Pharmaceutical Technology ePT Weekly
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PharmTech
April 30, 2020
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In this issue:

Pharma’s Leadership Role in a Pandemic

NIAID Plan Describes COVID-19 Research Priorities

More Coordination Sought for Exploding COVID-19 R&D Efforts


Top Stories

COVID-19 Update

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


Takeda to Divest OTC Products to Orifarm for $670 Million

The decision is part of the Takeda’s goal to divest $10 billion in non-core assets and focus on its key business areas.
/ read more /

 

Industry News

NIAID Plan Describes COVID-19 Research Priorities

A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.
/ read more /


Swiss Biotech Sector is Experiencing Continued Growth, Notes Sector Report

A report into the Swiss biotech sector has shown that there is continued growth in the sector, which has received investments from public and private companies worth CHF 1.2 billion (US$1.2 billion).
/ 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 /


Emergent and J&J Partner Up for $135 Million COVID-19 Vaccine Deal

Emergent will offer up its drug substance manufacturing services with support by investments from Johnson & Johnson starting in 2020.
/ read more /


More Supplier News


 

Bio/Pharma News

MicrofluidX Raises Funds to Develop Novel Cell Bioprocessing Technology

MicrofluidX has raised £1.4 million (US$1.7 million) in seed funding, which it will use to develop its novel cell bioprocessing technology for cell and gene therapy.
/ read more /


Industry-Led Manufacturing Group Welcomes UK Government Investment

A UK BioIndustry Association industry-led vaccine manufacturing group has welcomed a recent announcement by the government of the UK, that it will receive £14 million (US$17.3 million) in investment to rapidly scale up the development of vaccines for COVID-19.
/ read more /


More Bio/Pharma News

 
 

Regulatory News

FDA Approves J&J’s BTK Inhibitor for Chronic Lymphocytic Leukemia Treatment

The approval was based off of positive results from a Phase III study that showed patients 70 years or younger treated with the BTK inhibitor lived longer without disease progression.
/ read more /


More Coordination Sought for Exploding COVID-19 R&D Efforts

With hundreds of clinical trials for potential coronavirus therapies in the works concerns have mounted about the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.
/ read more /


More Regulatory News

 

Featured Topics

FORMULATION

Can Vaccine Development Be Safely Accelerated?

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.
/ read more /


OUTSOURCING

Packaging Preserves the Cold Chain

More sustainable and functional packaging protects temperature-sensitive drugs.
/ read more /

 
MANUFACTURING

Pharma’s Leadership Role in a Pandemic

As the coronavirus pandemic unfolds, Pharma must practice science over hype.
/ read more /


QUALITY SYSTEMS

Critical Knowledge for Preparing Audits

Addressing data integrity, quality culture, aging facilities, investigations/corrective actions and preventive actions, and risk management is key when conducting audits, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
/ read more /

 
 

ON DEMAND WEBCASTS

Integrated Preformulation Studies for Fast Advancement of Drug Candidates to Human Clinical Studies
On Demand
Learn More

 

WEBCASTS

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


OTC Trends, Monograph Reform, and Innovation
Tuesday, May 5, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm 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


Bulletproof your Supply Chain: Hope for the Best, Prepare for the Worst
Monday, May 18, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Learn More


Ensuring Integrity of Drug Formulation from Development to QC
Thursday, May 21, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST
Learn More


Analysis of Genotoxic Nitrosamine Impurities in Pharmaceutical Products under GMP Conditions using High-Resolution Accurate Mass (HRAM) Mass Spectrometry
Wednesday, May 13, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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, 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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