American Pharmaceutical News In Review

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January 21, 2019

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[Download Infographic] Extractables and Leachables Decoded

Extractables and leachables from drug packaging pose a significant risk and thus are part of the regulatory approval for new drug applications. Learn about the distinct testing and analysis strategies, conditions for contamination, contamination sources and more in this side-by-side comparison.

	Industry News

FDA Approves Modification to Clozapine REMS Program
The FDA approved a modification to the Clozapine Risk Evaluation and Mitigation Strategy (REMS) ... read more »

PhRMA Welcomes Genentech and Gilead Sciences to Association
The PhRMA announced Genentech, a member of the Roche Group, and Gilead Sciences have joined the ... read more »

Spectrum Pharmaceuticals Sells Marketed Portfolio to Acrotech Biopharma
Spectrum Pharmaceuticals has entered into a definitive agreement to sell its portfolio of seven FDA-... read more »

Aerpio Announces Completion of Patient Dosing in AKB-9778 Study
Aerpio announced the completion of patient dosing in the TIME-2b study to assess the efficacy and ... read more »

Sandoz launches SYMJEPI in the US
Sandoz announced the US market introduction of SYMJEPI (epinephrine) 0.3 mg Injection for the ... read more »

Terns Pharmaceuticals Announces the Appointment of Chief Medical Officer
Terns Pharmaceuticals announced the appointment of Erin Quirk, M.D. as Chief Medical Officer (CMO). read more »

	Featured Articles

Digital Transformation in Pharma Sector Heralds Era of Smarter Care Artificial intelligence, automation, blockchain and other technologies driving digital ... read more »

A Novel Downstream Monoclonal Antibody Purification Template to Address the BPOG Biomanufacturing Technology Roadmap The release of the BioPhorum Operations Group (BPOG) Biomanufacturing Technology Roadmap1 in July ... read more »

	Featured Video

Watch Video: Azbil BioVigilant Enabling the Clean Facility of the Future with Instantaneous Microbial Detection
Water is utilized abundantly to process, formulate, and manufacture pharmaceutical products. Traditional culture-based methods used to ensure water ... read more »

Watch Poster Video: How to Develop an Amorphous Solid Dispersion in Tablets with Less than 30 g API
In this poster video, João Henriques discusses How to Develop an Amorphous Solid Dispersion in Tablets with Less than 30 g API read more »

	Featured Products

TruCLEAN Pro Cleaning & Disinfecting System
read more »

Parteck LUB STA 50 Vegetable Grade Stearic Acid 50
read more »

	Featured Whitepaper

The Use of Advanced pH, Time or Microbial-Dependent Oral Drug Delivery Technologies for Precise Release in the Colon
The colon has emerged as an optimal site for the oral delivery of drugs targeting inflammatory bowel diseases (IBDs) including Ulcerative Colitis (UC), Crohn’s disease (CD), Amebiosis or colonic ... read more »

Detailed Formulation Development Helps Avoid Production Problems
Developing a robust tablet formulation is always a challenge. Formulators and research professionals alike must have an empirical methodology to characterize the properties of neat materials and ... read more »

	Events

CPhI South East Asia
Bangkok, Thailand – 03/12/2019
CPhI South East Asia strengthens ASEAN integration by opening Thailand edition in 2019 In 2019, CPhI South East Asia will take place at the Queen ... event details »

Changing a Paradigm: Implementing a Real Time Microbial Detection Analyzer in Pharmaceutical Water
Online – 03/14/2019
This presentation will cover the challenges associated with implementing an OWBA unit online, provide results from a benchtop comparability study and ... event details »

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