Industry News

Supply chain players are eligible to participate in FDA’s pilot program to develop an electronic system for tracking drug products.

PDA survey and conference discussion will generate information to guidance on technology transfer.

The US District Court for the Western District of Pennsylvania entered into a consent decree of permanent injunction against Ranier’s Rx Laboratory Inc., a compounding facility.

Researchers used magnesium particles as tiny motors to deliver an oral vaccine against the bacterial pathogen Staphylococcus aureus.

A study funded by the National Institutes of Health has created a virtual library expected to expand the availability of “make-on-demand” molecules for drug discovery.

The agency recommended six medicines for approval at its January 2019 meeting, including treatments for lung cancer, HIV-1, and autoimmune disorders.

The US Pharmacopeial Convention’s new plan will include new and revised quality standards and activities to support the development of new generic drugs.

New HHS proposal would remove the current safe harbor protection from the federal Anti-Kickback Statute for rebates or discounts provided to Medicare Part D drug plans and certain state Medicaid programs.

Company launches new services dedicated to emerging biotech and biopharma companies.

FDA staffers will be hard-pressed to process and review the wave of new drug application submissions in pre-established timeframes for action.

Merck & Co.’s V920 (rVSV-ZEBOV) vaccine is expected to pave the way for the development of vaccines for emerging infectious disease with unpredictable disease incidence or geography, according to data and analytics company, GlobalData.

The US and pharmerging markets will drive growth in drug spending; number of approvals to increase.

The guidance describes how to develop a REMS Assessment Plan, discusses the impact of REMS on patient access to drugs, and gives recommendations on reporting REMS findings to FDA.

The investigation into the root cause of the NDMA impurity found in API is still ongoing, but the agency believes the impurities may be caused by specific chemicals and reaction conditions in manufacturing processes.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has made two significant changes to its new 2019 Code of Practice with the aim of boosting business integrity on a global scale.

The companies will offer an IT platform that enhances the visibility and performance of the overall personalized medicine treatment process.

The agency revised draft guidance to enable more efficient and successful drug development programs for the treatment or prevention of rare diseases.

The revised guidance aims to strengthen the agency’s global approach to develop new antibacterial medicines.

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) revealed 22 new projects and funding aimed to advance US biopharmaceutical manufacturing.

Researchers at the University of Delaware have made a step forward in gene therapy by engineering microparticles that deliver gene-regulating material to hematopoietic stem and progenitor cells, which live deep in bone marrow and direct the formation of blood cells.

A new gene therapy can turn certain brain glial cells into functioning neurons, which could help repair the brain after a stroke or during neurological disorders like Alzheimer’s or Parkinson’s diseases, according to researchers at Penn State.

The plan details five goals to guide the development of Sentinel, a national electronic system for medical product safety surveillance established as part of the FDA Amendments Act of 2007, over the next five years.

The company is recalling 5 lots of Ceftriaxone for Injection, USP, 250mg; 10 lots of Ceftriaxone for Injection, USP, 500mg; 24 lots of Ceftriaxone for Injection, USP, 1g; and 3 lots of Ceftriaxone for Injection, USP 2g because of the presence of particulate matter in reconstituted vials.

In 2018, the agency authorized 42 drugs with new active substances, three advanced therapies, and 21 orphan drugs.

Drug pricing and reimbursement concerns will continue to hinder industry growth in 2019, according to data and analytics company GlobalData.

FDA sent a warning letter to Skylark CMC Pvt. Ltd. after employees refused to let agency inspectors enter the company’s Ahmedabad, Gujarat, India facility.

Core functions and those funded by fiscal year 2018 user fees are continuing, and 59% of the agency’s staffers are being retained.

The agency sent a warning letter to Roche’s Genetech for marketing unapproved stem cell products and puts other stem cell firms and providers on notice.