Pharmaceutical Technology ePT Weekly
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PharmTech
April 6, 2017
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In this issue:

EpiPen Recall Expanded to US

Novartis Nabs Priority Review for CAR-T

Moving Manufacturing Back to the US

Top Stories

FDA Approves First Treatment for Primary-Progressive Forms of Multiple Sclerosis

The mAb is the first approved treatment that targets the progressive form of the disease.
/ read more /


Insourcing vs Outsourcing: Choosing the Right Strategy

The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.
/ read more /


Sartorius Acquires Umetrics for $72.5 Million

Sartorius acquired the Swedish company that specializes in data analytics software for biopharmaceutical development and manufacturing.
/ read more /

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PODCAST

Finn Bauer talks about Parteck SRP 80, an excipient for direct compression of matrix-based, sustained-release tablets. Parteck SRP 80 won the Excellence in Excipients Award at the 2016 CPhI Pharma Awards.

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Industry News

Mylan Announces Expansion of EpiPen Recall to the US

The company announced that Meridian Medical Technologies is extending a recall of EpiPen and EpiPen Junior to the United States.
/ read more /


Singapore Facility Receives FDA Warning Letter

The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company's Singapore facility.
/ read more /


More Industry News

Supplier News

Capsugel Installs New Encapsulation Unit for DPI Applications at Bend, Oregon Facility

The newly installed Harro Hӧfliger encapsulation unit expands Capsugel's clinical- and commercial-scale capacity for dry powder inhalation projects.
/ read more /


MilliporeSigma Launches Supply Program for Single-Use Systems

The Mobius MyWay portfolio offers off-the-shelf and configured-to-order single-use assemblies.
/ read more /


More Supplier News

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Driving compounds forward
Every molecule presents its own set of challenges. Capsugel's unique combination of drug and process design capabilities – coupled with premier depth in bioavailability enhancement and targeted delivery technologies – enable us to deliver the right solution for meeting those challenges.
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Bio/Pharma News

Novartis Receives FDA Priority Review for CAR-T Therapy

The company received priority review for its investigational CAR-T therapy to treat leukemia.
/ read more /


Novimmune Opens Branch Office in Basel

The Basel office will house the clinical development team and other functions to progress the company's lead compound emapalumab.
/ read more /


More Bio/Pharma News

Regulatory News

Experts Propose Licensing Deal to Expand Access to Hep C Therapies

A new report states that wider access to new antivirals for HCV and better screening of patients would help avert 90,000 deaths by 2030.
/ read more /


EMA to Collaborate More Closely with Academia

EMA has developed a framework and action plan to foster relationships with the academic community.
/ read more /


More Regulatory News

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FEATURED TOPICS

OUTSOURCING

Will Pharma Manufacturing Move Back to the US?

Moving global manufacturing operations may be more complicated than it appears.
/ read more /

SUPPLY CHAIN

Testing GS1’s EPCIS Standards in the Real World

Johnson & Johnson Supply Chain (JJSC) and the distributor AmerisourceBergen launched a four-week pilot program to test GS1's EPCIS standards and to see how effectively data could be transferred between the two partners.
/ read more /

QUALITY

The Importance of Quality Agreements

Pharmaceutical Technology asked Siegfried Schmitt, principal consultant at PAREXEL, about the importance of quality agreements in the sponsor/contractor relationship.
/ read more /

MANUFACTURING

Understanding Containment

The new ISPE Containment Manual is a summary of the process involved in the manufacture of highly active or highly hazardous pharmaceutical substances.
/ read more /


On Demand WEBCAST

Titration in Early Drug Discovery and Development
On Demand
Learn more


Events

ExcipientFest Americas

April 24–26, 2017

Making Pharmaceuticals

April 25–26, 2017

CPhI North America

May 16–18, 2017

more events

REFERENCE BOOKS

Pharmaceutical Technology Solid Dosage Combo

Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
/ Click here /

More Reference Library

eBOOKS

Quality Throughout the Supply Chain

Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.


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