Pharmaceutical Technology ePT Weekly
Having trouble viewing this e-mail? CLICK HERE
PharmTech
July 12, 2018
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD
advertisement

In this issue:

Sanofi Plans R&D Hub in China

Targeting Drug Delivery with ADCs

Catalent to Acquire Juniper Pharmaceuticals


Top Stories

Takeda Receives US Clearance for $62-Billion Acquisition of Shire

The company has received clearance from the United States Federal Trade Commission for the proposed acquisition of Shire, a deal valued at $62 billion.
/ read more /


Pfizer Announces Restructuring

Pfizer creates separate business units for innovator medicines, generic drugs, and consumer products.
/ read more /


advertisement

Subscribe

Subscribers can enjoy each full issue of Pharm Tech in print, or via Pharm Tech apps.

subscription offers
subscribe

advertisement

Industry News

Call for Entries: 2018 CPhI Pharma Awards

Annual awards program recognizes innovation in bio/pharmaceutical drug development and manufacturing.
/ read more /


New Program Aims to Improve Patient Medication Adherence

Progressive Care’s DischargeRX program works with hospitals and patients to help improve patient medication adherence and minimize medication-related hospital readmissions.
/ read more /


More Industry News
advertisement

advertisement

Supplier News

Catalent to Acquire Juniper Pharmaceuticals

Catalent’s acquisition of Juniper Pharmaceuticals further expands its early development capabilities.
/ read more /

 

MilliporeSigma to Expand UK Operations

The expansion at the company’s Gillingham, UK, site, worth EUR 9 million (approximately US$10.5 million), will improve the company’s distribution capabilities.
/ read more /


More Supplier News

advertisement
advertisement

Bio/Pharma News

Sanofi Plans R&D Hub in China

Sanofi will open a R&D operations hub in Chengdu, Sichuan province, China, with a focus on digitalization and big data analysis.
/ read more /


 

Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements

Certain blister card packages that do not meet US child-resistant packaging requirements are being recalled because they pose a risk of harm if the tablets are swallowed by children.
/ read more /


More Bio/Pharma News

advertisement

At the 2018 PDA/FDA Joint Regulatory Conference, Sept. 24-26 in Washington, DC, industry experts and U.S. FDA regulators will explore the circumstances that impact the quality, safety, and availability of drugs. Gain new perspectives and best practices on the evolving regulatory landscape, supply chain risks, quality culture, and challenges in manufacturing. Register by Jul. 30 and save up to 400! Read more

 

Regulatory News

FDA Releases ANDA Submission Guidance

The agency published guidance on how the Generic Drug User Fee Amendments Reauthorization of 2017 applies to amendments to ANDAs and PASs.
/ read more /

 

EMA Reviews Product from China Facility

The agency is reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.
/ read more /


More Regulatory News

advertisement

From Facility Validation & Environmental Monitoring, Sterile & Non-Sterile Products Testing, Mycoplasma Testing to Organism ID, Eurofins Lancaster Laboratories offers personalized study designs, the highest standard of data integrity, and largest scope of Micro Testing solutions to get it done on time and right the first time. See why our Compliance, Consulting and Capacity are critical to ensuring the tiniest contamination does not become a big deal.

 

FEATURED TOPICS

DRUG DEVELOPMENT

Cleaning Validation for APIs

PDA reviews an industry survey of concerns and best practices regarding the EU GMP’s required PUPSIT test for filters used in sterile filtration.
/ read more /

OUTSOURCING

How to Get the Most from Regulatory Outsourcing

Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.
/ read more /

advertisement

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


MANUFACTURING

Breaking Through Obstacles to Improve Drug Manufacturing

Systems that discourage continuous improvement threaten pharma innovation, quality, and supply. Can the industry break through this deadlock?
/ read more /

DRUG DELIVERY

Targeting Drug Delivery with ADCs

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.
/ read more /


advertisement

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

 

UPCOMING WEBCASTS

Building a Faster, More Flexible Biologic Development Process for Targeted Therapies
Tuesday, July 31, 2018 at 10am EDT | 3pm BST | 4pm CEST
Register now


How Well Should You Understand Your Crystallization Process (and Solid-State Properties)?
Wednesday, July 25, 2018 at 11 am EDT | 8 am PDT | 4 pm BST | 5 pm CEST
Register now


Best Practices for Highly Potent API (HPAPI) Development and Manufacturing
Wednesday, July 18, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


Multiparticulate Formulation Strategies for Pediatric Drugs
Thursday, July 12, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


ON DEMAND WEBCASTS

Engineering and Manufacture of Second Generation ADCs: Tools and Techniques
On Demand
Learn more


A Rational Approach to Excipient Selection
On Demand
Learn more


E&L and Beyond: Qualifying Plastic Materials for Contaminants and Failure
On Demand
Learn more


Continuous Processing in Biomanufacturing Considerations for Adoption and Case Studies in Biologic Development and Manufacturing
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.

contribute | contact editors | CONTACT SALES | subscribe | advertise