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The Lead

Bayer Selects Cardinal Health as U.S. Based Contract Manufacturer for Xofigo Injection

December 18, 2014 1:20 pm | News | Comments

Bayer HealthCare and Cardinal Health have signed a 15-year agreement for the contract manufacturing of Xofigo.  As part of the agreement, Cardinal Health will build a state-of-the art, 64,000 square foot facility in Indianapolis, which will be dedicated exclusively to the manufacturing of Xofigo.

U.S. Incentive Program May Alter the Challenging Economics of Ebola Vaccines

December 18, 2014 8:09 am | by Helen Branswell, The Canadian Press | News | Comments

Earlier this week, President Barack Obama signed into law a little piece of legislation that may...

Halozyme Therapeutics and Janssen to Develop Subcutaneous Products Using ENHANZE Technology

December 17, 2014 10:11 am | News | Comments

Halozyme Therapeutics has entered into a worldwide collaboration and license agreement with...

PPD and ERT to Partner on Drug Development

December 16, 2014 9:10 am | News | Comments

Pharmaceutical Product Development and ERT today announced a strategic partnership to facilitate...

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Mice Used as "Avatars" for Cancer Patients Drug Testing

December 15, 2014 8:42 am | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

Scientists often test drugs in mice. Now some cancer patients are doing the same — with the hope of curing their own disease. They are paying a private lab to breed mice that carry bits of their own tumors so treatments can be tried first on the customized rodents.

Vetter Opens Third Cleanroom for Clinical Syringe Projects

December 11, 2014 9:59 am | News | Comments

Vetter has announced that its U.S. early-stage development site located at the Illinois Science + Technology Park in suburban Chicago, has completed the next step of its expansion with the addition of a third cleanroom. Clinical syringe projects are now being accepted at the facility, which can handle preclinical through phase II projects.

Merck Advances Breast Cancer Drug

December 10, 2014 1:44 pm | by The Associated Press | News | Comments

Merck will advance a new cancer drug into bigger patient tests, after promising findings in an early study against a very aggressive, common type of breast cancer.               

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Avid Bioservices to Expand cGMP Manufacturing Capacity

December 10, 2014 8:49 am | News | Comments

Avid Bioservices, the contract manufacturing subsidiary of Peregrine Pharmaceuticals, has initiated an expansion of its biomanufacturing capacity. The new production facility will more than double Avid Bioservices' current manufacturing capacity in a state-of-the-art facility design.

Biotech and Generic Drugs: 2015 Trends and Predictions

December 9, 2014 4:05 pm | by Ed Price, President of PCI | Blogs | Comments

Ed Price, President of PCI Synthesis, issues his annual list of trends that he feels will continue to affect the emerging biotech and generic drug industries in 2015.                        

Stem Cell Therapies Gathering Momentum but Significant Challenges Remain, says GlobalData

December 9, 2014 11:18 am | News | Comments

With 104 programs in late-stage clinical development, the stem cell therapy space could reach the commercialization threshold by 2017, but a number of challenges remain, according to research and consulting firm GlobalData.     

Romark Labs to Build Plant in Puerto Rico

December 8, 2014 8:46 am | News | Comments

Puerto Rico's governor says Florida-based pharmaceutical company Romark Laboratories is building a $110M plant in the U.S. territory. Alejandro Garcia Padilla says construction will begin in January and that nearly 200 jobs will be created in three years.

Dynavax and AstraZeneca to Move Asthma Treatment Into Phase 2a Clinical Study

December 8, 2014 8:18 am | News | Comments

Dynavax Technologies and AstraZeneca signed an amendment to the existing Research Collaboration and License Agreement under which AstraZeneca will fully fund and Dynavax will conduct a Phase 2a safety and efficacy trial of AZD1419 in patients with asthma.

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Acura Pharmaceuticals Receives Additional U.S. Patent for Abuse Deterrent Drug Formulations

December 8, 2014 8:15 am | News | Comments

The claims in the patent cover, among other inventions, Acura's IMPEDE® Technology, a unique polymer matrix that disrupts the conversion of pseudoephedrine into the dangerous drug, methamphetamine. This is the first issued U.S. patent directed at Acura's IMPEDE technology and products utilizing that technology.

Cholera Vaccine Trial Meets Phase III Goals

December 8, 2014 8:10 am | News | Comments

PaxVax has announced positive results from a Phase 3 safety and lot-to-lot consistency trial of its single-dose oral cholera vaccine candidate, PXVX0200, which utilizes the same attenuated vaccine strain (CVD 103-HgR) previously approved and marketed in several countries under the brand name Orochol®

Spark Therapeutics Announces $280M Gene Therapy Collaboration in Hemophilia B with Pfizer

December 8, 2014 8:04 am | News | Comments

Spark Therapeutics, a late-stage gene therapy company developing treatments for debilitating genetic diseases, has entered into a global collaboration with Pfizer for the development and potential commercialization of SPK-FIX, a development program advancing proprietary, bio-engineered adeno-associated virus vectors for the potential treatment of hemophilia B.

