American Pharmaceutical News In Review

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August 13, 2020

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	Industry News

FDA Revokes EUA for Autobio Diagnostics' Anti-SARS-CoV-2 Rapid Test
The FDA revoked the EUA of the Autobio Diagnostics' Anti-SARS-CoV-2 Rapid Tests. read more »

PTC Therapeutics Announces FDA Approval of Evrysdi for Spinal Muscular Atrophy
PTC announced the FDA has approved Evrysdi for spinal muscular atrophy in adults and children 2 ... read more »

Enlivex Announces First Patient Dosed in Allocetra Trial for COVID-19 with Respiratory Failure
Enlivex announced the first patient has been dosed in an investigator-initiated multi-center ... read more »

FDA Approves BLENREP
The FDA approved BLENREP for relapsed or refractory multiple myeloma who have received at least 4 ... read more »

Precigen ActoBio Announces Positive Topline Results from Type 1 Diabetes Treatment Study
Precigen ActoBio has met the primary endpoint assessing safety and tolerability in the monotherapy ... read more »

FDA Posts Additional Postmarket Information for Essure
On April 24, 2020, the FDA granted, in part, Bayer’s request for a variance from some medical device... read more »

	Featured Articles

Advanced Therapy Medicinal Products - Regenerative Medicine: ‘Mom Are We There Yet?’ Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, ... read more »

Fluidity Versus Certainty in Early Small Molecule CMC Development The transition of a drug from optimized medicinal chemistry lead to candidate nomination and ... read more »

	Infographic

Top 5 Secrets to a Successful Cleaning Validation Program
Here are five ways to ensure a successful and compliant cleaning validation program. read more »

	Featured Video

Making Data Work Leveraging Data for Better Outcomes
Data collection has been a common practice for years in the pharmaceutical industry. But with the explosion of devices and technologies to acquire ... watch »

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 »

	Featured Products

Gemini HPLC Columns
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BD Select BD Cell Hybridoma MAb Medium - Quantum Yield
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	Featured Whitepaper

Content Uniformity Measurement of an OTC Product Using a Dedicated Sample Preparation Station and a Fiber Optic UV Analysis System
Content uniformity (CU) is performed using a wide range of techniques for sample preparation and analysis. read more »

Cryo-EM accelerates drug discovery by delivering previously intractable structural insights
Cryo-electron microscopy (cryo-EM), a powerful biophysical technique that can analyse molecular assemblies, is changing the paradigm in structure-based drug design. As targets become more challenging,... read more »

	Events

CPhI Japan
Osaka, Japan – 09/30/2020
CPhI Japan is the ideal business platform for international pharma professionals to join in order to grow business in the rapidly changing Japanese ... event details »

Pre-Filled Syringes East Coast 2020
Virtual – 10/26/2020
SMi Group are proud to announce the 7th Pre-Filled Syringes East Coast conference returning to Boston, USA on 27th-28th April 2020. The global pre-... event details »

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