Pharmaceutical Technology ePT Weekly
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PharmTech
November 16, 2017
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In this issue:

Patient Centricity Takes Center Stage

EMA Recommends Ten Drugs for Approval

Dynavax Wins FDA Approval for Hep B Vaccine

Top Stories

FDA Approves Digital Pill

The agency approved Abilify MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication.
/ read more /


FDA Works to Get Pharma Up and Running in Puerto Rico

While most pharma companies are in partial production using generators, few are operating at 100% capacity.
/ read more /


PharmTech 2017 Employment Trends

The editors of Pharmaceutical Technology invite you to participate in the annual employment survey for individuals involved in bio/pharmaceutical development, formulation, or manufacturing.

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Changing the functional role of capsules in drug delivery
By combining polymer science, engineering and formulation know-how, we are creating breakthroughs in capsule and encapsulation technologies that are changing the functional role of capsules in medical research, drug formulation and drug delivery. Capsugel provides leading-edge solutions that protect high value compounds, optimize delivery to targeted sites in the body, and ensure the best operational performance in capsule filling. To learn more, visit www.capsugel.com.


Industry News

QuintilesIMS Changes Name to IQVIA

QuintilesIMS has changed its name to IQVIA to reflect its October 2016 merger with IMS Health.
/ read more /


EMA Recommends Ten Drugs for Approval

Two of the medicines recommended for approval are orphan drugs.
/ read more /


More Industry News

Supplier News

Cambrex Expands Small-Scale Capacity at Iowa Facility

The company has completed a small-scale capacity expansion at its site in Charles City, IA.
/ read more /


WuXi and Pall Establish Continuous MAb Manufacture

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.
/ read more /


More Supplier News
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Bio/Pharma News

AstraZeneca Gets Positive EMA Opinion on Respiratory Biologic

The EMA's Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca's benralizumab, a monoclonal antibody for treating severe asthma.
/ read more /


Dynavax Wins FDA Approval for Hep B Vaccine

The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Warns Against Using Kratom Products for Opioid Treatment

Commissioner Scott Gottlieb issued a statement warning about the risks associated with kratom.
/ read more /


FDA Overhauls Inspection Process and Field Operations

FDA seeks to focus on problematic facilities and inform firms quickly about site problems.
/ read more /


More Regulatory News

FEATURED TOPICS

Dosage Forms

Patient Centricity Takes Center Stage

Pharmaceutical companies are increasingly adopting patient-centric formulation development to ensure that drug products adequately meet the needs of end-users in all target patient populations.
/ read more /

Outsourcing Outlook

CDMO Acquisitions Build Strategic Supplier Base

Recent acquisitions are creating CDMOs with scale that rivals global bio/pharma.
/ read more /



Aseptic/Sterile

A Revised Aseptic Risk Assessment and Mitigation Methodology

The revised Akers-Agalloco aseptic risk assessment and mitigation method includes two sub-methods that can be used independently for risk assessment.
/ read more /

European Regulatory Watch

Europe Leads the Way in Continuous Manufacturing

The shift toward continuous manufacturing among European pharmaceutical manufacturers has not been accompanied by a similar strong increase in the use of automation and sensor-based on-line monitoring.
/ read more /


UPCOMING WEBCASTS

The Journey to a Successful Biologic License Application
Live Webcast: Thursday, December 7 at 12:00pm EST
Register now


Partnership of Chemical Engineers and Chemists Optimizes Process Development
Live Webcast: Tuesday, November 28, 2017 at 11:00am EST
Register now


ON DEMAND WEBCASTS

Beyond the Buy: The Critical Role of Data, Relationships, and Experience in Comparator Sourcing Success
On Demand
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Accelerating Method Transfer: Effective Automation of Biological Assays
On Demand
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Challenges in the Development of Complex Small-Molecule Drugs
On Demand
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Analytical Challenges in Extractables Studies of Plastic Single-Use Bioprocess Bags
On Demand
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Excipient Selection to Enable the Performance of Skin Delivery Dosage Forms
On Demand
Learn more


Events

ISPE UK Annual Event

November 30, 2017

Achieving Efficient Facilities

December 11–12, 2017

Next Frontier for Single-Use Technologies

December 12–13, 2017

more events

eBOOKS

Biologics and Sterile Manufacturing

New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics.


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