Meda to End Penicillin Contract with Recipharm; Layoffs Forecast

December 4, 2014 1:44 pm | News | Comments

Meda, a Recipharm’s customer, announced that they will transfer supply of their mainly Swedish penicillin products and manufacture offshore with other suppliers. The manufacturing contract with Recipharm Strängnäs will therefore be terminated as of December 31, 2015.

Ferring Pharmaceuticals Opens U.S. Operations Center

December 4, 2014 10:10 am | News | Comments

The facility recently completed the integration of staff into the state-of-the-art manufacturing suite and product development laboratories. The U.S. Operations Center will house 275 employees across management, administration, commercial operations, manufacturing and R&D, a set up designed to allow unique opportunities for collaboration across various operational disciplines.

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Catalent and Sellas to Collaborate on Therapeutic Reprofiling of Zolpidem

December 4, 2014 10:00 am | News | Comments

Catalent Pharma Solutions has reached an exclusive development and licensing agreement with Swiss-based development-stage biopharmaceutical company SELLAS Life Sciences Group, to support the development and therapeutic reprofiling of zolpidem using Catalent’s OSDrC® OptiDose™ drug delivery technology.

Catalent and Valerion Therapeutics to Develop New Treatments for Orphan Genetic Disorders

December 2, 2014 3:23 pm | News | Comments

The collaboration will focus on the delivery of muscle-protein fusions, and treatment of multiple indications, in the fields of muscular dystrophies, glycogen storage diseases, myopathies and enzyme-deficiency disorders.     

Evotec and Sanofi Form Major Multi-Component Strategic Collaboration

December 2, 2014 1:52 pm | News | Comments

Evotec AG has entered into exclusive negotiations with Sanofi on a major multi-component strategic alliance over the next five years. The collaboration will comprise three major strategic initiatives all focused on improving innovation effectiveness in the drug discovery and pre-clinical development space.

Vetter Adds Flexible Serialization Services

December 2, 2014 11:51 am | News | Comments

Vetter, a contract development and manufacturing organization (CDMO), now offers the option of clearly identifying packaging used for drugs. Vetter's comprehensive and flexible serialization service is in response to stricter guidelines from the regulatory authorities of many countries aimed at combatting counterfeit drugs.

Johnson Matthey Acquires Pharmaceutical Manufacturing Capacity in Scotland, UK

December 2, 2014 11:43 am | News | Comments

Johnson Matthey, a provider of pharmaceutical services, APIs and catalyst technologies, has announced completion of an acquisition of pharmaceutical manufacturing capacity in Scotland, U.K. The 109,000 sq. meter site was acquired to meet increasing demand for custom pharmaceutical services and active ingredients utilising enhanced manufacturing capabilities.

Alabama Company Boosted by Ebola Scare

December 1, 2014 9:20 am | by JAY REEVES, Associated Press | News | Comments

The Ebola scare has subsided in the United States, at least temporarily, but an Alabama manufacturer is still trying to catch up with a glut of orders for gear to protect against the disease. Located in north Alabama, the family-owned Kappler Inc. of Guntersville typically gets only a few orders annually for the type of suit needed by health workers who are in contact with Ebola patients.

POZEN and Sanofi Terminate Partnership for PA8140/PA32540

December 1, 2014 8:42 am | News | Comments

POZEN today announced that it and Sanofi US have mutually agreed to terminate their agreement for commercialization of the investigational products, PA8140 and PA32540 effective November 29, 2014. As of the effective date of the termination, all licenses granted to Sanofi US will be terminated and all rights to the products will revert to POZEN.

Mylan and Gilead to Enhance Access to HIV Treatments in Developing Countries

December 1, 2014 8:29 am | News | Comments

Mylan has entered into an agreement with Gilead Sciences under which Mylan has licensed the non-exclusive rights to manufacture and distribute Tenofovir Alafenamide (TAF) as both a single agent product and in combination with other drugs.   

Eli Lilly and AstraZeneca Start Pivotal Clinical Trial for Patients with Early Alzheimer's Disease

December 1, 2014 8:22 am | News | Comments

Eli Lilly and and AstraZeneca today announced enrollment of the first patient into AMARANTH, a Phase II/III study of an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer's disease.

BMS and Five Prime Therapeutics to Evaluate Investigational Immunotherapies Opdivo and FPA008 in Six Tumor Types

November 24, 2014 4:09 pm | News | Comments

Bristol-Myers Squibb Company and Five Prime Therapeutics have entered into an exclusive clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of combining Opdivo, Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, with FPA008, Five Prime’s monoclonal antibody that inhibits colony stimulating factor-1 receptor.

AstraZeneca to Expand Frederick, MA Biologics Manufacturing Center

November 24, 2014 8:46 am | News | Comments

AstraZeneca has announced plans to expand its biologics manufacturing center in Frederick, Md. The more than $200M project will increase production capacity at the facility to support AstraZeneca’s maturing pipeline, and will help position the company to keep pace with a growing demand for the development and use of biologics, which currently represent nearly 50% of AstraZeneca’s overall pipeline.

Merck and NewLink Genetics to Collaborate on Investigational Ebola Vaccine

November 24, 2014 8:26 am | News | Comments

Merck and NewLink Genetics Corporation have entered into an exclusive worldwide license agreement to research, develop, manufacture, and distribute NewLink’s investigational rVSV-EBOV (Ebola) vaccine candidate.       

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