American Pharmaceutical News In Review

View online

Forward to a friend | Facebook | Twitter

June 11, 2020

Newsletter Sponsor

NEOFLEX COATED PLUNGERS FOR SENSITIVE DRUGS

Datwyler’s NeoFlex™ plungers offer superior compatibility and functionality, taking into account the rising demands related to self-administration with drug delivery devices and meeting the most stringent regulatory requirements. NeoFlex is the ideal component for your drug product needs.

	Industry News

FDA Clears IND for iNKT Cells to Treat COVID-19 Patients
Agenus announced the FDA clearance of AgenTus' IND application for an allogeneic iNKT therapy. read more »

FDA Approves Atezolizumab, plus Bevacizumab for Unresectable Hepatocellular Carcinoma
The FDA has approved atezolizumab in combination with bevacizumab for patients with unresectable or ... read more »

FDA Accepts sNDA with Priority Review for FETROJA
Shionogi announced the FDA has accepted the company’s sNDA for FETROJA and granted Priority Review ... read more »

Braeburn Submits Request for Final Approval of BRIXADI for Opioid Use Disorder
Braeburn has requested final approval from the FDA of the NDA for BRIXADI weekly and monthly ... read more »

FDA Announces Alert of Amneal, Impax Epinephrine Auto-Injector Malfunctions
FDA is alerting patients, caregivers and health care professionals to immediately inspect certain ... read more »

Junshi, Merck Collaborate on Head, Neck Cancer Treatment in China
Junshi Biosciences and Merck announced their collaboration on a clinical trial program designed to ... read more »

	Featured Articles

Seeking the Golden Mean: Optimizing Your QRM Program If you were tasked with assessing your Quality Risk Management (QRM) program, would you find ... read more »

Continuous Manufacturing of Lyophilized Products: Why and How to Make it Happen This paper deals with the problem of continuous lyophilization of pharmaceutical products, focusing ... read more »

	Featured Video

On-Demand Webinar: Identifying & Mitigating Errors in Organic Extractables & Leachables Screening
In this webinar, you'll learn the risks of omission, inexact identification, and inaccurate and imprecise quantitation in chromatographic screening ... watch »

On-Demand Webinar: Validation Guidance for Residual Host Cell DNA Testing of Biologics
In this webinar, you'll learn the components of a method validation per ICH Q2(R1) in the context of a quantitative polymerase chain reaction (PCR) ... watch »

	Featured Products

BacT/ALERT 3D Microbial Detection System
read more »

i-Raman High Resolution TE Cooled Raman Spectrometer
read more »

	Featured Whitepaper

Why invest in cryo-EM? Design more effective drugs faster
Design more effective drugs faster. Find out your return on investment in our brochure. read more »

Impact of Data Integrity Audits on Pharma Microbial QC Labs
Most people are aware of the requirements of the code of federal regulations 21 CFR Part 11 for computer software security, which have been a major pharmaceutical IT focus for approximately 10 years. read more »

	Events

Amorphous Solid Dispersions by Spray Drying from Bench to Market
Online – 06/30/2020
Amorphous solid dispersions are an established enabling platform for low solubility BCS class II APIs. event details »

Sievers Eclipse BET Platform: A Closer Look at Efficiency Gains, Comparability, and Analytical Results
Online – 07/15/2020
In this webinar, attendees will receive an introduction to the groundbreaking Sievers Eclipse BET Platform to understand why it was created and how it... event details »

This information is being brought to you because you are a subscriber to
American Pharmaceutical Review. To ensure delivery to your inbox,
please add newsletters@americanpharmaceuticalreview.com to your address book.

Manage your Subscription | Unsubscribe | Contact American Pharmaceutical Review

American Pharmaceutical Review
395 Oyster Point Blvd, Suite 300
South San Francisco, CA 94080 USA