The Gold Cone X-Flo Filter Cartridge from Camfil APC stays cleaner and lasts longer than conventional pleated filters.

The company is investing approximately $14 million to expand biologics packaging capabilities and capacity at its biologics manufacturing facility in Bloomington, IN.

The company will use GE Healthcare’s off-the-shelf KUBio biologics factory, which is expected to start operations in 2020, to provide development and manufacturing for early- to late-clinical and early-commercial manufacturing stages.

FDA has approved Truxima (rituximab-abbs), a biosimilar to Roche’s anti-cancer biologic, Rituxan (rituximab).

The companies aim to advance research into inflammatory bowel disease.

GSK and TESARO have entered into a definitive agreement concerning GSK's acquisition of TESARO for an aggregate cash consideration worth approximately $5.1 billion.

The EMA has published a revision to its guideline on the environmental risk assessment of human medicines.

NICE has recommended the use of regorafenib as a treatment for NHS patients with advanced liver cancer, following consideration of a new commercial arrangement.

Novartis has announced that the European Commission has approved Gilenya (fingolimod) as a treatment for children and adolescents (10–17 years) with relapsing-remitting forms of multiple sclerosis (RRMS).

Shire has announced that the European Commission has granted marketing authorisation for Takhzyro (lanadelumab) subcutaneous injection.

AbbVie will grant Pfizer license to launch a biosimilar to AbbVie’s Humira worldwide.

The proposal from the Centers for Medicare and Medicaid Services (CMS) proposes to give plans more flexibility to limit coverage of certain drugs.

Kimberly-Clark Professional added the Kimtech A5 Sterile Integrated Hood and Mask XL for head shapes, sizes, and hairstyles that pose a challenge to standard aseptic gowning for cleanroom operators.

Bio/pharma companies cannot spell success without solving all elements of quality programs.

Taking stock on the ‘big-ticket’ news items, both good and bad, from the past 12 months.

EMA’s relocation to Amsterdam and resulting staff losses could severely weaken the agency’s role as a leading medicines regulator.

Owner of Immuno Biotech, David Noakes, has been sentenced to 15 months in prison over charges of manufacturing, selling, and supplying an unlicensed medicine, as well as money laundering.

In a strategic move to strengthen its core life science businesses, Bayer announces 900 R&D and 350 manufacturing job cuts.

Contract development and manufacturing organization (CDMO), Yposkesi, has entered into an agreement in principle with Axovant Sciences.

Five additional European Union member states have been confirmed by the US Food and Drug Administration (FDA) as capable of performing good manufacturing practice inspections at a level equivalent to that of the United Sates

The acquisition will give Genentech full rights to Jecure’s preclinical portfolio of NLRP3 inhibitors.

The investment builds on a collaboration the companies entered into in 2007 for various biomanufacturing projects.

Charles River Laboratories has announced a data expansion in its compendium of tumor models for oncology drug R&D.

A new, high-throughput microplate reader cuts down on screening time and works faster than standard ultra-high-performance liquid chromatography processes.

The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.

The contract research organization has increased its US-based early phase clinical capacity and doubled its specialty lab space.

Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.

GE’s new facility, which will be operational in 2019, will produce a fiber-based chromatography platform for more efficient biopharmaceutical purification.