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BioPharm International
January 03, 2019
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Top BioPharm International News Stories of 2018

Novartis Has Production Hiccup for Kymriah CAR-T Therapy

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.
/ read more /


FDA Issues CRLs to Celltrion for Two Biosimlars

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.
/ read more /


AstraZeneca to Create Independent Biotech Spin-Off

The pharma major will spin out six molecules in early stage inflammation and autoimmune programs into a new company called Viela Bio.
/ read more /


Sanofi to Acquire Biogen Spin-Off in $11.6-Billion Deal

The acquisition would boost Sanofi's position in hematology and specialty medicines.
/ read more /


Amgen to Build Next-Generation Biomanufacturing Plant

The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.
/ read more /


Roche Completes $1.9-Billion Acquisition of Flatiron Health

The acquisition is expected to accelerate progress towards personalized cancer healthcare.
/ read more /

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Takeda Acquires TiGenix

Stem-cell developer TiGenix has been acquired by Takeda Pharmaceutical for approximately EUR 520 million (US$604 million).
/ read more /


FDA Approves First-of-its-Kind RNA Therapy

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.
/ read more /


Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With

President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.
/ read more /


Novartis' AveXis to Invest $55 Million in New Gene Therapy Manufacturing Facility

The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.
/ read more /


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Top BioPharm International Feature Stories of 2018

Using Direct Transition Analysis in Chromatography

The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).
/ read more /


Industry Adoption of Single-Use Systems Remains Low

Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.
/ read more /


Evolving UF/DF Capabilities

Advances in TFF and single-use systems help advance UF/DF on the continuous processing path.
/ read more /


Impurity Testing of Biologic Drug Products

Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
/ read more /


FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies

More consistent and reliable production processes are critical for advancing innovative treatments.
/ read more /

Making the Move to Continuous Chromatography

Early adopters are benefiting from lower costs and increased productivity.
/ read more /


Wearable Injection Devices Address Delivery Challenges

Advances in wearable devices have made it possible to deliver high-volume, high-viscosity biologics.
/ read more /


Putting Viral Clearance Capabilities to the Test

Process understanding and careful assessment of risks are essential in developing viral clearance programs.
/ read more /


Identifying and Controlling CPPs and CMAs

Statistical methods to identify critical process parameters and critical material attributes–and approaches to control them–are needed to protect drug product and drug substances.
/ read more /


Stability Testing Ensures Proper Packaging for Drug Storage

Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.
/ read more /


UPCOMING WEBCAST

Understanding Absolute Stoichiometry of Oligomeric Protein Complexes using SEC-MALS
Tuesday, January 29, 2019 at 11am EST| 8am PST| 4pm GMT| 5pm CET
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ON DEMAND WEBCASTS

Optimizing SEC for Analysis of Antibodies and Antibody–Drug Conjugates
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Screen Hundreds of N-Glycans per Day: More Samples – Better Decisions – Faster
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Events

Pharmaceutical Microbiology UK 2019

January 21–23, 2019

Pharmapack

February 6–7, 2019

IFPAC Annual Meeting

March 3–6, 2019

more events

eBook

Biopharma Laboratory Best Practices 2018 eBook

This eBook covers method development, analytical techniques, and profiles of new instruments, equipment, and supplies used in the testing and analysis of raw materials, drug substances, and drug products.

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