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Pink Sheet

US Researchers Working Toward Universal Coronavirus Vaccine

By Sue Sutter 18 Feb 2020

Coronavirus Vaccine

The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.

Pink Sheet

Coronavirus Supply Chain Threats Demand Coordinated Industry Response

By Bowman Cox 18 Feb 2020

Emergency Agency Meeting

Just as they did during the heparin crisis a decade ago, pharmaceutical companies must coordinate on coronavirus, Rx-360 CEO says.

Pink Sheet

Coronavirus Efforts Could Benefit From Little-Used Medical Countermeasures Incentives

By Bridget Silverman 18 Feb 2020

Coronavirus Efforts Could Benefit From Little-Used Medical Countermeasures Incentives

US FDA’s Medical Countermeasures Initiative authorities like emergency use authorization have not yet had much of an impact on drugs and biologics, but agency is committed to supporting a swift response to the new strain of coronavirus.

Topic Infectious Diseases Vaccines Coronavirus

Pink Sheet

For Coronavirus US FDA Is At The Podium But Not On The Task Force

By Derrick Gingery 18 Feb 2020

Hahn speaks at Coronavirus briefing

The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.

Topic FDA Vaccines Infectious Diseases Coronavirus

Pink Sheet

Stress Test: Coronavirus Challenges China Emergency Approval Mechanism

By Brian Yang 18 Feb 2020

Beijing_returntowork

72 Products Approved Under Expanded Emergency Pathway A regulatory pathway set up in China post-SARS is under stress test in the latest coronavirus outbreak, while emergency measures adopted by the country's regulator mean it’s much less burdensome to obtain approvals than before.

Pink Sheet

UK Firms Asked To Check Coronavirus Supply Chain Impact

By Ian Schofield 18 Feb 2020

Supply

Authorities Also Investing In Vaccines And Tests Amid concerns that the coronavirus outbreak could have an impact on the supply of APIs and other materials sourced from Chinese manufacturers, pharmaceutical companies are to assess their supply chain situation to help ensure patients do not experience medicine shortages.

Scrip

A Positive Outlook For Deals, With Election Year Caveats

By Jessica Merrill 17 Feb 2020

Vote

Industry advisers at the BIO CEO & Investor meeting remained optimistic about the pharmaceutical deal environment in 2020 – even with the uncertainty around a looming US election year.

Topic BioPharmaceutical

Scrip

Another Alzheimer's Setback As Roche And Lilly Drugs Fail

By Kevin Grogan 17 Feb 2020

Alzheimers_Cell

As Biogen moves to file its controversial amyloid drug aducanumab for approval in the US, two similar investigational Alzheimer's drugs – Eli Lilly's solanezumab and Roche's gantenerumab – did not slow memory loss or cognitive decline in a rare, inherited form of the disease.

Topic Alzheimer's Disease

Generics Bulletin

Sun Finds US ‘Challenging’

By Penelope MacRae 17 Feb 2020

Flags_USA_India

Sun Pharma’s Indian domestic operations posted strong sales in the third quarter, but this was not enough to prevent the company from reporting a 26% tumble in consolidated net profit in the face of a “challenging” US generics market and slow approvals for complex products.

Topic Deal trends

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