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You are here: Home > Opinion & analysis

Opinion & analysis


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  • Amarin CEO Thero On Gearing Up For Success Ahead Of The Big Vascepa Ad Comm

    $131.00

    Speaking with Scrip recently, Amarin CEO, John Thero talked about the upcoming US advisory committee meeting for Vascepa and commercial expansion plans and deflected questions about a big pharma buyout. What he did say was that, “We’re planning for success.

    September 2, 2019
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  • Schakowsky’s Loaded Cosmetics Bill Described as ‘Floor, Not a Ceiling’ for States to Build On

    $200.00

    The Safe Cosmetics and Personal Care Products Act reintroduced to the US House of Representatives calls for greater duties and resource demands on companies and the FDA than the proposed Personal Care Act in the Senate and allows room for states to impose more stringent regulations.

    September 2, 2019
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  • A Hangover Is A Disease, German Court Rules

    $131.00

    Alcohol-related hangovers are genuine illnesses according to a recent ruling by a high-level German court. HBW looks at the case against a German wellness manufacturer for health claims made for its “anti-hangover” supplements and how deeming hangover’s a disease affects the outcome of the case.

    September 2, 2019
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  • Serious Skin Reactions Reported with Ibuprofen Use in Europe

    $131.00

    The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee advises ibuprofen manufacturers to add warnings on patient information leaflets concerning acute generalized exanthematous pustulosis associated with use of the drug. HBW provides details about the skin reaction being noted and the informational changes required.

    September 2, 2019
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  • Anti-Aging Cosmetics Or Unlawfully Marketed Drugs? Two Federal Court Cases To Watch

    $131.00

    Skin-firming and anti-wrinkle claims on products marketed as cosmetics are being tested in California federal course. The results will have considerable implications on the health, beauty and wellness industry. HBW looks at similarities and differences of the two cases.

    September 2, 2019
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  • Testing Ranitidine with Too Much Heat Could Generate NDMA, FDA Say

    $131.00

    The US Food and Drug Administration says reports of high levels of N-nitrosodimethylamine in the histamine-2 blocker ranitidine resulted from a third-party laboratory’s use of the incorrect test for the drug treatment. HBW covers the recommended testing method.

    September 2, 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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  • The Case For Agile Innovation In Health Care

    $131.00

    According to a recent Bain & Company survey, while nearly 80% of health care executives said they needed to be more agile, more than half said they were not familiar with formal agile methodologies and tools and were not using them in their companies.

    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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  • Can Novartis Reclaim Pioneering Role In Transplantation?

    $131.00

    Novartis is developing a new type of immunosuppressive agent, an anti-CD40 monoclonal antibody, which might allow organ transplants to last longer in recipients, reduce pressure on transplant waiting lists, and improve long-term outcomes. In Vivo interviewed Novartis’ Head of Immunology, Hepatology and Dermatology.

    September 2, 2019
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  • Defying FDA: Shanghai Lab Gets Warning Letter But Won’t Relent

    $131.00

    A Shanghai testing laboratory has been handed an FDA warning letter for refusing a GMP inspection but told the agency it rightfully did so. Pink Sheet shares the exact working of the FDA letter as well as the highly unusual response from the laboratory.

    September 2, 2019
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  • Nitrosamine Episode Could Lead To Paradigm Shift In Quality

    $131.00

    The detection of cancer-causing impurities in drugs with well-established safety profiles may call for regulators across the globe to revise their approach for evaluating quality. Pink Sheet looks at whether or not companies seem to know their own products.

    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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  • EMA under Pressure again as Staff Losses Worsen

    $131.00

    Higher than expected staff losses at the European Medicines Agency due to the relocations to Amsterdam are posing challenges to implement new EU legislation. While the planned move to a permanent HQ in the Dutch capital has led to a decrease in staff, the agency is having to further prioritize its business activities.

    September 2, 2019
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