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Manufacturing and Capabilities
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The Lead

High Potency, High Reward

October 31, 2014 10:43 am | by Nikita Ernst, Associate Editor | Articles | Comments

SAFC, a global supplier of a a wide range of services to the biopharm and pharmaceutical industry, has recently expanded their Madison, Wisconsin facilities to neighboring Verona to rev up their high-potency API manufacturing capabilities.

Lubrizol Forms Alliance with Particle Sciences after Vesta Acquisition

October 31, 2014 8:58 am | News | Comments

The Lubrizol Corporation has announced an alliance between Lubrizol LifeSciences, a supplier of...

Bristol-Myers Squibb and Lonza Expand Manufacturing Agreement

October 30, 2014 1:34 pm | News | Comments

Bristol-Myers Squibb and Lonza have announced a multi-year expansion of their existing biologics...

Could Google Pill Detect Cancer?

October 30, 2014 8:47 am | Videos | Comments

Google is developing a pill that would hunt for cancer cells in human bodies.   ...

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Novo Nordisk Now Hiring for New Manufacturing Facility in New Hampshire

October 29, 2014 2:20 pm | News | Comments

Novo Nordisk has announced plans to hire up to 90 people at its newly-acquired manufacturing plant in West Lebanon, NH. The facility was formerly owned by Olympus Biotech.             

US Health Care Unprepared for Ebola

October 29, 2014 2:00 pm | by JEFF DONN, Associated Press; GARANCE BURKE, Associated Press | News | Comments

The U.S. health care apparatus is so unprepared and short on resources to deal with the deadly Ebola virus that even small clusters of cases could overwhelm parts of the system, according to an Associated Press review of readiness at hospitals and other components of the emergency medical network.

Boehringer Ingelheim and Lilly Revising Operational Structure of Diabetes Alliance

October 29, 2014 8:19 am | News | Comments

In a move that will strengthen their alliance by enhancing efficiencies and enabling greater focus on product launches, Boehringer Ingelheim and Eli Lilly and Company are changing the operational and financial structure of their diabetes alliance in certain countries.

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Metrics Scientist Awarded Patent For Zero-Order Release Tablet Technology

October 28, 2014 1:35 pm | News | Comments

An expert scientist in pharmaceutical formulation development at Metrics Contract Services has been awarded a patent for intellectual property about controlled release technology.            

Ebola: Race for a Vaccine

October 28, 2014 9:04 am | Videos | Comments

Health officials say a vaccine against Ebola could be ready in 2015.                               

Flu Vaccine Shipments Delayed

October 28, 2014 8:58 am | Videos | Comments

Some key shipments of flu vaccine are delayed this season forcing some health care providers to put off vaccinations.                      

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 by injection, today announced that the company is accelerating its Ebola tablet vaccine program. Following a recent meeting with the FDA, Vaxart anticipates commencing human clinical trials in the first quarter of 2015.

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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 for people who are frustrated by how long it is taking to get it into use in West Africa. The race to get the vaccine safety tested and made in sufficient quantities so that large studies can be rolled out in affected countries early next year is moving at warp speed, he suggests.

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 could protect people from a strain of the deadly Ebola virus. The company has committed up to $200M to speed up and expand production of a vaccine program being developed by its Janssen Pharmaceutical Companies.

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. 

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.

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.

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