opened a new 24,000-ft2 research facility in Cambridge, Massachusetts. The company plans to expand its laboratory space and workforce to approximately 70 staff members. Eisai has pledged to provide H3 Biomedicine with up to $200 million in research funding.
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Merck & Co. has established an Asia R&D headquarters for drug discovery and development in Beijing, China. The new facility is part of a $1.5-billion commitment the company has made to invest in R&D in China during the next five years. The facility will consist of 47,000 m2 (505,903.789 ft2) of office and laboratory space. The first phase of construction, scheduled to be completed by 2014, will provide capacity for approximately 600 employees working in the areas of drug discovery, translational research, clinical development, regulatory affairs, and external scientific research programs.
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Momenta Pharmaceuticals, a biotechnology company specializing in the characterization and engineering of complex drugs, has signed an agreement to acquire the sialic switch assets of Virdante Pharmaceuticals, including intellectual property and cell lines, relating to the sialylation of intravenous immunoglobulin and other proteins. Momenta made an upfront payment of $4.5 million and may make additional contingent milestone payments, which, if all development and regulatory milestones are achieved, will total $51.5 million.
Pfizer has completed its acquisition of the biotechnology company Excaliard Pharmaceuticals. While specific financial terms were not disclosed, Pfizer provided Excaliard’s shareholders, which include Isis Pharmaceuticals, Alta Partners, ProQuest Investments, and RiverVest Venture Partners, an upfront payment and will make contingent payments if certain milestones are achieved in the future.
In other news, Pfizer has completed its previously announced acquisition of Ferrosan Consumer Health’s business, which includes dietary supplements and lifestyle products.
Q Chip, a developer of sustained-release drug depots, has signed an agreement with an undisclosed speciality pharmaceutical company to undertake the development of a sustained-release depot of an undisclosed therapeutic peptide. All the costs of preclinical and clinical development will be borne by Q Chip’s partner. In addition, Q Chip will receive success-based payments, and will provide the manufactured product after regulatory approval.
Roche, PTC Therapeutics, and the SMA Foundation, have entered into a licensing agreement for PTC’s Spinal Muscular Atrophy (SMA) program. SMA is a genetic neuromuscular disorder that causes muscle weakness. Under the terms of the agreement, Roche gains an exclusive worldwide license to PTC’s SMA program, which includes three compounds currently in preclinical development, as well as potential back-up compounds. PTC receives $30 million as an upfront payment, and up to $460 million upon successful completion of certain development and commercialization milestones, and up to double-digit royalties on commercial sales. Development will be overseen by a joint steering committee comprised of members from Roche, PTC, and the SMA Foundation.
Takeda Pharmaceutical plans to establish a vaccine business division, effective Jan. 1, 2012. The company also announced the appointment of Rajeev Venkayya as its leader of the division, effective Jan. 15, 2012.
Unigene Laboratories, a provider of drug-delivery and manufacturing technologies for peptides, has terminated its exclusive worldwide license agreement and related development services and clinical-supply agreement with GlaxoSmithKline (GSK) pertaining to an oral formulation of a recombinantly produced parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women. The termination of these agreements followed notification by GSK of its decision not to proceed based on its internal evaluation criteria. As a result, Unigene regains the exclusive worldwide rights to its oral PTH program with no financial obligations to GSK.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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Agensys, a subsidiary of Astellas has appointed Frank P. Hudson as vice-president of finance. He was previously vice-president of finance for Mannkind. The company has also named Wolfgang Noe vice-president of process sciences and manufacturing. Noe joins Agensys from Biogen-Idec, where he most recently served as vice-president of strategic development and technical alliances.
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Oral Drug Delivery
Which of the following breakthroughs has contributed the most to advancing oral drug delivery or oral product forms?
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View the poll archive. |
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