Pharmaceutical Technology ePT Weekly
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PharmTech
April 9, 2020
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In this issue:

FDA Removes Ranitidine Products from Market

MAA for Diurnal’s Chronocort Passes EMA
Validation Stage

GSK and Vir Team Up for $250 Million COVID-19 Solutions Collaboration


Top Stories

COVID-19 Update

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


Arch Venture Partners to Invest $1.46 Billion in Early Stage Biotechnology Companies

The company closed two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, for a total of $1.46 billion combined.
/ read more /

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Wait. What? Pfizer can manufacture my product for clinical trials and commercial supply?

We sure can. Collaborate with Pfizer CentreOne. And access Pfizer’s global manufacturing network and scale-up expertise.

Flexible oral solid dose manufacturing.

Pfizer CentreOne has integrated cGMP pilot facilities dedicated to process optimization, clinical drug manufacturing, and scale-up technology transfers. We offer commercial manufacturing for global / large-volume solid forms production.

/ Let’s collaborate. /

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Industry News

Global Plasma Providers Partner to Develop Potential COVID-19 Hyperimmune Therapy

The partnership, led by Takeda and CSL Behring, will focus on developing a hyperimmune immunoglobulin against COVID-19.
/ read more /


Merck, Pfizer, and Eli Lilly to Launch Medical Service Volunteer Programs for Company
Employees

The medical service volunteer programs will allow their employees who are licensed medical professionals to help fight against COVID-19 while maintaining their base pay.
/ 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 /


GSK and Vir Team Up for $250 Million COVID-19 Solutions Collaboration

The companies will collaborate on research and development solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19.
/ read more /


More Supplier News


 
 
 
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The NEW Virsa Raman Analyser.
Renishaw has developed the Virsa Raman Analyser using its expertise in optical design and detector technologies. It combines the power of laboratory–grade Raman with the convenience of a transportable unit. Use Renishaw's latest high-performance Raman spectroscopy system, to take your spectroscopic analysis away from the confines of the laboratory microscope to new samples and environments.

/ Read now /

 
 
 

Bio/Pharma News

Amgen and Adaptive Team up for Neutralizing Antibody COVID-19 Treatment

The companies are entering into a partnership to develop fully human neutralizing antibodies targeting SARS-CoV-2 to prevent or treat COVID-19.
/ read more /


FibroGenesis Announces Provisional Patent for a Fibroblast Therapy for COVID-19 Treatment

The patent includes the use of fibroblast cells and adjuvants such as peptides and hydroxychloroquine, which fuels the assembly of natural interferon to overpower the virus.
/ read more /


More Bio/Pharma News

 
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A Faster Oncology Drug Product with InnoOneTM.
InnoOneTM is an end-to-end, high potent drug product service, offering all the support you need to bring your high potent product to market. At Servier, we guarantee containment suite exclusivity, ensuring quality and mitigating risk. We rely on our history of excellence to help you optimize your process, bringing your drug product to market quicker and more efficiently.

/ Read now /

 

Regulatory News

FDA Removes Ranitidine Products from Market

With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.
/ read more /


MAA for Diurnal’s Chronocort Passes EMA Validation Stage

Specialty pharmaceutical company, Diurnal, has announced that the marketing authorization application (MAA) for Chronocort has passed validation with the European Medicines Agency (EMA).
/ read more /


More Regulatory News

 
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Premium Pharma-grade Pipets
Up to 70% off for a limited time on durable and reusable borosilicate glass pipets. Calibrated and ASTM-certified for traceability, you can rely on precise volumetric tolerances for your preparations. KIMBLE® brand pipets are made from heavy-duty, leach resistant glass, and perfectly packaged and delivered for your scientific journey. Contact DWK Life Sciences.

/ Click here to learn more. /

 

Featured Topics

QUALITY SYSTEMS

The Right Pieces for a Quality Program

An effective quality control unit is independent from manufacturing and ensures current standards are followed.
/ read more /


FORMULATION

Rising to the Challenge of Biologic Drug Formulation

As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.
/ read more /

 
MANUFACTURING

Orchestrating Success in Clinical Trial Manufacturing

Personalized medicine and direct-to-patient trial models have made the difficult even more challenging.
/ read more /


ANALYTICS

Meeting E&L Expectations

As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.
/ 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

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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