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.

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.

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.