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Sutro Biopharma and Celgene Corporation Enter Multi-Year Strategic Collaboration and Option to Acquire Agreement

October 23, 2014 10:31 am | News | Comments

The scope of the collaboration allows the parties to systematically interrogate the immuno-oncology space, including established targets, using Sutro’s cell-free biologics development platforms. During the collaboration, after an initial period, Celgene will have the exclusive option to acquire Sutro, including rights to all Sutro-owned programs at that time, on pre-specified terms.

Vaxart Accelerates Development of Ebola Tablet Vaccine

October 23, 2014 8:10 am | News | Comments

Vaxart, a privately held company developing vaccines that are administered by tablet rather than...

NewLink CEO: Testing of Canadian Ebola Vaccine Moving as Fast as Possible

October 22, 2014 8:20 am | by Helen Branswell, The Canadian Press | News | Comments

The CEO of the company that holds the license for a Canadian-made Ebola vaccine has a message...

J&J to Spend Up to $200M on Ebola Vaccine Program

October 22, 2014 8:09 am | News | Comments

Johnson & Johnson will start safety testing in early January on a vaccine combination that...

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NewLink Genetics Rises on Roche Cancer Partnership

October 20, 2014 2:59 pm | News | Comments

NewLink said it will get $150M upfront from Genentech, and could receive more than $1B in payments based on milestones, as well as royalties if the drug is approved. The drug, now called NLG919, is in early-stage clinical testing.    

Canadian Law Professor Urges Country to Cancel Ebola Vaccine License with NewLink, Transfer Rights to Bigger Company

October 20, 2014 1:57 pm | by Helen Branswell, The Canadian Press | News | Comments

A prominent law professor is urging the federal government to terminate an American company's licence for a Canadian-made Ebola vaccine. The company, NewLink Genetics, doesn't have the capacity to develop the much-needed vaccine, argues Amir Attaran, a professor of law and population health at the University of Ottawa.

Pharmaceutical Processing's October 2014 Issue

October 20, 2014 11:34 am | Digital Editions | Comments

The October issue of Pharmaceutical Processing describes Capsugel’s merger with Bend Research and Encap to create a comprehensive solid dosage form solutions group. The issue also features articles on supply chain trends including how to reduce risk, managing a clinical supply chain,  a look at the best printing and coding solutions, and the move to the fully connected enterprise. Other articles focus on particle size analysis, disposable chromatography technologies, and monitoring potency assays.

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Halozyme Receives FDA Approval for Additional Manufacturing Facilities For Hylenex Recombinant

October 20, 2014 9:02 am | News | Comments

The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon facility in Greenville, North Carolina, for production of finished Hylenex product.

Aduro Expands Collaboration with Johnson & Johnson Innovation and Janssen for Lung Cancer Immunotherapies

October 17, 2014 8:40 am | News | Comments

Under the agreement, facilitated by the Johnson & Johnson Innovation center in California, Aduro will receive a $30M up-front payment and is eligible to receive significant development, regulatory and commercialization milestone payments up to a potential total of $817M.

HHS Advances Development of Third Ebola Vaccine

October 16, 2014 3:39 pm | News | Comments

The development of a vaccine to prevent Ebola virus disease will be accelerated with support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).      

Lilly to Realign Puerto Rico Manufacturing Operations

October 16, 2014 3:28 pm | News | Comments

Eli Lilly and Company has announced plans to conclude production and pursue a sale of one of its three manufacturing plants in Puerto Rico. The manufacturing site, located in Guayama, Puerto Rico, will remain in operation until the end of 2015. 

Is McLaren Going to be Pharma’s “Creative Destructionist”?

October 15, 2014 8:51 am | by Girish Malhotra, PE; President, EPCOT International | Blogs | Comments

Since 2011 I have postulated that pharma needs a “creative destructionist” for its manufacturing technology innovations to get out from its archaic “quality by analysis” methods to “quality from the get go methods”. Current practices have cost patients billions in excessive costs. Generally most of the “creative destructionists” are from outside the industry, McLaren could be the one for the pharma and the chemical industry. 

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Sucampo Announces Extension of AMITIZA License and Collaboration Agreement With Takeda

October 14, 2014 9:08 am | News | Comments

Sucampo Pharmaceuticals has announced that it signed an amendment to the existing collaboration and license agreement covering the United States and Canada for AMITIZA with Takeda Pharmaceutical Company.        

Bristol-Myers Squibb, Pharmacyclics and Janssen Announce Clinical Collaboration to Evaluate OPDIVO® and IMBRUVICA® in Non-Hodgkin Lymphoma

October 14, 2014 8:48 am | News | Comments

The Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL).

Canadian-Made Ebola Vaccine Starts Clinical Trials in Healthy Humans

October 14, 2014 8:15 am | by Will Campbell, The Canadian Press | News | Comments

Human testing of an experimental Canadian-made Ebola vaccine began Monday, with federal officials saying the drug could be shipped to West Africa within months if it proves successful.           

PCI Opens North American Clinical Facility

October 10, 2014 8:27 am | News | Comments

The 97,000 square foot purpose built site was constructed in support of the growth PCI has experienced in its Clinical Trial services business, which includes drug development and manufacturing, laboratory services, packaging and storage services, global logistics, as well as client supporting consultative services for executing global investigational studies.

