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Pink Sheet
By Sue Sutter 18 Feb 2020
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
By Bowman Cox 18 Feb 2020
Just as they did during the heparin crisis a decade ago, pharmaceutical companies must coordinate on coronavirus, Rx-360 CEO says.
Pink Sheet
By Bridget Silverman 18 Feb 2020
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.
Pink Sheet
By Derrick Gingery 18 Feb 2020
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.
Pink Sheet
By Brian Yang 18 Feb 2020
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
By Ian Schofield 18 Feb 2020
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
By Jessica Merrill 17 Feb 2020
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
By Kevin Grogan 17 Feb 2020
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
By Penelope MacRae 17 Feb 2020
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
Medtech Insight
By Shawn M. Schmitt 17 Feb 2020
In a late Friday news statement, agency head Stephen Hahn also warned of possible “shortages of critical medical products” The US agency has suspended all routine surveillance inspections in China through the end of March because of coronavirus fears, commissioner Stephen Hahn announced late on 14 February. Despite expecting medical product shortages, Hahn said the agency is being proactive: “We are not waiting for drug and device manufacturers to report shortages to us” before acting. The timing of Hahn’s statement – at 6 p.m. EST on a Friday, at the beginning of a three-day US holiday weekend – suggests he isn’t particularly excited to share the information.
Topic Coronavirus
In Vivo
By William Masters 17 Feb 2020
Lyon, France-based Novadiscovery is developing a user-facing technology to run in silico studies, a method it expects to cut development costs and improve trial success rates. But acceptance of “new” data types is often a concern for drug developers, despite world-leading regulatory bodies stating their desire for 21st century approaches.
Topic BioPharmaceutical
Pink Sheet
By Brenda Sandburg 17 Feb 2020
Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).
Skipta
13 Feb 2020
Understanding the intricacies of pharma marketing can be tough, but Skipta has you covered. A leading social network of specialized online medical communities for over 700,000 verified healthcare professionals, Skipta can pinpoint and connect you to your exact targets – quickly and easily.
Skipta
13 Feb 2020
Healthcare professionals are notoriously hard to reach with new product messaging. Skipta makes it easier. A social network for verified physicians, Skipta communities are segmented by area of expertise or disease state. Use Skipta to create custom, targeted campaigns to reach your audience when they’re most ready to engage.
Scrip
07 Feb 2020
Go inside the 2020 J.P. Morgan Healthcare Conference with exclusive reporting from Scrip. Explore the most important news from each day, and access exclusive, real-time interviews with pharma and biotech movers and shakers, and discover insights into the trends revealed at this year’s event.
Medtech Insight
26 Feb 2020
Pink Sheet
26 Feb 2020
Generics Bulletin
26 Feb 2020
Medtech Insight
26 Feb 2020
Generics Bulletin
26 Feb 2020
Scrip
26 Feb 2020
Medtech Insight
26 Feb 2020
Scrip
25 Feb 2020
Generics Bulletin
25 Feb 2020
Medtech Insight
25 Feb 2020
Medtech Insight
25 Feb 2020
Pink Sheet
25 Feb 2020
Pink Sheet
25 Feb 2020
Scrip
25 Feb 2020
Generics Bulletin
25 Feb 2020
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