Pharmaceutical Technology ePT Weekly
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PharmTech
August 02, 2018
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In this issue:

Metrohm Acquires B&W Tek

Gottlieb Reshapes FDA to Elevate Centers

The Search for Next-Gen Expression Systems


Top Stories

Novartis Partners with MorphoSys, Galapagos in $1.1-Billion mAb Deal

Novartis is set to partner with MorphoSys and Galapagos in a deal worth up to $1.1 billion to develop and commercialize their joint investigational, fully human, IgG1 monoclonal antibody (mAb) directed against the target IL-17C.
/ read more /


Pfizer to Build Sterile Injectable Facility in Michigan

Pfizer will invest nearly half a billion dollars to build a sterile injectable facility in Michigan.
/ read more /


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Industry News

Augmenting Labeling for OTC Drugs

New FDA guidance suggests ways to supplement labeling, to ensure that patients select and use nonprescription drugs safely.
/ read more /


 

FDA Takes Actions to Secure Safety of Compounded Drugs

The agency announced two research collaborations on bulk lists, updates to categories of bulk drug substances, and issued a warning about a bulk drug substance used in compounding.
/ read more /


More Industry News
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Supplier News

Sangamo Therapeutics to Acquire TxCell

The acquisition would combine Sangamo's ex vivo gene-editing capabilities with TxCell's regulatory T-cell (Treg) expertise to create chimeric antigen receptor (CAR)-Treg therapies.
/ read more /


 

Metrohm Acquires B&W Tek

The acquisition will increase Metrohm's spectroscopy offerings and capabilities.
/ read more /


More Supplier News
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Bio/Pharma News

GSK, 23andMe to Partner on Genetic Drug Development

GlaxoSmithKline and 23andMe, a personal genomics and biotechnology company, will partner to research and develop new drugs using human genetics.
/ read more /

 

Gilead's Kite, Gadeta to Develop Cell Therapies

The companies will work together to develop novel gamma delta T-cell receptor therapies in various cancers.
/ read more /


More Bio/Pharma News
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Cleaning Validation:
As the industry's leading hands-on cleaning validation training, IVT's Cleaning Validation conference goes beyond best practices and solution oriented approaches; from bring your own challenge workshops and brainstorming think-tank discussions to solutions showcases and faculty "office hours" attendees are guaranteed to walk away with key actionable items for tackling the top challenges faced throughout critical cleaning process and validation lifecycles specific to their own environment. www.cbinet.com/cleaning

 

Regulatory News

EMA Recommends Sixteen Medicines for Approval

The recommended drugs include two orphan medicines and three biosimilars.
/ read more /

 

Gottlieb Reshapes FDA to Elevate Centers

Commissioner Gottlieb is reorganizing FDA in the hopes of streamlining policymaking.
/ read more /


More Regulatory News
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Data Integrity:
With FDA attention pinpointed on data integrity in recent 483s and warning letters, it is critical to arm yourself with the tools and resources to ensure data integrity in manufacturing processes. IVT's 4th Annual Data Integrity Validation provides a variety of industry perspectives in an unmatched training environment, diving deep into the nuances of building and maintaining a compliant data governance program across company-wide systems. www.cbinet.com/dataintegrity

 

FEATURED TOPICS

SUPPLY CHAIN

Meeting the Challenge of Patient-Centered Clinical Trials

Demand for direct-to-patient services is exploding. Michael Sweeney, senior director of patient-centric logistics at World Courier, discusses issues that the new model presents.
/ read more /

EXCIPIENTS

Selecting Excipients for Controlled Release

With the right excipients, formulators can control when, where, and how an API is released.
/ read more /

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PI18083 24th Annual Validation Week:
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry. Learn More

 

US REGULATORY WATCH

Biosimilars Raise Manufacturing and Regulatory Challenges

FDA seeks more efficient testing to spur development of less costly biotech therapies.
/ read more /

FORMULATION

The Search for Next-Gen Expression Systems

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.
/ read more /


UPCOMING WEBCASTs

A Collaborative Approach for Successful Method Transfers and Routine Quality Control Batch Release Testing
Tuesday, August 21, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


How Protocol Design Drives Comparator Sourcing Cost, Timelines, Complexity, and Risk
Tuesday, August 7, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


ON DEMAND WEBCASTS

Building a Faster, More Flexible Biologic Development Process for Targeted Therapies
On Demand
Learn More


How Well Should You Understand Your Crystallization Process (and Solid-State Properties)?
On Demand
Learn more


Best Practices for Highly Potent API (HPAPI) Development and Manufacturing
On Demand
Learn more


Multiparticulate Formulation Strategies for Pediatric Drugs
On Demand
Learn more

Events

The 67th Annual Denver X-ray Conference

August 6–10, 2018

MES 2018:13th Annual Global Forum on Manufacturing Execution Systems

August 13–14, 2018

4th Annual Data Integrity Validation

August 15–16, 2018


more events

eBOOKS

Biologics and Sterile Drug Manufacturing 2018

This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.

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