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In Vivo’s Quick Guide To Gene Therapy

$131.00

In Vivo looks at how gene therapies have gone from being just implausible science fiction premises, to becoming clinical realities taking an ever-larger portion of pharma R&D attention. This article covers how gene therapies work, where the field has been and where it’s going.
September 19, 2019
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GSK’s Hal Barron On R&D Progress At TwoYear Mark

$131.00

Hal Barron, Chief scientific officer at GSK recently spoke about winning the hearts and minds of 10,000 R&D employees and adopting practices from acquired company, Tesaro. In Vivo covers the talk topics including how doubters are coming around amid recent successful approvals
September 2, 2019
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Roche: We’ve Abandoned Budgets And It’s Liberated Employees

$131.00

Imagine what would happen if a huge corporation abandoned the core competency of controlling its multi-million-dollar budgets and accelerating processes across R&D and commercial divisions. Would it survive? Would it actually thrive? In Vivo talks to one CEO who knows.
September 2, 2019
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MorphoSys: A European Champion Crossing The Biopharma Rubicon

$200.00

MorphoSys, out of Munich, is one of a handful of mature European biotech companies appearing ready for greatness. In Vivo spoke with the CEO about the firm’s next generation antibody platform and why US expansion is crucial to its future.
September 2, 2019
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Countdown To Transition: US FDA Says 91 Drugs Will Become Biologics In March 2020

$131.00

A Pink Sheet infographic shows how insulins account for the largest category of transition products, with 27 NDAs that will be deemed BLAs in six months as the FDA is addressing the transition of authorized generic insulins to regulation under the PHS act.
September 2, 2019
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Made In China Gene Therapy A Father’s Quest To Save Son With UltraRare Condition

$131.00

China has the potential to be the world’s largest market for rare disease treatments but may need to develop their own gene therapies as imported products will be too costly. Read about a father’s journey to find a gene therapy to treat his young son’s rare condition.
August 5, 2019
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Two More EU Notified Bodies But Not On Nando Yet

$131.00

Nando has registered two new EU notified bodies as of August 2019, though the European Commission has said four notified bodies have been designated. Nando’s tardiness in updating their databases is affecting companies that need their medical products tested, especially given the huge volume of products compared to the number of notified bodies available.
August 2, 2019
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Farxiga Data Change Heart Failure Treatment Outlook

$200.00

AstraZeneca’s Farxiga (dapagliflozin) appears set to become new standard or care in the treatment of hear failure based on results of the DAPA-HF Phase III trial present at the European Society of Cardiology Congress on 1 September. Scrip looks at Farxiga and its nearest competitors.
August 2, 2019
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US FDA Looks To Standardize Premarketing Safety Assessments

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A US Food and Drug Administration initiative to standardize safety assessments of new drug and biologic applications could mean changes in how sponsors classify clinical trial adverse events and the types of information companies routinely submit to the agency.
August 2, 2019
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US FDA’s Office Of New Drugs Reorganization Approved, But Not Happening Overnight

$200.00

After more than two years of work, the US Food and Drug Administration is ready to formally begin its reorganization of the Office of New Drugs. Pink Sheet covers how this could cause signatory authority and other changes for sponsors with pending applications.
August 2, 2019
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European Commission Highlights Medtech Notified Bodies Giving It Cause For Concern

$131.00

With higher standards and new, demanding regulations for EU notified bodies, six notified bodies have been called into question by the European Commission. All are listed with warnings on the Commission’s Nando database. Some of those six offer testing in other medtech directives, and in those other directives, they remain competent.
August 2, 2019
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Breakthrough Designation Rescissions: Who Might US FDA Drop Next?

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Several drugs recently lost their Breakthrough Therapy Designations (BTDs), and Pink Sheet has identified others in the pipeline that might suffer the same fate soon. Take a look at the therapies possibly on the chopping block and the reasons behind it in this informative article.
March 10, 2019
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EMA Issues Guidance On Medical Devices That Are Integral To Pharma Products

$131.00

With its first issue of guidance for the EU Medical Devices Regulation (MDR), the European Medicines Agency has focused on products that contain an “integral medical device” component, such as pre-filled syringes. Find out more about the guidance here.
March 5, 2019
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AbbVie’s Skyrizi Poised To Enter Packed Psoriasis Market

$200.00

AbbeVie is banking on the success of a possible simultaneous European/US launch of Skyrizi, its psoriasis drug, to bolster the company’s declining revenues in Europe. Read about how the company plans to use Skyrizi to bounce back from the genericization of its blockbuster Humira in this informative article.
March 4, 2019
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Eudamed – A Moving Target But On Track For March 2020 Partial Go-Live

$131.00

In a recent update of the European Commission’s Rolling Plan, the Commission noted that while Eudamed, the EU’s databank on medical devices, is due to go live in March of 2020, some essential portions of the database may experience a delay in availability.
March 1, 2019
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