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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FDA Draft Guidance Offers Social Media Insight
FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites. 
Ben Venue Continues Suspension of Manufacturing Activity at Ohio Facility
Ben Venue Laboratories is extending its voluntary suspension of manufacturing at its Bedford, Ohio, facility. The company had originally announced the suspension on Nov. 19, 2011, and announced the extension of the suspension on Dec. 23, 2011.
NIH Establishes National Center for Advancing Translational Sciences
The National Institutes of Health has established the National Center for Advancing Translational Sciences, a center dedicated to the translation of scientific discoveries into new drugs, diagnostics, and devices.
FDA Creates Shared REMS System for TIRF Medicines
On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, which is intended to ease the burden on the healthcare system by allowing prescribers and pharmacies to enroll into one new single system instead of several different systems. |
 Thermoformer offers deep-draw capabilities
MG America’s Farmo Res Prima K7 thermoformer is designed for the deep-draw thermoforming of syringes, ampuls, vials, and medical devices. The Prima K7 can run as many as 35 cycles/min, and is operated by a programmable logic controller with transfer on one lane for the production of trays in polystyrene.
The Prima K7’s deep-draw capabilities include the ability to form blisters with depths as great as 40 mm. Other features include a syringe buffer system with a capacity of more than 2000 syringes, a loading station for vials and ampuls, and forming and loading capabilities from the operator side that results in a compact forming module and easier changeover procedures. |
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Karo Bio, a pharmaceutical company, has entered into a research collaboration agreement with Pfizer to discover and develop small-molecule RORgamma modulators for the treatment of autoimmune diseases. Under the agreement, Pfizer will provide full funding for the research costs and have the exclusive right to market any products that may be developed as a result of the collaboration. Karo Bio may receive up to $217 million in upfront and milestone payments in addition to potential royalty fees.
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Marina Biotech, an oligonucleotide-based drug discovery and development company, and the biotechnology company Mirna Therapeutics have formed a license agreement regarding the development and commercialization of microRNA-based therapeutics using Mirna's proprietary microRNAs and Marina Biotech's liposomal delivery technology.
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The biopharmaceutical company OPKO Health has completed its acquisition of FineTech Pharmaceutical, an Israeli provider of APIs.
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The biopharmaceutical company Zealand Pharma has received a milestone payment of EUR 3 million ($3.9 million) received under the license agreement with Helsinn Healthcare for elsiglutide, a GLP-2 peptide agonist in Phase I development.
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Abbott and Emergent Biosolutions have ended their partnership on a cancer drug candidate.
The CMO Albany Molecular Research (AMRI) restructures.
Alexion has agreed to acquire Enobia in a deal valued over $1 billion.
Arecor has formed a collaboration with Lilly to develop advanced formulations of protein therapeutics.
UCB and Immunomedics have restructured their epratuzumab license agreement.
Veloxis and Athena have formed a manufacturing and commercialization pact for AtorFen, a fixed-dose combination of fenofibrate and atorvastin.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
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Lyophilization advances
Is lyophilization technology advancing fast enough to meet demands from manufacturers of increasingly sensitive biopharmaceutical products?
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View the poll archive. |
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