Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

Health Sector On High Alert As Wuhan Coronavirus Spreads

The latest figures from China's National Health Commission show infections of the new Wuhan coronavirus are continuing to pile up, spreading to more cities in the country and abroad as travel for the Lunar New Year festival goes into high gear. Meanwhile, the Chinese government maintains that the situation is “preventable and controllable.”

Topic China infectious-diseases policy-and-regulation Coronavirus

In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース

From US To EU: Young Biotechs Going It Alone

Europe’s patchwork of reimbursement agencies make it a daunting place for a small US biotech to do business. Traditionally large pharma partners or CMSOs have provided an experienced hand to hold, but as a new wave of gene therapies and orphan drugs get the EMA green light, smaller drug developers are applying innovation to commercialization and choosing to go solo.

Topic Market Access Rare Diseases Strategy

Medtech Insight: 世界の医療機器・医療技術の最新情報

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 1)

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this first installment of a 10-part series, a procedure for hosting inspections is addressed.

Topic Compliance fda

Medtech Insight: 世界の医療機器・医療技術の最新情報

CES 2020: Panel Discusses Health Care In 2040 – Empowered Consumer, Digital Transformation, Data Sharing, Open Source

An expert panel at CES 2020 discussed Deloitte's vision for health care in 2040, with the empowered consumer managing their own health, enabled by a new ecosystem of secure, open access to data and "nudges" to change behaviors. Consulting firm Deloitte foresees outside disruptors dismantling the traditional health-care system, but panelists from Johnson & Johnson and Anthem flexed their muscles.

Topic business-strategies digital-health

Generics Bulletin: ジェネリック＆バイオシミラーニュース

California Plans To Create Own Generics Label

California’s 2020-2021 fiscal budget includes plans to work with manufacturers to establish the state’s own generics label. But industry is sceptical that the initiative will deliver the savings that the US state hopes for.

Topic Legislation policy-and-regulation

Generics Bulletin: ジェネリック＆バイオシミラーニュース

Biocon Biologics Gets True North Investment

Private equity group True North continues to back the Biocon group and is picking up a minority stake in Biocon Biologics in a deal that values the subsidiary at $3bn. Separately, another subsidiary, Biocon Biosphere, has also been set up as part of efforts to unlock the full potential of the business.

Topic deal-trends strategy

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

A Visual Guide To US FDA's Evolutionary Decade In Review

An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.

Topic fda policy-and-regulation

In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース

A Tale Of Two Pipelines

Immuno-oncology has produced some exciting successes, but the field has become intensely crowded. Enormous resources are being poured into duplicative work and shaky hypotheses—overshadowing other pursuits in cancer research while producing limited results. It is time to re-evaluate how the sector should be pursuing innovation in cancer and how it can be smarter in its use of resources—financial investment, talent, bandwidth, patients and data.

Topic Cancer Research & Development