Tufts Center Report: Drug Companies Outline Ways Strategic Partnerships Can Boost Innovation

October 9, 2014 2:03 pm | News | Comments

Strategic relationships between drug developers and contract research organizations (CROs) are generating innovative approaches to clinical trial design and execution, but creating lasting value for both parties requires them to act in new ways, R&D executives from the pharmaceutical and biotech industry said at a gathering recently hosted by the Tufts Center for the Study of Drug Development.

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Isis Pharmaceuticals Earns $18M From GSK for Advancing ISIS-TTR Rx

October 9, 2014 8:14 am | News | Comments

ISIS-TTRRx is an antisense drug in development with GSK for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues.  Including this $18M milestone payment, Isis has generated $45M of the $70M in upfront and milestone payments Isis is eligible to earn for advancing ISIS-TTRRx in development.

Finesse Solutions Announces SmartFactory for Optimized Deployment of Single-Use Facilities

October 8, 2014 9:29 am | News | Comments

Finesse Solutions has announced the launch of SmartFactory, which is a uniquely configurable design architecture for single-use facilities. The Finesse SmartFactory is based on Finesse SmartParts, the measurement and actuation building blocks which comprise SmartSystem process automation solutions.

Recent Developments Keep Gilead Ahead of the Pack in HIV Treatment Market, says GlobalData Analyst

October 8, 2014 9:14 am | News | Comments

Gilead’s announcement of positive Phase III results for its investigational single-tablet regimen (STR), elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate (TAF), caps a series of developments bolstering the company’s position as HIV treatment market leader, according to an analyst with research and consulting firm GlobalData.

Capsugel Expands Lipid Multi-Particulate Technology Offering

October 7, 2014 8:57 am | News | Comments

Capsugel announced today the broad commercial availability of its proprietary lipid multi-particulate (LMP) technology. Capsugel’s LMP technology is an innovative drug-delivery platform with multiple applications – including bioavailability enhancement, taste-masking and modified release – for both pharmaceutical and health and nutrition products.

Survey: Majority of CROs Exchange Regulated Clinical Trial Documents via Outdated, Hard-to-Track Methods

October 7, 2014 8:17 am | News | Comments

The vast majority of contract research organizations (CROs) surveyed lag clinical trial sponsors in how they exchange trial master file (TMF) documents, according to the Veeva 2014 Paperless TMF Survey: The State of CRO TMFs.    

Argos Therapeutics to Build New Manufacturing Facility in Research Triangle Park Area in Durham, NC

October 3, 2014 3:00 pm | News | Comments

In support of the development and implementation of the nearly 100,000 square foot facility, Argos will receive approximately $9.5 million in incentives as well as logistical and planning support from the State of North Carolina, Durham County, the City of Durham, and the North Carolina Biotechnology Center.

The Connected Enterprise

October 3, 2014 11:47 am | Videos | Comments

Ron Guido, President, Life Services discusses the connected enterprise and what does this age of Internet information sharing mean for businesses, especially in terms of brand marketing, customer interface and supply chain management. In order to be competitive in this highly connected world of the consumer, the business enterprise must be equally connected internally and globally with its commercial partners.

EU OKs Eli Lilly's $5.4B Bid for Novartis division

October 3, 2014 6:47 am | by The Associated Press | News | Comments

The European Union's antitrust authority says it has approved the $5.4 billion sale of Novartis' animal health division to U.S. pharmaceutical firm Eli Lilly. The 28-nation bloc's executive Commission said Friday the sale won't hinder competition because the merged firm will continue to face a number of strong competitors.

GEA Expands Continuous Pharma Manufacturing Technologies

October 2, 2014 11:26 am | News | Comments

GEA Pharma Systems (GPS) has announced a group restructure and appointments as it embraces a new corporate philosophy to overcome competitive challenges, expand and develop new markets and customers.         

Challenges of Scale-up and Commercialization

October 2, 2014 8:25 am | by Christopher Kulp, Executive Vice President, Richman Chemical | Articles | Comments

The development of new chemistry-based products for life science markets requires the expertise of talented researchers. However, these same researchers are typically not prepared to solve the many other critical problems necessary for successful commercialization.

West to Build Pharmaceutical Component Manufacturing Plant in Ireland

October 2, 2014 8:09 am | News | Comments

West Pharmaceutical Services announced today it plans to expand its global manufacturing operations to include a new site in Waterford, Ireland. The new facility will produce packaging components for insulin injector cartridges and other high-value packaging components, in order to meet growing demand from pharmaceutical and biotech customers.

Capsugel Awarded EXCiPACT™ Certifications for Excipient Good Manufacturing Practices

October 1, 2014 10:33 am | News | Comments

Capsugel announced today that it has received EXCiPACT™ certification for its sites in Bornem, Belgium, and Colmar, France. The certification provides independent validation that Capsugel maintains excipient Good Manufacturing Practices (GMPs) and complies with current European Union regulations in the manufacturing of empty, two-piece hard capsules.

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