News

  The European Medical Contract Manufacturing (EMCM) organization announced it will team up with VCC Medical NV for a unique personalized medicine initiative-the aseptic manufacture of a biologic therapeutic from the tissue of a patient’s tumor.

  Sandoz announced on Sept. 3, 2015 that despite the barriers erected by competitor Amgen, Sandoz officially launched Zarxio (filgrastim-sndz), its biologic version of Amgen’s neutropenia medication Neupogen (filgrastim). To complement the drug launch, Sandoz is also launching Sandoz One Source, a patient services center providing support for and information on the medication.

Reuters reports that Novo Nordisk will invest 500 million Danish Krone (approximately $75 million US dollars) into a new 19,000 m2 warehouse in Hillerød, Denmark. The warehouse will handle all inbound raw materials for Novo Nordisk's production in Denmark and will have a capacity of around 17,000 pallets of product, according to the news outlet.

The investigational monoclonal antibody targets interleukin-17 and is in clinical trials for the treatment of plaque psoriasis.

The platform, developed by Vectron Biosolutions, will be used for BI’s in-house pipeline and for its outsourcing clients.

The collaborative effort will be focused on fully humanized antibodies.

Under the terms of the agreement, Sartorius Stedim Biotech will manufacture membrane adsorber technologies for GE, which will be marketed as part of GE’s ReadyToProcess product offerings.

UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

When should CMOs and their pharma clients share the details of their partnerships with outside parties?

Adents’ Pharma Suite serialization software features track-and-trace capabilities.

Pharma scientists announced for AAPS executive council and section leadership positions.

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

The drug was the first PCSK9 inhibitor approved in Europe and the second approved in the US.

GSK announces plan to divest its rights in ofatumumab for auto-immune indications for up to $1 billion.

The TRUST project will focus on the process development of Col-Treg, which is TxCell’s autologous collagen type II specific Treg immunotherapy product for the treatment of autoimmune uveitis.

WuXi's Laboratory Testing Division will be the exclusive supplier of laboratory testing services for Hong Kong-based Lee's Pharm.

The company announced plans to begin PIONEER, a Phase IIIa program comprising seven trials of approximately 8000 people with type 2 diabetes.

Merus announced new investors and the sale of $80.5 million in shares to advance its immuno-oncology programs.

The new company, Immatics US, will develop autologous and allogeneic adoptive cellular therapies for various types of tumors based on novel immunotherapy targets.

Pfizer agrees to divest four sterile injectable assets to clear the way to complete acquisition of Hospira.

Shire requests a technical transfer from Sanquin to widen its manufacturer base for the production of Cinryze.

Cytovance Biologics anticipates continued expansion plans following acquisition by Hepalink USA

The acquisition will give IDT Biologika access to the veterinary vaccines market.

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.

Biopharmaceutical company BeiGene plans to build facility in Suzhou to expand its clinical capability and prepare for commercial manufacturing.

The acquisition occurs one day after FDA approval of Sprout’s Addyi, the first medication to treat hypoactive sexual desire disorder in women.