Pharmaceutical Technology ePT Weekly
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PharmTech
December 21, 2017
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In this issue:

EMA Approves mAb Production at Samsung BioLogics Facility

FDA Issues Guidance on Drugs Containing Nanomaterials

Critical Parameters in Transdermal Patch Manufacturing

Top Stories

Federal Circuit Decides in Favor of Novartis in Biosimilars Patent Dispute with Amgen

The US Court of Appeals for the Federal Circuit has decided in favor of Novartis� Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.
/ read more /


FDA Approves Sanofi�s Follow-On Insulin

The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a �follow-on� product.
/ read more /

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Industry News

New Research into Old Antibiotic May Lead to New TB Treatments

Research into an old antibiotic might open the door for new drugs to treat tuberculosis and other related microbial diseases.
/ read more /


New Immunotherapy for Pediatric Brain Cancer Targets Mutated Protein

Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.
/ read more /


More Industry News

Supplier News

Abzena Secures ADC Manufacturing Contract with US Biotech Firm

Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.
/ read more /


EMA Approves mAb Production at Samsung BioLogics Facility

The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company�s second facility in Songdo, Incheon, South Korea.
/ read more /


More Supplier News
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Bio/Pharma News

Aprecia Pharmaceuticals and Cycle Pharmaceuticals Partner to Develop 3D-Printed Orphan Drugs

Cycle and Aprecia will use Aprecia's 3DP Technology to improve rare disease drug formulations.
/ read more /


Novo Nordisk Expands Insulin Manufacturing Facility in India

In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent�s Indrad, Gujarat, India site.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Supports Target Therapies

The agency published guidance on the research and development of individualized therapies.
/ read more /


FDA Issues Guidance on Drugs Containing Nanomaterials

The draft guidance provides guidance on the development of drugs and biologics in which a nanomaterial is present in the finished dosage form.
/ read more /


More Regulatory News

FEATURED TOPICS
Standards and Regulations

Approaches to USP OTC Monograph Modernization

The authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.
/ read more /
Formulation

Opportunities with Softgels

Softgel capsules are a popular dosage form among patients but they also provide a number of manufacturing benefits over liquid-filled hardgel capsules.
/ read more /


Dosage Forms

Critical Parameters in Transdermal Patch Manufacturing

A QbD approach can address manufacturing complexities in transdermal patch manufacturing.
/ read more /

Manufacturing

Modernizing Lyophilization

A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.
/ read more /


ON DEMAND WEBCASTS

Risk Assessment and Testing Requirements for Elemental Impurities in Pharmaceutical Products
On Demand
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The Journey to a Successful Biologic License Application
On Demand
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Partnership of Chemical Engineers and Chemists Optimizes Process Development
On Demand
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Events

Pharmapack Europe

February 7–8, 2018

IFPAC-2018

February 11–14, 2018

ISPE 2018 Facilities of the Future Conference

February 20–22, 2018

more events

eBOOKS

Vaccines Development and Manufacturing 2017

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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