Pharmaceutical Technology ePT Weekly
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PharmTech
April 16, 2020
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In this issue:

EMA Sets Up COVID-19 Task Force

Orgenesis, RevaTis Partner on Cell Therapy Production

FDA Warns Company for Marketing Products Claiming to Treat COVID-19


Top Stories

COVID-19 Update

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


Alnylam Pharmaceuticals and Blackstone Life Sciences Enter into Collaboration for up to $2 Billion

The companies announced they are entering into a strategic collaboration under which Blackstone will provide up to $2 billion to fund Alnylam’s RNAi drugs to treat a range of diseases.
/ read more /

 

Industry News

EMA Sets Up COVID-19 Task Force

The task force will assist in the developing, authorizing, and monitoring of treatments of COVID-19.
/ read more /


Applied Biology, Brown University Collaborate on COVID-19 Drug Discovery Platform

The drug discovery platform was developed to rapidly predict blocking of COVID-19 pneumocyte cellular entry.
/ read more /


More Industry News
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Supplier News

Supplier Operations Status Report

Suppliers to the bio/pharma industry are sharing news about the business operations during the global COVID-19 pandemic. To view current information about the company’s business operations, click the company name.
/ read more /


Arrakis to Enter into $190 Million Collaboration with Roche for Small Molecule Drug Discovery

Through the agreement, Arrakis will receive an upfront payment of $190 million in cash and will have the potential to receive preclinical, clinical, commercial, and sales milestone payments and royalties for any resulting products.
/ read more /


More Supplier News


 

Bio/Pharma News

Orgenesis, RevaTis Partner on Cell Therapy Production

The partners have formed a joint venture to produce muscle-derived mesenchymal stem cells as a source of exosomes and other cellular products to develop related therapies and advance clinical trials.
/ read more /


Theravance Biopharma to Advance its Janus Kinase Inhibitor to Treat Acute Lung Injury

The company is advancing its lung-selective nebulized Janus kinase inhibitor into clinical development to determine its ability to prevent acute lung injury in patients with COVID-19.
/ read more /


More Bio/Pharma News

 
 

Regulatory News

EMA Publishes COVID-19 Q&A Guidance

The guidance answers questions on changes made to the regulatory framework to address challenges during the COVID-19 pandemic.
/ read more /


FDA Warns Company for Marketing Products Claiming to Treat COVID-19

The agency sent a warning letter to Genesis II Church for marketing fraudulent chlorine dioxide products the company claims treats and prevents COVID-19.
/ read more /


More Regulatory News

 
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Featured Topics

OUTSOURCING

Biomanufacturing: Demand for Continuous Bioprocessing Increasing

But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options.
/ read more /


REGULATORY

Biosimilars Poised for Gains in US Market

FDA is encouraging alternative insulins and challenging anticompetitive practices.
/ read more /

 
MANUFACTURING

Using Online Transition Analysis to Predict Chromatography Column Failure

Advanced analytics and modeling can be used to predict downstream failures, allowing for corrective action before batches are lost.
/ read more /


ANALYTICS

Alternative Cleaning Validation Methods for Biologics

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.
/ read more /

 
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2019 PDA Quality Week | Dec. 9-13 | Washington, DC
The Week is comprised of three individual, but contiguous events designed to educate you on all aspects of QRM. Each offering provides a different perspective, starting with a focus on the emerging regulatory landscape, framing the requirements and objectives of the regulations that govern this important but elusive concept.

/ Click here to learn more. /

 
 

WEBCASTS

Integrated Preformulation Studies for Fast Advancement of Drug Candidates to Human Clinical Studies
Wednesday, April 15, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Learn More


Leveraging Digital Assistance to Address Oral Solid Dosage Formulation Challenges
Tuesday, April 21, 2020 at 9am EDT| 2pm BST| 3pm CEST
Learn More


When Drug Meets Device: How to Assess Compatibility
Tuesday, May 19, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Learn More


Through Container Verification of Pharmaceutical Raw Materials with the New Agilent Vaya Handheld Raman System
Europe Broadcast: Thursday, May 14, 2020 at 9am EDT | 2pm BST | 3pm CEST
US Broadcast: Thursday, May 14, 2020 at 2pm EDT | 1pm CDT | 11am PDT
Asia Pacific Broadcast: Friday, May 15, 2020 at 8:30am IST | 11am CST | 12pm JST | 1pm AEST
Learn More

 

Rescheduled Events

CPhI South East Asia

CPhI South East Asia has been rescheduled for July 2020.

Interphex 2020

Interphex 2020 has been rescheduled for July 2020.

69th PDA Annual Meeting

PDA’s Annual Meeting has been rescheduled for July 2020.

Bioprocessing Summit Europe

Bioprocessing Summit Europe has been rescheduled for July 2020.

PDA Pharmaceutical Manufacturing Data Science Workshop

PDA’s Pharmaceutical Manufacturing Data Science Workshop has been rescheduled for July 2020.

Validation University

Validation University has been rescheduled for August 2020.

CPhI North America

CPhI North America has been rescheduled for September 2020.

CPhI Japan

CPhI Japan has been rescheduled for September 2020

Analytica 2020

Analytica 2020 has been rescheduled for October 2020.

Interpack 2020

Interpack 2020 has been rescheduled for February 2021.

more events

eBOOKS

Regulatory Sourcebook and Reference, December 2019

In Pharmaceutical Technology's ongoing Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, building a quality culture, and essentials for DOE and QRM.


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