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The agency’s CHMP recommended conditional marketing authorization for the hormone replacement therapy for the treatment of chronic hypoparathyroidism.

The industry is becoming more consolidated, but there needs to be some strategy behind the mergers and acquisitions.

Under the agreement, Abzena will manufacture magacizumab, an antibody created using the ‘Abzena inside’ Composite Human Antibody technology.

The trends in the year 2017 will present the industry with new challenges, and companies will be able to meet them successfully if they focus on the issues at hand.

The new commercial site, set to be located in Cambridge, Boston, MA, will serve clients on both the East and West Coast. It will also be the base for reaching new customers in the area.

Improved process analytical technology and new ways of thinking seek to enhance measurement and control for next-generation pharmaceutical manufacturing.

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

Soft sensors are powerful tools that can be used along with spectroscopic instruments in on-line measurement.

Aurobindo has added four cell-culture derived biosimilars to its product line.

The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.

EvaluatePharma and BioPharm International highlight the antibody-based therapeutics that may gain United States Regulatory approval in 2017.

Dr. Reddy’s has expanded its commercial operations in Europe with the introduction of its range of generic drugs in France.

Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.

This three-year partnership will explore and identify new tools and methods to modify and optimize the Chinese hamster ovary (CHO) cell line performance.

The investment will be used to advance Nemaura’s R&D programs, which include liquid vaccines that have been reformulated for administration through the skin using its micropatch drug delivery technology.

According to results from the FOURIER trial, Repatha significantly reduced the risk of cardiovascular events and death in patients with atherosclerotic cardiovascular disease.

Pump systems must be designed to meet the needs of specific processes, including preventing cross-contamination and damage due to shear forces.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.

This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved.

Alexandre Juillerat, PhD, innovation senior scientist at Cellectis, discusses novel construct UCART123, an investigational agent that is on deck to be the first gene-edited T-cell product in the United States.

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

ADMA will acquire BPC’s plasma-based fractionation and purification plant in Boca Raton, FL and plans to resolve issues at the facility noted in an FDA warning letter.

SGS invested in test equipment for analyzing extractables and leachables at its New Jersey laboratory.

Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.

Researchers from Cellectis investigate how external signals in the tumor microenvironment could control the cell-surface expression and specificity of engineered CARs.

Merck will pay a one-time fee of $625 million and additional royalties to BMS and Ono Pharmaceutical to settle the patent infringement case related to Keytruda.

Camfil Air Pollution Control has expanded its testing laboratory and added a dust collection test rig for the ANSI dust collection standard.

EAG Laboratories offers dermal absorption studies using OECD methods.

Researchers were not able to replicate all of the findings in five highly-cited cancer biology papers.

In a blog post, Robert Califf and Rita Nalubola discuss the agency’s approach to the use of genome-edited products.