The companies aim to develop a potential zinc finger protein transcription factor-based gene therapy for treating Lou Gehrig’s disease.

The companies aim to discover and develop locked nucleic acid oligonucleotides as orally available therapies for treating inflammatory bowel diseases.

A single-use DPI from Perlen Packaging, which offers lower-cost production and a more affordable device for emerging markets, won a 2017 CPhI Pharma Award.

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.

FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.

The company is voluntarily recalling product because of glass particles found in vials.

The companies will collaborate on the development of vaccines to expand GeoVax’s cancer immunotherapy program.

The IFPAC annual meeting on advancing the understanding and control of manufacturing processes using process analytical technology will be held Feb. 11-14, 2018.

The contract manufacturing company has completed construction on a new aseptic fill/finish facility in Wuxi, China.

PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance.

Bio/pharma professionals manage expectations amid industry uncertainty.

Will business decisions and drug pricing policies help or hinder science and drug approval advances in 2018?

Brexit-related challenges cast shadows on prospects for the European bio/pharma market in 2018, but optimism may let some sun shine through.

The companies have entered an agreement involving assay development and the manufacturing of kits supporting biomarker research programs.

The biotechnology company has filed for FDA approval of a new plasma manufacturing facility in Covington, GA, to support its immunology franchise.

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.

Mallinckrodt has agreed to acquire biopharmaceutical company Sucampo Pharmaceuticals for $18 per share, or a transaction value of approximately $1.2 billion.

Roche has agreed to acquire Ignyta, an oncology company specializing in precision medicines, in an all-cash transaction valued at $1.7 billion.

New tax legislation may result in savings for biopharma companies.

The company is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial because of glass particles found in a vial.

FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.

FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.

MilliporeSigma will collaborate with IPS and G-CON to offer end-to-end, turnkey, modular MAb manufacturing.

BioTek Instruments has released a second edition of its BioSpa software that now offers users a simplified but effective interface for kinetic imaging or detection workflows.

Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, have filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.