Bio/Pharma News

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.

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

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.

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.

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

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.

Allergan issued a voluntary nationwide recall in the US of specific lots of ophthalmic ointment after customers complained of black particles, which came from the cap.

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

Mylan received a warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.

GSK reports no employee injuries at the facility and is assessing damage.

The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.

Licenses could potentially bring antibody R&D to areas beyond oncology, such as diabetes treatments.

The expansion will enable relocation of its North American headquarters from Grayslake, Illinois.

Following a divestiture of certain assets in Europe, the acquisition of Sigma-Aldrich by Merck KGaA will be complete.

The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.

Deal includes rights to Inovio’s INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates.

Flexion will have a dedicated manufacturing suite at Patheon's Swindon, England facility for Flexion's osteoarthritis steroid drug product.

US generics manufacturer Amneal acquires a former J&J plant in Ireland.

The agreement gives Merck a non-exclusive license to use Codexis’ proprietary CodeEvolver protein engineering platform technology to develop novel enzymes for use in the manufacture of Merck’s pharmaceutical products.

The acquisition strengthens Shire’s ophthalmics portfolio.

Shire takes its offer for an all-stock transaction to combine with Baxalta to shareholders after Baxalta declines to discuss the proposal.

Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.

Lupin acquires businesses in Germany, the US, Russia, Brazil, and South Africa.

ARGX-110-based combination therapies have demonstrated potential in treatment-resistant cancers.