News

FDA approved Dupixent for the treatment of atopic dermatitis amidst a preemptive lawsuit filed by Sanofi/Regeneron involving the drug and an Amgen patent covering IL-4 inhibitors.

The Mobius MyWay portfolio offers off-the-shelf and configured-to-order single-use assemblies.

The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.

A new report states that wider access to new antivirals for HCV and better screening of patients would help avert 90,000 deaths by 2030.

The company has signed two separate agreements with the Agency for Science, Technology, and Research (A*STAR) and the Nanyang Technological University (NTU) to progress its therapeutic stem cell pipeline.

Manufacturers and regulators are working to reach consensus on the harmonization of management of postapproval changes.

Permira will acquire LSNE, a CDMO for the pharmaceutical and medical device markets.

The Basel office will house the clinical development team and other functions to progress the company’s lead compound emapalumab.

The agency recommended six drugs for approval in March 2017 including treatments for neuroblastoma, heart failure, and more.

FDA approved avelumab for the treatment of patients with Merkel cell carcinoma.

The company said it plans to expand diabetes manufacturing facilities in the United States.

The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.

Sanofi and Regeneron are asking a federal court to issue a judgment of non-infringement for Amgen’s ‘487 patent.

Will new generic drugs bring the cost of medicines down in the way policy makers hope?

In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.

FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.

The two pharmacopeias signed a Memorandum of Understanding as recognition of their collaboration for developing international science-based standards.

The company has invested in a new pharmaceutical chemistry and microbiology facility in Scotland.

The companies will be expanding their collaboration to discover novel therapies that will include up to eight additional targets using CytomX’s proprietary Probody platform.

Richard D. Braatz, PhD, will discuss using mathematical models to design a continuous drug manufacturing plant and the differences between batch and continuous operations for biologics.

Caladrius is selling the remaining percentage of the subsidiary in order to focus on cell therapy development.

The company announced that it would now be offering a portfolio of fresh and cryopreserved human and animal hepatocytes for ADME-Tox testing.

The company said that it has successfully completed its first in-orbit experiment using its miniature end-to-end space laboratory.

Human antibody for Zika virus could help in the treatment and prevention of the infection.

The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.

Transparency between pharmaceutical companies and suppliers and risk assessment efforts are vital to effective supply chain practices.

Under the agreement, Allergan will receive exclusive access to five of Editas’ ocular programs.

Trump’s choice for FDA commissioner faces drug pricing, regulatory, and approval challenges.