Pharmaceutical Technology ePT Weekly
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PharmTech
May 09, 2019
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In this issue:

Working for the Greater Good

FDA Requiring Boxed Warning on Insomnia Drugs

Novo Nordisk Installs Solar Arrays for US Operations


Top Stories

FDA Approves First Vaccine for Dengue Disease

Dengvaxia is the first FDA-approved vaccine for dengue disease caused by all dengue virus serotypes for individuals ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.
/ read more /


Amgen, Syapse Enter Precision Medicine Collaboration in Oncology

The companies will work together to develop observational research analytics to assess treatment outcomes for areas of unmet need in oncology.
/ read more /

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Industry News

Event Addresses Biotech Startup Challenges

MilliporeSigma event scheduled to recognize biotech challenges and support development potential.
/ read more /


China Facility Receives FDA Warning Letter

FDA sent a warning letter to Dong Yuan Technology Co., Ltd. detailing CGMP violations including failure to follow laboratory and process controls.
/ read more /


More Industry News
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Supplier News

Eppendorf Hosts Vaccine Development and Bioprocess Cell Culture Technology Day

The Vaccine Development and Bioprocess Cell Culture Technology Day will take place on May 16, 2019 in Baltimore, MD.
/ read more /


SGS Acquires Chemical Solutions

The acquisition is expected to strengthen SGS's agriculture, food, and life business in the United States
/ read more /


More Supplier News

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Bio/Pharma News

Dyadic in License Agreement with Alphazyme

The companies have entered into a sub-licensing agreement to develop products based on Dyadic’s C1 expression platform and Alphazymes’ enzyme technology.
/ read more /


Novo Nordisk Installs Solar Arrays for US Operations and Moves to Complete Renewable Power Globally

A solar panel installation at Novo Nordisk's North Carolina facility was initiated in March 2019 as part of the company’s commitment to zero environmental impact globally.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Approves First Treatment for Lupus in Pediatric Patients

The agency approved Benlysta (belimumab) intravenous infusion for treatment of children with systemic lupus erythematosus.
/ read more /


FDA Requiring Boxed Warning on Insomnia Drugs

The agency is updating its warning requirements for eszopiclone, zaleplon, and zolpidem after reports of complex sleep behaviors.
/ read more /


More Regulatory News

FEATURED TOPICS

QUALITY SYSTEMS

Maxims of Electronic Records Integrity

Managing and controlling e-records is vital for maintaining CGMP data integrity.
/ read more /

VIEWPOINTS

Working for the Greater Good

Pharma delivers a positive message with renewed efforts to eradicate malaria.
/ read more /

DRUG DEVELOPMENT

Designed with the Patient in Mind

Patient-centric drug development is becoming more important in the bio/pharma industry.
/ read more /

APIs and EXCIPIENTS

Select Suppliers with Demonstrated Expertise to Avoid Sourcing 'Bad' APIs

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.
/ read more /


UPCOMING WEBCASTs

Impact of New FDA Guidance on Bioanalytical Testing on Drug Development
Thursday, May 30, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


Requirements for Fully-Integrated Service Offerings in a HPAPI and Cytotoxic Environment
Two Live Events: Tuesday, May 28, 2019, at 10am JST | 9pm EDT | 6pm PDT
Tuesday, May 28, 2019, at 5pm JST | 10am CEST
Register now


Designing Amorphous Dispersion Formulations for Poorly Soluble Drugs
Thursday, May 23, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Technologies to De-Risk Biologic Candidates to Successfully Transition from Research to Clinic
Wednesday, May 22, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


Geographic Advantage: Accelerating Clinical Supply in China and Global Trials
Thursday, May 9 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Register now


ON DEMAND WEBCASTS

Sustainable Sourcing & Supply Chain Engagement in Pharma
On Demand
Learn More


Beating the Clock: Case Studies in Expediting Biologic Development
On Demand
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Patient-Focused Drug Design – A View from the R&D Front Lines
On Demand
Learn More


The Future of Highly Potent API Manufacturing – Lonza Perspective
On Demand
Learn More


Approaches to Analyze and Understand 1–100 µm Particles/Aggregates in Biotherapeutics
On Demand
Learn More


Events

BIO International Convention

June 3–6, 2019

Pharmaceutical-Nutraceutical Extrusion Seminar

June 12–13, 2019

ISPE Biopharmaceutical Manufacturing Conference

June 18–20, 2019

more events

eBOOKS

Laboratory Best Practices 2018 eBook

The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing.


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