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FDA publishes the final Q3D Elemental Impurities guidance.

The Biosimilars Forum argues that the assignment of a unique Healthcare Common Procedure Coding System (HCPCS) for each biosimilar product is in alignment with the intent of Congress.

The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.

The agency releases guidance on the nonclinical evaluation of endocrine-related drug toxicity.

The agency releases guidance on good review practice for formal dispute resolution in regards to appeals.

  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?

The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.

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

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

The Pre-Connect Congress will explore pharma industry trends, such as mergers and acquisitions, the biologics market outlook, and innovation in drug delivery among others.

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