Analytics

FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.

Gilead will gain a robust pipeline of cell therapy products, with one lead candidate, a CAR T therapy, anticipated to gain FDA approval in the fourth quarter.

AstraZeneca and Takeda will partner to develop and commercialize MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD).

Steris added the Amsco 430LS and 630LS sterilizers to its line of medium steam sterilizers.

FDA grants priority review for emicizumab, an investigational bispecific monoclonal antibody, for treating hemophilia A with factor VIII inhibitors.

With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

FDA approves new molecular entity developed by Pfizer for treating a rare form of leukemia in adults.

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

The antibody therapeutic failed to meet its primary endpoint in a Phase III study.

The expansion at its Lincolnshire, IL, facility will double the footprint of the site’s range of services, including microbiological evaluation, drug stability studies, and medical devices testing.

The Thermo Scientific Pharma mini implant line is built around the Thermo Scientific Pharma mini HME twin-screw micro compounder.

Artificial intelligence offers a number of opportunities in pharmaceutical drug development and manufacturing, but there are barriers to overcome, notably around how well and how quickly the regulatory environment can adapt and keep pace with to the rapid changes.

The Washington-headquartered biotech firm plans to use the newly purchased facility to produce antibodies for its current and future pipeline.

Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker. 

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.

Amid contentious debate about “fake news,” peer-review papers offer vital, objective insight.

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.

Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.

A sampling of new laboratory equipment showcases streamlined operations.

Catalent expands the scope of the OptiForm Solution Suite to bridge gap from late-stage discovery to Phase I trials.

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

Industry experts discuss how advances in analytical testing tools have helped address challenges in pharmaceutical analysis.

A bathless dissolution tester from Distek operates without a water bath and associated maintenance.

Real-time alternatives to dissolution testing are required for continuous manufacturing to reach mainstream use.

The more pharma science and technology change, the more business and policy concerns stay the same.

Incorporating structural constraints into pharmacokinetic studies of iron sucrose formulations.

Russell Madsen, president, The Williamsburg Group, and member of the Pharmaceutical Technology editorial advisory board, shares his thoughts on technology innovations and regulatory implications.