News

Univercells, a business-to-business provider focused on biologics, has commercially launched its proprietary bioproduction system, NevoLine.

Cell and gene therapy platform company, Locate Bio, has announced that it is set to receive key patents for its IntraStem technology covering the United States and Europe

A strategic collaboration has been formed between 4D pharma and The University of Texas MD Anderson Cancer Center.

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The agency revised draft guidance to enable more efficient and successful drug development programs for the treatment or prevention of rare diseases.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 agreement gives Sanofi access to Biomunex’s proprietary bi- and multi-specific-antibody-generating platform.

Industry investment and regulatory support combined to move many important new medicines to market.

Sanofi’s Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis [Tdap] vaccine adsorbed) is approved for a repeat dose in people 10 through 64 years of age, 8 years or more after the first vaccination.

The company is set to expand biologics and fill/finish capacity at its biologics manufacturing sites in Madison, WI, and Bloomington, IN.

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 companies will collaborate to improve the manufacturability for two of Sanofi’s biotherapeutics.

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.

Agenus will leverage Selexis’ SUREtechnology Platform to progress Agenus’ portfolio of next-generation antibody programs.

Fujifilm increases capacity of its Bio-CDMO business with an expansion of production in North Carolina.

The $8-billion acquisition will broaden Lilly's oncology portfolio in precision medicines and treatments that target cancers caused by specific gene abnormalities.

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.

The companies entered a license agreement for the Trianni Mouse, a transgenic mouse R&D platform for the discovery of fully-human monoclonal antibodies (mAbs), to support MacroGenics’ discovery programs for mAb-based therapeutics.

A new plasma B cell antibody discovery workflow launched by Berkeley Lights enables the shortening of antibody drug discovery from month to a day.

The new reagents are designed to support clinical-phase and commercialization stages of cell and gene therapy production and to enhance DNA transfection.

The companies will work together to discover and develop new treatments for neurological conditions such as Alzheimer’s and Parkinson’s disease.

The partnership provides Sarepta with capacity and manufacturing slots for GMP-grade plasmid production for its micro-dystrophin Duchenne muscular dystrophy gene therapy program, as well as plasmid capacity for future gene therapy programs.

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.

The Massachusetts site, formerly associated with an affiliate of Shire, is Rentschler Biopharma’s first facility in the US.

AbbVie and immunotherapy company Tizona Therapeutics will join forces to develop and commercialize CD39-targeted therapeutics to treat cancer.