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Webinar Recording: Pharma R&D Review: What Changed In 2018, What To Look Out For In 2019

15 Jun 2022

April 17, 2019,  Pharma R&D Review: What Changed In 2018, What To Look Out For In 2019

Topic drug-approval research

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 drug-approval clinical-trials Coronavirus policy-and-regulation

FDA Launches Pilot Program To Streamline EtO Facility, Process Changes

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 drug-approval Compliance Regulation

Diagnostics Development For Coronavirus Begins As Second US Patient Tests Positive

By Sue Darcey 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

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 drug-approval

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 drug-approval Coronavirus fda

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

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 drug-approval business-strategies

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

08 Nov 2019

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

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 drug-approval drug-review

Webinar: Outlook for NASH Therapies and Market Dynamics

By Joseph Haas 04 Nov 2019

Non-alcoholic steatohepatitis (NASH) is poised to become an even greater epidemic and pharma companies of all sizes are competing to be the first to bring a NASH drug to market. Listen to an in-depth discussion about new and repurposed drug exploration treat NASH, as well as deal making, licensing and partnerships activity for the area.

Topic cell-and-gene-therapy drug-development-landscape drug-approval

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