Pharmaceutical Technology ePT Weekly
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PharmTech
July 2, 2020
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD

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In this issue:

CHMP Recommends EU Authorization of Remdesivir for COVID-19

New Cybersecurity Features Protect Facilities with Remote Operations

FDA Speeds New Guidance Development to Inform Manufacturing and Research During Pandemic



Top Stories

COVID-19 Update

Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
/ read more /


uniQure, CSL Behring Collaborate on Hemophilia B Gene Therapy in Over $1.6-Billion Deal

The companies are entering into a license agreement to provide CSL Behring with exclusive global rights to etranacogene dezaparvovec, uniQure’s investigational gene therapy for patients with hemophilia B.
/ read more /

 

Industry News

Global Regulatory Collaborations Aim to Speed Access to New Vaccines and Drugs

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.
/ read more /


CHMP Recommends EU Authorization of Remdesivir for COVID-19

The European Medicines Agency’s (EMA’s) Committee for Human and Medicinal Products (CHMP) has recommended Veklury (remdesivir) be granted conditional marketing authorization in the European Union for the treatment of COVID-19.
/ read more /


More Industry News

Supplier News

Ajinomoto Bio-Pharma Services Introduces Fast-Track Drug Product Manufacturing Platform

Aji Bio-Pharma launched Ajility, a flexible platform for manufacturing vaccines and therapies.
/ read more /

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New Cybersecurity Features Protect Facilities with Remote Operations

Honeywell Forge Cybersecurity Suite’s improved industrial-grade remote access and added protection and risk monitoring aids remote operations.
/ read more /


More Supplier News
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Bio/Pharma News

Vaxart’s Oral COVID-19 Vaccine Chosen for Operation Warp Speed

The company’s oral COVID-19 vaccine has been chosen to participate in a non-human primate challenge study organized and funded by Operation Warp Speed.
/ read more /


PPD to Expand its Laboratory Portfolio for COVID-19 Vaccines and Therapies

The company has expanded its laboratory test portfolio with five new molecular, serology, and functional assays for COVID-19 vaccine and therapy development programs.
/ read more /


More Bio/Pharma News

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Regulatory News

FDA Speeds New Guidance Development to Inform Manufacturing and Research During Pandemic

FDA is placing emphasis on developing guidance documents more quickly and efficiently, and agency officials expect that such approaches may continue in the future.
/ read more /


EMA to Give Free Advice to Academia Developing Treatments for Rare Diseases

The agency will be waiving fees for scientific advice for academia developing orphan drugs.
/ read more /


More Regulatory News

 

Featured Topics

MANUFACTURING

Optimizing Machine Health

Data collected through the Industrial Internet of Things enable predictive maintenance.
/ read more /


 
 
PEER-REVIEWED RESEARCH

Optimizing Compression Coating for Pulsatile Release Tablets

Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis.
/ read more /

 
QUALITY SYSTEMS

Ensuring Quality Control in Vendor Relationships

Best practices to ensure that quality control is maintained in the client–vendor relationship.
/ read more /


FORMULATION

The Search for Transparency in Excipient Sourcing

Researching excipient grades and sources, as well as screening suppliers and materials, form the basis of programs to mitigate risk.
/ read more /

 
 

WEBCASTS

Engineering Approaches to Respiratory Drug Delivery: Mannitol Case Study
Thursday, July 30, 2020 at 11am EDT | 8am PDT | 4pm GMT | 5pm CEST
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Editors’ Series
Genotoxic Impurities and Drug Quality: Lessons from the Nitrosamine Contamination Crisis
Learn More


Effective Imaging for Identification and Sizing API Domains
Tuesday, July 21, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Learn More


Best Practices for Meeting and Exceeding Regulatory Standards in Primary Packaging USP <381> and <382>
Part II: Wednesday, July 22, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST
Learn More


Expedite Regulated Documents in the Era of COVID-19: From Development to Trials and Manufacturing
Wednesday, July 15, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST
Learn More

 

Events

69th PDA Annual Meeting

July 20–22, 2020, Virtual

Bioprocessing Summit Europe

July 21–23, 2020, Virtual

Validation University

August 24–26, 2020

more events

eBOOKS

Regulatory Sourcebook and Reference, March 2020

The Pharmacopoeia Compliance Series features a description of ways bio/pharma companies can participate in monograph development, a practical approach to pharmacopoeial compliance, and a summary of this 12-part series.


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