Datamonitor Healthcare

Understand Market Access Trends in the US, Europe and Emerging Markets

14 Nov 2022

This essential whitepaper looks at how increased drug spending and a rising desire for expenditure controls are influencing access dynamics across key markets. It is available to you now, for free.

Topic Drug Development Landscape Approvals Drug Review

Medtech Insight

FDA ‘Stands Ready’ To Fight Coronavirus Via Emergency-Use Test Kits While WHO Mulls Virus Spread, Gets Out Guidance

27 Nov 2020

The US Food and Drug Administration (FDA) stands poised to proceed with hastened approvals for 2019-coronavirus (nCoV) diagnostics, treatments and vaccines, if a public health emergency is declared, after an infected US traveler who caught the disease in Wuhan, China returned from the province to Washington State. Spread of the disease has reached a crisis level in China, and the World Health Organization met on 22 and 23 January to consider what actions to take to contain the virus, while issuing an interim laboratory test guidance for use in diagnosing the disease.

Topic Approvals Clinical Trials Coronavirus Policy & Regulation

Medtech Insight

FDA Launches Pilot Program To Streamline EtO Facility, Process Changes

By Ferdous Al-Faruque 27 Nov 2020

As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.

Topic Approvals Compliance Regulation

Medtech Insight

Diagnostics Development For Coronavirus Begins As Second US Patient Tests Positive

27 Nov 2020

Bioresearchers at the Centers for Disease Control and Prevention are hoping that diagnostic platforms previously used to develop tests for outbreaks of other epidemic respiratory diseases, including SARS and MERS, can be built on to develop new diagnostics to detect more cases in the current coronavirus outbreak, US infectious disease authorities say. This comes as more patients are monitored around the US for the disease, and a Chicago woman returning from China tests positive.

Topic Approvals Clinical Trials Coronavirus Policy & Regulation

Pink Sheet

Act Quickly On Converted EU Product Approvals GB Firms Urged

By Ian Schofield 23 Nov 2020

The UK medicines regulator has written to pharmaceutical companies outlining the actions they need to take regarding products with a centralized EU approval that will be converted to Great Britain marketing authorizations next year. 

Topic Pharma-Brexit Brexit Approvals

Medtech Insight

QUOTED. 24 January 2020. Megan McSeveney.

30 Jan 2020

The FDA has readied plans for hastened emergency-use approvals of coronavirus test kits after an infected US citizen returned to Washington State from Wuhan province in China. See what the FDA’s Megan McSeveney said about it here.

Topic Approvals Coronavirus FDA

Scrip

Podcast: Significant Approvals, Diabetes and NASH In India, Japan M&A

By Brian Yang 18 Dec 2019

Join the Asia-based content team for Scrip and the Pink Sheet for their first podcast as they take a look at some of the most significant regional pharma stories of the past few weeks.

Topic Approvals Business Strategies

Topic Cell & Gene Therapy Drug Development Landscape Approvals

Datamonitor Healthcare

Insight into NASH Pricing Strategies

By Hannah Cohen 25 Oct 2019

Explore the key hurdles to anticipating the initial and potential value of the NASH therapy market.

Topic Approvals Business Strategies