News

Under a global strategic partnership, Siemens will become GSK’s preferred supplier of manufacturing automation, focusing on process control, equipment control, and building management systems.

Lannett Company agreed to purchase Kremers Urban Pharmaceuticals, the US specialty generic-pharmaceuticals subsidiary of global biopharmaceuticals company UCB S.A., for $1.23 billion.

Mumbai-based Cipla agreed to acquire US companies InvaGen and Exelan, giving Cipla US tablet and capsule production capacity, a more diversified portfolio, and market access.

Aragen Bioscience has licensed ProteoNic Biotechnology’s 2G UNic recombinant protein production technology, which increases manufacturing efficiency and reduces cost of goods for recombinant biologicals.

FDA warns that compounded or repackaged drugs stored in certain syringes made by Becton-Dickinson may lose potency because of an interaction with the rubber stopper.

FDA publishes the final Q3D Elemental Impurities guidance.

This agreement is a follow-on to an established collaboration between LobSor and Recipharm for the development and the manufacturing of Lecigon batches for the recently completed clinical trial.

Tuzistra XR for cough relief is said to be the only twice-daily, extended-release codeine-based cough and cold syrup available in the US.

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

The partners will collaborate on a project to capture and integrate clinical trial data metrics on investigational cancer medications.

Pfizer closes the acquisition of Hospira, adding sterile injectables business to portfolio.

After many legal proceedings surrounding the first FDA-approved biosimilar, Zarxio officially launched commercially on Sept. 3, 2015.

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

The collaborative effort will be focused on fully humanized antibodies.

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

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.

Label Vision Systems (LVS) will be fully integrated into Microscan and the LVS name will become a brand within Microscan’s barcode label verification portfolio.

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

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

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

United Cargo signs global rental agreement with va-Q-tec for controlled transport of pharmaceuticals.

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.

Novo Nordisk plans to invest approximately $2 billion over the next five years in new production facilities in Clayton, North Carolina, US and Måløv, Denmark. The facilities are expected to be operational during 2020.

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

Shimadzu Scientific Instruments reports its EDX-7000/8000 spectrometers are compliant with electronic signature regulations.

Mayne Pharma plans to double oral-dose manufacturing space and expand contract services.

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