Pharmaceutical Technology Editors

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.

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.

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.

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

Catalent will expand primary packaging capabilities and commission an automated, high-speed bottling line for clinical packaging of capsules and tablets.

Cobra, Pall, and Cell and Gene Therapy Catapult are collaborating to develop continuous manufacturing for gene therapy production.

The new center will integrate biologics drug discovery, development, clinical manufacturing, and commercial manufacturing.

The agency has approved two new chemical entities, Daurismo (glasdegib) from Pfizer, and Vitrakvi (larotrectinib) from Loxo Oncology, for treating cancers.

FDA has issued a warning letter to Mylan citing GMP violations of finished pharmaceutical products manufactured at the company’s Morgantown, WV, facility.

ADC Biotechnology will invest downstream formulation, fill/finish capabilities, and Lock-Release conjugation technology.

The University of South Australia is working to develop needle-free vaccines for Zika, chikingunya, and peanut allergy in a collaboration with Australian biotechnology company Sementis and Enesi Pharma, a United Kingdom-based pharmaceutical company.

A coalition group from the UK's health sector has called on both the UK and EU to ensure the protection of patients and public health when considering the future relationship of the regions post-Brexit.

IRBM has extended its collaboration with CHDI Foundation to progress the development of therapeutics for Huntington's disease.

GSK has filed for a sBLA to FDA for the expansion of the indication of Nucala to include paediatric patients between 6 and 11 years old.