The merged companies will provide histopathology services in the research and pre-clinical therapeutics markets.

A new facility in California will expand Orchard Therapeutic’s capacity to develop and deliver lentiviral vector and gene-corrected hematopoetic stem cells.

FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.

The $62-billion acquisition of Shire by Takeda Pharmaceutical was approved by both sets of shareholders.

New FDA guidance developed to identify lapses in data integrity and promote best practices.

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

TrendMiner 2018.R2 software for analysis of time-series data includes the ContextHub platform for expanded, self-service analytics capabilities.

AqVida, winner of the 2018 CPhI Excellence in Pharma Award for manufacturing technology and equipment, identifies advantages of robotics compared to conventional automation in fill/finish operations.

The SafeGuard Preventative Maintenance Solution from PSG’s Griswold provides remote monitoring for a centrifugal pump and its motor.

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).

The UK's government has revealed the details of the second Life Sciences sector deal, forming part of the Industrial Strategy.

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.